AGENDA AT A GLANCE - Manufacturing Events and Media …€¦ · AGENDA AT A GLANCE DAY 1: FEBRUARY 10TH, ... Engineering Overhauling your Process ... M.D., Founder & Chief Medical

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AGENDA AT A GLANCE

DAY 1: FEBRUARY 10TH, 2015 DAY 2: FEBRUARY 11TH, 2015 DAY 3: FEBRUARY 12TH, 2015

TRACK A:

Disruptive Innovation in Design of Medical Devices

TRACK B:

Managing Risk, Quality and Validation

TRACK C:

Speed to Market, Scale Up & Post Market Compliance

TRACK A:


TRACK B:


TRACK C:


TRACK A:


TRACK B:


TRACK C:


9:3

0 –

10:0

0

KEYNOTE ADDRESS

Computers we can wear

KEYNOTE ADDRESS

Personalizing Surgery: 3D Printing and The Digital Thread

KEYNOTE ADDRESS

The Hackers Guide to the Galaxy

10:0

0 –

11:4

5 Designing

Devices Towards Consumerization, Wireless Capabilities and Wearable Technology

Creating and Implementing a Fully Compliant CAPA System

Accelerating Speed to Market through Effective Prototyping and 3D Printing

IDEO DESIGN WORKSHOP PART 1: Design research and inspiration

How to Audit Proof your Processes and Effectively Prepare for an Inspection

Financing, Funding and Start-Ups

Improving User Experience and Usability Engineering

Overhauling your Process Validation Part 1

How to Avoid Product Warning Letters and Recalls

1:0

0 –

2:3

0 Integrating

Advanced Sensor Technology and Power Management into your Device Design

Building Robust Risk Management Part 1

3D Printing Materials Guide For Medical Devices

IDEO DESIGN WORKSHOP PART 2: Ideation and prototyping

Improving your Supplier Quality

Strategies for Successful Scale-Up from Design to Manufacturing

Designing for Better: Hospital Collaboration, Usability and Design Control


Regulations for the Engineer: Aiming for First Time Submission Approval

2:4

5–

4:0

0 Integrating your

Medical Device into an Interconnected Wireless Ecosystem


Addressing the Regulatory and Legal Challenges of 3D Printing

IDEO DESIGN WORKSHOP PART 3: Innovation thought leadership round table discussion

Effectively Implementing a Quality Management System

Lean Manufacturing: Beyond the Basics

Practical Applications of Design Control

Complying with Biocompatibility Testing Standards and Guidance to get your Product to Market Faster

UDI: What’s in store for 2015 and beyond?


DAY ONE – TUESDAY, FEBRUARY 10th

TRACK A: Disruptive Innovation in Design of Medical Devices

TRACK B: Managing Risk, Quality and Validation

TRACK C: Speed to Market, Scale Up & Post Market Compliance

THE NEW WIRELESS FRONTIER: Innovations in Wireless Capabilities, Interoperability, and

Sensor Technologies in Medical Devices

CHAIR: Liam Pender, Ph.D., President & Chief Executive Officer, EGRET TECHNOLOGIES

REFINING YOUR RISK MANAGEMENT AND CAPA PROCEDURES

CHAIR: Geoff Hutchins, Chief Operations Officer, REGULATORY COMPLIANCE

ASSOCIATES

ENTER THE 3D ERA: A New Dawn in Medical Device Design &

Manufacturing

CHAIR: Donovan Weber, Chief Operating Officer, FORECAST3D

9:30AM –

10:00AM

KEYNOTE ADDRESS Computers we can wear

Babak Parviz, Ph.D., Vice President, Amazon | Former Google[x] Director

This industry juggernaut, creator of Google Glass and Google Contact Lens, will open the conference with a look into the current and future wearable technologies taking hold of the medical device and healthcare industries.

10:00AM –

11:45AM

Designing Devices Towards Consumerization, Wireless Capabilities and

Wearable Technology

10:00 – 10:30 Designing for simplicity – Making products customers will love to buy

- Examples of where a simple design can be disruptive

- Examining current devices that apply the disruptive innovation principles

- Determining how much the current regulatory landscape disrupts disruptive innovation

- Exploring how to break the mold with a simpler next generation device

Sridhar Iyengar, Co-Founder and Chief Technology Officer, MISFIT WEARABLES

10:30 – 11:15 Wireless medical device design considerations for reimbursement, security and data management

- Will the “wireless” distinction in medical devices mean anything in 5 years or will it just be ubiquitous and table stakes?

