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THE REGULATORY ATMOSPHERE: Execs From Smiths, Transenterix, Bausch and Tandem Offer Insights

Our panel of experts:

GARY BARRETT

GARY BARRETT

VP Regulatory Affairs, Quality Systems and Compliance

Smiths Medical

STEPHANIE FITTS

STEPHANIE FITTS

Vice President Regulatory Affairs, Quality Assurance, Clinical Research and Compliance

TransEnterix, Inc.

LIBETTE LUCE

LIBETTE LUCE

Senior Director Regulatory Affairs

Bausch Health Companies

MICHAEL SARRASSIN

MICHAEL SARRASSIN

Senior Director for Regulatory and Clinical Affairs

Tandem Diabetes Care

Like almost every other part of our industry, regulatory affairs is growing and changing. With pressures coming from impending compliance with EU MDR standards, drug pricing reform, and FDA pre-certification programs, it is no wonder regulatory affairs teams are busy. Regulatory affairs professionals are also often busy filling open roles. As some of the hardest to fill in the industry, it is no surprise that Jacobs Management Group’s annual Compensation and Hiring Survey found that companies spend an average of 7 months filling a regulatory role. This all falls on top of regulatory’s already time-consuming and very important primary function of getting approvals through. To keep it all in check, regulatory needs support within the organization. This is where sales and marketing come in. We sat down with top regulatory leaders whose experience ranges from device to pharma, consultant firms to industry, and companies big to small. These regulatory professionals made it clear that: regulatory affairs and sales and marketing need to work as a team, from the very beginning of the product development process, in order to find success, shared language around a product and its claims is key, sales success is indicative of regulatory success, and much more. Read on to hear from the best!

In your experience, how does regulatory affairs view marketing and sales?

GARY BARRETT: Regulatory affairs views marketing and sales as valuable sources of information and as partners. The regulatory process must include marketing and sales at the initiation of any project in order to know expected base claims and other expectations. Without understanding what the device is intended to be sold/marketed as, it is impossible to accurately gauge what a registration should look like. Conversely, once a device is on the market, marketing and sales provide crucial information for post-market surveillance and clinical evaluation. As MDR rises to prominence, this information is more and more crucial. This reinforces the holistic nature of the med device business.

STEPHANIE FITTS: Generally, we regard marketing and sales as internal customers, and, like all customers, they can sometimes be challenging. Regulatory tries to get the right products approved in the right market with the right claims so that sales and marketing can bring in revenue. The timeframes for each department are extremely different which leads to frustration on occasion.

LIBETTE LUCE: In my experience, I value marketing and sales very much, as they support the continued success of an organization. I have always engaged both departments early in product development to ensure that there is alignment between R&D and the commercial units.

MICHAEL SARRASIN: I generally view marketing and sales quite favorably. They are integral parts of the success of any company, and you have a really good idea as to how successful your company is by way of how successful your salespeople have been. Although a somewhat simplistic view, product sales and market acceptance provide the most basic and raw data for how well a company is doing.

What “disconnects” have you seen between regulatory and marketing/sales?

FITTS: When a product is being developed, the sales and marketing teams try their best to indicate which markets are critical for market access. Regulatory then works with R&D to get the right testing and documentation in place for regulatory submissions, which can take months or even years. A common disconnect is that either the sales/marketing strategy shifts over time, or the market itself changes or becomes more known to the sales/marketing team. Often, regulatory cannot shift quickly enough to get new or different testing and make regulatory submissions in time to respond as quickly as sales/marketing would like. Another common disconnect is the claims that the sales/marketing teams would like to make regarding the product. New claims can take additional R&D testing or even new market authorizations prior to being launched. Regulatory has difficulty understanding why these claims cannot be market tested and finalized alongside the product development timeline and instead are developed closer to the launch phase. The lack of alignment can result in R&D having to test all over again – and, worst case, regulatory having to apply for new market authorization.

BARETT: The development of silo mentality is prevalent in many companies. The separation of functions into specific “camps” with individualized priorities and disconnected goals is the result.

