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Scale Down Before Scaling Up: Digital Innovation in a Highly Regulated Industry


The highly-regulated pharmaceutical industry poses serious challenges that can derail digital health programs. But, there are solutions.

The pharmaceutical industry, like other highly regulated industries, is inherently restricted, with long-standing limitations put in place for good reason. Testing and manufacturing medications is a time-intensive, expensive, and complex process, heavily regulated to ensure both the efficacy of the drug and the safety of the patient. The marketing and promotion of these medications have their fair share of efficacy and safety guardrails as well, enforced by extensive medical, legal, and regulatory (MLR) processes.

Within these guardrails, pharmaceutical marketers are tasked with implementing new digital solutions to educate healthcare practitioners, improve patient outcomes, and drive their business forward. It’s a constant push-pull that can result in otherwise innovative people feeling stuck and stagnant in their roles.

But it’s important to remember that guardrails aren’t roadblocks: they delineate safe and efficacious pathways to follow en route to innovation. So, while taking risks by trying something new in pharma might seem counterintuitive, that doesn’t mean it shouldn’t be done. On the contrary, marketers should strive to adopt safe, sensible approaches to implement modern solutions that can garner results and improve the outcomes of the patients they serve.

Vish Khanna

Vish Khanna

The Waterfall Effect of a Restricted Industry

No matter how hard we collectively try to address issues and ease burdens within the pharmaceutical industry, some things will remain constant. The very nature of the industry will always present marketing professionals with two primary challenges:

  • MLR protocols that slow the pace of innovation: There’s no denying the importance of MLR review of any branded promotional material. That’s the baseline requirement of our industry. But MLR processes are oftentimes manual, they vary based on the person, team, or organization, and are slow-paced. It takes 55 days on average for a document to progress through the MLR process and be distributed to customers for a mid-to-large pharma company.

When pharmaceutical marketers start to explore digital health programs to solve their brand’s educational and other patient-facing problems, their promise and excitement can quickly diminish due to the time-consuming, resource-intensive MLR processes ancillary to all promotional work.

  • Individuals are unwilling to push the limits:This second challenge exists solely because of the first challenge. It’s the waterfall effect of a regulated industry. Even if a marketer has data-backed evidence of the effectiveness of a digital health intervention, for example, the intensive MLR process that they will eventually come up against can halt progress altogether. The energy and time that it will take to implement a program correctly can feel like too much, and even more, those people might not even be in their same roles by the time the program is up and running. They essentially never reap the benefits of putting their neck on the line.

How can pharmaceutical marketers who want to learn, grow, and evolve their strategies to inspire behavior change in their patient populations rethink their approach? The answer to this complex question is actually simpler than you might think: scale down before scaling up.

How to Take Safe, Sensible Risks

Because of these two primary challenges that loom over pharmaceutical marketers, when they decide to search for proven digital solutions that will work for their designated indication and patient population, they’re typically unable to find the right match. That’s because the promise of additive digital health programs tends to fall short, primarily because they’re too daunting given the challenges to get up and running in the first place.

This puts the onus on today’s pharmaceutical marketers to forge ahead and create their own success stories for others to learn from, which again, can feel like a very tall order. There are, however, safe and sensible risks that can be taken with digital solutions today—you just need to ease into it, then scale once you’ve seen markers of success.

Here’s what that looks like in practice:

  • Smaller upfront investment: When you scale down a digital health program, which comes with a significantly reduced upfront investment in time, money, and effort, you will have a better chance of getting your strategy and all its resources approved. Instead of a one-year program, you might instead opt to commit to a three-month-program, lightening the resources needed for the MLR process. This smaller budget and time commitment can likely push past the typical internal threshold for marketers (and their executive team) and get the green light in terms of acceptable risk.
  • Reduced patient cohort: With a scaled-down program comes a scaled-down patient cohort. With a shortened time for engagement, a digital health program can truly focus on an enhanced, personalized patient experience, which also significantly helps with recruitment for the program – a notoriously difficult task. Rather than 1,000 patients, you might be recruiting 100 patients.
  • More confidence to scale: With a shorter, smaller pilot approach, marketers can test and measure more often, and if they’re seeing positive results, they can start to scale with greater confidence. They gain access to early indicators that showcase what’s feasible and what isn’t, including rate of acquisition, patient engagement levels such as check-ins and self-assessments, and 90-day fill behavior. They can then measure performance against other patient programs and databases to truly understand what it will take to succeed. Through this, the guesswork often associated with implementing digital health programs is removed altogether.

Pharmaceutical marketers responsible for assessing new digital health solutions that can solve their brand’s challenges want and need to see success sooner rather than later. Instead of waiting one or two years for results, they’re expected to show progress in six months. That’s what scaling down allows for—it’s about testing more and testing faster, so they can scale up with confidence. Plus, if the program fails – if results aren’t promising enough to continue – it was a smaller investment to begin with, and it’s still a great internal story to share in terms of lessons learned.

The pharmaceutical industry can be challenging to navigate and even more challenging to evolve, but the guidelines are there for a reason – it’s simply how we need to function. And innovation is still possible. Marketers looking for a proven, sensible approach to digital health programs that work with the industry, not against it, have options available to them that make it easy to scale down and win.

Vish Khanna is chief commercial officer of HealthPrize, a digital health pioneer in the use of behavioral economics, education, and gamification to inspire health behavior change.

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