- What will the wireless landscape look like in

Creating and Implementing a Fully Compliant CAPA System

10:00 – 10:30 Avoiding and responding to a CAPA specific warning letter Corrective and preventative action deficiencies have accounted for an increasing number of warning letters. Some may argue that CAPA discrepancies are overtaking 510k/ PMA submission regulatory headaches. This interactive presentation will help you effectively respond to a warning letter and help you avoid any future CAPA associated warning letters. Jay Jariwala, Quality System Specialist, Regulatory Compliance Officer, Office of Compliance, FDA

10:30 – 11:15 CAPA gap analysis: Tell me something I don’t know about CAPA! This concentrated but intensive workshop will help you identify the most common CAPA shortfalls and eliminate your chance of receiving a CAPA associated warning letter.

- Uncovering the usual CAPA tripwires

Accelerating Speed to Market through Effective Prototyping and 3D Printing

10:00 – 10:30 Bringing life to your functional prototypes through 3D printing

- Insightful real life industry case studies demonstrating how 3D printing prototyping can cultivate innovation

- Evaluating the cost implications of 3D printing prototypes versus traditional methods

- Overcoming design challenges by utilizing additive manufacturing

Justin Conway, Product Development Engineer, Orchid Orthopedic Solutions

10:30 – 11:15 PANEL DISCUSSION Integrating 3D printing into your established processes Over the last 12 months, most medical device companies have dipped their toe cautiously in the 3D printing pool. Going into 2015, companies are getting ready/are already integrating 3D printing capabilities into their processes. This panel


5 years?

- Most devices are standalone these days and are reimbursed based on medical necessity or protocols. Will that be the same in the next few years or will device connectivity with EHRs change the reimbursement landscape?

- What is ONC and the FDA likely to require in terms of cybersecurity and what will that mean to medical device designs?

- Assuming big data and analytics progress continues unabated, what changes to device designs are required for improved data capture and management?

Shahid N. Shah, Chief Executive Officer, Netspective Communications | Influential Blogger, HealthcareGuy.com

Steve Abrahamson, Director, Product Security Engineering, GE Healthcare

Melissa Masters, RAC, Director of Electrical Software and Systems Engineering, Battelle Memorial Institute

11:15 – 11:45 Remote patient monitoring devices for the Aging Population and for Chronic Diseases: The good, the great and the exceptional! Gain real-life insights from three leading remote patient monitoring manufacturers and one medical design innovation consultancy giving detailed case studies on how they overcame design and engineering challenges for their remote patient monitoring devices for the aging population and chronic diseases. David Albert, M.D., Founder & Chief Medical Officer, AliveCor

Brian Russell, Vice President Business Development Wireless, Respiratory and Monitoring Solutions, Covidien

James Moon, Chief Technology Officer, Sotera Wireless

Craig Scherer, Co-Founder & Senior Partner Insight Product Development

- Best practices in managing CAPA investigations

- Reviewing and correcting a non-conformity - Verifying CAPA implementation and

validating CAPA effectiveness

- How to apply risk management in the CAPA process

- Writing appropriate recurrence control and preventative action plans

Diane Kulisek, Director Quality & Performance Improvement, Bruin Biometrics

11:15 – 11:45 PANEL DISCUSSION Rebooting your CAPA An esteemed panel of CAPA experts will share their best practices and lessons learned on implementing a successful CAPA system

- Implementing a compliant CAPA system that brings business value

- Aligning regulatory requirements with the GHTF CAPA guidance

- Discussing performance of CAPA investigational tools currently available

Kevin Posey, Executive Quality/Regulatory Consultant, MAETRICS

Marcelo Trevino, Senior Regulatory Compliance Manager, Medtronic

Diane Kulisek, Director Quality & Performance, Bruin Biometrics

Andrew Harrison, Vice President & General Counsel, Regulatory Compliance Associates

brings together a wealth of knowledge discussing the vital checkpoints of integrating 3D printing into your departments design and/or manufacturing methods

- Discussing where the medical device industry is now and where is it heading

- How to successfully collaborate with 3D printer vendors and material suppliers

- Converting 3D printing into business value - Are you solving a clinical problem by 3D

printing your product or device? Tyler Reid, Manufacturing Application Manager, GoEngineer

Dave Flynn, Senior Business Development Manager, Materialise

Justin Conway, Product Development Engineer, Orchid Orthopedic Solutions

Ross Tsukashima, Engineering Director, Revision Optics

Eric Utley, Additive Manufacturing Application Specialist, PROTO LABS

11:15 – 11:45 Using 3D printing for complex, high volume medical devices

- Exploring the major obstacles for the medical device industry when integrating 3D printing into the development and manufacturing life cycles

- Evaluating the potential to streamline and accelerate your concept to market time line

- How will 3D printing impact your manufacturing bottom line?

