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Minutes of a Roundtable Meeting of the(proposed) Industry-Managed Critical Manufacturing Process Supply Chain Quality Oversight Program

for the Medical Device Industry

15 May 2013 at Westin Hotel in Chicago, IL (USA)

1. Participants

Participants AffiliationKen Stopar Baxter HealthcareDan Whalen Baxter HealthcareVance Kyle DePuyBruce Badger GE HealthcareMatt Binkley GE HealthcareWilliam Brennan GE HealthcareJose Luis Estrada GE HealthcareJoe Gendron Paragon MedicalRavi Nabar Philips HealthcareJim Ahle Stryker Corp

Rebekah Braun PRIJustin McCabe PRIJoe Pinto PRI

2. Introduction

Joe Pinto welcomed participants to the meeting Participants were reminded of PRI’s guidelines for antitrust compliance Participants introduced themselves

3. Internal OEM Buy-in

Joe Pinto reviewed the Value Proposition document and asked participants to provide additional or clarifying detail. A few editorial changes were made, and are included in the updated embedded presentation (15May13 Revision)

Ravi Nabar suggested changing the term “Special Process” to “Critical Manufacturing Process” for this program, as the CGMP no longer makes reference to Special Processes and the medical device industry uses the terminology Critical Manufacturing Process and understands what this means. The previous CGMP definition for Special Processes does not fully cover the scope of this program and would cause confusion. For example, aspects of PCBA are not considered a Special Process by the FDA definition.

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Ken Stopar attended the MedCon conference at Xavier University (6-8 May 2013), and reported that Steve Silverman of the FDA has rolled out the “Case for Quality.” This document aligns with the goals of this program and further enhances the FDA’s Quality System Inspection Technique (QSIT) style of auditing

ACTION: (Ken Stopar - Item CLOSED 15May13) Ken Stopar to send PRI the PowerPoint version of Steve Silverman’s “Case for Quality” presentation

An IMDRF guidance document exists for conducting audits. Investigate how IMDRF aligns with our current activity. Kim Trautman of the FDA is very active in this activity.

ACTION: (Ravi Nabar – Item CLOSED 16May13) Ravi Nabar to distribute the IMDRF audit guidance documents to PRI

Ken Stopar stated that the Value Proposition was generally well received within Baxter, noting that this program goes beyond the high level QMS audit.

Ken Stopar mentioned the need to gain momentum on the supplier side, since Rx-360 has had some reluctance from suppliers in getting involved.

Bruce Badger responded that once we have enough Letters of Intent that we can take this to the FDA.

Ken suggested that PRI and program participants may want to consider presenting an update at the next

AdvaMed 2013 conference (23-25Sept13) ACTION: (Ravi Nabar - Item CLOSED 16May13 - PRI to review information and consider membership

options) Ravi Nabar to determine potential for PRI becoming a member of AdvaMed Ravi Nabar informed participants that he and Steve Niedelman submitted a paper on this program’s

development to Medical Device Congress, and were accepted to give a presentation at the 5 June 2013 MDC in Washington DC.

Ken Stopar stated that he presented a high level program overview at the recent MedCon conference and received some favorable responses from attendees. He volunteered to contact the organizer of the conference, Marla (??) of Xavier University, and see if she could provide us with a list of attendees.

ACTION: (Ken Stopar – 30Jun13) Ken Stopar to contact Marla (surname?) of Xavier University/MedCon to obtain a list of attendees

Joe Pinto presented a list of medical device industry OEMs and suppliers currently participating in program development at various levels activity. He also presented a list of top 40 companies to approach in order to achieve a critical mass of industry participation.

The question was asked whether we have enough critical mass to move forward. How do we generate excitement from the rest of industry? Do we need to develop a strategy? What can we do to get Letters of Intent signed?

Suggested strategy for additional OEM participation and buy-in:o Jim Ahle suggested a 3-pronged approach:

Present the program concept and activity at industry conferences and events Form sub-teams and task groups to conduct proof of concept audits and develop program

documents and to start doing the work Present Critical Mass list to OEMs, as well as the number of signed Letters of Intent

o Ravi Nabar suggested that currently participating OEMs could show more concrete examples to higher level management, ie showing how many audits annually would need to be conducted to break even

o Ken Stopar suggested to set up the next roundtable meeting in the Minneapolis-St. Paul to get additional companies involved (Boston Scientific, St. Jude Medical, Medtronic, etc.)

