For life sciences companies seeking to develop, deploy and successfully commercialize digital health products and solutions, the pathway to success can have many twists and turns, and be littered with false starts, roadblocks and more than a few misdirections. The pace of technological development—which is significantly faster than the current pace of technologically informed regulatory guidance and oversight—coupled with a lack of harmonization at the state and federal levels can make these challenges even more difficult to navigate. But close attention to common pitfalls and pursuit of tips and best practices for success can facilitate and accelerate development and adoption of life sciences digital health tools. This article will examine some of the major challenges to bringing digital health products to market and explore potential opportunities.

Key Challenges

To better understand today’s healthcare delivery challenges and opportunities, we should start at the beginning: Once upon a time in the United States, there stood a four-legged chair. On the chair sat the healthcare delivery model.  Each leg of the chair had a name, easily remembered because each keyword began with the letter P: patients, individual and institutional healthcare providers, health insurance plans, and pharmaceutical and medical device companies.

The relationships among these four legs involved shifting alliances and at times opposing forces: providers and patients against plans, providers and plans against pharma, and so on. Over the course of many years, the expense of healthcare delivery in the United States, poor health outcomes and a range of other systemic shortcomings have forced a shift in the healthcare delivery model. One example of this shift has been the arrival of a new “p” on the scene—phones and the consumer digital apps they allow patients to access. A second example is the intense interest on the part of life sciences companies to incorporate digital health strategies in their product and services offerings. These shifts reflect novel and fluid forms of collaboration and less concretized assumptions of how different types of stakeholders can participate in and contribute to healthcare delivery.

While life sciences companies can play a vital role in the development and deployment of digital health solutions, any number of pitfalls can impede results. For example, data strategies that work well for traditional product development and commercialization are not always the right match for digital health. In addition, many companies lack regulatory wisdom and experience in the digital technology space.

Following are some of the key challenges to developing and commercializing digital health technologies in today’s health care and regulatory system.

Minding Your P’s (and Q’s): Although the traditional ways the 4P’s participated in the healthcare delivery model are changing, it is important to understand (i) these traditional roles, (ii) the normative expectations of providers, plans and patients when it comes to healthcare delivery, and (iii) how these norms have filled the interstices of the regulatory structure. Understanding the current regulatory and legal structures in the U.S., as well as liability and other risk stressors facing these traditional players can help life sciences and medtech companies develop solutions that are not only technologically better, but will also integrate into, align with, and buttress the existing system. While breaking down old ways of doing things can lead to innovation and efficiency, out of the box thinking needs to be first and foremost constructive.  If the solution, however well designed for its specific purpose, is not also designed for the healthcare system within which it will be deployed, it will face resistance.

Last Mile Conundrum: For most products manufactured by life sciences and medtech companies, the hardest work—and greatest risk of failure—occurs prior to regulatory approval. Once the product is approved by the FDA (or other applicable regulatory framework), the company’s hardest work is done. For digital health solutions, the inverse is typically true. Digital health products and services often have a shorter development timeline. Once released in the market, however, they face numerous challenges involving adoption, adherence, persistence and integration. Among other issues, customers will expect regular software updates. Life sciences companies are not always adequately prepared for this last mile.

Customer Confusion, Part 1 (Customer versus Consumer): For standard healthcare products, the customer is the healthcare provider that purchases the product and then uses or prescribes it. The life sciences company generally does not deal directly with patients (i.e., consumers) except, perhaps, through patient assistance programs, post-approval risk evaluation and mitigation strategies (REMS) or other safety monitoring. In the case of digital health, the solution is often delivered, at least in part, directly to an end-user patient via web interface or app.

Customer Confusion, Part 2 (Consumer or Patient): Depending on a variety of factors, the end user may be a “patient” protected by the Health Insurance Portability and Accountability Act (HIPAA) or may be a “consumer” protected by the regulations promulgated by the Federal Trade Commission (FTC). Even seasoned healthcare stakeholders find the nuances and implications of these types of complex delivery models to be challenging; for life sciences product teams, they can be downright disorienting. This is particularly true if they are accustomed to sitting at some distance from the individual end user and think of their audience as the provider-prescribers. The distinction between patients that are and are not protected by HIPAA is not intuitive but can have far-reaching implications for data rights and enforcement.

FDA Fallacy: A common misstep is for life sciences companies to conflate FDA experience with regulatory experience more generally. The FDA’s approach to the regulated community is different than that of the Department of Health and Humans Services Office for Civil Rights (HHS-OCR), the FTC, CMS, state licensing boards and state attorneys general, among others.  Certain assumptions about the cadence, political calculations, enforcement resources and philosophy, and degree of cooperative spirit between regulator and regulated that may characterize the FDA may or may not also apply in other regulated contexts. A team that is familiar with the regulators that have oversight of their products and services can help a life sciences company achieve success, especially as many of these regulatory agencies may be less familiar for life sciences companies and these agencies may be less familiar with life sciences companies.

