Medical Design & Outsourcing - MEDICAL DEVICE HANDBOOK - Dec. 2015

DECEMBER 2015

www.medicaldesignandoutsourcing.com


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From the operating room to the manufacturing fl oor, Bimba offers a variety of pneumatic, electric and fl uid control solutions to help you tackle your medical device applications. Whether you are designing a new system or improving an existing one, learn more about how our investment in medical device components can support your medical device needs at bimba.com/medical.

FLUID AND MOTION CONTROL COMPONENTS TO BRING YOUR DEVICE TO LIFE.

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STANDARD AND CUSTOM MANIFOLDS

Multiple connection manifolds provide a convenient junction point for the distribution of fl uids or gases.

FITTINGS

Corrosion resistant stainless steel barbed and push-to-connect style fi ttings available in a wide variety of shapes and sizes for virtually any application.

SOLENOID OPERATED VALVES

Single or double solenoid operations internally piloted for high fl ow and lower power consumption.

PINCH VALVES

Designed for disposable tubing to maintain sterility, each pinch valve is calibrated for pinch force, pinch gap and stroke to ensure optimal performance.

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E D I T O R I A L S T A F F

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EDITORIAL

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4 Medical Design & Outsourcing 12 • 2015


JUNE 2015 www.medicaldesignandoutsourcing.com

PREMIERISSUE

It’s a sellers’ market at all levels of the medtech industry

CONSOLIDATION NATION:

IS THERE AN UNSERVED MARKET FOR DEVICES IN PSYCHIATRY? Jan Svarka, CEO of medical device maker Tal Medical, thinks so.

STRUCTURES THAT DISSOLVE

MATERIALS THAT ARE

CHANGING MEDICINE

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SEPTEMBER 2015www.medicaldesignandoutsourcing.com

E X C L U S I V E : I n s i d e t h e B o s t o n S c i e n t i f i c t u r n a r o u n d w i t h C E O M i k e M a h o n e y

BIG1OOMEDTECH'S 100 LARGEST PLAYERS

• The Top Medical Device Employers• R&D: Who's Spending the Most?• The Year Medtech M&A Exploded• CEO Moves: Who's In & Out of the Corner Office• Medtech's Global Hotspots• Ones to Watch: Medtech's Up-and-Comers

Cover_SEPTEMBER 2015_Vs7.indd 1 9/15/15 2:45 PM

DECEMBER 2015



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HOW DO I KNOWIF I’M TALKING TO AN ENGINEER OR A SALESMAN?

THE ENGINEER’S CHOICE™

Ask Smalley. We have nothing against sales people. But when it comes to differentiating Inconel from Elgiloy or overcoming dimensional variations within a complex assembly, wouldn’t you rather work with an engineer?

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6 Medical Design & Outsourcing 12 • 2015 www.medicaldesignandoutsourcing.com

HERE’S WHAT WE SEE

Welcome to the first edition of Medical Design & Outsourcing’s annual medical

device compendium.

The medical device category covers a wide range of products, from 3D printing to design services, such as product development. Add in the myriad components and materials used to make each device, and you’re looking at thousands of different products used to assemble these life-improving – and often life-saving – devices.

We’ve attempted to assemble a guideline covering some of the more important product categories used to design and manufacture medical devices. Whether you’re coming to this handbook as a seasoned veteran,

looking for a refresher on a particular topic or component, or you’re new to the industry, we’ve got you covered.

We especially appreciate feedback from our audience and always welcome more. Please let us know how we’re doing as we look for ways to improve. Is there something we’ve missed? Do you want more detail, or less? You’re welcome to send any feedback directly to me at [email protected], Founding Editor Paul Dvorak at [email protected], or Managing Editor Nic Abraham at [email protected].

Also follow us on twitter at @MedTechDaily. And don’t forget to check in at MedicalDesignandOutsourcing.com, along with at our sister site, MassDevice.com, for the latest news on the business of building medical devices. M

B r a d P e r r i e l l o | E x e c u t i v e E d i t o r |

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CONTENTS medicaldesignandoutsourcing.com ∞ December 2015 ∞ Vol.1 No.3

INSIDEthe medical device handbook

06

WELCOME TO THE FIRST EDITIONof Medical Design & Outsourcing’s annual medical device compendium

10

RAPID MANUFACTURING 3D printing, automation, prototyping

14

MATERIALSPlating, PTFE, adhesives, nitinol, high-performance polymers, lamination, metalizing

20

CATHETERSBalloon, stents, guidewire

24

MACHININGStamping, CNC, laser, grinding, EDM, ultrasonic welding

28

MOLDINGHigh-performance plastics, silicone, dip, injection molding, rubber, synthetic lubricants

34

MANUFACTURINGContract, single-use, electromechanical devices, minimally invasive devices, ratcheting, disposable devices, metal joining, heat treating, electropolishing

41

DESIGN SERVICES

42

MOTION CONTROL COMPONENTSMotion controllers, AC motors, brushless motors, gearmotors, electric motors, linear motion

50

LINEAR MOTIONLinear motors, actuators, ball screws, leadscrews

54

FLUID POWER COMPONENTSValves, seals, pumps

58

NEEDLES & SYRINGES

60

ELECTRICAL / ELECTRONIC COMPONENTSBattery, connectors, sensors, cables & cable assembly

69

STERILIZATION SERVICESSteam, EO, gamma & E-beam, nitrogen dioxide, plasma

72

TUBINGHoses, reinforced, bump, paratubing, radiopaque

74

VALIDATION & TESTING

76

AD INDEX

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RAPID MANUFACTURING

3D printing, or additive manufacturing, is the process of making three-dimensional solid objects from a digital file. This contrasts to subtractive processes, such as the NC machining of traditional manufacturing, in which material is removed rather than being added.

An object is made in an additive manner by depositing successive layers of material until the entire object is built. Each layer can be visualized as a thinly sliced horizontal cross-section of the eventual object.

It all starts with a digital or virtual design of the object you want to create, made with a 3D modeling program or by using a 3D scanner to copy an existing, usually hand-sculpted object. The 3D scanner makes a 3D digital copy of the

object that is used as the template for 3D printing.From prosthetics to teeth to heart valves, the

tech brings custom designs into operating rooms and doctors’ offices. Hospitals and researchers are

experimenting with 3D printers in hopes of printing human tissue and organs. M

What is 3D printing?

What is automation?

Automation is the use of equipment in a system of manufacturing or other production process that needs minimal human intervention. Automation can also be the use of a machine designed to follow a predetermined sequence of individual operations. M

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ADDITIVE MANUFACTURING

CNC MACHINING

INJECTION MOLDING

2016 COOL PARTS CALENDARRequest your free calendar atgo.protolabs.com/DWM5MCISO 9001:2008 Certified | ITAR Registered Major Credit Cards Accepted | © 2015 Proto Labs, Inc.

Rapid Manufacturing That’s a Real LifesaverTech-driven injection molding, CNC machining and

3D printing for those who need parts tomorrow

Proto Labs is the world’s fastest source for on-demand, low-volume manufacturing. We make quick-turn prototypes

and production parts including device handles, housings, strain reliefs and other components used in the medical industry.

Got a project? Get 1 to 10,000+ plastic, metal or liquid silicone rubber parts in 1 to 15 days.

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RAPID MANUFACTURING

Prototyping is the process of building a model or early working version of a product. A prototype is an original type, form, or instance of something serving as an example, basis or standard for other things of the same category.

What is prototyping?

Advantages • Reduces development time and

costs• Requires user involvement• Gives developers quantifiable

feedback• Facilitates device

implementation because users know what to expect

• Results in higher user satisfaction

• Reveals potential future device enhancements

Disadvantages• May lead to insufficient analysis• Lets users expect the

performance of the final device to equal the prototype

• Developers can become too attached to their prototypes

• May cause devices to be left unfinished or implemented before they are ready

• Sometimes leads to incomplete documentation

• May require too much time M

Electronics • Controls • Medical Components • General Applications • Precision Tolerance • Virtually Flash-free Parts • Rubber to Metal • Rubber to PlasticDiaphragms With +/– .0015” Tolerance • Custom Compounding • Prototype Tooling Designed to be Incorporated Into Multi-cavity Production Tooling

Injection - Compression - Transfer - LIM • ISO 9001:2008 • Class 10,000 Cleanroom • ITAR RegisteredUSA 918.258.9386 • Europe 49.251.32266.0 • Singapore 65.6264.1880 • EMail - [email protected] • ©2009 DaPro Rubber, Inc. All rights reserved.

UNSURPASSED QUALITY IN PRECISION, CUSTOM ELASTOMER MOLDING FOR RUBBER, PLASTICS AND TPE. With over 40 years experience, superior capabilities and unmatched service, even the smallest detailed component is no big deal for Da/Pro. Call today for more information. Or visit us online at www.daprorubber.com.

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Leader in Advanced Material Technologies21-90-3320-50

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China: +86-512 6273 2700U.S.: 952-927-1400


Precision Molded Medical Components and Assemblies For a project evaluation call : 952-927-1400.

Email requests to [email protected] our complete literature and design guide at mnrubber.com/medical2

Every day at Minnesota Rubber and Plastics we produce high tolerance medical components and assemblies for the most demanding applications. Our experience in advanced material formulation enables us to be compliant with FDA, ISO 10993 andISO 13485 to meet your unique product requirements. Our over 60 year history in the design and manufacture

of complex devices makes us the preferred partner for industry leaders throughout the world. The next time your component or assembly project seems impossible, there’s no one better to partner with than Minnesota Rubber and Plastics. We’ll make your tough application a reality.

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MATERIALS

Nitinol is a metal alloy of nickel and titanium with unique properties, including superelasticity or pseudoelasticity and “shape memory” properties. That means nitinol can remember its original shape and return to it when heated. It also shows great elasticity under stress.

Medical applications for nitinol include:

What is nitinol and where is it used?

• Dentistry, especially in orthodontics for wires and brackets that connect the teeth. “Sure Smile” dental braces are an example of its application in orthodontics.

• Endodontics, mainly during root canals for cleaning and shaping root canals.

• In colorectal surgery, the material is used in various devices for reconnecting the intestine after a pathology is removed.

• Stents.• Orthopedic implants.• Wires for marking and locating breast tumors.• Tubing for a range of medical applications. M

What are high-performance polymers?

High-performance polymers are hard-wearing plastics with a thermal resistance >150°C. A few examples include:

• PEEK - Polyetheretherketon • PES - Polyethersulfon • PI - Polyimide M

Metalizing is a process that deposits a thin metallic film on the surface of a non-metallic object. Metalizing is a common coating process used to improve resistance to corrosion, wear, and fatigue.

Common metalization processes include:

• Diffusion • Vacuum • Contact • Galvanic • Thermal metal spraying• Fire M

What is metalizing?

