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© Performance Review Institute
© Performance Review Institute
Leveraging Growth Opportunities Through MedAccredMarch 21, 2018
© Performance Review Institute
Connie Conboy
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Connie Conboy, Director, MedAccred, is responsible for the MedAccred program, an industry managed critical manufacturing supply chain oversight process for the Medical Device Industry.
© Performance Review Institute
Bill Donohue
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Bill Donohue, President, Executive Director, GENEDGE, has consistently been able to incorporate expertise within a wide variety of high impact disciplines such as Supply Chain Optimization, Growth Services and Innovation, Lean Six Sigma, and Strategic Planning. The creation and delivery of unique client solutions has been enhanced by his prior executive experience with market leaders such as General Electric (GE).
© Performance Review Institute
Anthony Cerilli
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Anthony Cerilli, Director of National Programs, GENEDGE, is leading the national Manufacturing Extension Partnership (MEP) program to assist medical device manufacturers in achieving MedAccred accreditation. This important MEP program is focused on growing manufacturing jobs within the United States while improving medical device product quality and patient safety.
© Performance Review Institute
MedAccred Addresses Current Industry Challenges…
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Outsourcing and globalization of the supply chain
Inadequate Purchasing Controls (one of the top cited FDA-483 observations)
Inadequate Flow Down of design requirements from OEMs to first-tier and sub-tier suppliers
Quality issues in specific technology areas:
Batteries, PCBAs, Power Sources, Sterilization, Cable & Wire Harnesses, etc.
Outsourcing and Globalization of the supply chain
Increased number of Recalls
Need to enhance Patient Safety
© Performance Review Institute
Cost of Poor Execution
At a recent FDA meeting, a leading industry executive discussed the significant Cost of Poor Execution:
1 CAPA = $50,000 - $100,000 to close out
1 FDA 483 = $500,000 - $1.5M to address
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October 10, 2017
FDA - Voluntary Medical Device Manufacturing and Product Quality Program
© Performance Review Institute
What is MedAccred?
MedAccred is an industry-managed supply chain oversight program for critical manufacturing processes that:
• reduces risk to patient safety
• assures quality products
• verifies compliance with requirements
Actual MedAccred Cable & Wire Harness Audit
© Performance Review Institute
MedAccred audits verify an Accredited Supplier has the:
• critical process capability, • necessary equipment, • controls, • qualified personnel, • process validation, • and sub-tier controls
following requirements as defined by industry standards, manufacturing best practices, and OEM requirements.
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What does MedAccred Do?
Actual MedAccred Plastics Injection Molding Audit
© Performance Review Institute
MedAccred Audits are Production and Process Assessments
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In D
epth
Crit
ical
Pro
cess
Focu
s
Quality Systems Audit
Crit
ical
Pro
cess
Aud
it
General Quality Focus
“1 mile deep on the critical process, 1 inch
wide on the quality system”
“1 inch deep on the critical process, 1 mile
wide on the quality system”
...NOT a General Quality (QMS) audit.
Actual MedAccred Cable & Wire Harness Audit
© Performance Review Institute
How Did MedAccred Start?
Johnson & Johnson conducted a benchmarking study of Heat Treating suppliers
• Found significant quality differences between PRI Nadcap Accredited and non-accredited suppliers
• To achieve better quality, they asked PRI to start a new program
Leaders from the other major Medical Device companies supported creating this new program
With encouragement from FDA, the industry established the MedAccred program
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© Performance Review Institute
MedAccred Subscribers and Other Active Participants
• Abbott• Becton, Dickinson & Co.• Benchmark Electronics• Cordis (a Cardinal Health Co.)• Flex• GE Healthcare• Illumina• Kaynes Technologies• Kimball Electronics
• Mack• Paragon Medical• Plexus• Sanmina• Sterigenics• Steris• Steri-Tek• Varian Medical Systems
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Subscribers fund program, determine audit criteria, have full access to audit findings, and determine who is granted MedAccred Accreditation.