- Determining the opportunities of using 3D printing for tooling and production when manufacturing medical devices

Naomi Murray, Senior Manager, Additive Manufacturing, Stryker


1:00PM –

2:30PM

Integrating Advanced Sensor Technology and Power Management into your Device Design

1:00 – 1:40 Better, Faster, Stronger: Advances in new intelligent feedback systems and sensor technology and how to practically build this into your design plans

- Keeping up with technology upgrades and continuous product innovations in sensors to maximize their current and future capabilities

- Exploring soft sensors, self-calibration and wireless communication for monitoring and control applications

- Practical issues behind incorporating multiple sensors into medical devices

- New applications in pressure sensor technology, new semiconductor chip and low power sensor technologies

Saeed Azimi, CEO & President, Dynosense

1:40 - 2:00 Use of miniaturized implantable devices for patient empowered health care

- Focusing on current and future miniaturization challenges with batteries and battery-pored medical devices

- Detailing new developments in rechargeable and primary cell systems to enable increased longevity

- Assuring that your battery meets the unique requirements for its application whilst performing reliably and safety

Todd M. Zielinski, Ph.D., Senior Principal Scientist, MEDTRONIC

2:00 – 2:30


1:00 – 1:40 Updating your risk management protocol when using a new material

- Overcoming the risk management challenges of evaluating and implementing new materials within your medical device

- Determining if and when you need to change your risk analysis protocol for a new material

- What new materials have been added to RoHS?

Kevin Posey, Executive Quality/Regulatory Consultant, MAETRICS

1:40 - 2:00 Refining software risk management when designing your medical device

- How to successfully embed your software risk management into your overall risk management practice

- Developing your software with international regulations in mind

- Best practices in preparing documentation for medical device software

- What software process improvement risk management model is best for your device?

- Best practices in documenting risk management

- Combining results from various risk analysis tools such as FMEA, FTA, etc.

Seyed Khorashahi, Director, Software Engineering, Covidien

3D Printing Materials Guide For Medical Devices

1:00 – 1:40 Material developments for 3D printing: From biocompatible polymers to metals

- Exploring the various materials currently available for 3D printed medical devices

- Discovering the range of available materials and finishes for single or multi-material use

- Addressing sterilization testing and longevity concerns with new materials

- Reducing costs using new materials in the rapid prototyping process

- Mobilizing new materials straight into production

Scott Hollister, Ph.D., Professor, Biomedical Engineering, Associate Professor, Surgery, Professor, Mechanical Engineering, University of Michigan

1:40 – 2:00 Development of an advanced 3D printed scaffold for skeletal reconstruction

- OPM manufactures FDA cleared PEKK implants using a 3D printing technique

- 3D printed PEKK suitable for load bearing applications (VBR)

- Ability to manufacture implantable devices with complex geometries is driving innovation for the next generation of devices

Severine Zygmont, Co-Founder, Oxford Performance Materials

http://www.bme.umich.edu/people/index.php?un=scottho


People Power: biomechanical energy harvesting for portable devices

- How much power is available to from the human body?

- What can be powered with human energy harvesting?

- What is the state-of-the-art in biomechanical energy harvesting?

Max Donelan, Chief Scientific Officer, Bionic Power | Associate Professor, Department of Biomedical Physiology & Kinesiology, Simon Fraser University

2:00 – 2:30 ISO 9001 2015 update: The major changes heightened towards risk

- Managing the transition when the new standard is published in 2015

- Discussing the new requirements for review, documentation updates and risk management

- Analyzing outcomes as a result of risk management changes

- Exploring the more risk-driven approach and actions to address risk

Walt Murray, Director of Quality & Compliance Services, MASTERCONTROL

2:00 – 2:30 The realities, myths and future potential of bioprinting

- Latest in organ printing technologies and applications in tissue engineering and regenerative medicine

- Uncovering the limitations and challenges of this technology

- Detailing breakthroughs in printing human stem cells

- Practicalities of taking a quantum leap into the commercial arena

Ibrahim T. Ozbolat, Ph.D., Assistant Professor, Mechanical & Industrial Engineering Department, The University of Iowa


2:45PM –

4:00PM

Integrating your Medical Device into an Interconnected Wireless Ecosystem

2:45 – 3:30 Panel Debate: Future medical device communication: Which platform is best for different device portfolios and will a single platform emerge?

- Addressing the connectivity conundrum - WiFi, Bluetooth or Cellular for different types of devices?

- Debating the best approach to incorporate cloud – needs a bit more detail

- Discussing if and how Bluetooth and 802.11 Wi-Fi can co-exist

- Understanding what are the most optimal RFs for short range and long range devices

- Tips for overcoming the security concerns of cloud storage and overall data management

MODERATOR: Andrew Malcolmson, Director, Integrated Patient Intelligence (Vital Sync), Covidien

Michael Mensinger, Director of Mobile and Cloud Software, DEXCOM

Amnon Ptashek, Chief Architect, WESTECH Medical Technologies

Paul Krause, Director, Connectivity Systems Engineering, Medtronic

3:30 – 4:00 A Practical Guide to gain Mobile Medical App regulatory approval

- Exploring the most important takeaways from the Mobile Medical Apps Guidance

- Best practices for developing apps and getting them approved quickly per FDA

- What is the definition of a mobile medical app?