SARRASIN: Most disconnects for me with marketing and sales have always arisen in terms of where is the gray area and how can we use it, work with it, and where the guard rails are. Questions seem to arise from where the nuances are in terms of discussions, and from educating on how certain phraseology can be used, but other phraseology, although seemingly similar, may in fact be significantly different. This has always been an issue, and it relates to the amount of time that would be needed to fully understand the limits of commercial speech, especially considering any marketing limitations placed on the device/drug’s indications dictated by FDA.

LUCE: The repeated “disconnects” that I have seen between these sectors are the distinctions between the “needs” and “wants” from marketing/sales as they relate to product claims. As we begin early stages of development, we discuss the Target Product Profile (TPP) and competitive landscape of the product in development. In regulatory, it is my responsibility to obtain the best label based on the data for approval for market entry and patient access. It is my responsibility to adjust the regulatory strategy and communicate that to my cross functional team in R&D to ensure that the clinical studies reflect the appropriate endpoints to use as the basis for product claims.

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How can regulatory foster better two-way communication with marketing and sales?

SARRASIN: The easiest way for regulatory to foster better communications with marketing and sales has always been, in my opinion, to keep an open-door policy, give clear direction and application on guidelines to likely FDA interpretations of regulations, guidances, etc. It’s also important for regulatory to be able to discuss the risks intelligently with marketing and sales regarding associated pathways that may be utilized for marketing and marketing communications. Most marketing and sales groups would like a clear and reasonable discussion of the risks at hand, rather than a pedantic, overbearing simplistic discussion of how much jail time one would get.

BARRETT: The communication needs to be two-way; regulatory cannot be expected to constantly be the bridge builder. This requires both sides to realize the needs of the business over individual goals. It is pointless for one group to succeed if the other fails. The important objectives are those of the company, not individuals. This needs to be realized by both management teams and overlaps need to be reinforced. If this requires dedicated time and/or resources, then it needs to be a priority.

LUCE: To foster better two-way communication between marketing and sales is to do it often. Competitive landscape and product positioning is highly variable in this marketplace. I need to know if commercial priorities have changed or if there is an interest in different data for a product. I only have the ability to modify a development strategy and/or program if I know what the focus of a product claim(s) is, so that clinical studies can be adjusted as required. Additionally, I need to assess the risk the organization is willing to take on a development program if there is a shift in product scope, i.e., patient population, treatment, etc.

FITTS: It comes with building relationships between the teams. If you can establish yourself as someone who is interested in their processes and invested (as we surely are) in their success, then in the heat of a contentious issue, you can draw on that trust.

How have you measured regulatory success in your company beyond approvals?

LUCE: The way in which we can measure regulatory success beyond approval is by patients’ access to the drug via sales and distribution data, but moreover seeing the repeated safety and efficacy of a drug for the patients via annual reports. As regulatory professionals, we want to ensure the continued safety of an efficacious treatment to patients.

FITTS: As a maker of medical devices that are also capital equipment purchases by a hospital, we measure utilization of the product during market introduction as a measure of success. Utilization means both that the product is sold to customers and also that the product is then used by those customers to the benefit of the patients. If the sales are not there, or if the product is abandoned due to not having clinical utility, then the product will have a short life. It could mean that regulatory did not get a broad enough indication for use, or that companion products are needed to make the system more useful. Either way, there are lessons for the team moving forward when armed with this metric.

BARRETT: We measure through integration and the success of other groups. If regulatory succeeds in getting a registration but sales fails to land accounts, then the company loses despite regulatory’s success. The obverse is that sales cannot sell what is not approved. Extrapolating to the first question, if sales wants to sell a device for a pediatric indication but this was not communicated, then regulatory will not have tailored the submission, due to poor communication; the approval is useless. Communication is key.

SARRASIN: Although approvals are key indicators for the regulatory group itself, other factors weigh heavily, including relationships with the agencies and trust that has been built between the regulatory group and the agencies, which reflects on the company as a whole. Also providing the company with a ”benefit of the doubt” scenario should it ever be needed. I also think that trust and those fostered relationships translate to success internally as well. Having a regulatory group that is trusted and reliable is easily integrated into the other aspects of the company, including marketing and sales, speeding the process of product design, development, and review.

How early should regulatory be involved in the marketing/sales process, and to what extent?

