Digital Health Regulations — the big picture

The medical technology industry in the United States began to lean into digital health a few years ago (FDA’s first guidance document on “Software As A Medical Device” was published on December 20, 2017) and there is a massive spread of technology and devices which are linked to this growth. Digital health products can range from a web app reading radiology data, to robots positioning diagnostic probes, all the way to AI-driven mobile apps that identify clinical trial participants.

I’ve seen this regulatory environment grow and change substantially since I made my start in compliance over ten years ago. I’ve had the opportunity to enhance quality processes at F100 medical device powerhouses, create QMS from the ground up at venture-backed startups, and advise founders on compliance strategies for companies still in the “back of the napkin business plan” phase.

The single most important thing I’ve learned about digital health regulation is that it sits at the center of every other medical device concentration, and you need to understand how all the pieces fit together to be successful. Seemingly minor product changes like a wellness app startup deciding to expand from “fitness tracker” to “care management platform” could have major impacts on the time and cost to bring the product to market. A related (but opposite) problem happens for more established, traditional medical device manufacturers hoping to expand into digital health. A product development process that produced catheters and bone screws will create piles of unnecessary paperwork and delays if applied to a consumer-facing mobile application.

This confluence of products, industries, and technology has led to a regulatory environment in which compliance professionals truly must understand the breadth of requirements and systems in order to be effective. It’s easy to make strategic mistakes that could lead to delays in regulatory approvals or compliance risks after commercializing a device: at first it might seem wise to fast-track a mobile application that summarizes biometric data and does not require a 510(k), but what if you want to start providing insights or predicting health outcomes? Or maybe your app users aren’t willing to pay out-of-pocket, and you need to generate health economic data to unlock reimbursement? You need to ensure that your design process can satisfy the data quality requirements necessary to create submission-quality documents at any time. At the same time, an early-stage startup may not have the time or resources to plan out design activities months in advance or review each and every test report with a fine-tooth comb.

The approach I advocate to address this challenge is to be humble and learn from as many people as possible. I listen to software engineers and understand what levels of test coverage are really critical for product quality. I speak to companies in adjacent disease areas with similar product profiles to understand how their users react to new features. I actually read FDA’s guidance documents and participate in town halls and workshops. There may not be a “right answer” every time, but by understanding the big picture of digital health regulation and keeping an open mind for new ideas you can put yourself in the position to make the best decision when the time comes.

FDA — Helping out, or punching down?

A few recent FDA actions have made the headlines in the last week or two. Is FDA a villain here, destroying thousands of jobs and billions of dollars in shareholder value? Or is it a hero, protecting US consumers from companies that put profit over public health?

Let’s start with Juul…

At one time Juul was the the market leader in electronic cigarettes and was valued at as much as $38B in the private market. On June 23, FDA issued a Marketing Denial Order (MDO) to Juul, ordering them to stop selling and distributing all products in the United States. FDA’s explicit reason for the MDO was that “the [marketing] applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”

The first thing that occurred to me is how different the atmosphere and remit of FDA’s regulation of tobacco (via the Center for Tobacco Products) is when compared to the regulation of medical devices (via the Center for Device and Radiological Health) or pharmaceuticals (via the Center for Drug/Biologics Evaluation and Research). For tobacco, the starting premise is that “tobacco kills, so if you make a tobacco product you have to prove that it will reduce cigarette use and otherwise be safer for public health” — akin to “guilty until proven innocent”. For medical devices and pharmaceuticals, the starting premise is that the products will inherently improve public health provided all safety testing meets FDA’s requirements — closer in practice to “innocent until proven guilty.” FDA is often criticized for getting in the way of medical innovation by requiring broad clinical trials or extended review periods for medical devices. The same public criticism does not appear for reviews or approvals of tobacco products.