Materials_Vs6-BP.indd 14 11/24/15 10:51 AM

Building a better future means innovation and finding new ways tosolve product design challenges. Extruded aluminum is already a partof many of the most exciting advances in healthcare. Aluminum givestoday’s design engineers the ability to develop parts and productswhich are strong, lightweight, and easier to produce and machine.

With complete engineering and design assistance plus full fabricationcapabilities at multiple locations across North America and the globe,Sapa can provide finished components for all of your needs.

Contact us for more about Sapa and designing with aluminum!

Advanced Aluminum Solutions for Medical Device Development

Sapa Extrusions North America

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MATERIALS

What is plating?

Plating is a manufacturing process in which a thin layer of metal coats a substrate. This is done through electroplating, which requires an electric current, or through electroless plating, an autocatalytic chemical process. The benefits of both techniques include:

• Reduced friction• Improved corrosion

resistance• Enhanced paint

adhesion• Increased

magnetism• Decorative appeal• Increased

solderability• Enhanced strength• Altered

conductivity M

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Stainless Steel Machine Components

J.W. Winco, Inc. offers stainless steel parts for industry with very high corrosion resistance, hygienic properties, and the ultimate in material quality. Pictured is just a sampling of our products.

Explore our full line at www.jwwinco.com or contact us with your application requirements.

What is PTFE?What is lamination?

Polytetrafluoroethylene (PTFE) is a synthetic fluoropolymer of tetrafluoroethylene with numerous applications. The best known brand name of PTFE-based formulas is Teflon by DuPont, which discovered the compound. It is a strong, tough, waxy, and nonflammable synthetic resin produced by the polymerization of tetrafluoroethylene. PTFE is distinguished by its slippery surface, high melting point, and resistance to attack by almost all chemicals. It is used in a variety of products, including vascular grafts used to bypass obstructed blood vessels and grafts used for dialysis access. M

Lamination is the technique of manufacturing a material in multiple layers, so that the composite material is stronger, more stable, and has sound insulation from the use of different materials. A laminate is often permanently assembled by heat, pressure, welding, or adhesives. When an item is given a plastic coating, it becomes tear-proof and waterproof because the laminating film encapsulates the item completely. M

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• Extensive inventory of Tubing, Bar Stock, Hollow Bar, Flanges, Pipe, Fittings

• Cut-to-length stainless tubing

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• Bending and coiling of stainless and other materials

• Redrawing of stainless tubing, rod and bar stock

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The performance leader in fabricated products inStainless Steel, Nickel Alloys, Aluminum, & Titanium

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ask for a copy of the Eagle catalog and

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MATERIALS


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Low volume resistivity USP Class VI approved

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Silver Conductive Epoxy EP21TDCSMedAdhesive for medical electronic assembly

Think. Create. Deliver.

Partner with us today.

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The right partner can take you from concept to market faster. Meet Scapa Healthcare. Our dedicated teams work with you every step of the way, from your earliest concept and product design through manufacturing and delivery. We design for manufacturing, building in process and product validations early on, so we can deliver high-quality products and rapid speed to market.

What are adhesives?

CHARACTERISTIC AVAILABILITY

Chemistries Epoxies, polyurethanes, polyimides , and more

Form Paste, liquid, film, pellets, tape, and more

Activation Hot melt, reactive hot melt, thermosetting, method pressure sensitive, contact, and more

Load-carrying Structural, semi-structural or non-structural capacity

A brief classification of adhesives

Adhesives are materials used to hold two surfaces together. An adhesive must wet the surfaces, adhere to the surfaces, develop strength after it has been applied, and remain stable. The accompanying table classifies adhesives several ways. M

Materials_Vs6-BP.indd 18 11/24/15 1:21 PM

From the moment medical devices went wireless, the risk of cyber attacks became possible, theoretically. But when a diabetic stood on stage at a conference and hacked into his own insulin pump to change its settings, the medical device industry saw the risk become reality.

Though the U.S. Food and Drug Administration has yet to see any reports of patient safety problems from hacked medical devices, a recent Information Week article notes that a U.S. Department of Veteran Affairs study found 173 incidents of medical devices being infected with malware over a two-year period. Moreover, the U.S. Department of Homeland Security has issued a warning that wireless networked medical devices are vulnerable to malicious intrusion and patient data theft.

The risks to patients and the potential liability exposures for medical device businesses posed by hacking come from multiple directions:

• Data theft: Private health information, including medical identification numbers, can be stolen and misused. The incentive is huge. A recent American National Standards Institute report found that data thieves can get $50 for a medical information number compared to only $1 for a Social Security number. The same report noted that in the past two years, 18 million Americans have had their health information breached electronically

• Malicious tampering: Manipulating someone’s defibrillator or insulin pump to cause medical harm may sound like the plot line for a thriller. However, devices with wireless capabilities to download patient data and upload software updates are vulnerable to hackers with malicious intent

• Device malfunction: Even when there is no intent to cause harm, cyber interference with a device’s wireless communications could cause the device to malfunction or report erroneous data, endangering the health of patients

The potential for medical device hacking makes building effective wireless security measures a high priority. It also means that companies need to be concerned about their own potential exposure to liability.

At Travelers, we stay ahead of the curve on emerging risks and evolving threats by tracking developments in the field and monitoring expert opinions on the consequences to our customers. This information helps us shape products – like MedFirstSM – that are designed to protect medical device companies long before they face a claim for damages.

MedFirst addresses cyber vulnerabilities in a coordinated fashion by covering product liability, errors and omissions (E&O) liability, and information security liability.

• Products/Completed Operations Liability – coverage for damages because of bodily injury or property damage included in the products-completed operations hazard, which includes bodily injury arising out of your work for a clinical trial

• Errors & Omissions Liability – coverage for consequential or compensatory damages because of economic loss that arises out of your work and caused by an error, omission or negligent act

• Information Security Liability – coverage for failure to prevent unauthorized access to, or use of, personal identity information or protected health information of others

Medical device companies have a vital interest in protecting patients – but they also need to protect themselves. With MedFirst, companies can be confident that they have the right coverage, even in a wireless world.

Patty Nichols Underwriting Director – Medical Technology Travelers

Device hacking – a new risk for medical device companies

travelers.com

The Travelers Indemnity Company and its property casualty affiliates. One Tower Square, Hartford, CT 06183

This material does not amend, or otherwise affect, the provisions or coverages of any insurance policy or bond issued by Travelers. It is not a representation that coverage does or does not exist for any particular claim or loss under any such policy or bond. Coverage depends on the facts and circumstances involved in the claim or loss, all applicable policy or bond provisions and any applicable law. Availability of coverage referenced in this document can depend on underwriting qualifications and state regulations.

© 2015 The Travelers Indemnity Company. All rights reserved. Travelers, the ‘Travelers & Umbrella’ logo, and ‘Umbrella’ logo are registered trademarks of The Travelers Indemnity Company in the U.S. and other countries. CP-7678 Rev. 9-15

A D V E R T I S E M E N T

Travelers 11-15.indd 1 11/24/15 10:53 AM

CATHETERS


What is a catheter?

A balloon catheter incorporates a small balloon that may be introduced into a canal, duct, or blood vessel and then inflated to clear an obstruction or dilate a narrowed region to drain body fluids. Drug-coated catheters, a more recent innovation, are designed to deliver anti-restenosis compounds like those used in drug-eluting stents. M

What is a balloon catheter?

Medical catheters are tubes used in healthcare to deliver medications, fluids, or gases to patients, or to drain bodily fluids such as urine. Examples include vascular access devices or intravenous catheters, urinary catheters, and chest drainage tubes.

Catheters are generally inserted into a body cavity, duct, or blood vessel. They may be thin, flexible tubes called soft catheters or thicker and more inflexible catheters called hard catheters. A catheter that may be left in the body, whether temporarily or

permanently, is referred to as an indwelling catheter. M

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CATHETERS

What is a stent?


A stent is a wire mesh tube intended to prop open an artery. When made from stainless steel or nickel-titanium (nitinol), stents are intended to be permanent. More recent stents are made of polymers designed to dissolve over a period of months.

Fatty deposits called plaque can build up in an artery and reduce the flow of blood. When this happens in a coronary artery – one that directs blood from the heart – chest pain or angina can result. A complete blockages of blood flow to a part of the heart muscle results in a heart attack. Stents help keep coronary arteries open, reducing the chance of a heart attack.

To open a narrowed artery, percutaneous coronary intervention or angioplasty may be used. A balloon-tipped

catheter is inserted into an artery and moved to the point of blockage. The balloon is inflated, compressing the plaque to

restore flow. When the opening in the vessel has been widened, the balloon is deflated and the catheter withdrawn.

During manufacturing, stents are collapsed over a balloon catheter. In a placement procedure, the balloon catheter-stent is

moved into the area of blockage. When the balloon is inflated, the stent expands and stays in place when the ballon is deflated and withdrawn,

providing a scaffold to hold the artery open. M

A guidewire is a wire or spring that provides extra strength and stability during catheter placement and exchange during contralateral access (the opposite side of the body on which a particular condition exists) and in carotid procedures involving the two main arteries that carry blood to the head and neck. A guidewire also aids in catheter delivery. M

What is a guidewire catheter?

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How are lasers used in medical manufacturing?

What is grinding?

MACHINING

Medtech manufacturing has become more challenging as more functions and features are added to medical devices. There is a growing need for smaller devices with precise,

high-quality, small features made with techniques beyond those found in traditional manufacturing. Laser processing has been filling this need. Today, lasers routinely

mark, cut, and drill various materials for the production of medical devices.As with most things related to human health, there are stringent

requirements for materials and the methods used to process them. Materials for which laser tools are selected tend to be of high strength, purity, and chemical resistance, often making them difficult to fabricate and process by other means. They also run a gamut of materials, such as:

• Corrosion-resistant and high-strength metals, such as stainless steel and titanium;

• High-strength ceramics such as zirconia and alumina; • A recent class of medical-grade polymers composed of various

TPUs (thermoplastic polyurethanes), polycarbonates and fluoropolymers such as PTFE (Teflon).

Such materials must be extremely pure. In addition, their manufacturing processes, such as drilling and cutting, must be as

clean as possible, leaving behind minimal debris and residue to cut down on costly and time-consuming postprocessing.

Laser tools in medtech manufacturing are dominated by high-average-power CO2 and high-pulse-energy excimer designs. But as medical devices

continue to shrink and become increasingly specialized, leading to lower production volumes, these lasers are proving unsuitable in some cases. M

Grinding, a material removal and surface generation process, shapes and smooths finished components made of metal or other materials.

Grinding employs an abrasive product, usually a rotating wheel, brought into controlled contact with a work surface. The grinding wheel is composed of abrasive grains held together in a binder. These abrasive grains act as cutting tools, removing tiny chips of material from the work piece. M

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Medical Design & Outsourcing 25

What is ultrasonic welding?