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o Suggestion was made to create a LinkedIn PRI Medical Device Industry group in order to send information to current participants, invite new participants and promote the program to the broader industry.

o ACTION: (Industry Participants, Ken Stopar, PRI – 30Jun13) Participating stakeholders to follow-up with companies that have not attended recent meetings and determine reasons for not participating/not signing the LOI. Document these responses and determine a strategic go-forward plan.

(Ken Stopar) Ken Stopar to contact Aric Anderson of Boston Scientific. (Ken Stopar) Ken Stopar to contact Matt Anderson of Merz Aesthetics. (Ken Stopar, PRI) PRI to set up meeting with Monica Wilkins of Abbott. Ken Stopar to contact

Monica prior to PRI. (PRI) PRI to contact Mark Price of Beckman Coulter.

ACTION: (Item CLOSED 16May13) Ravi, Ken and Justin to meet offline to decide which current members will contact those with less participation on the critical mass list

o 16May13 Telecom notes: A LinkedIn group would reduce cold calls. Cold calling should be for those who attended the

5Dec12 Chicago Roundtable ACTION: (PRI – 30Jun13) PRI to work with their Marketing department to develop the

LinkedIn group Following creation of the LinkedIn group, set up a Webinar to give the PRI & Nadcap

overview and Medical Device program development status. Face to face roundtable meetings should be scheduled regionally, in order to pull in

regionally diverse stakeholders ACTION: (PRI – Item CLOSED 21May13) PRI to add a column to critical mass list for

participant “Address Location” and “Reason why have not shown interest” ACTION: (PRI, Ravi Nabar, Ken Stopar – 30Jun13) Current active participants to reach out to

less active participants. Ask less active participants the reason why they have not shown interest and document.

PRI to send Ken and Ravi the list to divide up amongst themselves. PRI will then request other active participants to contact the remaining less active

participants

4. Engaging the Supply Chain

Discussed strategy for reaching additional supplier participants: o Prioritize working through current participating OEMs for names of suppliers. Suppliers who supply

to multiple OEMs are desirable. o PRI has drafted a supplier letter to support this activity

o Hold off on approaching supplier industry associations for now

ACTION: (Industry Participants, PRI – 30Jun13) PRI and OEMs to identify potential suppliers to get involved in program development and proof of concept audit activity:

o Sanmina – (Ravi Nabar, PRI) Ravi Nabar to meet with Tim McGinnis (20May13); PRI to follow-up after this meeting

o Flextronics – (Ravi Nabar, PRI) Ravi Nabar to meet with Harry Hari (23May13); if needed, PRI to follow-up after this meeting

o Plexus – (Jose Luis Estrada, PRI) Jose Luis Estrada to approach; PRI to follow-upo Benchmark Electronics – (Jose Luis Estrada) Jose Luis Estrada to approach; PRI to follow-upo Jabil – (Jim Ahle) Jim Ahle to approach

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o Coli (sp?) Foundry - (Matt Binkley) Matt Binkley to approacho Lake City Heat Treating – (Vance Kyle, PRI) Vance Kyle to approach; PRI to follow-up

5. Proof of Concept Audits

Joe Pinto provided an overview of proof of concept (PoC) audit process and summary of the Welding PoC audit (Fusion and Laser) conducted at a DePuy supplier.

Vance Kyle provided feedback on the Welding PoC audit:

o Very appreciative of PRI’s assistanceo The audit confirmed DePuy’s suspicions that there were some weaknesses in their current approach

to qualityo Current Nadcap welding checklist was 99% compatible with medical device requirementso Now aware of the need to expand specification follow-down to supplierso Now in no doubt that the medical device industry needs its own program

DePuy supplier stated that undergoing the PoC has strengthened their systems and found areas they know they can improve on

Ravi Nabar proposed to conduct PoC audits during currently scheduled QMS audits, to potentially save on cost.

Vance Kyle stated that there is value in going on site with the Nadcap checklist and auditor to conduct the audit

Joe Pinto presented a collaborative approach for conducting additional proof of concept audits. The goal for conducting these audits will be to get the most value and develop strong evidence, while saving resource for participating companies

Suppliers will be nominated by participating OEMs for participation (diversity of suppliers is recommended) PRI will work with OEMs and Suppliers to schedule the audits and prepare participating companies It was agreed that going forward, program participants will conduct 4 total PoC audits, 1 audit per

technology (Welding, Heat Treating, PCBA and Wire Harness). Each Task Group can decide whether to conduct additional PoCs if necessary

A sub-team was formed to coordinate PoC audits. This team will be responsible for identifying suppliers and coordinating PoC activity.

o Baxter (Ken Stopar) o DePuy (Vance Kyle) o Paragon (Joe Gendron) o Philips (Ravi Nabar) o Stryker (Jim Ahle)

The sub-team will attempt to identify suppliers who currently have scheduled QMS audits and who are common among multiple OEM customers.

