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© Performance Review Institute


Leveraging Growth Opportunities Through MedAccredMarch 21, 2018


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.


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).


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.


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


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


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


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


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


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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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


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


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


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…


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


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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U.S. Government Support for MedAccred

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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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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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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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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.


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.


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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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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During the rollout, activities will be focused regionally with our partner centers.


For more information about the MedMMAP program, or to express interest in MedMMAP assistance, visit our website at MedMMAP.org

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Or email [email protected]


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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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


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


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]

http://www.medaccred.org/

http://www.medmmap.org/

mailto:[email protected]




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

leveraging growth opportunities © performance review ......ams 2750 standard ams 2750 pyrometry is...

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