Program Title: Leadership and Innovation: A Medical
Device Project from Concept to Implantation
Activity Sponsor: PMINJ Chapter (C020)
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.
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.
Topic: Quarterly 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.