Ultrasonic welding is an industrial technique in which high-frequency acoustic vibrations are applied to workpieces held together under pressure to create a solid-state weld. It is mostly used for plastics, and for joining dissimilar materials.

High-frequency vibrations are applied to two parts or layers of material by a vibrating tool, such as a sonotrode or horn. Welding occurs as the result of heat generated at the interface between the parts or surfaces.

This technique is fast, efficient, non-contaminating, and requires no consumables. In addition to welding, ultrasonic processes can be used to insert, stake, stud-weld, degate, and spot-weld thermoplastics as well as seal, slit, and laminate thermoplastic films and fabrics. Ultrasonic components can be easily integrated into automated systems. M

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MACHINING

What is stamping?

Stamping, or pressing or sheet metal fabrication, is the process of placing flat sheet metal in either blank or coil form into a stamping press, where tool and die surfaces form the metal into a net shape. Stamping includes a variety of manufacturing processes, such as punching, using a machine press or stamping press, blanking, embossing, bending, flanging, and coining. Sheet metal is metal formed into thin and flat pieces. It is one of the main materials used in metalworking, and can be cut and bent into many different shapes. M

What is subtractive manufacturing?

Subtractive manufacturing, such as CNC milling and turning, removes material from a block or stock until only the required shape remains.

Computer Numerical Controlled (CNC or just NC for short) machining describes end-to-end component manufacturing that is highly automated, thanks to computer-aided design and

manufacturing programs. A part starts as a digital CAD file, which is converted into the commands and toolpaths needed to produce the part in a particular machining center. These commands dictate

what tools to use and when to use them to cut the features of the required part. M

When it comes to reliability, nothing protects like Parylene.Parylene is the ideal conformal coating for medical devices, implants and surgical tools. SCS Parylenes can be applied to virtually any material to create an ultra-thin, uniform, pinhole-free conformal coating with superior moisture, chemical and dielectric barrier properties. These coatings also provide a low coefficient of friction for applications where lubricity is a concern and they are biocompatible, biostable and sterilizable.

Specialty Coating Systems is the world leader in Parylene coatings for medical applications and offers the most comprehensive FDA Device and Drug Master Files.

Contact SCS today for more information on using Parylene to assure the reliable performance of your medical products.

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SCS 2015 Medical_9X5.25 4C MDE.indd 1 11/17/15 10:34 PMMachining_Vs5-BP.indd 26 11/24/15 1:23 PM

What is EDM?

can be inclined, thus making it possible to make parts with a taper or with different profiles at the top and bottom. There is never a mechanical contact between the electrode and workpiece. The wire is usually made of brass or stratified copper, and is between 0.1mm and 0.3mm in diameter.

Depending on the needed accuracy and surface finish, a part will either be cut once or roughed and skimmed. On a one-cut, the wire ideally passes through a solid part and drops a slug or scrap piece when it is done. This gives adequate accuracy for some jobs, but most of the time, skimming is necessary.

A skim cut passes the wire back over the roughed surface with a lower power setting and low-pressure flush. There can be from one to nine skim passes, depending on the required accuracy and surface finish. Usually two skim passes are needed. A skim pass can remove as much as 0.002 in. of material or as little as 0.0001 in. During roughing, the first cut, water is forced into the cut at high pressure to provide cooling and flush eroded particles as quickly as possible. During skimming, water is gently flowed over the burn so as not to deflect the wire. M

Electric Discharge Machining (EDM), a metal-removal method, works when an electrical spark is created between an electrode and a workpiece. The spark, the visible evidence of the flow of electricity, produces intense heat with temperatures reaching 8,000°C to 12,000°C, melting almost anything. The spark is carefully controlled and localized so that it only affects the surface of the material. The EDM process does not usually affect the heat treatment below the surface. With wire EDM, the spark always takes place in a dielectric of deionized water. The conductivity of the water is carefully controlled, making it an excellent environment for the EDM process. The flow of water also acts as a coolant and flushes away eroded metal particles.

EDM wire cutting uses a metallic wire to cut a programmed and complex contour in a workpiece. Extrusion dies and blanking punches are often machined by wire cutting. Cutting is always through the entire work piece. To start machining, it is first necessary to drill a hole in the workpiece or start from an edge. On the machined area, each discharge creates a small crater in the workpiece and an impact on the tool. The wire

When it comes to reliability, nothing protects like Parylene.Parylene is the ideal conformal coating for medical devices, implants and surgical tools. SCS Parylenes can be applied to virtually any material to create an ultra-thin, uniform, pinhole-free conformal coating with superior moisture, chemical and dielectric barrier properties. These coatings also provide a low coefficient of friction for applications where lubricity is a concern and they are biocompatible, biostable and sterilizable.

Specialty Coating Systems is the world leader in Parylene coatings for medical applications and offers the most comprehensive FDA Device and Drug Master Files.

Contact SCS today for more information on using Parylene to assure the reliable performance of your medical products.

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SCS 2015 Medical_9X5.25 4C MDE.indd 1 11/17/15 10:34 PMMachining_Vs5-BP.indd 27 11/24/15 1:23 PM


What is injection molding?

How are high-performance plastics used in medical devices?

MOLDING

Injection molding makes parts by injecting heated and nearly liquid material (usually plastic) into a mold where it cools and holds a required shape.

Plastic injection molding is a manufacturing process for producing thermoplastic and thermosetting polymer materials. It can be used to produce a variety of parts, from micro-sized components to complete medical devices.

Simple molds can be one-part devices in which a two-part material is poured. Parts required in high quantities and at tight tolerances are made in molds cut from tool steel and polished so that parts can be removed

easily. Prototypes or noncritical parts may be formed in molds cut in aluminum to save time and test ideas. A mold

may have several cavities along with slides and screws that produce relatively complex parts. M

Prior to the development of high-performance plastics, many medical devices were heavier, more expensive, and ultimately less efficient than the equipment used today. Recent plastics and polymers have improved existing technologies, helped create new medical solutions, and are on the cutting edge of future devices.

So common are plastics in the medical industry that their presence in almost every facet of healthcare can easily go unnoticed. Child-proof locking systems for prescription pill bottles, tamper-evident seals, prosthetic limbs, surgical gloves, MRI and X-ray machines, all rely on plastics. Depending on the specific application, there are many different types of plastics created for medical needs. The basic composition for these materials begins with polymers.

Polymers are large macromolecules comprised of repeated subunits called monomers. Monomers chemically bind to each other to create polymer chains that are either linear, branched or cross-linked. In linear polymers, such as polyvinyl chloride (PVC), the molecular structure is a single, extended chain. Branched polymers have extensions or “branches” attached to the molecule chain, but do not connect with separate macromolecules. Branched polymer materials tend to be stiffer than linear polymers.

Cross-linked polymers, or network polymers, also have extensions; the difference is that these branches bond to other polymer chains. The result is a material that is more brittle than the two other chain types, but harder, that doesn’t lose its shape when heated. Thermoset plastics are an example of a cross-linked polymer. These materials are the building blocks of high-performance plastics.

Thermal and radiation stabilizers, tougheners, plasticizers, antistats, and catalysts are just few additives used to optimize plastics for specific uses. M

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RESCUE STORY #2 A client approached MTD with their bioresorbable fastener design seeking a product with minimal inherent viscosity loss and crisper features to improve functionality. While most competitors have difficulty realizing less than a 20% IV loss, MTD developed a superior fastener with an IV loss of less than 4%.

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MOLDING

Synthetic lubricants are artificially created compounds used primarily for reducing friction. In medical device applications, this friction reduction increases mechanical component life, reduces noise, and protects from dust and other external elements. Beyond this, synthetic lubricants can also

act as a crucial component of the precision of a device.Damping grease, a specific type of synthetic lubricant common

in medical devices, is used on nearly all microscopes, telescopes, and zoom lenses to help increase accuracy across the devices’ range of motion. Specifically, damping grease helps eliminate “coasting” (traveling past a set point after a user stops applying force) and backlash, or “play.” The “feel,” or the smoothness and resistance in the range of motion, is determined largely by the shear resistance of the damping grease. Temperature range is also an important consideration for synthetic lubricants.

While this holds true for the focusing mechanisms mentioned above, high-speed applications such as drills require the most attention to temperature ranges.

Dental handpieces, for example, rotate at upwards of 500,000 rpm when polishing or drilling teeth. The turbine that accelerates the rotating element contains a bearing that requires synthetic hydrocarbon oil lubrication. In addition to preventing contaminant damage at the micron level, the oil must also stand up to reuse protocol. Dental handpieces are washed with cleanser, dried, re-lubricated and then sterilized in an autoclave. The high-temperature, high-pressure environment in an autoclave demands specialized oil.

Synthetic lubricants are a broad category. With all of the engineering behind each different type of synthetic lubricant, it’s important to account for the unique elements of each. Different lubricants may have some overlap in performance characteristics, but correct lubrication is largely application-specific. Other medical applications for synthetic lubricants including laser controls, small motors, insulin pens and more. M

What are synthetic lubricants?

What is silicone molding?Injection molding with liquid silicone rubber (LSR) is a process capable of producing durable parts in high volume.

LSR molding is a thermoset process that mixes two components that are heat-cured in the mold using a platinum catalyst. An injection-molding

process is used similar to conventional plastic injection molding, but the material delivery system is cooled while the mold is heated.

LSR parts are considered strong and elastic with exceptional thermal, chemical, and electrical resistance. Their physical properties also maintain at severe temperatures and withstand sterilization. Additionally, the parts are biocompatible and work well for products that come in contact with human tissue. M

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32 Medical Design & Outsourcing

MOLDING

What is dip molding?

What is rubber molding? Rubber molding is a process that creates a useable rubber part. Rubber products are typically made from elastomers or uncured rubber. An elastomer is any material

with sufficient resilience or memory for returning to its original shape in response to pressure or distortions. A wide variety of elastomers and rubber can be derived from natural sources, but are usually synthetic, produced through highly controlled chemical processes. In tasks that require materials to stretch and revert to their original shape, rubber work is about the best.

As another molding method, rubber molding injects a block of rubber into a metal cavity to create parts. The mold is then heated to activate a chemical reaction that will retain the shape of the mold. While there are method variations, the majority of rubber manufacturers use three types of heat and pressure for rubber molding. Those molding methods include rubber injection, compression, and transfer. M

Dip molding is any process in which a mold is dipped into a polymer for the purpose of molding a part. This process is ideal for caps, grips, formed parts,

and more. To begin the process, aluminum or steel mandrels/molds are mounted on a handling rack. The rack is ideal for dipping in a mold-release agent to help remove a part, prior to preheating. The mandrels are then dipped into a plastisol material for a predetermined time. Ready parts are cured, dip-quenched, and stripped off the mandrels. M


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What are disposable devices?

