A summary of my understanding of medical devices from prototype development to marke.
Business driven product development is a solid base for a company to obtain competitive advantage. Market is the final objective of products.
Medical Devices is a highly regulated industry and need multidisciplinary knowledge and skills involving medicine, materials, chemical, biology, and engineering. A successful medical device need to consider the problem and need, market size and growth, current and potential competitive products, clinical trials, intellectual property, regulatory strategy and insurance reimbursement. Quality and risk management thoughts should be run through the entire process of product development to ensure safety of effectiveness of medical devices.
Medical device development is a high-risk procedure, but the success of the product will give companies, especially start-ups, a huge return and improve the company's core competencies and a wide moat.
Summary of product development phases:
Some good or excellent books are recommended for the persons who move from the university to industry:
Business driven product development is a solid base for a company to obtain competitive advantage. Market is the final objective of products.
Medical Devices is a highly regulated industry and need multidisciplinary knowledge and skills involving medicine, materials, chemical, biology, and engineering. A successful medical device need to consider the problem and need, market size and growth, current and potential competitive products, clinical trials, intellectual property, regulatory strategy and insurance reimbursement. Quality and risk management thoughts should be run through the entire process of product development to ensure safety of effectiveness of medical devices.
Medical device development is a high-risk procedure, but the success of the product will give companies, especially start-ups, a huge return and improve the company's core competencies and a wide moat.
Summary of product development phases:
Some good or excellent books are recommended for the persons who move from the university to industry:
- Biodesign: The Process of Innovating Medical Technologies, Highly Recommended
- A Guide to Project Management Body of Knowledge PMBOK
- Biocompatibility and Performance of Medical Devices
- Design Controls for Medical Device Industry
- Medical Device Packaging Handbook
- Sterilisation of Biomaterials and Medical Devices
- Clinical Evaluation of Medical Devices
- The Design and Management of Medical Device Clinical Trials
- Pharmaceutical and Medical Device Validation by Experimental Design
- Blue Ocean Strategy
- Business-driven Research and Development
- Innovation and Entrepreneurship, Highly Recommended
- Competitive advantage, Highly Recommended
- Project Management and Systems Engineering Handbook
- Marketing Management, Highly Recommended
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