LUCE: The question that should be raised is the opposite. How early should commercial (marketing/ sales) become involved on a development program within R&D, specifically regulatory? The answer is as soon as possible. What regulatory looks for from commercial as soon as a development program gains traction (e.g., ready to begin Phase I studies) is the Target Product Profile (TPP). The TPP is the foundation for the product labeling, specifically, the product’s indication and claims. Regulatory will need to know the competitive landscape of the product and the overall positioning of the product to provide an accurate regulatory/ development strategy plan. In short, regulatory needs to obtain alignment from commercial at very early stages of development to ensure that the clinical development program reflects the needs and desires of commercial for a product.

FITTS: Regulatory and sales/marketing need to be active members of the product development team from the beginning as requirements are being decided. Strategy is as much what you are NOT going to do as what you ARE going to do. So being involved in features, claims, and markets for the new product as it is developing can help alleviate frustrations down the road.

BARRETT: Start at initiation and continually through the process. Likewise, marketing should be included in the registration process, ensuring that the claims matrix meets the needs of the company.

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Moving Forward

SARRASIN: For me, as early as possible, to set the right expectations in terms of regulatory review and regulatory requirements. Regulatory should be part of the design and development team in order to chart the course that needs to be taken to approval/allowance.

What does regulatory want marketing and sales to know with respect to product information that may not be off-label and how that can be best communicated?

SARRASIN: The only thing I would say is that I would like marketing and sales to not feel bound by convention. Bring your ideas to regulatory to review and make recommendations, and discuss risk. And to regulatory I would advise that the discussions not always end in ”No,” but with suggestions on how to exploit the advantages you have without running afoul of the law.

BARRETT: Marketing and sales need to know that off-label promotion is not ”pushing the envelope”; that just because competitor X has that specific claim on their advertising brochure does not mean we can include it; that ”best in the world” and ”preeminent design” are not supportable claims. The first class in any marketing course lays out that the goal of marketing is to sell a result or emotion rather than a product – that does not apply in med devices. Go to a conference; the majority of marketing literature is a picture of a device, the device name, the company name and the booth. There is a reason for that.

LUCE: We continually provide clinical data to marketing and sales regarding information that is on-label through results of clinical studies and clinical paper authored by our medical affairs department. Informing marketing and sales in real time when information is available is crucial to the launch of a program. Commercial is also well aware of the information that will be in the product labeling during the time of NDA preparation and throughout the FDA review process of a marketing application at the very latest. The shell of the product labeling is well known prior to the initiation of Phase 3.

FITTS: The concept of fair balance, if it can be truly understood and embraced by the sales/marketing team, can go a long way toward bridging the understanding between the teams.

Can you relate any incidents in which coordination between marketing/sales and regulatory were well handled? Can you give an example of the result?

FITTS: In one instance a particularly organized marketing manager was preparing for a US launch of a product. She had first developed and market-tested a series of claim “areas” such as ergonomic benefits and cost. Then, once she had her concepts that tested well with customers, she worked to develop imagery and text for claims. At this point she pulled in regulatory and we worked collaboratively to either modify text or commission test reports to substantiate her most needed claims. We developed a claims matrix to speed the review of launch materials – and this matrix (of claims, images, and the substantiation proof source) was released in document control. With this tool, launch materials review was extremely efficient and timely. Regulatory could meet a 48-hour review turn around commitment as long as there were no different claims or images on launch materials. We were happy to review novel claims and images, but for these we would not hold ourselves to the 48-hour commitment. This launch went very well in that the sales team had professional-looking, consistent tools to drive messaging with customers.

SARRASIN: We were in a very compressed time frame, in conference with FDA, working on an approval of certain labeling claim negotiations. I specifically brought marketing into the meeting to provide a perspective to the discussions so FDA could hear where we wanted to go with the approval. It was successful in that the approval was granted with deference to marketing’s certain requests.

BARRETT: Key to the process are communication and discussion. Regulatory needs to stop saying “it’s hard to explain…” and marketing needs to understand that the guidance documents do not portray an exact answer. The FDA needs to clarify its position on a number of issues with regard to marketing.

LUCE: My best example was during labeling negotiations with FDA during NDA review. Providing commercial a seat at the table informing them of FDA’s recommendation to a label that may limit claims is essential. Additionally, regulatory can be the expert in explaining the level of risk in responding back to FDA with either accepting agency’s recommendations or providing a rebuttal and proposed wording to obtain the label desired. Having regulatory as the sounding board for commercial is always helpful during labeling negotiations, so that there are no surprises in the label for product launch.