ACTION: (PRI – 31May13) PRI to schedule an initial conference call with the PoC sub-team to begin coordinating activity

ACTION: (PRI – 31May13) PRI to send eAuditNet log-in details and system logic map to participants. Explain how to access checklists and program documents.

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Joe Pinto presented a DRAFT Non-Disclosure Agreement to participants and explained the importance of all parties to sign this document prior to conducting PoCs audits

ACTION: (PRI – 31May13) PRI to distribute electronic version of NDA to participants for review and

signature. Include in 15May13 Chicago meeting minutes ACTION: (Industry Participants – 30Jun13) Industry participants to review and return signed NDA to PRI

prior to conducting PoC audits

6. QMS Discussion

Ken Stopar mentioned that this is something the industry needs to address. He doesn’t think the industry can shift their resources toward process-audits until the QMS issue is resolved. Will have difficulty moving resources from QMS to critical manufacturing processes

Ravi Nabar doesn’t think this group should get distracted with QMS, as the issue might undermine our charter

Ken suggested working in parallel on both activities. Working with Rx-360. Jose Luis Estrada wants to focus on process audits and sees QMS reform as a medium to long-term goal Joe Pinto mentioned that we currently do a shortened version of AS9100 audits for the aerospace industry.

It is an extra 1-day audit. PRI could conduct a similar audit for the medical device industry Ravi Nabar has proposed to his leadership to shift their frequency of QMS audits from one every 1-3 years to

every 3-5 years and supplement those audits with critical process audits. Jim Ahle has similar feelings to Ravi Nabar Ken Stopar responded that QMS covers more segments of Baxter, as medical devices is only one of many,

and would therefore cover more ground.

7. Formation of Critical Manufacturing Process Task Groups

PRI presented a list of current Subject Matter Expert volunteers to participate in the critical manufacturing process Task Groups. During the discussion, participants provided/said they would provide the names of additional volunteers

o Welding – GE Healthcare (Matt Binkley); DePuy (Claire Wagner); Stryker (TBD); Symmetry Medical (volunteered as a supplier)

o Heat Treatment – GE Healthcare (Matt Binkley); DePuy (TBD); Stryker (TBD)o Electronics – PCBA – GE Healthcare (Bruce Badger); Baxter (Robyn Miller); Philips (TBD); Stryker

(TBD); Plexus (potential supplier?)o Wiring Harnesses – GE Healthcare (William Brennan); Baxter (Robyn Miller); Philips (TBD); Stryker

(TBD)o Sterilization – Stryker (Rod Parker); Baxter (Ken Stopar); DePuy (TBD); Philips (TBD)

ACTION: (Industry Participants, Stryker, DePuy, Philips) – 14Jun13) Participating companies to provide names of volunteers to participate in each critical manufacturing process Task Group activity

ACTION: (PRI – 30Jun13) PRI to schedule conference calls with each technology Task Group and a PRI Staff Engineer to with the objective to: provide educational content on member roles, objectives and expectations; provide background on how an industry-managed audit program works (if necessary); audit checklist development

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Sterilization Task Group discussion:o PRI has nominated a staff member, Mark Aubele, Senior Program Manager (Aerospace Quality

Systems / Electronics / Non-Destructive Testing / Measurement & Inspection) to guide Sterilization Task Group development

o Next Steps:

Medical Device industry Sterilization SME to assist Mark Aubele to gain a basic understanding of the sterilization process (June 2013)

Mark Aubele could meet with Rod Parker (Stryker) and Ken Stopar in the Chicago area to receive basic Sterilization training.

ACTION: (PRI – 30Jun13) PRI to schedule a conference call with Mark Aubele and Al Hartman (Baxter SME) to gain a basic understanding of the sterilization process

ACTION: (Ken Stopar – 30Jun13) Ken Stopar to send PRI details for a Baxter Sterilization training course for Mark Aubele to potentially participate

Finalize list of Task Group members (June 2013) Once Task Group members have been confirmed, PRI to schedule conference call with SMEs

and Mark Aubele with the objective to: provide educational content on member roles, objectives and expectations; provide background on how an industry-managed audit program works (if necessary) (July 2013)

Schedule 1-day working meeting to kick-start the Task Group, begin developing a checklist and other activities (Q3 or early Q4 2013)

8. Paris Nadcap meeting (3-7Jun13) – Medical Device Industry attendance and meeting

Participants discussed whether to send company representatives to the Paris Nadcap meeting (3-7Jun13). The objective of attending this meeting would be to pull new European stakeholders and gain additional buy-in from European representatives of currently participating companies.