- Determining what current technologies and development platforms are best to support a medical device app

- Understanding the requirements for device approval and what is meant by enforcement discretion

Bakul Patel, Senior Policy Advisor, CDRH FDA


2:45 – 4:00 ROUND TABLE Risk Control of ISO 14971 A distinguished group of risk management experts will explore why the industry continues to struggle with ISO 14971, and will provide complete take away solutions to overcome the most common challenges with this standard through practical case study projects.

- Detailing how to establish and maintain a more robust risk management program

- Going beyond Failure Modes and Effects Analysis – Exploring the most effective risk assessment methods

- Discussing the updated change of the use of risk control of ISO 14971 amendment 2

David Vogel, Ph.D., Founder and President, Intertech Engineering Associates

Orlando Guillory, Director of Quality Engineering, Edwards LifeSciences

Walt Murray, Director of Quality & Compliance Services, MasterControl

Seyed Khorashahi, Director, Software Engineering, COVIDIEN

Addressing the Regulatory and Legal Challenges of 3D Printing

2:45 – 3:30 PANEL DISCUSSION The FDA and 3D printing waltz

- Discussing the current and future role of the FDA in additive manufacturing regulations

- Detailing the types of medical devices that the FDA have cleared/approved to date

- Addressing the potential technical concerns with 3D printing including mechanical properties, biocompatibility, process validation and interactive design

- Determining which technical assessments should be considered for review

Steven K. Pollack, Ph.D., Director of the Office of Science & Engineering Labs, FDA

William Brodbeck, Director, Regulatory Affairs, STERIS Corporation

Dave Flynn, Senior Business Development Manager, MATERIALISE

Severine Zygmont, Co-Founder, Oxford Performance Materials

3:30 – 4:00 Legal and intellectual property concerns associated with 3D printing

- Overview of patent, copyright, and trade secret law

- Review of current litigation involving 3D printing companies

- Exploring steps your company should be considering both from an offensive and defensive perspective to address intellectual property concerns

Reese Nguyen, Associate Attorney, KEKER & VAN NEST LLP


DAY TWO – WEDNESDAY, FEBRUARY 11th

TRACK A: Disruptive innovation in Design of Medical Devices



DESIGNING THE NEXT-GEN MEDICAL DEVICE: IDEO DESIGN WORKSHOP AND

ROUND TABLE

CHAIR: Brian Mason, Director, Design for Health, IDEO

TAKING CONTROL OF QUALITY: Dealing with Inspections, Managing Suppliers, and Improving

your QMS

CHAIR: Andrew Harrison, Vice President & General Counsel, Regulatory Compliance

Associates

Securing Finance, Scaling-Up from Concept to Market, and Best Practices in Lean

Manufacturing

9:30AM –

10:00AM

KEYNOTE ADDRESS Personalizing Surgery: 3D Printing and The Digital Thread

Andy Christensen, Vice President, Personalized Surgery & Medical Devices, 3D Systems Corporation

The Founder and CEO of Medical Modeling, who’s company pioneered 3D printing-centric personalized surgery and patient-specific medical device

solutions, will present the potential of a new 3D printing technology that will transform the healthcare industry.

10:00AM –

11:45AM

IDEO DESIGN WORKSHOP PART 1: Design research and inspiration

Improve your ability to deliver great design by learning and practicing key elements of the IDEO design process IDEO, the global design and innovation firm, has a history of delivering impactful, compelling, human-centered design to the world of medical and consumer products. Recently, IDEO received its 18th MDEA award—more than any other company in the world. At MD&M, IDEO will lead a fully interactive design workshop allowing the participants to flex their creative muscles and learn how to uncover and prioritize unmet user needs, brainstorm novel and creative solutions, and quickly prototype experiments to test concepts. The workshop will use case studies of existing products on the market to describe the steps and tools of the design process.

How to Audit Proof your Processes and Effectively Prepare for an Inspection

10:00 – 10:45 Being audit ready at all times in an inconsistent inspection environment

- What have been the most problematic aspects of FDA audits and inspections over the last 12 months?

- Defining what true inspection readiness is to pass any inspection with flying colors

- Focusing your quality programs on the right thing to overcome inspection inconsistencies

- Discussing if and why audit and inspection challenges going to overtake 510(k) and PMA submission headaches?