MANUFACTURING

be used because of its flexibility. Reusable devices, on the other hand, are typically made of more costly, sturdier materials such as ceramics or steel.

Disposable-device assembly depends primarily on injection-molded plastic, assembled by bonding, gluing, ultrasonic welding or radio-frequency welding. The high production volume of single-use devices calls for an automated assembly in clean rooms to minimize human contact.

Unlike reusable devices, which are often sterilized at the healthcare facility, disposable devices are sterilized before leaving the manufacturing site. The device and packaging must be designed to accommodate sterilization.

The reprocessing of medical devices labeled for “single use” has been a standard practice in U.S. hospitals for years, because it can cut costs and reduce medical waste. But before medical devices can be reprocessed and reused, a third-party or hospital reprocessor must comply with the same requirements that apply to original equipment manufacturers, according to FDA regulations. M

A disposable device is any medical apparatus intended for one-time or temporary use. Medical and surgical device manufacturers worldwide produce many types of disposable devices.

Examples include hypodermic needles, syringes, applicators, bandages and wraps, drug tests, exam gowns, face masks, gloves, suction catheters, and surgical sponges.

The primary reason for creating disposable devices is infection control. When an item is used only once, it cannot transmit infectious agents to subsequent patients.

One might think the most important factor in the design of single-use products is cost, but disposable medical devices require a careful balance between performance, cost, reliability, materials, and shelf life.

Plastics are often used in the manufacturing of disposables because they are relatively inexpensive and there are many different types. In a device such as a syringe that must undergo extreme pressure, polycarbonates are used because of their strength. PVC can also

Manufacturing_Vs5-BP.indd 34 11/24/15 10:58 AM

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MANUFACTURING

A heat treatment process heats and cools metals to alter their physical and mechanical properties without changing their shape. The process uses

extreme temperatures to achieve the required results. Heat treatment is typically a method for strengthening materials, but it can also change some mechanical properties, such as improved formability and machining. The process is most commonly used in metallurgy, but heat treatment is also used in the manufacture of glass, aluminum, and steel. M

What is heat treating?

What is electropolishing?

Electropolishing is an electrochemical process similar to electroplating, but in reverse.

Electropolishing smooths and streamlines

the microscopic surface of a metal object, such as 304, 316 or 400 series stainless steel. The resulting surface is microscopically featureless, with no torn surface remaining.

In electropolishing, material is removed ion by ion from the surface of the metal being polished. The fundamental principles of electrolysis and electrochemistry replace traditional mechanical finishing techniques, including grinding, milling, blasting, and buffing as the final finish. In basic terms, the metal object to be electropolished is immersed in an electrolyte and subjected to a direct electrical current. The metal object is maintained anodic, with the cathodic connection being made to a nearby metal conductor.

In addition, the polarized surface film is exposed to the combined effects of oxygen gassing. This occurs with the removal of electrochemical metal, saturation of the surface with dissolved metal, and the agitation and temperature of the electrolyte. M

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www.medicaldesignandoutsourcing.com 12 • 2015 Medical Design & Outsourcing 37

What are minimally invasive devices?

What is single-use manufacturing?

Minimally invasive surgery refers to surgical techniques that limit the size of incisions needed, or has a short recovery time. When a medical device is placed within a patient during such a surgery, it is a minimally invasive device. Many procedures involve the use of arthroscopic or laparoscopic devices, and remote-control manipulation of instruments with indirect observation through an endoscope or large display panel. The surgery is usually carried out through the skin or through a small body cavity or anatomical opening and can involve a robot-assisted system. M

• Lower production costs. They reduce capital expenditures and require less facility space. Single-use systems are adaptable to patient-proximity manufacturing, a consideration for epidemic and bioterrorism vaccine deployment.

• Energy reduction. Single-use systems reduce the need for the steam, hot water, ultra-pure water, and chemicals used to clean stainless steel components, and eliminate the need to revalidate conventional equipment. By one estimate, single-use systems use 46% less water and produce 35% less CO2. Researchers also calculate that the total energy consumption of single-use systems is roughly 50% that of stainless steel reactors.

• Improved safety. Single-use systems reduce the possibility of cross contamination while improving sterility assurance.

• Wider supply chain. More qualified vendors are ready to provide timely supply and service of components and systems.

• Speed. Less time is spent in changeovers for batch-to-batch and product-to-product.

In addition, some single-use systems are delivered gamma-sterilized and pre-qualified by the supplier. One online stat says 60% of contract manufacturing companies have begun implementing single-use technology. M

Single-use manufacturing, or more clearly manufacturing single-use devices, emerged about the mid-1980s and stemmed from single-use systems which were gaining wider use in the pharmaceuticals industry, in particular for the production of specialized drugs. Single-use manufacturing now involves the production of relatively complex disposable devices used in surgical procedures such as electrosurgery. Razor blades and their holders are another example. Such devices are usually complex items intended for a single use, as opposed to simple disposables.

If you’ve donated blood, you’ve seen that the PVC blood bags that hold your donation are more than just bags. They are examples of relatively simple single-use products. At first, the bags replaced glass bottles and soon became available with a plastic tube or two, connectors, valves, and vials for taking samples. More complex disposable products are used in systems for specialized or boutique drug production and may include disposable filters, electronics, and sensors.

The alternative to single-use systems, to follow the drug example, would be processes made of relatively inflexible stainless-steel vessels and reactors, hard piping, valves, and so on. Such a fixed system must be cleaned and sterilized, a relatively labor- and energy-intensive operation.

Single-use devices, by one calculation, are more cost-effective and faster to implement. Initial investments are said to be about 40% lower. Other advantages of single-use systems include:

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MANUFACTURING

What do ratcheting devices do on surgical tools?

A ratchet mechanism on a medical tool is a step-locking device. In one application, as the handles of a clamping mechanism are closed, its jaws also close and the ratchet holds them in a locked position. The ratchet consists of a notched bar on each handle, the notches facing and overriding when the handles are closed. M

What methods are used to join materials?

The joining of materials is an important technology in many manufacturing industries. Most products, machines or structures are assembled and fastened

from parts, and the joining of these parts may be achieved through rivets, seaming, clamping, soldering, brazing, welding and the use of adhesives.

With continuing advances in the medical industry, medical devices are becoming increasingly complicated. Such devices are usually comprised of components and materials that must be joined in some way, whether used outside the body, in the case of instruments and surgical tools, or inside the body, for diagnostic or therapeutic purposes.

To create highly reliable devices, one must choose which joining process is appropriate at every step. Many factors influence those choices, from production economics, to mechanical properties such as strength, vibration damping and durability, corrosion or erosion resistance, as well as the ability to correct defects.

Joining processes are typically divided into three categories: Mechanical joining, welding, and adhesive bonding. Medical devices

are manufactured using a variety of materials, from metals to polymers to ceramics, and can be joined using all three methods.

Mechanical joining is a process for joining parts through clamping or fastening using screws, bolts or rivets. Advantages of mechanical joining include

versatility, ease of use, and the option to dismantle the product in cases where regular maintenance requires it. The ability to join dissimilar materials is another

benefit. A drawback of using mechanical joining is the lack of a continuous connection between parts, because the joint is achieved through discrete points. Also, holes created for

joining are vulnerable to fractures and corrosion.Welding includes fusion welding, brazing and soldering, and solid-state welding. In fusion welding, melting

and solidification occur in the zone being joined. For metals and plastics, both the work pieces and the filler material experience melting. Brazing and soldering join materials by adding a melted filler material between the joined surfaces. Solid-state welding requires no melting of base of filler materials, because it only involves plastic deformation and diffusion.

Adhesive bonding joins parts using bonding chemicals. This process may be used to join polymers and polymer-matrix composites, as well as polymer-to-metal, metal-to-metal, and ceramic-to-metal. In this method of joining, joints can withstand shear, tensile and compressive stresses, but do not have good resistance to peeling. M



What is contract manufacturing?

the process is essentially outsourcing production to a partner that privately brands the end product, a number of different business ventures can make use of this arrangement. There are many contract manufacturers in pharmaceuticals, as well as food production, and the creation of computer components and other forms of electronics. Even industries such as personal care and hygiene products, automotive parts, and medical supplies are often produced under the terms of a contract-manufacturing agreement. M

Contract manufacturing is a process that establishes a working agreement between two companies. As part of the agreement, one company custom-produces parts or other materials on behalf of the client. In most cases, the manufacturer also handles ordering and shipment schedules. As a result, the client does not have to maintain manufacturing facilities, purchase raw materials, or hire labor to produce the finished products.

The basic working model used by contract manufacturers translates well into many different industries. Because

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MANUFACTURING

What are electromechanical devices?

Almost any single device with an electrical and mechanical component can be referred to as electromechanical (EM). You might even call an electric motor an electromechanical device, because it turns electricity into rotary (mechanical) motion.

For this discussion, let’s focus on a few examples of simple designs most often used externally for manufacturing medical devices. Also, a controller somewhere in the design governs the functions of the EM device. (A brief Controller section accompanies this discussion.) Presently, few EM devices, other than mechanical hearts or cardiac assist devices, are implantable, but that will change.

A trend in the design of a few EM devices is toward miniaturization, to make them as unobtrusive as possible, either for healthcare setting or as wearable units. Exploring a few examples of EM devices can sketch the landscape of the variations available.

Consider a particular AC-powered electric actuator that operates from 100 to 240 Vac. It comes with positioning electronics (to define the limits of the motion) that are UL Listed, which means that device meets UL safety standards. The actuators combine a brushless servomotor with either rotary or linear (output) actuation and digital position control.

Electromechanical cylinders (although they are not cylindrical) give users control over positioning accuracy, axial thrust, torque, and speed, providing more flexibility to applications that traditionally use hydraulic or pneumatic cylinders. The devices use a precision-rolled, ball-screw actuator that ensures high positioning accuracy and repeatability, and eliminates the stick-slip effect.

To give an idea of what is available from such cylinders, the units from one manufacturer come in six sizes with stroke lengths to 2,000mm and speeds to 1.6 m/s. Each unit is rated to an IP65 level of protection.

As you can imagine, the quality of EM devices spans a range. Those with a rating of IP65 (International Protection) are protected against solids, objects, and water. The 6 indicates protection against dust, while the 5 indicates protection against liquids and low-pressure jets of water from all directions.

A second example of an EM device is a linear-actuator line that includes explosion-proof devices. The linear actuator meets ATEX (EU directives for explosion-proof equipment) requirements for use in potentially explosive atmospheres, such as high-oxygen areas. This type of linear actuator includes a roller screw with a servomotor in a self-contained package, intended for reliable and precise operation over thousands of hours, handling heavy loads – even under arduous conditions. These servo-electromechanical systems are said to offer a clean, fast, simple, and cost-effective alternative to hydraulics and longer life compared to pneumatics.

