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Subject Matter Expertise

Spiral Medical Development has wide and varied experience with medical device development.  Josh Simon, Principal Consultant has spent the last 16 years working in the field in various capacities beginning with Academic Research and ending with Sales, with several years of Marketing, Product Management, Operations, and peripherally with Quality, Regulatory and Clinical Research.

Much of this experience was spent in the field of Orthopedics and hydrophilic coatings.  As the head of Marketing and Product Development for a major hydrophilic coatings company, Dr. Simon had his hand in projects from a wide array of fields including: cardiovascular, neurovascular, urinary, and fertility.

Tap into this experience and see how it can ease your development in one of the areas below:

The base process of device development is similar among all fields.  Help with Design Controls is available from Spiral Medical Development as a service and so are the following:

  • Regulatory Pathway Determination

  • Clinical Trial Design

  • Project Management 

  • Market Analysis / Business Assessment Models

Whether it is training for your sales force on basic orthobiologics science or products, or focused literature searches, market analyses, and expertise on a new bone void filler or graft, Spiral Medical Development is up to the task.  See Dr. Simon's publication list for further ideas on orthobiologics knowledge.

As a scientist and later a Product Manager working on electrical stimulation devices at Biomet (formerly EBI, now Zimmer Biomet), Dr. Simon has extensive knowledge and experience in this field.  He has trained over 1,000 sales representatives and given Grand Rounds, CME, and conference presentations in a couple hundred locations.  Along with Orthobiologics, this constitutes a main area of Dr. Simon's expertise and training, and he is able to pass on that knowledge with his reputation for putting complicated subjects in easy layman terms that sales resp, patients, and other stakeholders enjoy.

While in charge of marketing and product development at Biocoat, Dr. Simon commercialized five new hydrophilic coatings for the company resulting in a doubling of revenue.  He has used this knowledge to help other companies in their business and technical decisions for hydrophilic coatings projects since then.  Those years of experience also presented a good general knowledge of component manufacturing and regulations.   Several publications talk about Dr. Simon's thoughts on the hydrophilic coatings industry and are available on the web.

General Medical Device Development
Electrical Stimulation of Bone Healing
Hydrophilic Coatings
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