• Baxter
• Boston Scientific
• Johnson & Johnson
• Medtronic
• Philips
• Stryker
Other Actively Participating OEMs and Contract ManufacturersSubscribers
© Performance Review Institute
MedAccred Critical Process Accreditations
• Cable & Wire Harness
• Heat Treating• Metal Systems (Carbon & Alloy Steel / Tool Steel / Stainless Steel /
pH Steel/ Cast Iron / Aluminum Alloys / Titanium Alloys/ Heat Resisting Alloys / Other Nonferrous Metals)
• Heat Treating Processes (Normalizing / Annealing / Hardening & Tempering / Solution & Aging / Carburizing / Nitriding / Stress Relieving)
• Heat Treating Equipment (Furnace / Pyrometry / Instrumentation / Atmospheric Control / Quench Systems / Refrigeration)
• Brazing (Vacuum Brazing / Atmosphere Brazing)
• Plastics – Extrusion• Tubing / Profile• Sheet / Film• Blown Film
• Plastics - Injection Molding • Compression Molding• Injection Blow Molding• Insert Molding
• Plastics – Mechanical Assembly• Adhesives / Bonding• Mechanical Fasteners• Ultrasonic Welding
• Printed Boards (Bare Boards)• Flexible• Rigid
• Printed Circuit Board Assemblies (PCBA)
• Sterilization• Ethylene oxide• Radiation (Gamma & E-Beam)
• Sterile Device Packaging• Forming Sterile Barrier Systems• Assembly of Packaging Systems• Sealing
• Welding• Electron Beam • Fusion • Laser
Key:Completed Audit CriteriaCurrently Piloting Audit CriteriaAudit Criteria Under Development
• Over-Jacketing• Co-Extrusion• Ram Extrusion
• Overmolding• Transfer Molding
© Performance Review Institute
How Does MedAccred Work?
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Audit Criteria Developed
Process Evaluation/ Improvement
Corrective Actions Completed
Audit Reviewed
Auditors Selected
Medical Device Industry leaders manage all key
stepsAccreditation Granted
Audit Conducted
Administered by the Performance Review Institute (PRI), a not-for-profit trade association, on behalf of leaders in the Medical Device Industry.
© Performance Review Institute14
Through MedAccred, the industry is…
… enhancing requirements through technical Task Groups,MultipleCustomer
Requirements
Medtronic
Johnson & Johnson
Stryker
Philips
… conducting more rigorous critical process audits annually with experienced technical experts…
Tiers 1 & 2
… and reaching further down the supply chain.
Supply ChainTiers 1 & 2
Tier 3
Tier 4
Tier 5
Rigorous Industry Standards
Manufacturing Best Practices+
OEM-specific Requirements
Medtronic
Baxter
OEM
© Performance Review Institute
Global Reach
Accreditations have been granted in the following countries:
• United States
• Mexico
• Costa Rica
• China
• United Kingdom
• France
• Romania
• Austria
• Malaysia
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MedAccred Accreditations reach around the globe, with many additional countries planning audits soon…
© Performance Review Institute
MedAccred Supports Key Elements in the Maturity Model for Quality…
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FOCUS: Ensure compliance to critical
manufacturing process requirements
Supplier Quality
Critical to Quality
FOCUS: Derived fromDFMEA/ PFMEA
FDA Case for Quality
FOCUS: Improve quality with a CtQ
focus
Support SupportSupport
…beyond just compliance
© Performance Review Institute
US FDA CDRH Recognition of AMS 2750 - Pyrometry
FDA CDRH provided complete recognition of AMS 2750 Standard
AMS 2750 Pyrometry is the cornerstone standard used in the MedAccred audit criteria for Heat Treating Pyrometry
FDA defers to recognized consensus standards when reviewing products during the pre-market phase
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© Performance Review Institute
U.S. Government Support for MedAccred
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© Performance Review Institute
The MEP National Network™
A unique public-private partnership that delivers comprehensive, proven solutions to U.S. manufacturers, fueling growth and advancing U.S. manufacturing. It comprises:
• 51 MEP Centers located in all 50 states and Puerto Rico
• Over 1,300 trusted advisors and experts
• More than 400 MEP service locations,
Providing any U.S. manufacturer with access to resources they need to succeed.
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© Performance Review Institute
The MEP National Network™
The MEP National Network is built on three unique qualities:
1. Comprehensive services, national reach, and thousands of connections
2. Focused on affordable solutions for small and medium-sized manufacturers (SMMs), and
3. Demonstrable, measurable, validated business results/impact
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© Performance Review Institute
In 2017, the MEP National Network connected with 26,313 manufacturers, leading to
• $12.6 billion in client sales,
• $1.7 billion in client cost savings,
• $3.5 billion in new client investments, and
• helping to create and retain more than 100,000 U.S. manufacturing jobs.