For a third example, consider the gripper, a device often used with pick-and-place robotic systems. Fingered tooling, or jaws, attach to the grippers to hold an object. They come in a variety of styles and powered designs. Three common types are parallel (two-fingered), three-fingered, and angled designs. The most common are parallel designs, with two fingers that close on a workpiece to grip it, or open out to create contact friction on an inside surface. Three-finger designs hold the workpiece in the center. M


What is product development?

product or its presentation, or developing a brand-new product for niche market segments. Continual product development is necessary for companies striving to keep up with innovation and technology to ensure future profitability and success. M

Product development is the process of designing, creating, and marketing a product. The procedure mainly focuses on developing systematic methods for guiding all the processes involved in getting a cutting-edge product to market.

The product development process can involve improving an existing

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What are motion controllers?

MOTION CONTROL COMPONENTS

A motion controller governs the motion and position of an object on a machine axis. A properly functioning machine also requires motors or fluid-power cylinders for motive power, sensors for judging position and speed, a computer to store and execute rules that govern the motion and other conditions, and a network for taking in sensor signals and outputting command signals. For further discussion of linear guides, motors, and sensors, see the accompanying sections.

Motion controllers are often implemented using computers, but it is also possible to control motion with analog devices. Most medical applications for motion controllers are on manufacturing equipment and patient-assist devices.

A simple and inexpensive controller might be a single-chip microcontroller running a real-time operating system. Windows-based application development software may provide a setup wizard to shorten installation and evaluation time.

This could be appropriate for a simple one- or two-axis medical device. A large manufacturing machine, however, would require something that can handle more inputs, make decisions quickly, and provide appropriate outputs, such as alarms when something goes wrong.

The variety of available controllers is considerable. At the physical level, most motion controllers are stand-alone versions based on PCs, or are microcontrollers built into equipment. Stand-alone controllers are complete systems that include all electronics, power supplies, and external connections which all mount in a physical enclosure.

PC-based controllers can resemble the motherboard of a basic personal computer or a ruggedized industrial PC,

combined with PC-type hardware components and a high-speed, dedicated bus that transmits information to and from the processor.

In addition, the controller interfaces with lab and clean-room devices, and other equipment. Typical I/O includes the electric motor and actuators, as well as discrete sensors, pushbuttons, signaling lights, and mechanical switches for feedback. One big plus for PC-based controllers is that they provide a ready-made graphical user interface for easier programming and tuning.

Another type of controller typically handles simple motion along a few axes. Called a Programmable Logic Controller, it also includes the processor, I/O modules to handle inputs to the processor and outputs to controlled devices, and a user interface. The latter can be anything from a single keypad or a touchscreen, to an Ethernet connection with a PC for more complex programming. No matter its form, the PLC is programmed through the user interface.

I/O modules bring input signals to the PLC’s CPU and output control signals to devices such as electric motors, sensors, and fluid-power valves and actuators.

One key aspect of PLC operation is I/O scanning. The PLC consistently scans through all its inputs, looking for changes, then updates its outputs depending on commands in its programming. This usually takes only a few milliseconds; faster scan times accommodate processes with more real-time demands. M

What are electric motors?

Electric motors can be powered by direct-current (DC) sources, such as batteries, motor vehicles, or rectifiers, or by alternating-current (AC) sources, such as from the power grid, inverters, or generators. Small medical motors are found some active prosthetics and lab equipment. General-purpose motors with highly standardized dimensions and characteristics provide convenient mechanical power for industrial use. The largest of electric motors are used for ship propulsion, pipeline compression, and pumped-storage applications with ratings reaching 100 megawatts. Electric motors may be classified by electric power source type, internal construction, application, type of motion output, and other characteristics. M

An electric motor is an electrical machine that converts electrical energy into mechanical energy. The reverse would be the conversion of mechanical energy into electrical energy – an electric generator.

Most electric motors operate by the interaction between an electric motor's magnetic field and winding currents to generate force within the motor. In certain applications, such as in the transportation industry with traction motors, electric motors can operate in both motoring and generating or braking modes to also produce electrical energy from mechanical energy.

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What are gearmotors?

Gearmotors are motive-force systems consisting of an electric motor and a reduction gear train, combined into one easy-to-mount and configure package. This greatly reduces the complexity and cost of designing and constructing power tools, machines, and appliances calling for high torque at relatively low shaft speeds or rpm. Gearmotors allow the use of economical, low-horsepower motors to provide great motive force at low speed, such as in lifts, winches, medical tables, jacks, and robotics. They can be large enough to lift a building or small enough to drive a tiny clock. M



Motors powered by alternating current are considerably different from those powered by direct current (DC). AC motors come in a variety of designs, but each has two major components: The stator or stationary parts and the rotor or rotating components. The stator is made of sheet-steel laminations. The slotted inner surface holds coil windings that induce the magnetic forces that turn the rotor.

Because brushless AC motors have no commutators or brushes, they require less maintenance than brushed DC motors. DC motors are controlled by varying voltage and current. With AC motors, voltage and frequency (along with the number of magnet poles) control the motor speed.

There are two fundamental types of AC motors: induction and synchronous.

In induction motors, the rotor turns in response to the induction of a rotating magnet field within the stator. The most common design for AC induction motors is the squirrel-cage configuration, consisting of two rings, one at each end of the motor, with bars of aluminum or copper connecting the two ends.

The properties of induction motors make them suited to several medical applications. For instance, they are simple, rugged, and easy to maintain. They also run at constant speed across a range of loads, from zero to full load. Their only drawback is that they are generally not amenable to speed control, although the availability of sophisticated, usually three-phase, variable frequency drives means that even induction

motors can be speed-controlled.

Synchronous motors are so named because they run synchronously with the frequency of the source. The motor speed is fixed and does not change with load changes or voltage. These motor are mostly used where precision and constant speed are required. Most synchronous motor are used in heavy industrial applications.

Comparing AC and DC brushed and brushless motors, all three have power losses in the form of I-R losses. Because DC motors use permanent magnets, no energy is used to generate the magnetic field, as with AC motors. The energy used by AC motors to create the magnetic field decreases their efficiency compared to DC motors.

The frequently encountered National Electrical Manufacturer Assn. reference deserves a few words. NEMA and its classifications are a further way to characterize motors and size. For instance, a NEMA 1 motor is best used indoors and has some protection against falling dirt. A NEMA 13 refers to a motor enclosure constructed for indoor use to provide some protection to personnel against access to hazardous parts. NEMA 23 refers to a mounting area of 2.3 in. x 2.3 in. M

What are AC motors?

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What are brushless motors?

Brushless motors come in AC and DC varieties, but there are more DC versions so this discussion will focus there. Brushless DC motors (BLDC) remove brushes and their associated wear and arcing. They are more efficient than brushed motors because they have less internal friction. Better yet, they usually last longer and expose their surroundings to less electromagnetic interference. Brushless DC motors are suitable in low-power applications, such as consumer products, as well as high-power uses. The design, however, is slightly more expensive than a similarly rated brushed DC motor.

All DC motors generate a magnetic field, whether with electromagnetic windings or permanent magnets. An armature,

which is often a coil of wires, is place between the north and south poles of a magnet. When current flows through the armature, the field

produced by the armature interacts with the magnetic field from the magnets and generates torque and, from that, rotary motion.

In BLDC motors, the permanent magnet (PM) is housed on the rotor and the coils are placed in the stator. The coil windings produce a rotating magnetic field because they are separated from each other electrically, which allows them to be turned on and off. The BLDC’s commutator does not bring the current to the rotor. Instead, the rotor’s PM field trails the rotating stator field, producing the rotor field.

A sampling of recent BLDC motor announcements reveals a fast pace of evolution. For instance, one manufacturer has unveiled its smallest DC brushless motor yet. With a 4mm diameter, the motor comes in two different lengths. Certified to ISO 13485, the brushless micro drive is useful in medical applications. The manufacturer says it has no common wear parts, such as brushes or commutators, so is highly reliable. For higher-torque applications, many manufacturers offer gearboxes or speed reducers that mate neatly with their motors.

Another manufacturer offers the CANopen communications protocol for its brushless DC motors. This allows connecting multiple brushless motors built with the same networking protocol to various components in a system, reducing wiring and installation costs while increasing system communications and integrity. The CANopen interface allows connecting up to 127 brushless DC motors with a single, shielded two-wire cable. Data may be transmitted at speeds up to 125 kBd and over 550 yards. At lower baud rates, the transmission distance can exceed three miles, making communications flexible to almost any location.

Another manufacturer offers a high-torque density motor as an economical yet higher-performance, general-purpose servomotor. Its NEMA 17 mounting configuration is adaptable to most metric mounting requirements, making it an easy upgrade for many stepper motor applications. The motor comes in three lengths with a continuous torque range of 11 to 31 Ncm and a peak torque range of 35 to 99 Ncm. M

A B R I E F M O T O R G L O S S A RY

CANopen: A communication protocol for embedded systems used in automation. It allows device monitoring and communication between nodes or motors.

ISO 13485: Harmonizes medical device regulatory requirements for quality management systems. It includes particular requirements for medical devices and excludes some requirements of ISO 9001 that are not appropriate as regulatory requirements.

NEMA 17: A motor with a 1.7 x 1.7-in. faceplate. It is not a power indicator.

N-cm: Newton-centimeter, a torque unit and a unit of force applied at a distance from a rotary axis.


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What is linear motion?

designs use sets of balls or cylindrical rollers contained within the carriage and supported on rails. By one calculation, the coefficient of friction on a linear guideway that uses rolling-element bearings is only 1/50 that of a traditional slide and can take loads in all directions.

Rolling element-based linear guides are further categorized as either re-circulating element or guide wheel. In a re-circulating design, rolling elements are contained in circuits in the carriage and continuously circulate within the circuit when the guide block moves.

An alternative design uses rolling-element bearings with special circumferential profiles that let them roll on rails with complementary profile surfaces. The most common profile sets are V-wheels (with a V-shape profile that matches a V-rail). Guide wheels use rolling elements contained within circular circuits to support loads. With these features, a linear guideway can provide greater precision than plain bearings.

Linear actuatorsThe carriage is moved using a wide variety of drives. Motion may come from a lead screw, a ball screw, a belt drive, or a linear motor. See the following sections for more on each of these.

Trends in linear motionWhile there are several trends in this industry segment, two that stand out are at opposite ends: Miniaturization and the creation of the most complete systems. Both should interest medical device designers.

Miniature-motion slides let devices make fine adjustments, often 0.001-in or less, in products that, for instance, inspect stents for flaws. Such a carriage on a linear guide with manual drive would let lab workers position a specimen under a microscope and move it around in small, precise increments.

At the other end of trend scale, more complete units can include x, y, and z axes driven by servomotors with an accompanying controller programmed through a user interface. M

Linear motion, as you would expect, is motion in a line. But keeping a load moving in a line and stopping where needed is much more interesting. Briefly, it involves linear guides, actuators, sensors, and controllers. This article briefly introduces the first two items.

