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:
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:
