The “Phase 0” Global Center for Medical Innovation (CGMI) Product Development Process with Michael Fisher, a CNYBAC C-2-C Event

February 9, 2022
3:00 - 4:00 p.m.

CNY Biotech Accelerator, Upstate Medical University presents

 The “Phase 0” Global Center for Medical Innovation (CGMI) Product Development Process

February 9, 2022, 3:00 – 4:00 p.m. EST

Michael Fisher, Director of Product Development, Global Center for Medical Innovation

Register at*:

Michael Fisher, Director of Product Development at GCMI, will discuss their “Phase 0” product development process.  This process helps develop a project plan, understand development costs and timelines, realize overall product opportunities, and estimate the product’s true value proposition.  Through collection of data, the client has an opportunity to challenge findings, question their own assumptions, prepare a defensible strategy to discuss with investors, and compete for various grant applications.  Most importantly, this process helps the client spend their limited resources to make the best decisions for their company.

The Phase 0 Process includes:

  1. Regulatory Pathway (how others went through the approval process and what will be expected for your project)
  2. Clinical Need (disease state, the patient care pathway, prevalence of pathology, alternative treatment paradigms, etc.)
  3. Market Analysis (competitors, average sales prices, healthcare economics, etc.)
  4. Intellectual Properties (patent landscape, key players, potential white space, and freedom to operate)
  5. Technology (basic user needs and product specifications, benchmark testing of competitive devices, and prototyping)

Michael Fisher, Director of Product Development, Global Center for Medical Innovation, has 24 years of experience developing medical technologies and products with research universities, academicians, not-for-profits, and corporations.  Mr. Fisher understands how to translate concepts into regulated medical devices.  His experience combines medical research skills with experience in defining user needs, defining regulatory activities, program management, financial valuations, intellectual properties, quality systems, risk analysis, engineering design, operational qualifications, manufacturing transfer, financial program analysis, and project execution.  Michael has experience with implanted devices, high-volume consumable medical products, pilot & scale-up manufacturing processes, sterile packaging, industrial sterilization, labeling development, regulatory documentation and submissions, intellectual properties, cost constraints, sales support, and commercialization activities.  Mr. Fisher is eager to support efforts to translate new technologies and opportunities into viable medical devices that can serve diverse market needs.

*This is a free virtual presentation open to the public.  After registering, you will receive a confirmation email containing information about joining the meeting.

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