Linear guides, for instance, are devices used to keep loads moving in one direction. They come in a wide variety of lengths, widths, load capacities, and bearing designs. Linear guides usually consist of a stationary component, a track, and a load-carrying part (a carriage) riding on bearings. The bearings can be plain or use rolling elements.

Linear motion components are used in a variety of precision applications, from the light loads of medical equipment to heavy loads of machine tools. Plain-bearing linear guides, the simplest design, have no moving parts and rely on low-friction sliding surfaces to smoothly move on their rails. In contrast, the more common rolling-element


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What are linear motors?

moves across the magnet track. This pull creates a detent force that degrades the motor’s smoothness of motion. Manufacturers have various ways of reducing the cogging effect.

Ironless linear motors eliminate iron from the primary by using coils embedded in an epoxy plate. This reduces mass and lets them achieve highly dynamic motion. Where iron core linear motors consist of a flat magnet track, ironless linear motors typically consist of a U-shaped magnet track, with two plates of magnets facing each other. This reduces heat dissipation and means that ironless linear motors have lower thrust forces than iron core motors. But their lower mass (due to a lighter primary part) gives them better acceleration and short settling times, making them ideal for precise, rapid movements.

Another plus for ironless versions: No attractive forces between the primary and secondary parts, because there is no iron in the primary. This makes them easier and safer to assemble than ironcore linear motors. It also means that the supporting bearings need not be sized to accommodate the attractive forces, and will generally have a longer service life. M

Linear motors produce linear motion, not rotary motion, as do most motors. Like many rotary motors, linear motors consist of a coil (primary part or forcer) and magnets (secondary part). Although there are many types of linear motors, brushless ironcore and ironless designs prevail in automation and positioning applications. Each has special construction features and performance characteristics.

Linear motors offer several advantages over belts, screws, and other drive mechanisms, including almost unlimited lengths, low maintenance, and higher accuracy and repeatability. There are no mechanical-transmission components – such as pulleys, couplings, or gearboxes – to introduce elasticity and backlash. The system’s accuracy and repeatability are determined by the controls and do not degrade over time. The lack of rotating or sliding components also means linear motors are almost maintenance-free, with only the support bearings (linear guides) requiring periodic maintenance.

Linear motors can also provide unlimited travel by simply stacking magnet tracks end-to-end. (It’s important to note, however, that cable management may become the limiting factor for systems with unusually long stroke lengths.) And with the ability to use more than one primary part on a single secondary part, systems can be built with multiple carriages performing independent movements, simplifying the system design and reducing space.

Ironcore linear motors, as their name suggests, are constructed with the coils of the primary wrapped around an iron core. The secondary part is typically a stationary, flat magnet track. Ironcore linear motors are characterized by their high continuous force and ability to move large loads, which make them ideal for machine tool, injection molding, and pressing applications.

One downside of ironcore linear motors is an effect known as cogging, which is caused by the magnetic pull of the secondary on the primary as it

LINEAR MOTION

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What are leadscrews?

A positioning device without a linear motor is likely to use a leadscrew or a ball screw (discussed in an accompanying section). The leadscrew or power screw is a threaded shaft on which rides a simple threaded nut. It has no ball bearings. Leadscrews use the helix angle of the thread to convert rotary motion to linear motion. The nut attaches to a load (a movable table or carriage) so that, as the shaft turns, the nut and load transits one way or the other. This simple design is open to wide variations, such as length, thread pitch, coating, and nut design. The shaft can be turned by any of the motors discussed in another section.

With attention to selection and application, leadscrews can work with the efficiency that comes close to ballscrews on many applications – as well as high load capacity and positioning accuracy. In addition, engineers can more easily tailor leadscrews to an application, thanks to a flexible configuration and form factor, the ability to operate without lubricant, quieter operation, and lower cost.

Leadscrew performance depends heavily on the coefficient of friction between the nut and screw, which in turn depends upon the materials of the nut and screw. Leadscrews typically use nuts made of internally lubricated plastic or bearing-grade bronze. Plastic nuts usually travel on stainless-steel screws, while bronze nuts often run on carbon-steel screws. A few simple steps can help determine whether or not a leadscrew is a good fit for an application (and select the most appropriate leadscrew features).

Leadscrew load capacity: When considering whether leadscrews or ballscrews are better for an application, look at the required load capacity. Plastic nuts are suitable for light loads of less than 100 lb, although plastic nut designs for 300 lb and beyond are possible. Bronze nuts, on the other hand, are useful for much heavier loads.

Leadscrew efficiency: The efficiency of leadscrews typically ranges from 20% to 80%, a value highly dependent upon helix angle. Helix angle is the

arctangent of the lead divided by the pitch diameter. It is the angle of the advancement of the thread. As a general rule, higher helix angles mean higher efficiency. A higher helix angle is more efficient because less of the energy driving the leadscrew goes into overcoming friction. This is because the number of times the screw must rotate to get a given linear displacement is lower on a high helix screw. One disadvantage of a high-helix angle is that it necessitates more torque to turn the screw.

Leadscrew speed: Leadscrews come in leads from less than 0.050 to 2.00 in./rev and more. This range can deliver jog speeds to 70 in./sec. This leadscrew feature can provide advantages in many applications. For example, devices that must accurately position payloads can use a leadscrew with a low helix angle to get high positioning resolution. Other applications benefit from fast jog speeds and low screw rpm, providing quiet operation and long life. The maximum rotational speed of a leadscrew is limited by the critical speed of the screw – the speed at which resonance occurs. Leadscrew nuts can be driven at high rpm, but depending on the applied load, heat buildup may limit duty cycles. M

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What are actuators?

What are ball screws?

An actuator is a device that converts energy into motion or applies force. The mechanical device takes energy in the form of hydraulics, pneumatics, or from a motor, and converts it into motion. That motion can come in many forms, such as ejecting, blocking, or clamping. Actuators are used in manufacturing applications such as switches, pumps, motors, and valves. M

A ball screw, like a lead screw, converts rotary motion into linear motion. The device consists of a threaded shaft and a ball nut. The latter device rides on the screw, supported by a series of ball bearings that provide a rolling surface rather than the sliding surface of a lead screw. The balls roll between the nut and shaft. Because there is no sliding motion, ball screws run more efficiently than lead screws. This is their great advantage. The efficiency of ballscrews is relatively constant and is typically better than 90%.

Ballscrews are often a first choice for linear-motion applications because the use of recirculating ball bearings provides high efficiency, load capacity, and positioning accuracy. Furthermore, ballscrews generally provide equal or better load capacity than

leadscrews, and so are a better choice when load requirements exceed leadscrew capabilities.

One drawback to ballscrews is that they require high levels of lubrication. Ballscrews should always be properly lubricated with a proper formulation to prevent corrosion, reduce friction, ensure efficient operation, and extend operating life. Backlash, that little bit of play between several mechanical components, can be eliminated with preloading.

A few ballscrew terms, such as circuits, turns, lead, pitch, and starts, are widely used – and misused – terms that quantify various aspects of ball screw assemblies. Although these terms are related, each has a unique meaning and significance to ball-screw design and performance.

LINEAR MOTION


Lead and pitch are related but different specifications. Lead refers to the linear distance traveled for each complete turn of the screw, while pitch is the distance between screw threads. These terms are often used interchangeably, and for single-start screws lead and pitch are equivalent. However, lead and pitch are not equal for screws with multiple starts. Ballscrews are commonly available in medium leads between 0.200 to 0.500 in./rev, although high-helix products exist.

Considering the geometry of a screw assembly, it makes sense that as the lead of the screw becomes larger, the number of tracks inside the ball nut becomes smaller, so fewer balls are carrying the load. While larger lead screws offer longer travel per revolution and higher speeds, their ability to provide a high load capacity is compromised. In theory, the number of ball tracks could be increased by making the ball nut longer, but manufacturing constraints and limits on ball nut length make this an impractical solution.

Circuits and turns are also related concepts. A ball circuit is a closed path of recirculating balls. “Turns” refers to the number of trips the balls make around the screw shaft before being recirculated. The relationship between circuits and turns is influenced by the recirculation method. Ball returns that use the deflector or thread-to-thread (aka cross-over) method recirculate each turn of balls individually. Therefore, the number of turns is equal to the number of circuits.

When balls are returned by an internal channel or an external tube, the recirculating balls can cross several threads, so one circuit can have multiple ball turns. That is, the balls make several trips around the screw shaft before being recirculated. Multi-start ball screw assemblies typically use the internal channel method of recirculation (pictured). These can be designed for multiple circuits, by incorporating more than one internal recirculation channel in the nut body. M



FLUID POWER COMPONENTS


What are seals?

• Rotary seals and the commonly used O-rings, seal around rotating shafts. They let a spinning shaft pass through the inside dimension of the O-ring. Motorized systems, such as scanning devices, require rotary seals. In these applications the important consideration is heat from friction where the rotating component meets the seal material. M

Seals, important components in many medical devices, are used to isolate and sometimes transmit fluids and gases. They are also occasionally used to provide structural support for other components of the device.

There are three basic seal designs:

• Static seal applications, in which there is no movement and are the most common, include preventing fluids and drugs from escaping into or out of a medical device. Static seals range from basic O-rings to complex shapes and can be found in medical devices ranging from pumps and blood separators to oxygen concentrators.

• An example of a reciprocating seal, one with linear motion, is found in endoscopes, devices used in minimally invasive surgery. These trocar seals allow the insertion and manipulation of surgical instruments in procédures ranging from hernia repairs to complex cardiac procedures.

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What is a pump?

What is a valve?

that lets patients self-administer a controlled amount of medication as needed.

• Enteral pumps deliver liquid nutrients and medications to a patient’s digestive tract.

• Insulin pumps typically deliver insulin to patients with diabetes. Insulin pumps are frequently used in the home.

Infusion pumps may be powered electrically or mechanically and operate in different ways:

• Syringe pump: Fluid is held in the reservoir of a syringe and a moveable piston controls fluid delivery.

• Elastomeric pump: Fluid is held in a stretchable balloon reservoir, and pressure from the elastic walls of the balloon drives fluid delivery.

• Peristaltic pump: A set of rollers pinch down on a length of flexible tubing, pushing fluid forward.

• Multi-channel pump: Fluids can be delivered from multiple reservoirs at multiple rates. M

A pump is a mechanical device that uses suction or pressure to raise or move liquids, to compress gases, or to force air or gases into inflatable objects, such as balloon catheters.

The most common pump used in medicine is the external infusion pump. This device delivers fluids into a patient’s body in a controlled manner. There are many different types of infusion pump, used for a variety of purposes and in different environments.