Supporters of Juul rightfully point out that FDA has approved products with similar technology and safety profiles as Juul’s and accuse the FDA’s decision of being politically motivated. To put some numbers around this: there are currently seven companies that have been approved to market e-cigarettes in the United States, and there are two hundred and sixty-three e-cigarette companies that have received Marketing Denial Orders. In other words, there is a high bar for approval: less than 3% of companies who applied to sell tobacco product have been allowed to do so.

Beyond that objective fact, there is a long history between FDA and Juul. Anyone who was surprised at FDA’s decision must not have been paying attention — or doesn’t appreciate that FDA is indeed a political organization, composed of humans with memories and a dislike of being “worked”.

Juul’s meteoric rise came on the back of a marketing strategy designed specifically to appeal to teenagers. This was shown through reviews of early advertising images, conversations with company executives, and first-hand evidence from “sting operations” conducted by FDA. This is the type of issue which takes some time to prove, but once it “sets in” it is very hard to shake. Although Juul ultimately changed its advertisements and got a new CEO, it had already become the target of FDA’s sweeping anti-vaping campaign and in many ways the writing was already on the wall.

This speaks to the critical nature of a company’s reputation and rapport with regulators. The laws governing FDA’s authority are generally broad and open to interpretation. “Goodwill” goes a long way in shading regulatory approval to favor a company which is perceived to be following both the letter of the law as well as the spirit of the law.

FDA’s decision sends a message that marketing addictive and dangerous products to teenagers will put you out of business. I believe this decision is helping out the public good, not punching down at an innovative tech company.

Design Reviews That Work

Oh, the “design review”. Depending on your company’s culture, a design review may be a glazed-over rubberstamping exercise or a grueling technical critique.

Whether it is one of these extremes or somewhere in between, there’s a good chance people aren’t getting much value from the meetings. These are the top three reasons I’ve seen torpedo the design review process, and a few simple ways to fix them.

1. Your cross-functional team doesn’t feel empowered. Design Reviews typically invite representatives from all functional groups, but how often do you hear feedback on a prototype design from your customer support manager? What input does your marketing lead provide during design transfer reviews? I’m not advocating a mandate that “everyone in the meeting must participate”, but I do caution against creating a culture of only speaking when your specific area is impacted. Have a private conversation before your next design review with one person who you *don’t* expect to participate much, and plant a seed with them while ensuring they feel supported by you to express themselves. Over time, you will see dialogue opening up and creative ideas begin to flow during these meetings.

2. The technical team doesn’t understand the point of design reviews. “The requirements are documented, the test cases are approved, all the results passed. Can we leave now?” This is a typical sentiment from engineers who are skeptical of the value of design reviews. One of the best cures for this is to have engineers sit in on audits, whether internal or external. Witnessing the “audit dance” between an auditor and a compliance lead can do wonders in helping engineers understand how critical it is to perform and document robust design reviews.

3. Your quality assurance personnel aren’t familiar enough with the product. Effective participation from QA requires a person who understands the intended use of the device, the technological principles upon which it operates, and the steps necessary to manufacture or deploy the product. This is a tall order for a position that isn’t always a technical expert. To combat this, have your QA folks “rotate” through different functions periodically. Sitting in on a user discovery call with your product manager, observing code reviews with developers, anything you can do to help them get real-world awareness of the user needs and design requirements.

Design Reviews have the potential to be much more than a box-checking activity. This is an opportunity to bring together different voices and opinions to add real value to the product, and to build a team that can support the designers and engineers long after the product has been transferred.

Doing the Hard Thing

“You’re too much of a coward to fire me.”

I’ve always thought of myself as brave. Integrity, transparency, and clear communication are extremely important to me. Yet here I was, on the receiving end of an emotional resignation because I had been afraid of doing the Hard Thing. It only got worse as I realized that he was right.

How did this happen??

After an unexpected reorganization (and equally unexpected promotion), I had been given the opportunity to recruit and develop my own team from the ground up. This meant, of course, that I was the only member of a one-man team until I did so. At the same time, my “team” was expected to maintain the same output as the previous group, which was fully staffed.