Risk Appetite, Risk Approach: For the life sciences industry, traditional FDA regulation of products has given rise to an understandably cautious, and deliberative culture. This stands in sharp contrast to, for example, the software industry, which is designed to anticipate missteps and to optimize, when necessary, the so-called “fast fail.” Blending the best of these two cultures within the innovation lifecycle can be tricky, but it is important for team success.

Blurry Strategic Vision: Digital health “fear of missing out” (FOMO) is real. Life sciences companies want to meet the moment and realize the strategic value to be found at the intersection of health care and data/computing, and often fear that every other life sciences company is ahead of the curve. Such enthusiasm can outpace the speed with which life sciences companies can develop dedicated digital health strategies, either as companions to existing products or as complementary clinical services. Companies should take the time to develop clear strategic objectives, articulate why a product or service is under development, how it will complement, drive, or enhance other company products, develop realistic goals and investments, and form a clear regulatory vision.

Deployment: The pushes and pulls on provider and patient/consumer end-users can lead to rapid adoption followed by slow deployment. Key contributors to sagging demand include products and services that are misaligned with the regulatory risks facing providers, interoperability concerns and IT resource constraints, and poor integration with existing workflows. Products and services that are confusing to patients/consumers, that present perceived or real privacy risks, that require extensive or time-consuming data entry, or do not provide actionable insights or obvious benefits also may fall by the wayside. It may seem obvious, but digital products and solutions are only useful when they are in use. Implementing features and functionalities that foster ongoing adoption and are sensitive to the regulatory environment of your market can facilitate adherence by providers and patients.

Opportunities

Look for Hidden Value: Digital health strategies—such as using the data obtained from digital health tools to promote research—can provide hidden value. As part of the development and marketing strategy, life sciences companies need to be prepared to articulate these benefits, internally and externally. The successful deployment of a digital health tool (e.g., a patient- or consumer-facing app) is predicated on the persistent adoption of that tool. It must provide discernible, ongoing benefits for the user.

Secure Executive Sponsorship: Digital health products and services typically straddle multiple departments. They require significant cross-functional cooperation and can languish without dedicated executive sponsorship. Strong leadership that holds decision-making authority and champions these products and services can pay significant dividends. The existence of teams that understand the regulatory lifecycle for these products and the normative and operational constraints that physicians and patients experience when using them can also increase the odds of success.

Don’t Fear HIPAA: Life sciences companies often overestimate the risk of HIPAA regulation, to the detriment of product design and deployment. Put simply, HIPAA privacy and security standards are manageable and, in some cases—particularly from a data-rights perspective—can offer certain advantages.

Strategize Your Data Plan: Companies should ask questions surrounding the desired data strategy up front. Among other topics, such discussions should involve the types of information and data rights they wish to collect and use (processes that are rather difficult to reverse engineer if not determined at the outset). Companies should build their data strategy into their protocols as early as possible.

Walk the End User Journey/Your Lawyer is Your Friend:  For innovative digital health products and solutions, legal should not be your last stop. It should be one of your first. Involving legal team members with regulatory design-thinking experience along relevant and critical path lines, such as data strategies (which encompasses but exceeds privacy), patient consent and treatment expectations, FDA, etc, will accelerate the development of products and tools that are deployment-ready and minimize wasted development time and avoidable dead-ends.  As part of this legal design-thinking, work with attorneys and other experts who can walk the end user journey to understand, among other things, i) how data will be acquired, used and disclosed at each step, ii) what normative provider, patient and other expectations may run counter to the operations of the product or solution that should be surfaced and addressed and iii) whether there are any inadvertent points of potential consumer confusion or misunderstanding that could create regulatory risk or suppress on-going adoption. This exercise—one might call it RWE future proofing—is vital in priming the digital health product or solution for successful deployment.

Prepare for the 2.0: For all software and digital products and solutions, we are accustomed to the “MVP” (minimally viable product launch) model. While “minimally viable” needs to be carefully considered and vetted when in the healthcare context, an MVP digital health product or solution may still have components that need to be reworked once the company sees how it performs with real people every day. Software companies plan for this; a 2.0 launch (and a 3.0, and a 4.0…) is presumed. But for life sciences companies, this can be a big of a development mind shift. Identifying the features and functionalities that should be monitored and redeployed is part of success, not failure.

Ultimately, life sciences companies have a unique role in bringing digital health products and services to healthcare providers, plans, patients and consumers. To do so successfully involves building on the existing strengths of the company and recognizing new capabilities and expertise that need to be developed and deployed. By developing a comprehensive understanding of the regulatory and customer pressures facing their products and services, businesses can accelerate approval, facilitate adoption and maintain deployment.