Infusion pumps may be capable of delivering fluids in large or small amounts and may be used to deliver nutrients or medications, such as insulin or other hormones, antibiotics, chemotherapy drugs, and pain relievers. Some infusion pumps are intended for stationary use at a patient’s bedside. Portable or wearable versions are called ambulatory infusion pumps.

A number of commonly used infusion pumps are intended for specialized purposes:

• Patient-controlled analgesia pumps deliver pain medication. The pump is equipped with a feature

FLUID POWER COMPONENTS

A valve is a device that controls the passage of fluid through a pipe or duct, especially a device

that allows movement in one direction only. A common example of such a valve in a medical

context is a replacement heart valve.In most cases, heart-valve replacement is an open heart

operation. This means the surgeon breaks the patient’s ribs or sternum for access to the heart and to replace the damaged valve. The new artificial (usually a prosthetic) valve is then sewn

into place. In paitents too sick to undergo surgery, the valve can be replaced via catheter without opening the chest. M



What is a peristaltic pump?

contamination of the fluid and pump, ensuring that the pump is not damaged by the fluid or particulates within the fluid, and that the fluid remains completely pure and undamaged by pump operation. The design also minimizes cleanup. When a tube has worn excessively, it is usually easy to remove and replace.

Specialized peristaltic pumps are used in various medical applications. In some cases, the pumps move blood through the patient’s veins and arteries. The action of the pump is such that it does not damage blood vessels or blood cells. These devices assist blood flow in various surgical procedures and medical operations, such as open heart surgery, in which the beating heart must be stopped so the surgeon can properly place a new valve. M

Peristaltic pumps generate fluid flow in a tube through the use of external, rotating rollers. These rollers are mounted on a rotor turning on an axis. As it rotates, the rollers make contact with the outer diameter of the tubing. The rollers then press into the tubing, which must have some flexibility, to propel the media. As one roller rotates away from the tube, another makes contact, continuing the constant motion of the contained fluid.

At the points of contact, the flexible tube becomes compressed and forces the media in the direction of the rollers’ movement.

Peristaltic pumps have a number of advantages over other pump designs. For instance, the fluid within the tube is not exposed to other pump components and only makes contact with the inside of the tube. This prevents



What is a syringe and how does it work?

What is a hypodermic needle?

NEEDLES & SYRINGES

A syringe is a pump consisting of a sliding plunger that fits tightly in a tube. The plunger can be pulled and pushed inside the precise cylindrical tube, or barrel, letting the syringe draw in or expel a liquid or gas through an orifice at the open end of the tube. Pressure is used to operate a syringe. It is usually fitted with a hypodermic needle, nozzle, or tubing to help direct the flow into and out of the barrel. Plastic and disposable syringes are often used to administer medications. M

A hypodermic (hypo – under, dermic – the skin) needle is a hollow needle commonly used with a syringe to inject

substances into the body or extract fluids from it. They may also be used to take liquid samples from the body, for example taking blood from a vein in venipuncture. Large-bore hypodermic intervention is especially useful in treating catastrophic blood loss or shock.

A hypodermic needle also provides for rapid delivery of liquids. It is also used when the injected substance cannot be ingested orally, either because it would not be absorbed, as with insulin, or because it would harm the liver.

Hypodermic needles also serve important roles in research requiring sterile conditions. The hypodermic needle significantly reduces contamination during inoculation of a sterile substrate in two ways. First, its surface is extremely smooth,

preventing airborne pathogens from becoming trapped between irregularities on the needle's surface, which could subsequently be

transferred into the media as contaminants. Second, the needle's point is extremely sharp, significantly reducing the diameter of the

hole remaining after puncturing the membrane, which consequently prevents microbes larger than the hole from contaminating the

substrate. M

Needles and Syringes_Vs4-BP.indd 58 11/24/15 1:23 PM

Bishop Wisecarver 11-15.indd 56 11/23/15 4:06 PM

ELECTRICAL / ELECTRONIC COMPONENTS


What are electrical connectors?

Just search on electrical connectors, scan the headlines, and you see these devices are available to do nearly everything. Some are small, or hold many connectors, work reliably after many connections and disconnections, and stay connected and disconnect easily when necessary. Some come with electronics for several functions, such as the prevention of short circuits. Plug arrangements must prevent misconnections, tolerate sterilizations, come with the right wires, be long and short, and lots more.

A few significant standards guide the designs of connectors:

ISO 13485 helps maintain the good quality and design of medical connectors (as well as other medical devices). This regulation helps ensure product safety and puts in place specific requirements for inspection, documentation, validation, and verification for medical connectors. It is considered a standard requirement for medical devices, with its guidelines slowly becoming universal.

IEC 60601 is a series of medical connector standards that require medical device companies to check the safety and risk potential that electrical connectors pose to patients and healthcare workers. To comply, companies must examine their products using an approved process and give every device a risk-management file. Manufacturers must be able to specify which connectors comply with technical

requirements, and which satisfy the required performance

characteristics.

Furthermore, any found with an unacceptable risk level must be eliminated.

Medical equipment is further governed by IEC/UL 60601-1, which harmonizes safety requirements from North America and Europe. An important recent addition to this basic standard for medical devices is IEC/UL 60601-1-11, for protection in a Class II environment. The safety requirements in the -11 standard place additional restrictions on in-home medical equipment, such as:

• Altered ambient conditions (storable at -25ºC - 70ºC and operable at 5ºC - 40ºC at 93% relative humidity)

• Protection Class II (permitting no protective ground connection)

• Enclosure protection from water and dust must be at least IP 21 (light rain)

• Stricter shock and vibration tests (30 min random vibration test per axis)

Devices certified to Protection Class II have double insulation between the main circuit and the output voltage or metal enclosure. Even when they have electrically conductive surfaces, they are protected against contact with other live parts through the double insulation.

IEC standard 60320 describes requirements for detachable plug connections. Depending on the application, it is recommended to include a mechanism to protect against any unintentional plug removal from the equipment's power socket. M

Electrical_Vs6-BP.indd 60 11/24/15 9:40 AM

TEST YOUR MEDICAL PRODUCTS FOR EXPORT

The Interpower® International Power Source is an AC power source used to verify your product design and for product testing. The unit can be used on a bench top or is rack mountable.

Interpower has four models available which have an input of 100–240VAC/50–60Hz. The first two models are supplied with a NEMA 5–20 plug and have an output of 2200VA maximum with a Low Range variable of 10–138VAC at 16Arms maximum and High Range variable of 10–276VAC at 8Arms maximum, 47–450Hz. The second two models are supplied with a NEMA 5–15 plug and have an output of 1725VA maximum with a Low Range variable of 10–138VAC at 12.5Arms maximum and High Range variable of 10–276VAC at 6.25Arms maximum, 47–450Hz. For each output option we offer a model with a RS232 and USB port and a model with no communication ports.

The Interpower International Power Source can also be ordered for international use with a country-specific input power plug. We offer a 1-week U.S. manufacturing lead-time and same day shipping for in-stock products. From 1 to 1,000 pieces or more, we have no minimum order requirements.

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You cannot control what you cannot measure, goes an old engineering saw. The measurement reference is accomplished by sensors.

Sensors are available to measure a variety of parameters:

• Acceleration and vibration • Acoustic and ultrasonic waves • Chemicals and gases• Electrical and magnetic fields• Fluid flow rates• Force, load, torque, and strain• Humidity and moisture• Leaks and fluid levels• Velocity and displacement • Temperature and pressure

Each of these may have several methods of measurement. For temperature, pressure, and others, a sensing element experiences a change in electrical resistance in proportion to the change in the phenomenon, which produces a change in signal voltage (often 0 to 5 volts, but PCB-mounted sensors are likely to have mV outputs) that is calibrated to the changes in the measured phenomenon. One position sensor locates the position of a magnetic field along a sensing tube. There are many other methods.

A transducer, a type of sensor, is a device that converts one form of energy into another. Common units in medical apps include sensors to measure temperature, pressure, forces, liquid levels, and flow rates. These physical quantities are converted to electrical signals in either analog or digital form. In motion control applications, transducers can refer to any one of a number of sensors, such as rotary or linear encoders, or resolvers for position feedback, such as tachometer for speed sensing, and even proximity switches to initiate or halt mechanical action.

If there is a trend in medical sensors, it is toward small and light-weight designs, and those that can sense small changes, and then function on millivolts.

The need for sensors will increase as more healthcare devices are connected to the Internet and wearable technologies become more prevalent. M

What are sensors?

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What are tubing connectors?

disconnected, and prevent air from entering the system. Connectors with integral precision flush-face valves are considered "dry-break" connectors and should be selected when there is a critical need to avoid any spills, contamination, or the introduction of air upon connection.

Find the range of temperatures and pressures and those the connectors might encounter in storage or shipping.

Connectors and O-rings should be compatible with the anticipated media. Start with a review of published data in chemical-compatibility charts to understand what materials will work acceptably with the range of chemicals, media, or reagents in the application.

A connector's manufacturing quality affects its performance and aesthetics. Parting lines and mold defects on couplings should be minimal on the connector body and absent from the first hose barb.

In addition, the FDA, the international standards community, and the medical device industry are taking action to reduce the likelihood of tubing misconnections. This includes the development of standardized connectors for specific medical applications that cannot be interconnected with devices for other medical applications.

Briefly, the FDA recognizes the AAMI provisional American National Standards AAMI/CN3(PS) 2014 "Small-bore connectors for liquids and gases in health care applications" – Part 3: Connectors for enteral applications and AAMI/CN20:2014 - Part 20: Common test methods. M

Tubing connectors for medical applications come in an almost endless variety, but the recent thrust in their design is to prevent accidental connections. For instance, by one estimate a hospital room could have nine different fluids in use, making the possibility of a misconnection too high.

That makes it important to have a simple and repeatable process for selecting the best connector. The process requires an analysis of the application to ensure connectors will be compatible with the physical, chemical, and biological environment, and be easy to use as well as help prevent misconnections. Concerns over the wider use of Luer connectors has prompted a series of new, small-bore medical connector standards from the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC). The ISO 80369 series of standards will define non-interchangeable connectors that affect connector selections for a range of medical-device applications.

In addition to design standards, the following factors should be part of a process that selects a fluid connection:

The tubing ID should be a connector's first consideration. Pressure drops across connectors and valves vary greatly by manufacturer. Some designs exhibit less turbulence and resistance to flow than others. Compare CV factors for various connectors to determine the pressure drop across them.

Many valve styles mean flow rates and pressure drops will vary. Connectors with built-in valves prevent spills when


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What is a battery?