Uwe Degenhardt, Director, Quality Compliance, EDWARDS LIFESCIENCES

Dennett F. Kouri, Jr., JD, Senior Director, Quality, Regulatory & Clinical, EDWARDS LIFESCIENCES

Financing, Funding and Start-Ups

10:00 – 10:45 Startup Shark Tank California 3 hammerhead financiers will grill 4 Californian medical device start-ups on why they should be given finance. Only 1 startup will come out alive.

The sharks and the audience will decide… Anne DeGheest, Managing Director, Healthtech Capital

David M. Anderson, Managing Director, GE CAPITAL

Rik Vandevenne, Director of Capital Funds, River Cities Capital Funds


Whether you are working on upgrading an existing device or creating a completely novel offering, this hands-on workshop will provide you with some new tools and perspectives in how to deliver disruptive human-centered products to the market.

- Design research: Uncovering user needs through in-context observations and analogous inspiration

- Synthesizing insights: Identifying patterns and human-centered insights that will set the foundation for the product design

A great group of innovators and designers led by Brian Mason, Director, Design for Health, IDEO

Megan Huston, Business Development Associate, IDEO

Jason Wilkins, Senior Mechanical Engineer, IDEO

10:45 – 11:05 How to survive an FDA inspection

- Step by step instructions on how to get a green light first time from the FDA

- Examining the importance of a mock inspection

- Best practices in improving your internal auditing and reliability testing protocols

- It’s all in the prep: Internal pre-audits and tighter controls on data and documents

Dawn Haake, Senior Director Global Quality Assurance, NuVasive

11:05 – 11:45 CDRH Quality Update 2015 Hear directly from the FDA where this in-depth presentation and Q&A forum will provide more clarity on quality updates for this coming year.

- Enforcement trends - Quality initiative

o Quality information for inspections o Quality library of successful practices

William MacFarland, Director of Division of Enforcement, CDRH, FDA

10:45 – 11:05 How to secure funding from a Financier’s perspective

- Overview of investment trends in early and late stage start ups

- Discussing the real impact of the reimbursement strategy on finding finance

- Making sure you have a strong capital efficient business model

- Discussing future VC finance strategies and what they look for in a medical device start up for long-term success

Rik Vandevenne, Director of Capital Funds, River Cities Capital Funds

11:05 – 11:45 PANEL DISCUSSION Learn the secrets to a successful startup An already thriving group of startups will give the audience a closer look at what differentiates them from the many startups who have failed within the medical device industry. David Mills, President & Chief Executive Officer, Dallen Medical

Richard Meyst, President & Chief Executive Officer, Fallbrook Engineering

Charlie W Chi, Ph.D., President & Chief Executive Officer, Somersault Orthopedics


1:00PM –

2:30PM

IDEO DESIGN WORKSHOP PART 2: Ideation and prototyping

- Brainstorming: Learn seven rules that unlock the creative power of a brainstorming session, to generate a huge range of ideas, opportunities, and concepts—tips you will for sure take back and change how your teams brainstorm

- Prototyping: Experience the incredibly effective way of making ideas tangible, learning through making, and quickly getting key feedback to learn (or fail) early

- Feedback: Tools for prioritizing feedback and other design constraints in play

A great group of innovators and designers led by Brian Mason, Director, Design for Health, IDEO

Megan Huston, Business Development Associate, IDEO

Jason Wilkins, Senior Mechanical Engineer, IDEO

Improving your Supplier Quality

1:00 – 1:50 PANEL DISCUSSION Building an airtight supplier quality agreement

- Detailing best practices in supplier quality audit plans

- Best practices in how to renegotiate your supplier contracts

- Supplier risk management – how to comply with changing compliance

- Discussing FDA guidance for CMO quality agreements

David Parkin, Senior Supplier Quality Lead, VOLCANO CORPORATION

Gus Rathgeber, Ph.D., Director of Global Supplier Quality & Vascular Products, DJO GLOBAL

Jeffrey Ray, Principal Engineer, Supplier Quality, CareFusion

Marindy Waldron, Senior Manager, Supply Chain, Procurement and New Projects, St. Jude Medical

Jarod Oldham, Global Supplier Assurance Manager, St. Jude Medical

1:50 – 2:10 Protecting your Intellectual Property (IP) when working with your suppliers

- Conducting Intellectual Property due diligence and protection strategies for large and small companies

- Gaining insight into foreign filing considerations, licensing and distribution

- Updates on technology confidentiality and branding strategies

Mircea Tipescu, Intellectual Property Attorney, BRINKS, GILSON & LIONE

Strategies for Successful Scale-Up from Design to Manufacturing

1:00 – 1:50 PANEL DISCUSSION The outsourcing tipping scale: Making it work for you

- Evaluating the pros and cons of this ever changing outsourcing/inhousing landscape

