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Resources on the Stages of Starting a Biomedical/Biotech Business

The following external resources, describing the stages of biotech/biomedical startups, go beyond the early stages presented on this website to include later stages through the stage of having a mature product.

Understanding Prototype Development Phases For Medical Products Med Device Online. 2019: Describes five phases of development for medical products:

  1. Proof of concept – Mockup used to evaluate feasibility, performance, usability
  2. Alpha –  Initial design and prototype that looks and works like final product and testing that it meets requirements and specifications.
  3. Beta – Refinement, planning, and preparing for production and testing.
  4. Pilot – Further refinements to the design and production process. Transfer to manufacturing with quality control.
  5. Mature product  –  Refinements based on user feedback, refinements to production for cost saving and yield.

5 Phases of Medical Device Development Greenlight Guru. 2023: Describes the following phases of medical device development:

  1. Initiation, opportunity, and risk analysis
  2. Formulation, concept, and feasibility
  3. Design and development verification and validation
  4. Final validation/project launch preparation, product launch
  5. Post-launch assessment.
      

The Four Stages of Startup Growth and How to Manage Them. Inc. 2023: Describes four steps for startup growth and their management:

  1. Prototyping
  2. Developing a customer base
  3. Market expansion
  4. Exiting from CEO role or selling the company (for many scientists, but not all)

What Different Biotechnology Startup Stages Face LinkedIn. 2023: In addition to the stages described by most sources, this resource includes a description of a very early “bootstrapping” stage, which is before the seed funding stage.

This project is funded by National Institute of General Medical Sciences (Grants 1R43 GM131458-01 & 2R GM131458-02)


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