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Spiral Medical Development consults with small to medium-sized medical device companies to help them get their products to market faster. With broad experience at every stage of the concept-to-market journey, it partners with project team members to meet their needs through training, courses, and subject matter expertise.

Josh Simon, PhD is Principal Consultant with 20 years of experience in medical device development. Over the course of his career to date, he has touched every aspect of device development from conception through sales and marketing, both for small and large-sized companies.  Through varying involvement on upwards of over a hundred device projects, he gained broad understanding of the processes for pre-clinical research, regulatory, quality, marketing, sales, clinical studies, and surgeon education.

Josh holds a PhD and Master’s in Biomedical Engineering from the joint program between the former University of Medicine and Dentistry of New Jersey and Rutgers University, now both combined into Rutgers University.  He also holds an MBA in General Business, and a Bachelor’s degree in Biochemical Engineering.  This education allowed him to start his career as a Research Scientist developing orthopedic devices at Biomet (now Zimmer Biomet) in 2004, quickly moving into the marketing department as a Product Manager two years later where he continued leading device projects.  Five of the next seven years were spent leading product development and marketing efforts at a small company called Biocoat, where he commercialized five new hydrophilic coatings which are now used in medical devices all over the world including India and the United States.  The results of his efforts contributed to doubling the head count and revenue at Biocoat.


Since his days in coatings development, Josh has become an expert in the EU Medical Device Regulation and the Clinical Evaluation process therein. He has authored over 70 Clinical Evaluation Reports and other documents related to the process (SSCP's, PSUR's, and more.) He has also been involved in gap analyses for quality systems to prepare them for MDR, and answering Notified Body audit findings on Technical Documentation.

As someone that loves to give back and feels obligated to teach those that are coming after him in the medical device industry, Josh thinks it is important to excel in at least two things over the course of one’s career.  For him, this means using his backgrounds in research and business to bridge the gap between the two.  This usually involves conversations from all perspectives covering project management, medical device product development, marketing, training, and research planning.

Being able to explain tough concepts to audiences without background in a subject has been his forte, and he has used it in numerous device companies, sales training classes, CME, and Grand Rounds presentations around the world.  Going the other way, he has conveyed crucial business strategies to motivate product development and research professionals both in industry and academia.

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