October 1-2, 2020 | 10:00 am – 1:00 pm EDT
The Medical Device Development Primer is a fast-paced, two-day preparatory course designed for professionals seeking a basic understanding of the industry. This course examines all aspects of medical device development, including the five development phases—market opportunity, evaluation, design, verification, and manufacturing. The course delves into the changing regulatory environment and focuses on the different pathways that devices travel for agency approval. Take this course to develop an understanding of the entire process required to bring a new medical device to market.
1. Fluency in essential terminology and acronyms of the medical device industry.
2. Knowledge of the various approval pathways for a medical device to be marketed to patients.
3. An understanding of how to mitigate risk in a medical device.
4. An improved ability to communicate with engineers, colleagues and clients.
5. The ability to construct a medical device by following the traditional five phases of development.
Instructor: Jim Macemon
Mr. Macemon is a medical device executive with extensive experience in diagnostics, critical care, patient monitoring, imaging, and lab products. During his 40+ year medical device focused career, he led numerous R&D and manufacturing teams, successfully launching products to aid laboratory and health care professionals and improve patient care. During his career, he held senior positions with companies such as Baxter Healthcare, Richardson-Vicks, and SpaceLabs Medical, leading programs to develop laboratory and point-of-care diagnostic systems. Mr. Macemon’s focus during the last 20 years has been with Venture Capital funded start-up companies developing revolutionary diagnostic and imaging technology. He has 13 patents issued and several more pending.
Registration for the course can be added on to your conference registration or purchased separately.