- Best methods in utilizing CMO’s expertise - Discussing how the digital health

movement will bring about new outsourcing partnerships

- Gaining insight into future outsourcing trends in the BRIC markets

- Utilizing the CMO’s capabilities to improve time to market

MODERATOR: Shriram Venkataramana, Manager, China MedTech Insights, Decision Resource Group

Noreen King, Founder & President, Evolve Manufacturing Technologies

Barry Kazemi, Chief Executive Officer, Life Science Outsourcing

Julia Wall, Consulting Analyst, Decision Resources Group

1:50 – 2:10 Minimizing supply chain costs on new launches and product redesigns

- Understanding the impact of launch on existing products, materials, and suppliers

- Streamlining cross-functional NPI and redesign projects to minimize costs of transition

- Choosing agile suppliers to support ramp up of product demand

Irina Cantez, Director Global Strategic Sourcing, DJO Global


2:10 – 2:30 Reviewing the significant developments in EU Medical Devices Regulation and Notified Bodies unannounced visits

- Learn the latest on the future for the proposed EU Medical Device Regulation replacing the current Directive

- Evaluating the proposed changes to understand the implications for device manufacturers

- Making sure your processes support EU expectations and increased scrutiny

- Understanding and being prepared for NB unannounced visits now occurring for CE Marking

Paul Brooks, Senior Vice President, Healthcare Solutions, BSI Group

2:10 – 2:30 Streamlining your scale-up processes to accelerate speed to market

- Exploring top 10 must do best practices to shorten concept-to-market time

- Increasing your efficiency with your current technology

- Acquiring and agreeing on stable and sufficient product requirements before embarking on development

- Incorporating user needs and risk management at the start of a product development plan

Eric Steuben, Vice President, Operations, Asante Solutions, Inc.


2:45PM –

4:00PM

IDEO DESIGN WORKSHOP PART 3: Innovation thought leadership round table

discussion

As time permits, bring your specific challenges or questions from inside your design teams, cubicles, lab benches, or fieldwork… and we will engage in a discussion with leading innovation experts about how you can use design thinking and create novel medical device concepts in disruptive ways. Brian Mason, Director, Design for Health, IDEO

William Pratt, Director of Creative Design, KINAMED

Matt Duncan, President, Morphix Design

Kenny Dang, Vice President, Global Innovation & Development, Lombard Medical Technologies

Effectively Implementing a Quality Management System

The importance of a global Quality Management System: Drug Device Combination product case study and workshop The global market for DDC products is expected to grow to $115.1 billion. With many medical device manufacturers partnering with Pharma companies or growing their own DDC portfolio, making sure you have a strong DDC QMS in place should be a priority. This hands-on workshop will discuss examples of internal and external supplier relationship challenges and opportunities in exploring combination product development strategies, as well as the regulatory strategy of DDCs to comply with 21 CFR 210/211 and 21 CFR 820. James Wabby, Director, Quality Systems and Risk Management (Medical Devices and Combination Products), Allergan

Lean Manufacturing: Beyond the Basics

Lean Transformation for Medical Device Development and Manufacturing

- Identifying why most lean programs fail to produce lasting results

- Explaining why a lean transformation model should be based on Key Process Indicators (KPI) and Key Behavioral Indicators (KBI)

- Exploring how strategy deployment and A-3 thinking can be used to cascade metrics and goals down to the front lines

- Explaining how to operationalize lean daily management and daily Kaizen using A-3 and the Improvement Kata

Darren Dolcemascolo, Senior Partner, EMS Consulting Group

Ken Flaherty, Lead Lean Transformation Consultant, EMS Consulting Group


DAY THREE – THURSDAY, FEBRUARY 12th

TRACK A: Disruptive Innovation in Design of Medical Devices



DESIGNING FOR THE USER: Improving User Experience, Usability

Engineering, and Design Controls

CHAIR: Andrew Schaudt, Director of Usability Services, MEDSTAR HEALTH

BEST PRACTICES IN PROCESS VALIDATION AND BIOCOMPATIBILITY TESTING

CHAIR: Suhas Kulkarni, President, FIMMTECH

POST MARKET COMPLIANCE CHECK-UP: How to avoid warning letters, submission reviews,

and UDI updates

CHAIR: Elaine H Tseng, Partner, King & Spalding

9:30AM –

10:00AM

KEYNOTE ADDRESS The Hackers Guide to the Galaxy

Jay Radcliffe, Senior Security Consultant & Researcher, Rapid 7

The cybersecurity expert famously known for hacking his own insulin pump in 2011, takes to the stage to question how medical device security has progressed over the last 4 years.