A battery is a container with one or more cells, in which chemical energy is converted into electricity, and used as a source of power for medical tools, devices, and more. For medical devices, batteries are now available in a wide variety of chemistries. The accompanying table considers a few lithium possibilities. M

LiSOCl2 LiSOCl2 WITH LITHIUM CHARACTERISTIC BOBBIN HYBRID LAYER METAL OXIDE LiSO2 LiMnO2 TYPE CAPACITOR

Energy density 1,420 1,420 680 410 650 (Wh/liter)

Power Low High High High Moderate

Voltage, (V) 3.6 3.6 to 3.9 4.1 3.0 3.0

Pulse Small High Very high High Moderate amplitude

Performance at elevated Fair Excellent Excellent Moderate Fair temperature

Performance at low Fair Excellent Excellent Excellent Poor temperature

Operating life Excellent Excellent Excellent Moderate Fair

Self-discharge rate Low Low Low Moderate Moderate

Operating temperature, -80 to 125 -40 to 85 -40 to 85 -55 to 60 0 to 60 (°C)

Operating life, 20+ 20+ 20 10 5 years

Automatic Bone external AEDs, Typical apps healers, defibrillators cauterizers, AEDs Glucose oxygen (AEDs), devices disposable monitors meters that are power tools sterilized

How the primary lithium chemistries compare

Source: Tadiran Batteries


C

M

Y

CM

MY

CY

CMY

K

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What are cables and cable assemblies?

Cable jacketWire Insulation

Stripped Wire

In medical device applications, cables are used with nearly all electrically operated devices. As such, cables can be found in everything from medical robotics and medical imaging devices to wearable electronics. This diversity of uses leads to an immeasurable amount of differing conditions to consider when selecting the right cable and cable assembly for a device.

For example, many medical device cables must be reused and therefore must undergo repeated sterilizations. Electron-beam sterilization is a common method, but can compromise the plastic jacket at a molecular level. The branched-chain polymers in the plastic can bond with each other, making the cable brittle. The cable might also be subjected to chemicals and heat, leading to additional wear. These elements can all affect the flexibility of the cable, which must flex freely and repeatedly to be efficient. This performance element is another consideration when choosing the type of cable for a medtech device.

Lastly, to ensure that cables can meet the demands of the conditions listed above, cables are subjected to many requirements and certifications. It is important to always refer to a manufacturer’s specifications for a cable when not having the cable specifically customized for your individual application. M

Cables are long wire strands covered by a protective shielding material (jacket) and an insulation material. Cable assemblies are a small grouping of individual cables or wires bound together to increase the wires’ efficiency, protect them from external contaminants, and help them fit more efficiently in a given application. Protective coverings for cables and cable assemblies vary greatly, depending on the application environment. They can be made of polyvinyl chloride (PVC), polyethylene (PE), ethylene-vinyl acetate (EVA), thermoplastic elastomer (TPE), perfluoroalkoxy alkane (PFA), and more. The internal wires (conductors) are made mostly of copper and occasionally aluminum.

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What is sterilization and what different methods

sterilize products?

Sterilization refers to any process that eliminates (removes) or kills all forms of microbial life, including transmissible agents (such as fungi, bacteria, viruses, and spore forms) present in a specified region, such as on a surface, in a volume of fluid, medication, or in a compound such as biological culture media.

Sterilization is accomplished with one or more of the following: Heat, chemicals, irradiation, high pressure, and filtration. Sterilization is distinct from disinfection, sanitization, and pasteurization in that sterilization kills or inactivates all forms of life. M

Preconditioning exposes the product to a warm, humid environment for at least 12 hours (70% RH, 55°C) to ensure the product is at a reliable temperature and humidity. Next, a vacuum is pulled to introduce EO gas. The product is exposed for 4 to 8 hours. Lastly, the EO gas is removed by repeatedly flushing the chamber with air and pulling a vacuum. This cycle is repeated until the EO gas is cleared out. There is no standardized cycle for EO sterilization, which is performed at a wide range of exposure times and gas concentrations. M

What is Ethylene Oxide sterilization?Ethylene Oxide (EtO or more recently EO) sterilization is the process of sterilizing medical and products that cannot withstand heat, such as electronic components, catheters, plastic packaging, and plastic containers.

Important specifications to control in an EO process are relative humidity (RH), temperature, and pressure. Vacuum (negative pressure, less than 0 psia) is pulled prior to introducing the EO process, to ensure that gas permeates the product being sterilized.

A common sterilization cycle has several stages.

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What is plasma sterilization?Plasma sterilization uses hydrogen peroxide (H2O2) gas plasma technology. A common use of this method employs a chamber to draw a vacuum. Hydrogen peroxide is then introduced and ionized by a radio-frequency field, turning the H2O2 into electrons and reactive free radicals, or ions. When these components encounter a microbe, they take an oxygen ion from it, which upsets its chemistry and kills it.

The process is usually performed at room temperature, eliminating high temperature hazards. Plasma sterilization is considered non-toxic, as it uses no harsh chemicals. Treatment time is one minute or less. Additionally, the process offers versatility, and can sterilize almost any material and crevice. M

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What is gamma and E-beam sterilization?

Gamma and E-beam sterilization are radiation-based techniques. Neither method, however, results in radioactivity. Exposing a product to continuous gamma rays performs gamma sterilization, and E-beam sterilization uses electron beams. E-beam is more powerful and has a shorter exposure time. Reusable devices sterilized by these methods must undergo a "Quarterly Dose Audit" to ensure that they meet the established standards and sterilization levels.

Sterilization through irradiation is considered efficient because it leaves no residue on the sterilized device and doesn’t require a quarantine period. The rays can penetrate dense materials and closed package products with minimal temperature increase or effect on the product material. E-beam radiation, however, has certain limitations when penetrating dense materials or products with varying densities. M

What is steam sterilization?

Steam sterilization is considered a simple and effective decontamination method. In steam sterilization, products are exposed to saturated steam at temperatures of 121°C to 134°C. Products are placed in a pressure chamber called an autoclave and heated with saturated steam at about 30 psi to kill spores and microorganisms.

Steam sterilization’s high temperatures mean it cannot be used for many materials. A quarantine and down-time period is also required after sterilization as packages must dry completely before being removed from the autoclave to prevent contamination. Once removed, they must be allowed to cool to room temperature, which usually takes several hours.

To be considered effective, it is critical that the steam entirely covers all device surfaces. Many autoclaves have built-in meters and

dataloggers to display temperatures and pressures to help achieve optimal conditions. Biological indicators and indicator tape also help gauge performance. The tape is placed inside and outside of the sterilized packages, and bioindicator devices release spores inside the autoclave. The spores are incubated for about 24 hours and then their growth rate is measured. If the spores have been destroyed, the sterilization process is deemed successful. M

What is nitrogen dioxide sterilization?Using nitrogen dioxide (NO2) gas for the sterilization of medical equipment offers many advantages. NO2

sterilization is a rapid, room-temperature process performed without using a deep vacuum. The in-house process is considered efficient and cost effective.

NO2 sterilization is done in custom chambers in load volumes of 360 to 5,000 liters. The sterilization process is

similar to other gas-sterilization methods: The chamber is evacuated to a predetermined pressure before the sterilant and humidity are introduced. Medical devices are sterilized during a dwell period in which spores and microbes are killed, and the NO2 and humidity are removed. Multiple injections and dwells ensure the required sterility assurance level. M

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TUBING

What are hoses?

What is the purpose of reinforced tubing?

How is tubing made, and what is bump tubing?

Hoses are flexible tubes that have been reinforced with an embedded braid or wire mesh. Hoses often are made with stiffer plastic, dual walls, or a

heavy wall. Hose is usually used and rated for high-pressure applications. M

larger diameter is formed as the extrudate leaves the die, in the gap between the die and a cooling device. This is achieved by controlling the internal air pressure while varying the speed at which the product is extruded. That is, the puller speed slows while internal air pressure increases to create the larger diameter. The reverse brings the tube back to the smaller diameter. The rate of change must be accurately controlled to maintain consistent diameters. M

Bump tubing is a tube that has different diameters at each end. The diameter may also vary along the tube’s length. Generally, the smaller diameter end is inserted into the body and the larger diameter attaches to a medical device.

The manufacturing process is similar to other extruded tubing processes, except bump tubing adds the complexity of forming and sizing more than one diameter as the part is continuously extruded. The

Reinforced tubing is typically used to support access devices or as a delivery method for another device. Reinforcing the walls of plastic tubing increases its internal pressure rating, provides kink resistance, adds column strength, and increases torque transmission. The result is stronger tubing compared to non-reinforced tubing. Some applications that use reinforced tubing include MRI-compatible catheters, stent placement shafts, vascular access sheaths, and endoscopes. M

Tubing_(w Validation)_Vs4-BP.indd 72 11/24/15 1:02 PM

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TUBING

Paratubing joins two or more tubes in a side-by-side formation, allowing for customization for specific medical applications. The tubes are thermally welded or solvent-bonded longitudinally, and are used in applications in which several fluid lines are joined in one conduit, and then branch apart to different connections. Multiple tubing configurations are possible. M

What is paratubing?What is radiopaque tubing?

Tubing placement during surgical procedures is critical for many device applications. To make the tubing visible during imaging processes, such as fluoroscopy or x-ray, a radiopaque filler is added the plastic. M


VALIDATION & TESTING

Photo: Nelson Laboratories

What is validation & testing?

Validation & testing is the process of making sure a medical device meets all of the engineering requirements that make up its product requirements. Developers must also track all the data generated from bench-top, in-tissue, animal and human testing.

All medical devices, from simple Class I products to complex Class III devices, must be tested against all product requirements to verify that they meet engineering specifications and are validated to meet product specifications.

During an FDA audit, the device developer must be able to demonstrate that all reasonable tests were done to lower the risks associated with the device. M

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torque and 40% longer life while maintaining zero-back-

lash, 1 arc-min accuracy, and ± 5 arc-sec repeatability.

A high capacity cross roller bearing and output fl ange is

used to support the driven load. A wide variety of sizes

and reduction ratios are available with maximum peak

torques ranging from 9 Nm to 3,400 Nm.

Made in USA

TM

Harmonic Drive is a registered trademark of Harmonic Drive LLC.

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©2015 B. Braun Medical Inc. Bethlehem, PA. All rights reserved. OEM 15-5024 7/15 LMN

Do you need a supplier that makes managing complicated projects look simple and speeds you to market?

How about one with world-class design chops and quality systems for ensuring excellence?

&Or one that saves time and money with sterilization, packaging and

regulatory capabilities all under one large roof?

&

&

If your answer is yes, then B. Braun OEM is the only supplier you’ll need. Beyond a full roster of

capabilities, we offer a vast array of products. You’ll fi nd parenteral pharmaceutical solutions in a

variety of bags, a thick catalog of standard and custom valves, all the admixture accessories you’ll

ever need, and the products and capabilities to build a custom kit for your device or drug. It all adds

up to a single-source supplier that goes far beyond being a vendor to becoming a true partner.

B. Braun Medical | OEM Division | USA

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Documents

Medical Design & Outsourcing - MEDICAL DEVICE HANDBOOK - Dec. 2015