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

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. 

Suttons Creek, a combination product device consultancy based on the Los Angeles area, has been a relied upon support structure for pharma, biotech and medical device companies delving into new delivery device spaces, finding gaps in their internal resources and knowledge-base, and requiring change management to shift their processes and culture toward these new endeavors. Its diverse and talented pool of expert consultants assesses client needs, performs essential trainings and embeds to provide hands on support to their internal teams across the product’s entire life cycle. As this everchanging world of science and technology demonstrates new areas that require combination product consulting, Suttons Creek has always been agile and proactive about bringing on new talent to fit every need.

During 2020, a year of many pivots, new priorities and business assessments in the pharmaceutical industry particularly, Suttons Creek 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.

Steve Badelt, PhD, Suttons Creek’s founding partner and CEO has built the company from the ground up, strategically creating the one-stop consultancy shop that the pharma and biotech industries need. “Suttons Creek has grown into the only medical device consultancy that offers full support across every function of device development, regulatory approval and commercialization,” he says. “What is unique about SCI is our ability to jump in at any point of a combination product’s life cycle, providing quick, streamlined and cohesive support no matter where the knowledge or infrastructural gaps may be.”

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, who has led teams across diverse roles in the Commercial Organization of AstraZeneca in sales, marketing, commercial operations and other business development roles. Stephanie not only took on the management of Sutton Creek’s own brand marketing and sales activities but 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. In the short time since the addition of these experts to Suttons Creek’s roster, the team has uncovered needs that have resulted in many new projects geared toward creating and elevating Human Factors initiatives for clients.

“During our client satisfaction sessions, the overwhelming value that clients voiced as a key influencer in their decision to partner with us is our experts,” says Julie Gordon, VP of Organizational Development & Strategy at Suttons Creek. “Having a consortium of respected, experienced, and available resources to support our agility and our unique ability to align within a client’s organization quickly upon the commencement of work.  As we grow and scale to provide more value and results excellence to our client community, we seek new ways to expand our impact in our industry, new divisions to provide more value and services, and new introductions to continue to do what we love!”

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. We have learned that If companies do not have internal resources to effectively manage the project, ensure coordination and engage with external suppliers, these programs inevitably fail. Luckily for Suttons Creek clients, Rob has experience in this world and can embed in early stages and lead them to success.

As 2021 gets underway, Suttons Creek’s new additions have resulted in a significant increase in year-over-year Q1 contracts and the promise of more to come. The team is keeping its ear to the ground with clients and in the industry in general to ensure that their roster can grow and remain agile enough to cover any client needs that come their way.

To learn more about Suttons Creek, visit or call 877.611.4724 to speak to a member of the Suttons Creek team.

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Last Updated: 23-Feb-2021