10:00AM

–

11:45AM

Improving User Experience and Usability Engineering

10:00 – 10:45 PANEL DISCUSSION: How to design a robust usability study and understand the relationship between usability testing, risk management, and product development

- Designing your study and exploring what variables you want to incorporate

- Top tricks in early identification of use errors

- Discussing how to best document and apply task analysis and use error analysis

- Addressing the constraints of usability testing

- Making a strong business case for Human Factors and demonstrating how it can directly reduce the bottom line

Eric Bergman, Human Factors Engineering Director, Fresenius Medical Care

Merrick Kossack, Manager, Human Factors Engineering, Intuitive Surgical

Tressa Daniels, User Interaction Design Manager, CareFusion

Joely Gardner, Ph.D., Professor of User Experience & Usability, Cal State Fullerton


10:00 – 10:45 Standardizing your validation master plan

- Covering the key principals of process validation and addressing the main issues the industry continues to struggle with

- Defining the regulatory definition of process validation

- Encompassing different products and devices under 1 validation plan

- Designing a better reliability test program and QC testing after validation

- Using process validation for ISO 14971 risk reduction

Robert Launsby, President, Launsby Consulting

Thomas Oesterle, President, MedHouse Innovations

10:45 – 11:15 WORKSHOP: Improving quality through a DoE approach to process validation

- Exploring the advantages of the DoE approach versus one factor at a time

- Making sure QSR 820 Part 21 and ISO 13485 are met

How to Avoid Product Warning Letters and Recalls

10:00 – 10:45 Effectively responding to 483’s and warning letters

- Making sure you are not a repeat offender - Gain insights from interactive case studies and

examples from other compliance initiatives

- Highlighting the key 2013/2014 warning letter findings

- Identifying the appropriate course of action and preparing for a timely response

Kristen Grumet, Executive Director, Medical Devices, NSF International

10:45 – 11:15 Preparing for an effective review and response of medical device recalls

- How to survive and manage a successful recall

- Determining when a recall is needed - Minimizing the current and potential risk

Doris M. Apel, Recalls Manager, Varian Medical Systems


10:45 – 11:15 The ‘How To’ in implementing and executing IEC 62366

- How to practice usability above and beyond IEC 62366

- Gaining insight into real world case studies on how to follow this new standard

- Simplifying the standard and detailing essential details for Part 1 and Part 2

- Getting to grips on how to obtain FDA approval in Human Factors and usability testing

Edmond Israelski, Ph.D. Director Human Factors, Abbvie

11:15 – 11:45 Back to the Future: Usability in the Year 2045 Since MD&M West launched 30 years ago, the medical device industry has seen staggering change. Stuart Karten, product designer and 30-year industry veteran, will transport you to the future to imagine what the next 30 years has in store. Come learn how successful medical device companies can create positive user and patient experiences that adapt to tomorrow’s needs.

- What human factors challenges will shape the industry?

- Who will use medical devices, and how will their lives, abilities, and expectations change?

- What’s in store for the burgeoning field of wireless, wearable devices?

Stuart Karten, Founder and President, Karten Design

- How can DoE highlight opportunities to improve quality?

- Using DoE to demonstrate what variables can be tolerated

Robert Launsby, President, Launsby Consulting


11:15 – 11:45 Validation project management rapid workshop Now to get your hands dirty with some process validation practical work. Bounce ideas off your peers, benchmark your process validation procedures and work out your validation kinks to take back to the office. Robert Launsby, President, Launsby Consulting


11:15 – 11:45 Insight: FDA’s Review & Classification of Medical Device Recalls

- Discussing the fundamentals of medical device recalls

- Examining the roles and responsibilities associated with a medical device recall

- Exploring recall related challenges and best practices

Jessica Paulsen, Biomedical Engineer, FDA


1:00PM –

2:30PM

Designing for Better: Hospital Collaboration, Usability and Design Control

1:00 – 1:45 PANEL DISCUSSION: Straight from the hospital’s mouth: Improving collaboration between the end user and manufacturer A panel of physicians will discuss the benefits of bringing the end user into the design stage. This discussion will emphasize the importance of physician feedback: is this considered at the design phase? What is the interaction between engineer and doctor? How can you strengthen your relationship with your end users? MODERATOR: Andrew Schaudt, Director of Usability Services, MedStar Health

Ross Donaldson, MD, MPH, CTropMed, FACER, Director of Emergency Medicine, Global Health Program, Harbor-UCLA Medical Center

Raj Khandwalla, MD, MA, FACC, Director of Cardiovascular Education Cedars Sinai Medical Foundation, Cedars-Sinai Medical Group and Cedars-Sinai Heart Institute

William B. Armstrong, M.D, Professor of Clinical Otolaryngology-HNS, Chair, Dept. Otolaryngology-HNS, UNIVERSITY OF CALIFORNIA

1:45 – 2:30 Prioritizing Human Factor considerations in design control

- Best practices in building Human Factors into your design control program

- Identifying the vital role that human factors plays in designing a safe and effective device

- What is the FDA looking for? - Exploring Human Factors Engineering

processes related to Design Control in 21 CFR 820

Dennis Rubenacker, Senior Partner, NOBLITT & RUELAND


1:00 – 1:30 Validating software used for process automation Participate in this hands-on session to problem solve the toughest software process automation ‘glitches’.