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The MEP National Network™
© Performance Review Institute
NIST MEP Federal Funding Award
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GENEDGE received a $1 million multi-year award from the National Institute of Standards and Technology (NIST) to assistance in establishing a program to help U.S. medical device and medical instrument manufacturing facilities gain MedAccred Accreditation.
The Medical Manufacturers MedAccred Accreditation Pathway (MedMMAP) is a national program which is being led by GENEDGE, with 6 partner MEP Centers.
© Performance Review Institute
Medical Manufacturers MedAccred Accreditation Pathway — MedMMAP
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MedMMAP provides manufacturers (suppliers) with efficient and effective audit preparation for MedAccred Accreditation, to increase competitiveness, decrease industry costs, and improve patient safety.
We help to increase the competitiveness of American medical device and medical instrument manufacturing supply chains in the global marketplace.
© Performance Review Institute
MedMMAP’s industry experts will perform a pre-audit assessment to the MedAccred audit criteria and work with supplier to develop a plan to address each area of need.
MedMMAP’s industry experts have the resources of the MEP National Network to help close the gaps identified in the pre-audit, all the while mentoring facility staff in the accreditation process.
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Medical Manufacturers MedAccred Accreditation Pathway — MedMMAP
© Performance Review Institute
MedMMAP works with suppliers with a manufacturing NAICS code at facilities within the United States who are committed to achieving MedAccred accreditation.
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Medical Manufacturers MedAccred Accreditation Pathway — MedMMAP
During the rollout, activities will be focused regionally with our partner centers.
© Performance Review Institute
For more information about the MedMMAP program, or to express interest in MedMMAP assistance, visit our website at MedMMAP.org
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Medical Manufacturers MedAccred Accreditation Pathway — MedMMAP
Or email [email protected]
© Performance Review Institute
What are the Benefits to Suppliers?
Improves quality of products, reduces scrap and re-work
Opportunity to reduce liability insurance costs
Potential to expand business
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© Performance Review Institute
Upcoming Events
Q1 Productions - 7th Semi-Annual Risk Based Medical Device Supplier Quality Assurance Conference
• April 23-24, 2018 - Arlington, VA • Scott Dauphinee, Johnson & Johnson
• Paul Hugo, Global Technologies
• Connie Conboy, MedAccred
2018 Florida Medical Device Symposium• May 14-15, 2018 – St. Petersburg, FL
• Courtney Young, Medmarc
Q1 Productions - 8th Semi-Annual Risk Based Medical Device Supplier Quality Assurance Conference
• June 11-12, 2018 - Minneapolis, MN• Scott Goolsbey, Stryker
• Ann Sheldon, Medtronic
• Connie Conboy, MedAccred
© Performance Review Institute
Thought Leaders See the Impact…
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MDT Magazine Editor identified MedAccred as 1 of 3 top medical device industry trends
Medical Design Technology Magazine, 2016
© Performance Review Institute
For more information:
www.medaccred.org
www.MedMMAP.org
Concluding Thoughts & Next Steps
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TO IMPROVE PATIENT SAFETY
Connie ConboyDirector, [email protected]
Anthony CerilliDirector of National Programs, [email protected]
Justin McCabeMedAccred [email protected]
© Performance Review Institute
Medmarc and MedAccred Webinar Series: Critical Manufacturing Processes
• PCBA / PB (7Dec16)• Michael Brown – Stryker, Julia Markardt – MedAccred
• Heat Treating (18Jan17)• Bruce Dall – Stryker, Ed Engelhard – Solar Atmospheres, Marcel Cuperman – MedAccred
• Electronics: Cable & Wire Harness (17May17)• William Brennan – GE Healthcare, Paul Hugo – Global Technologies,
Julia Markardt – MedAccred
• Plastics: Injection Molding & Extrusion (21Jun17)• Sasha Brishkovski – Johnson & Johnson, Roy Holmberg – Stryker,
David Rittenhouse - MedAccred
• Sterilization (12Jul17)• Kim Patton – Becton, Dickinson & Co., Rod Parker- Stryker, Mark Aubele - MedAccred
• Welding (13Sept17)• Brent Esch – GE Healthcare, Ra’Shaaun Lane - Johnson & Johnson,
Gabe Kustra – MedAccred
• 2018 Webinar Series Plans:• Plastics – Mechanical Assembly, and Sterile Device Packaging
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View Recordings Here:youtube.com/MedmarcIns