There is a need within the medical device industry, especially with startups and individuals who have a new device idea but do not have the knowledge to navigate the pathway to take their concept from the page or screen and get it to a stage that it can improve patients’ lives. There are a lot of steps that need to be followed so the idea can become an actual product that meets both customer needs as well as the standards and requirements set by regulatory agencies.
There are four key components that need to be followed and understood, to ensure a product will be successful in being able to reach market:
- Structuring a Plan – how a technology is developed.
- Business – How an organization executes a development plan.
- Technology – How a technology develops after it is discovered in the research phase of the development cycle.
- Approval – how to sell and market your device.
If these stages are not only met, but their importance acknowledged by those with a new medical device idea to develop, then there will be a firm foundation on which to successfully create, understand, and launch to market.
The speaker will give decades of experience on all these stages, utilizing his almost 30 years of industry experience, as well as being the president of a medical device development company. His robust history of working with diverse clients from Fortune 100 companies to individual doctors, companies large and small throughout the globe, is a valued and unique view on how to traverse the roadmap from a simple napkin sketch all the way through clinical trials.
This presentation will offer both new companies, as well as those well established, a unique and vetted guide on the product development pathway.