Suttons Creek, Medical Device Industry's One-Stop-Shop Consultancy, Is Building Its Talent Pool

LOS ANGELES - Feb. 22, 2021 - PRLog -- One key understanding pharma, biotech and medical device companies learn – usually the hard way – is that when you combine a drug or biologic with a delivery device or software as a medical device (SaMD), the sum is a unique entity to itself. This is especially true in the eyes of regulatory bodies. FDA/MDR rulings on combination products require quality systems to be integrated for both drug and device. The amalgamated system is not simply made up of both quality systems together but is a newly created system to assess how the products work together, not as individuals. As more and more companies build their combination product portfolios, they often require expert guidance to develop this specific genre for successful regulatory approval and consumer benefit.

During 2020, a year of many pivots, new priorities and business assessments in the pharmaceutical industry particularly, Suttons Creek, a combination product device consultancy based on the Los Angeles area, spent its time building up its executive team and consultant roster to ensure its clients' needs would be covered from initial strategic planning, through all elements of device development and regulatory approval, all the way to commercialization and post-launch activities. Four of the biggest areas of growth were in Commercial, Human Factors, EU MDR Preparedness and In Vitro Diagnostic / Companion Diagnostic specialties.

Seeing that many industry players, big and small, had a knowledge disconnect between device developers and the commercial teams that would take the combination products to market, Suttons Creek brought on a new Director of Sales & Marketing, Stephanie Sobel (previously from the Commercial Organization of AstraZeneca). Stephanie uses her pharmaceutical industry experience to bridge the gap with client commercial teams through specialized trainings and strategic guidance for all aspects of commercialization of combination products.

Suttons Creek recently found that combination product developers tend to be unfamiliar, and often undervalue or even ignore the benefits of performing Human Factors as part of their device development. It is a critical element in the validation, regulatory approval and user experience of a combination product, but also an element that can be new to pharma and biotech companies taking their first few steps into the combination product arena. To help increase awareness about, and support for, this critical aspect of device development, Suttons Creek hired Matthew Nare, a Human Factors and clinical observations research specialist, and brought three Human Factors consultants onto his team. Another new specialty now strongly represented in the Suttons Creek consultant pool is In Vitro Diagnostic and Companion Diagnostic, thanks to Suttons Creek's new Director of Regulatory, Rob Schulz. Diagnostic filings are a unique "animal" all to themselves and require specialized knowledge of rules, regulations, core technology and best practices.

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Julie Gordon
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Tags:Combination Product
Location:Los Angeles - California - United States
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