The process of developing biomedical/life science technology and introducing into the marketplace for use in the diagnosis and treatment of people is one of the most stringent and regulated processes in industry. Investigators seeking to translate their research into product development for commercialization need to be aware of the requirements and necessary steps involved in order to:
- Identify and qualify opportunities that address real market and customer needs
- Develop solutions that meet the strict safety and efficacy regulatory requirements for product use in patients, and
- Plan the steps, timelines, resources, and financial needs to commercialize new products in the marketplace.
The requirements are different for medical device, diagnostic, and therapeutic products as depicted in the following flow diagrams which list some of the major activities along the development process.
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