Philips, GE Healthcare, Baxter, Stryker and DePuy stated they may send representatives if there was enough participation.

ACTION: (PRI – Item CLOSED 20May13) PRI to correspond with interested companies regarding the number of representatives planning to attend the Paris Nadcap meeting and determine whether to hold a medical device-specific meeting or not.

ACTION: (PRI – Item CLOSED 22May13 – due to lack of response, decision made not to hold a medical device-specific meeting) If adequate participation from participating companies, PRI to schedule a medical device industry meeting on 4 June during the Paris Nadcap meeting for new participants

ACTION: (PRI – Item CLOSED 24May13) PRI to schedule an industry roundtable meeting in London, UK on 9 July 2013 with the purpose to involve European medical device stakeholders. Send formal meeting invitation to industry.

9. Review of DRAFT Program Documents

Rebekah Braun presented the purpose and a brief overview of the DRAFT program document contents and highlighted a few key sections for discussion.

Discussion:o William Brennan proposed that Electronics (including PCBA’s) and Cable and Harness should be

considered as separate technologies and therefore separate Task Groups. Each technology would require a different SME. Suppliers rarely do both processes in the same facility.

Participants decided to develop separate Task Groups for each of these technologies

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o A tiered-approach to program subscription was discussed. For example, Tier 1 OEM subscribers would pay full subscription fee and have full access to supplier data, while Tier 2 OEM subscribers would pay a reduced fee and have limited access to supplier data

o One participant proposed dividing subscription by global multinational OEMs and regional OEMso ACTION: (PRI – 14Jun13) PRI to draft a tiered-subscription approach for inclusion in the Program

Document and distribute to Program Document sub-team members for comment. Include cost, requirements, access to data, etc.

o It was discussed that industry wants regulatory bodies to recognize this program t, but recommended that these bodies should not have voting rights in the Program Management Council or Task Groups

A sub-team was formed to continue to develop of the program document:o Baxter (Dan Whalen)o GE Healthcare (Bruce Badger)o GE Healthcare (Matt Binkley)o GE Healthcare (William Brennan)o Philips (Ravi Nabar)o Stryker (Jim Ahle)

ACTION: (Industry Participants – 14Jun13) Additional companies to volunteer participants for the Program Document sub-team and provide PRI with contact names

ACTION: (PRI – 21Jun13) PRI to schedule initial Program Document sub-team conference call, week of 17Jun13

10. Auditor Recruitment

New Sterilization auditors will be required as this technology does not currently exist for aerospace. Sterilization auditors will require specific medical device industry experience.

Additional auditors for other technology Task Groups (those currently existing in aerospace) will also be

required in the future. It has not yet been determined whether auditors for other technologies will require specific medical device experience.

ACTION: (Industry Participants – 30Jun13) Industry participants to consider potential auditor candidates for 5 initial technologies, especially Sterilization, and provide PRI with contact names.

11. Next Meetings

It was decided that face to face roundtable meetings should be scheduled every 2 months. Attendees should be senior leaders and managers from industry. Roundtables should be scheduled in conjunction with industry conferences and in different regions to assist in diversifying OEM and supplier attendance

Proposed 2013 face to face meeting dates/locations:o MD&M East – Philadelphia (17-20Jun13)

ACTION: (Ken Stopar – 7Jun13) Ken Stopar to ask MD&M East organizer for an opportunity to provide an update on our program’s activity

ACTION: (PRI – 7Jun13) PRI to follow up with Sara Dyson (Medmarc) who has a contact at MD&M, regarding a speaking opportunity at MD&M East and Minneapolis

o MD&M Minneapolis (29-30Oct13)

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ACTION: (Ken Stopar, Jim Ahle – 30Jul13) Ken Stopar to approach MD&M Minneapolis organizer for an opportunity to share the work of this initiative. Jim Ahle to support the presentation if needed.

ACTION: (PRI – 31May13) Draft a bi-monthly face to face meeting schedule for the remainder of 2013 and propose to industry participants for approval

ACTION: (PRI – 31May13) PRI to schedule reoccurring bi-weekly conference calls starting the week of June 17 to provide status updates on sub-team and task group activities and continue the momentum of program development. All medical device industry stakeholders will be invited to attend. Meetings will be scheduled for 1 hour, but length can be extended if necessary.