- What kind of software needs to be validated?

- 21 CFR 820.70(i) requirements of software validation for process automation

- Exploring the 21 CFR Part 11 demands Vincent DeFrank, Software Validation Manager, Philips Healthcare

1:30 – 2:00 Global validation programs: Sharing the knowledge

- Proving the importance and cost saving opportunities

- Discussing the benefits of transforming your global validation paper processes to electronic

- Exploring the best electronic validation systems available

- Is there still a language barrier? Regina Rohe, Senior Director, Global Validation, bioMerieux

2:00 – 2:30 ROUNDTABLE DISCUSSION: Process Validation Question Time Now to get all your questions answered! This expert panel of speakers will talk through some real life case studies and discuss how successful process validation procedures and techniques will keep you on track with FDA’s Quality System Regulation and the Process Validation Guidance. Robert Launsby, President, Launsby Consulting


Vincent DeFrank, Software Validation Manager, Philips Healthcare

Regina Rohe, Senior Director, Global Validation, bioMerieux

Regulations for the Engineer: Aiming for First Time Submission Approval

1:00 – 1:30 Developing a regulatory strategy for fulfilling FDA regulatory requirements

- Recognizing regulatory opportunities for achieving company objectives

- Understanding the advantages and disadvantages associated with the pathways to market

- Anticipating submission requirements for PMA, 510(k), de novo classification and IDE

- Understanding FDA requirements for device modifications

- Developing and implementing an effective submission strategy

Phil Phillips, President, Phillips Consulting Group

1:30 – 2:30 WORKSHOP: Getting your submission approved in under 1 hour Now that you are even more familiar with the various submission processes, you will be given group projects to get your teeth into. 3 real life case studies that didn’t gain approval first time round – what lessons can you learn from these previous errors? Elaine H Tseng, Partner, King & Spalding


2:45PM –

4:00PM

Practical Applications of Design Control

Design control tune-up check Finish off your MD&M West Conference experience with a practical Design Control workshop which will give you more hands-on knowledge on how to identify noncompliance areas and implement improvements to accelerate speed to market. - Evaluating different methods of managing

the design control process

- Focusing on design controls related to risk management

- Understanding the benefits of early implementation and creating innovative test plans

- Avoiding a slowdown in development and increase in costs

- Updates on where the FDA is commonly finding noncompliance issues

- Making sure your regulatory processes fit hand in hand with your design control procedures

David Amor, Managing Partner, MEDgineering

Complying with Biocompatibility Testing Standards and Guidance to get your Product

to Market Faster

Biocompatibility testing: All you need to know in 75 mins! This intensive end of day workshop will give you the latest information on how to comply with the new standards. Go back to your office invigorated and up to speed with everything you need to know about biocompatibility testing.

- Insightful guide to the newest FDA guidance document on biocompatibility

- What are the main challenges of ISO 10993-1 and how can they be overcome?

- Exploring FDA expectations for biocompatibility testing

- Determining which biocompatible tests are best for your products and devices

- Improving your risk management strategies for testing

Edward Reverdy, Ph.D., Director of Global Toxicology & Biocompatibility, Boston Scientific

Thor Rollins, Biocompatibility Specialist, Nelson Laboratories

UDI: What’s in store for 2015 and beyond?

Looking past the regulation: Understanding how UDI will impact your department in 2015 This dedicated UDI session will take both a retrospective look back on the September 2014 deadline for class III medical devices to address how effective the implementation has been, but will also detail what lessons can be learned for the approaching 2015 deadline.

- Exploring how class II medical device companies can get ready for the deadline

- Comparing other company UDI methodologies to improve and re-engineer your 2015 implementation

- Update on international UDI guidance - Detailing what additional software and data

management requirements will be needed for successful UDI implementation

- Discussing real case studies where UDI implementation has resulted in better quality and lower costs

Dawn Fowler, Senior Manager, Labeling/Documentation/Training, Endologix

4:00PM –

4:15PM To celebrate the end of a successful MD&M West Conference, we are giving away a free 3D printer. It’s well worth the wait!

Documents

AGENDA AT A GLANCE - Manufacturing Events and Media …€¦ · AGENDA AT A GLANCE DAY 1: FEBRUARY 10TH, ... Engineering Overhauling your Process ... M.D., Founder & Chief Medical