The Marketing & Regulatory Session at SEMDA 2018 explored the goals, responsibilities, and possible pathways of medtech marketers when building awareness and adoption for their products. This session featured panelists Mike Fisher, Director of Product Development for GCMI; Allyson Bower-Willner, Senior Marketing Manager for Molnlycke; and Machelle Shields, Senior Executive Healthcare Policy & Compliance Advisor for Butler Snow. Write2Market VP of Healthcare Paul Snyder served as moderator. The group discussed how marketing and compliance can work best together, how to avoid common pitfalls, and how marketing relates to compliance from beginning to end.

Here are the big takeaways from the session:

First, marketing. Then, engineering.

According to Mike Fisher, marketing often comes into play before engineering during the pathway and selection process. “Upstream marketing is what happens in most traditional companies,” says Fisher. “Upstream marketing is constantly surveying the horizon, looking for viable opportunities to meet unmet medical needs with new products which fit into or are adjacent to the companies product portfolio.” If the upstream marketing people have done their job, then the product development team is the expeditionary force that is aimed at a clear target.

Communication is key.

The relationship between a marketing and regulatory person is a partnership and should be treated as such. “Frequent communication is absolutely critical,” says Bower-Willner. “We have to have an ongoing dialogue.”  

Claims and marketing are done right when the marketing and regulatory person have a discussion to decide the “line” when it comes to their approaches to language. Shields says, “[A compliance person’s] job is to advise you of the business risk that you are about to take. You should really see compliance as revenue protection.

Certain levels of tension are healthy.

There must be a healthy level of tension between marketing and regulatory. “The best collaborations that I’ve had with my regulatory partners is when we have honest and mutual respect,” says Bower-Willner. “They’re going to frustrate me and I’m going to frustrate them. I know that to be true. But secondly, I would say that we [as marketers] always have to be flexible, even though it pains me to say that.

The marketing person is there to ensure that the interpretation is appropriate and that differentiating claims are vetted,” says Fisher. “So the marketing person is my natural enemy, but they’re also my best friend.

Save a seat for regulatory strategy from Day 1.

In regard to marketing strategy’s impact on cost and timeline, the process of developing a new product is too complex to not have a regulatory person involved the entire time. “Once you get the product ready, you now have at least a year’s worth of data collection,” says Fisher. “The big companies make sure that the regulatory people are at the table on day 1. Small companies tend to miss that.

“But regulatory bodies don’t care about the dollars. They care only about what’s on your label, which is deeply tragic in some ways because the rest of the market does not. Faith based regulatory science doesn’t exist.

Utilize multiple variants and make it easy for regulatory to say yes.

Marketers must learn to come to foundational agreements with the regulatory team, and then build out the basic messaging from there. “Use as many variations of the language as possible in your submission early on to describe what you’re trying to say so that you can see what’s going to work later and have a number of jumping off points,” says Allyson.

Marketers should try to make it easier for regulatory to give the OK to a wide variety of things so that they can have flexibility later on. “I’m constantly getting language pre-approved with [regulatory and compliance] that I can use on a regular basis,” says Allyson. “Just make sure to keep the common industry terms in mind.

Baby submissions: small, but mighty.

Allyson has said before that she’s a big fan of “baby submissions” for FDA approval, and here’s why: “You can start out with something very generic and then hone your marketing message later via baby submissions. They’re just really small, maybe 30-60 page 510K documents, getting me a more specific claim.” Baby submissions help you get to where you want to be, and quicker.

Fantastic fails and how to avoid them.

The biggest mistake that I see young companies make too often is the statement ‘I have 510K approval for my product’ being used as marketing,” says Machelle. Other avoidable media errors include failing to adhere to claims and instructions for use on websites and social media.

Managing the practice of medtech innovation and off-label marketing can be tricky from a marketing standpoint. You need supporting information, especially if it’s off-label. Allyson handles this by telling clinicians, “Your clinical judgement supersedes my recommendation, but here is our product use recommendation.

Sometimes what you think is going to be the next big thing unexpectedly fails in the most spectacular fashion. What exactly do we learn from these failures? “My general rule with compliance and regulatory is take your lumps up front,” says Machelle. “They are always smaller than the lumps you try to cover up and deal with the on the back end.

“Compliance and regulatory is here to provide solutions.” Mike adds, “It comes down to individual accountability and responsibility. You have to work with ethical people.” Allyson agrees with Mike, putting an emphasis on the team’s moral compass.

If you are a physician innovator, small medtech company or one of the industry’s stalwarts and are seeking an efficient path from concept to commercialization – from market analysis to regulatory pathway, design and development and preclinical testing and training, contact, or visit

Allyson Bower-Willner on LinkedIn

Mike Fisher on LinkedIn

Machelle Shields on LinkedIn

Paul Snyder on LinkedIn