PANELISTS

GARY BARRETT

GARY BARRETT

VP Regulatory Affairs, Quality Systems and Compliance Smiths Medical

Gary began his career as a scientist at Triton Systems and Nimblegen before moving on to become MEMS Project Manager at IBT. After stints at KEMA Medical as Senior Project Manager, Merit Medical as VP Regulatory Affairs and DEKRA Certification B.V. as Business Development Manager, he moved to AngioDynamics as Senior VP for QA and RA. In 2018 he joined Smiths as VP Regulatory Affairs, Quality Systems and Compliance.

gary.barrett@smiths-medical.com

SMITHS MEDICAL is a leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world’s healthcare markets. Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services, their products are found in hospital, emergency, home and specialty care environments and are used during critical and intensive care, surgery, post-operative care and for support in managing chronic illness.

STEPHANIE FITTS

STEPHANIE FITTS

Vice President Regulatory Affairs, Quality Assurance, Clinical Research and Compliance

TransEnterix, Inc.

Stephanie had experience as Clinical Program Manager at Medtronic and Senior Director of Regulatory Affairs and Regulatory Compliance at Stryker Orthopaedics, then was named VP of Regulatory, Quality and Compliance at Baxano Surgical. Following that, she was a quality and regulatory consultant for OBX Associates, working with small med device companies. She moved to TransEnterix in 2015, where she has been responsible for the successful first marketing applications to the U.S. FDA for a complex electromechanical device system.

sfitts@transenterix.com

TRANSENTERIX is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients, while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. TransEnterix also developed the SPIDER device and the SurgiBot System, a singleport, robotically enhanced laparoscopic surgical platform.

LIBETTE LUCE

LIBETTE LUCE

Senior Director Regulatory Affairs

Bausch Health Companies

Libette was Associate Regulatory Affairs at Schering-Plough Research Institute, a sales representative for Novartis, Associate Regulatory Affairs at Hoffman-LaRoche, and Senior Manager of Regulatory Affairs at Forrest Laboratories/Allergan and Amarin. After becoming Director of Regulatory Affairs at Valeant Pharmaceuticals, she accepted the position of Senior Director of Regulatory Affairs at Bausch in 2017.

Libette.Luce@bauschhealth.com

BAUSCH HEALTH manufactures and markets a broad range of branded and generic pharmaceuticals, over-the-counter (OTC) products and medical devices (contact lenses, intraocular lenses, ophthalmic surgical equipment and aesthetic devices) directly or indirectly in more than 90 countries and regions, including the United States, Canada, Europe, the Middle East, Africa, Asia Pacific and Latin America. Each day, their products are used by up to 150 million people around the world. Their portfolio of products covers eye health, gastrointestinal diseases and dermatology.

MICHAEL SARRASSIN

MICHAEL SARRASSIN

Senior Director for Regulatory and Clinical Affairs

Tandem Diabetes Care

While at Tandem Diabetes, Michael has led the Regulatory/Clinical Affairs Groups that prepared numerous groundbreaking FDA PMA submissions for the Artificial Pancreas, Alternative Controller Enabled Infusion pump, the first interoperative approved insulin infusion pump for children and adults, and remote device updating for more complex algorithms. He began his career with the Millipore Corporation in Bedford MA, working on PMA and 510(k) applications for various medical products. He has held director and vice president level positions in regulatory, quality, and clinical affairs at Whalen Biomedical, Kimberly Clark, Lysonix, and the DAKO Corporation. His background includes expertise in worldwide regulations and their implementation, as well as the management and conduct of various complex clinical studies and marketing applications worldwide.

msarrasin@tandemdiabetes.com

TANDEM DIABETES CARE is a public US medical device manufacturer. The company develops medical technologies for the treatment of diabetes and specifically insulin infusion therapy. The company’s goal is to make the lives of people with diabetes better through relentless innovation and revolutionary customer experience. Its strategy is to excel in its area of expertise and partner with other technology leaders to create the best options available. These partnerships include leading researchers in the artificial pancreas space, where Tandem technology has been used worldwide.

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