19 June 2012 Parsippany Hilton

Leadership and Innovation:  A Medical Device Project from Concept to Implantation

PDP Information:
Program Number: C020-19062012
Program Title:   Leadership and Innovation:  A Medical Device Project from Concept to Implantation
PDUs: 1.5
Category: A
Activity Sponsor: PMINJ Chapter (C020)

The meeting slides can be downloaded.


Robert C. Cohen

In the medical device industry, innovation is rapid and product offering competition is intense.  The time to market from concept to market release must account for many factors such as complexity of design, testing standards, production process determination, sterile packaging validation and the FDA acceptance cycle.  The more novel the design or biomaterial, the more uncertainty the product performance and development milestone timelines.  Budgetary considerations and go / no go decision points must be closely monitored.  The meeting of the product's plan objectives including revenue and margin targets will only be achieved with exceptional project management. 

An orthopedic joint reconstruction implant with a novel metal coating will be detailed through the milestones of a project plan and will highlight all phases of the project including R&D, manufacturing, quality assurance, sourcing, and finished goods to the end customer.  This example of accelerated product development and operations activities will demonstrate how a company-wide commitment to the product and project management resulted in a successful, on-time release of the implant system.

Robert C. Cohen is the Chief Technology Officer, Pipeline Biomedical.  Robert provides extensive experience in the strategic positioning of medical products and technologies for investment return. His technical engineering background brings in-depth knowledge to all phases of the product development cycle including research, design, intellectual property, manufacturing, physician evaluations, clinical studies and global regulatory.

Most recently, 
Robert served as Senior Vice President Tissue Engineering for Osteotech Inc., a biologic science & human tissue processing company. Robert had executive management responsibilities, including involvement with R&D, marketing, regulatory & clinical affairs, medical education, sales training and strategic business planning.   Previously, Robert served as President of Zimmer Spine, with world-wide annual sales of $150 million at that time. Prior to that, he was General Manager, Vice-President R&D, of Zimmer Trabecular Metal Technology Inc. where he directed the dramatic growth of the NJ based operation resulting in sales of over $140 million.   Robert  served as Vice-President of R&D at Implex Corp where he was a key member of the Zimmer acquisition and integration team, heavily involved in all aspects of due diligence and the transition. Robert also served as Director of Product Development at Stryker Osteonics, managing a large technical group focusing on all aspects of design for hip, knee, shoulder, elbow, and wrist reconstructive systems and specialty custom products.   Robert has over 20 patents, numerous peer-review publications, and has presented globally at large medical conferences and hospital Grand Rounds.  Mr. Cohen holds a BS and Masters in Mechanical Engineering and a Masters in Management, all from the New Jersey Institute of Technology, where he currently holds a position on their Board of Visitors, as well as sits as Chairman of their Industry Relations Committee.

Networking Program:

Topic:  Winning with Recruiters

Job search in the doldrums?  Can’t get past that career hiccup?  Bring your questions to expert recruiters who have successfully placed PMs, and know how to position the career glitches that PMs endure.  This will be a PM-specific networking session with advice that may guide you past the rocks of a difficult search, and perhaps present new opportunities that you had not considered.  Join us in a meet-the-recruiters session.


TopicQuarterly Panel Discussion

The PMINJ PMO LCI will host its quarterly Panel Discussion facilitated by Fareed Hosain. It will be an interactive session where participants will have an opportunity to discuss best practices, challenges, and other information about PMOs.