I tried to move as quickly as possible and started by hiring Tom* on a six-month contract. Tom had substantial experience and made an immediate positive impact on the backlog of work, but I could tell within the first week that he wouldn’t be a good long-term fit. That being said, I had every intention of honoring the full contract and my team’s success was relying on his continued productivity.

The next month, I began to recruit for a permanent position that would replace Tom’s temporary role. I was transparent about this opening to Tom, going so far as to invite him to apply for the position. This certainly seemed like the right thing to do: Tom had been vocal about wanting the security and benefits of a permanent position; and I knew that if I told him not to bother applying at all, he would leave earlier than I planned. When I said “your application will be considered along with all other qualified applicants”, the words were true…but I knew that I already had considered him for the position and decided against it. This is where I experienced a gut feeling of the Hard Thing. I know at some level that the right thing to do was to be open with Tom and let him decide what to do. At that point though, my goal was to keep him working as long as possible until I could recruit and train a replacement. It wouldn’t do politically for me to have my first hire resign within two months, and I desperately needed him if I wanted to keep up with the production schedule. So I kept leading him on, and avoided the Hard Thing.

I spent the following weeks contacting and interviewing candidates (including Tom) for the full-time position. Every week Tom would ask for an update, and every week I told him that we were taking our time to ensure we had seen the best possible candidates. Looking at this in the rearview mirror with some experience, I am embarrassed that I thought that might work. Obviously if there is a permanent position is being created from what had been a temporary opening, the person filling the temporary role should be hired right away — unless there are significant red flags. To put it another way, as soon as Tom realized I didn’t think he was a shoe-in for the permanent role, he must have known that he wasn’t going to get the job.

This explains why the final months of our time together were so antagonistic. Here I was, naively shocked that someone who had been a willing team member “suddenly” developed a poor attitude and started to alienate people. And here Tom was, having to come into the facility every day knowing that as soon as I found a better candidate, he was out the door. A few weeks before his contract ended, I met with him to talk about his attitude. I went into the meeting confident that if I spoke clearly and listened actively, I would find the right words to win him over and finish the position on a high note. That confidence evaporated in the first thirty seconds of the conversation.

Tom: “I know you’re not going to give me the permanent position. You’ve been leading me on for weeks.”

Me: “Like I said, this is an important role and I need to make sure I’ve executed a thorough recruiting process.”

Tom: “We both know I’m not getting the job. Why don’t you just fire me already?”

Me: “Why would I fire you? You’re doing a great job — ”

Tom: “If I’m doing a great job, you should offer me the full time position.”

Me: “…OK Tom. You’re right. I don’t think you’re the right person for the role. Is there any way you could finish out the contract and get back to the attitude you had a few months ago?”

Tom: (silence)

Me: “If you don’t think this is working out, it’s probably best if we part ways at this point.”

Tom: “If I quit, I can’t collect unemployment. The only way you’re getting rid of me is to fire me, and you’re too much of a coward to do that. You’re going to keep paying me for the next six weeks while I look for a new job, even though I’m going to come in late, leave early, and have a bad attitude.”

Me: (shocked silence)

And wouldn’t you know it, Tom was right. It took me another month to find a permanent replacement, and in the meantime Tom and I had a cold and dysfunctional relationship. I had to put in extra hours on the production floor to make up for his tardiness, and the rest of the manufacturing team commented on how unpleasant he had become. When I finally told Tom that I had filled the position, he nodded and continued working. He stayed on the payroll through the end of his contract and left on his last day without saying a thing to me.

No Hollywood ending. I wish I could say we met up a few years later and talked through our disagreements, but no.

At the end of the day, I had managed to keep my department’s output up during a challenging period. I ultimately hired a permanent engineer who grew within the company and was a great asset. On paper, things looked like that had worked out well. I learned though, how terrible it feels to take advantage of someone’s trust and be disingenuous for my own benefit.

Doing the Hard Thing — that’s what matters.