Due-diligence and Gap Analysis in Decision Making Process for Medical Companies

Scheduled On : Wednesday, February 26, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

In this seminar, we will discuss practical decision making steps you can follow to analyze whether to transfer or invest in keeping production in-house from a successful case study.  If it is decided to transfer production what are the options and next steps to transferring it to the right facility or contract manufacturer (CMO).

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 cash and floor space for new product initiatives. This webinar will give you the steps to follow in making decisions that could save money, time and people.  We will explore the importance of quality, cost and on time delivery/flexibility in making the right decisions.

CMO’s 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 Covered in the Session :

• Gap Analysis, Due-diligence and Decision Making 
• Choosing A Contract Manufacturer
• Request for Information (RFI), Request for Proposal (RFP), Request for Quote (RFQ)
• Supplier Audits
• Final Selection & Contract Negotiation
• Project Management
• Supply Chain/Inventory
• Master Validation Plan
• Protocols/Validations
• Transfer Process to an in-house facility or Contract Manufacturer
• Benefits
• Pitfalls
• Post Review/Lessons Learned

Who Will Benefit: 

This webinar will provide valuable assistance and give a procedure to the medical device industry that is thinking of transferring production to a Contract Manufacturer or transferring it to another facility. The personnel who will benefit include:

• Medical Device OEM’s
• OEM and Contract Manufacturing (CMO) Senior Management
• Decision Makers in regulated industries
• R&D and Product Development Engineers and Managers
• Business Development
• Pilot Plant Manager
• Operations Managers
• 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
• Contract Manufacturers
• Decision Makers in regulated industries
• Business Development
• Contract Manufacturers
• Plant and Production Managers
• Operation Managers
• Engineering and Contract Manufacturing Transfer Teams
• Project Management Teams
• Project and Process Engineers
• Quality and Validation Teams

Speaker Profile

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.