Transferring OEM Medical Device Production to a Contract Manufacturer – Decision Making Process with Procedures and Full Validation

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This webinar will provide methodology, processes and procedures to all medical OEM’s that have to make critical decisions concerning transferring equipment, molds, dies, systems and processes to contract manufacturers. It will follow a recent successful case study in the medical industry.

The medical industry is in transition. OEM’s are in the process of transferring more product and operations to contract manufacturers. Some OEM’s and contract manufacturers are struggling with how to deal with these transfers and validation standards. With the economy, many medical OEMs are deciding whether to invest in upgrading equipment, technology, new personnel, transfer it to a lower cost in-house facility or transfer it to a contract manufacturer. In many cases this could save the OEM from investing in costly bricks and mortar, new technology and higher labor cost. It also frees up floor space for new product initiatives.

This medical device webinar will provide valuable assistance and give methodology, processes and procedures to all regulated companies that are thinking of transferring equipment, molds, dies, systems and processes to contract manufacturers. It will guide you on how to choose the right world class contract manufacturer. It will also cover how important a master validation plan is to meet today’s a standard.

The presenter will use a case study-approach to guide you in the procedures and process of transferring equipment, systems and processes to meet the evolving standards for the medical industry. With the regulations for quality and validations getting more stringent with every transfer, it is imperative that companies are armed with the skills to plan and execute equipment, tools and process transfers properly. This is a step-by-step process to guide you in your transfer. It will follow a recent successful case study in the medical industry.

This webinar on outsourcing medical device manufacturing will discuss practical decision making steps you can follow to analyze whether to transfer or invest in keeping production in-house. If you decide to transfer production, then this training will detail the options and next steps to transferring it to the right facility or contract manufacturer.

This session will also benefit contract manufacturers, since they have to be ready for a seamless transfer of production by understanding their responsibility and the requirements for a medical device transfer, including the transfer process, validations and the pitfalls that could lead to delays.

Areas to be Covered:

Senior management responsibility
Team responsibility
Gap Analysis
Decision Making
Project Management
Choosing A Contract Manufacturer
equest for Information (RFI), Request for Proposal (RFP), Request for Quote (RFQ)
Supplier Audits
Final Selection & Contract Negotiation
Cost of validation
Risk plan
Contract negotiation
Master validation plan
Mold and component transfer
Supply Chain
Master Validation Plan
Transfer Process
Post Review

Who will Benefit:

This webinar will provide valuable assistance and give a procedure to the medical device companies that are in the decision making process of transferring production to a contract Manufacturer or transferring it to another facility. The personnel who will benefit include:

At Medical Device OEM’s:

Senior Decision Makers
R&D and Product Development Engineers and Managers
Pilot Plant Manager
Plant and Production Managers
Project and Process Engineers
Supply Chain Managers
Global Contract Manufacturing Transfer Teams
Global Strategic Managers
Quality and Validation Teams
Quality and Corporate Auditors

At Contract Manufacturers:

Senior Decision Makers
Senior Strategist looking to get into medical device contracting
Contract Manufacturers working in the medical industry
Plant and Production Managers
Engineering and Contract Manufacturing Transfer Teams
Project and Process Engineers
Quality and Validation Teams

Robert Braido

Robert Braido has 40 years of experience in the medical industry. He is president of Visionary Consulting LLC and has been consulting with medical OEM’s and CMOs for over 7 years. Mr. Braido’s has a broad breadth of medical industry experience in prototype/product development, global strategic/tactical planning, technical due-diligence/gap analysis for acquisitions, engineering, operations and business development. He has had great success working at Ethicon Endo-Surgery a J&J Company, Baxter Healthcare, Teleflex Medical, GW Plastics and The Tech Group with increasing responsibilities to the level of VP of Advanced Technologies. He was a member of the Board of Directors for the Society of Plastic Engineers Medical Division for over 10 years and elected Chairman of the Medical Division twice.

Mr. Braido was selected as a member of a Johnson & Johnson Integration Team that took a small fledgling endoscopic medical device company with totally new products, technologies and structure from $75 million to $850 million in 5 years. His career is built on the ability to motivate, lead and coach people in different disciplines throughout the medical industry. The key factor has been driving innovation.

Mr. Braido was elected, as the Consortium Chairman for the Government Reinvestment Program with MIT, the National Science Foundation and seven leading Fortune 200 companies to commercialize 3D Printing and emerging technologies in plastics and metal. He represented J&J as the principal investigator in the development of 3D Printing with the consortium. He has also been an independent reviewer for the National Science Foundation, J&J, MIT, EdgeOne Medical and others.

He has published numerous technical and leadership articles and white papers. In the past he has shared his extensive experiences at seminars, workshops, technical conferences, symposiums and webinars on subjects relating to the medical and plastics industries on due-diligence/gap analysis, product development, plastic and metal manufacturing, plastic product and equipment transfers, compliance, leadership and developing an innovation culture.

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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance