The Critical Role of Medical Affairs in Healthtech Companies

The Critical Role of Medical Affairs in Healthtech Companies

“Great discoveries and improvements invariably involve the cooperation of many minds.”
Alexander Graham Bell

Medicine is shifting toward a more personalized, value-based experience. As this transformation continues, healthtech companies need to be able to communicate the value and clinical differentiation of their solutions more effectively. This will require incorporating healthcare experts, who are usually hired into medical affairs roles.

This, in turn, will require tight collaboration between the medical affairs group and other groups within the company, including commercial, R&D, market access, and product teams. Katie Anders, the head of medical affairs strategic solutions at Medscape, said, “Today, medical affairs must liaise with their R&D colleagues and fully grasp the science that supports their work. They need access to real-world data. They need the strategic thinking abilities and insights of their marketing counterparts, and the customer-facing skills of those in sales. And they must understand and operate under all of the rules and regulations governing industry interactions.” The healthtech companies that adopt this strategic model will ultimately create more clinically and commercially viable healthtech products and increase their chance of widespread adoption.

The importance of generating real-world data 

According to Bain & Company (see figure below), 88% of US physicians consider real-world evidence a top criterion in their prescribing practices. Within a healthtech company, medical affairs can play a key role in helping to generate the real-world evidence required for health products to be widely adopted in the marketplace.

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Furthermore, medical affairs experts are poised to help educate not only physicians, but also payers, to identify relevant data and real-world applications for higher quality patient care.

An overview of the medIcal affairs role 

In health companies, medical affairs departments evolved to serve as an independent counterbalance to sales and marketing departments. In FDA-regulated companies, specific laws dictate the claims that sales/marketing can discuss versus the information and indications that medical affairs is allowed to discuss.

Medical affairs very specifically never carries a quota and their KPIs are not based on sales performance or projections. The healthcare industrial complex is conditioned to expect different things from a medical affairs professional than from a sales/marketing professional—it is almost impossible for a single individual or department to serve both roles effectively, since the natural tension is part of a successful balance.

The essential elements of the medical affairs role are to:

  • Be the voice of and advocate for the patient. For example, would you want your doctor to be acutely aware of the likelihood of a false positive result? If so, then medical affairs needs to be the voice for the company’s collateral to meet this need.

  • Represent the needs and concerns of healthcare professionals

  • Be trusted by our healthcare professional clients.

The cross-functional role of medical affairs

If medical affairs departments are deployed and embraced strategically within a healthtech company, they can play a critical role in various aspects of the organization, including:

  • Business development Accelerate business development efforts when assessing new technologies for acquisition

  • KOL programs Engage and develop KOL-led sites to generate appropriate, necessary data proof points required for successful go-to-market strategies. This data generation allows the healthtech company not only to showcase its capabilities to other physicians, but also to payers for reimbursement strategies

  • Medical content Provide support for marketing in reviewing content and advising on messaging that resonates with target medical audiences

  • Product development Be a core part of the product development process to help make products with the correct product-market fit that truly solve  problems in health care

  • Market access Foster an understanding of the reimbursement landscape and provide the scientific messaging and dossiers so that payers understand the added value and ROI of their technology.

  • Stakeholder education Educate physicians and other potential stakeholders in health care. Help educate the leadership and commercial teams on how to accurately and effectively communicate about the technology with their customers.

  • Spreading the word, scientifically Medical affairs team members can also be medical spokespeople at conferences and with the media, by writing articles for scientific and medical journals as well as speaking at medical society meetings.

The value that medical affairs can bring to a healthtech company

McKinsey & Company interviewed numerous medical affairs executives to create a 2020 vision for medical affairs. Collectively, they identified  four aspirations that would create the most value for their organizations as well as the industry as a whole:

  1. Enhance patient access to, and best use of, optimal medical treatment
  2. Embrace patient-centric healthcare
  3. Facilitate coordination and integration of different medical data and types of knowledge
  4. Acquire and develop talent

Along with broadening the spectrum of external stakeholders with which medical affairs interacts, healthtech companies that strive for increased internal interactions will further excel.  These examples show how medical affairs can provide significant value to healthtech companies:

  • To further enhance patient access: medical affairs can collaborate with market access efforts to demonstrate economic and medical value.

  • To embrace patient-centric healthcare: medical affairs can collaborate with marketing colleagues to create collateral that integrates patient advocacy groups.

The preferred way to engage with healthcare professionals is changing; the primary focus is now on improving health outcomes for a greater portion of the patient population. If medical affairs collaborates with internal forces to provide business intelligence, business development, marketing, market access, and sales with a more patient-centric perspective, medical affairs’  value within the organization will increase. Providing real-world data, and increasing access to it, creates an opportunity for medical affairs leaders to leverage data while continuing to establish and maintain trust with external stakeholders and the medical community.

Medical affairs professionals who want to lead the change must be involved in various projects across the organization and communicate not only to the medical community but also to colleagues within the organization. This collaboration will only become more critical as therapeutics increase in complexity and as big data is utilized to assess outcomes in a value-based system. 

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Daniela Crandall MHS, PA-C

MDisrupt Guest Blogger

As a clinician, I’ve cared for patients in outpatient, operating room, and inpatient settings. As a sales director in healthtech, I created strategic direction and handled tactical business plan administration and talent management. As a director of medical education, I was in charge of training strategies for both sales professionals and surgeons. Medical affairs experience included engaging KOLs, making C-suite level presentations, and engagement with healthcare systems, payers, and medical device executives.

Incorporating medical affairs into your company

If you are in the healthtech industry and want to assess the value of increasing medical affairs involvement with your organization, consider engaging with our consultants. We all want to provide the highest-quality care for patients; having  medical affairs experts work closely with your company can accelerate the widespread adoption of your health product. Talk to us—we can help.

How Healthtech Companies Can Successfully Access the Self-Insured Employer Market

How Healthtech Companies Can Successfully Access the Self-Insured Employer Market

So, you have a new health technology that you’ve packaged into a hot product offering. You’re excited about your product. As you think about going to market, you practice reciting all the great things about your offering. This product’s going to take the world by storm! Your largest potential market: self-insured employers.

You’re not alone. The self-insured employer (SIE) marketplace is enormous. And with each year, more medium-sized and smaller employers are joining the fray. According to the most recent EBRI (Employee Benefit Research Institute) findings research, 78.5% of employers with 500 or more employees offered a self-insured health plan. That’s translates into more than 56,000 plans covering more than 75 million participants, according to a recent Deloitte study prepared for the Department of Labor.

However, self-insured employers are barraged by “next best thing” solutions touting a new technology that will revolutionize the marketplace in a new or unique way. Some recent examples include:

  • A new diagnostic blood test to help fine tune the treatment for certain kinds of cancer

  • A new application of telecommunications technology to optimize patient/provider interaction

  • Targeted pharmacogenomic testing for psychiatric therapeutics

  • A new stem cell treatment for joint injuries

  • A condition-specific self-management app

  • A new imaging technology that can be offered onsite.

Key Strategies That Drive SIE’s Business Goals

So how can you break through the noise and get attention in this crowded market? First, you need to understand what  self-insured employers are trying to accomplish. The four key strategies that usually drive SIE business goals for benefits are:

  1. Medical cost reduction through plan design
  2. Medical cost reduction through marketplace innovation
  3. Improved member engagement in health and wellness
  4. Improved workplace engagement and performance 

Self-funded health insurance plans enable employers to better customize plan and coverage options, as well as to better target cost-saving strategies. Naturally, employers struggling with escalating medical costs are looking for the next big thing. SIEs, in particular are sensitive to medical costs since they are spending “their own” money. 

To do this, employers typically choose one of two options: an Administrative Service Only (ASO) plan from an insurance carrier, or a Third Party Administrator (TPA) plan. ASOs tend to be more turnkey, offering ease of administration and more limited plan options. TPAs tend to be more flexible and enable employers greater choice in plan design and offerings. The distinction is important, as the appetite and feasibility for new solutions increases with greater employer flexibility.

How to Convince SIE’s to Adopt Innovation 

Many SIEs are willing to consider leading edge solutions if they can be convinced that the return on investment is worth the risk and the hassle. 

Understanding not just what your new product offers but how it aligns with what a particular SIE wants to accomplish makes all the difference in the world. Understanding employer cost drivers and identifying specific ways that those costs might be avoided or reduced is key to making a smart, targeted pitch to your potential customers.

Many healthtech companies promise medical cost reduction through marketplace innovation. But they often underestimate the level of detailed understanding of medical spending that SIEs and their advisors have. Increasingly, employers can influence cost trends and clinical drivers to an impressive degree.  Some of the key factors many SIEs consider include

  • Cost per member

  • Utilization trends 

  • Acute and chronic conditions 

  • Gaps in care 

  • Risk scores pharmacy/medical ratios for their plans.

These metrics can be further analyzed by company location, member type (employee, spouse and dependent), and by plan.

It is vital to understand precisely what metrics your new health product will impact, and how it will change them in new ways.

What the Self-Insured Employer Needs to Know From You

Do commercial medical carriers pay for your service? If not, why not?

Most SIEs have an insurance carrier, or some other plan administrator, process their medical claims. These carriers and administrators abide by a set of clinical policies that relate to medical necessity. Some policies may be developed internally, some externally. Some common examples include: 

  • Is your service  in accordance with generally accepted standards of medical practice?

  • Is it clinically appropriate and effective?

  • Is it not primarily for convenience?

  • Is it less expensive than an equivalent alternative service?

  • Is it endorsed or recommended by national medical societies and associations?

  • Does your technology have final approval from the appropriate governmental regulatory bodies, when required? (FDA approval, where applicable, is necessary but not sufficient to meet coverage criteria.)

  • Is your service covered by Medicare? While carriers are not obligated to follow Medicare policy for their commercial members, it is often considered in formulating clinical policies for commercial plans.

How will your health product disrupt the status quo? 

When considering a new diagnostic, therapeutic or behavioral change solution as part of an employee benefits plan, there are some basic questions you should be prepared to answer for a SIE:

  • What does the new capability offer?

  • What is the upside of offering the new technology?

  • What are some of the potential downsides?

  • Do the benefits outweigh the costs?

  • Is it medical necessary? Is it advisable?

  • What population is it intended for?

  • How will it be implemented and what are the costs associated with implementation? (I.e. does it require a blood draw or physician order, and if so are those baked into the solution and costs?)

  • What are the ethical and legal ramifications of including this in the benefits program? 

  • What’s the ROI or the VOI (Value on Investment)? Can you prove it?

  • Are any other employers doing this? Why or why not?

The Practicalities: What a Smart Self-Insured Employer Looks For

In addition to understanding the details of what you offer and believing that it will accomplish what you say it will, employers need some assurances about your own credibility. Here are a few additional questions they might have for you? 

  • Can you do what you say you will do, and do it well?

  • Do you have a proven track record?

  • What will the service experience for the employees? For their families?

  • What will we see from you?

  • What kind of reporting do you offer back to us?

Anticipating this piece of the conversation is vital for new healthtech disruptors: The more you can answer these questions truthfully and with confidence, the better your position to get to the next step.

Wherever possible, providing a predicted ROI is advisable (a range is acceptable). Assume that your SIE has a sophisticated understanding of ROI and be as specific as possible. Dollars spent on your product and program should be demonstrable by key indicators. Thinking through the “what ifs” shows you understand their world. An even stronger case can be made if you’re willing to put dollars at risk. 

How Healthtech Companies Can Successfully Access the Self-Insured Employer Market 3

Before you knock on the door, have proof of concept. Pilots or case studies are critical to your credibility. Upstart enterprises will inevitably face a “chicken and egg” conundrum for this.  You need to solve for that. Funding your own study in some way may be something to think about.

Key Considerations

  • Every employer is different. Be prepared to pivot your pitch to meet what the SIE is really after.
  • An employer’s appetite for change and innovation will vary widely based on the views of decision makers, and the realities of benefits delivery for that company. Most times, “new and shiny” just isn’t enough.
  • Claims of medical cost reduction need to be credible and data driven. Understand the actual drivers of medical costs for SIEs and, if possible, touch on key cost “hot spots.”
  • Make sure you have carefully thought through the member (user) experience, as well as the employer experience.
  • Be prepared to explain why carriers don’t cover your diagnostic or therapeutic services as part of their core plan offering.

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Ronald S. Leopold, MD, MBA, MPH, Physician Consultant

MDisrupt Guest Blogger Specializing in Employee Benefits, Medical Cost Solutions, New Medical Technology

As a credentialed and experienced professional, Dr. Leopold brings credibility and a breadth of knowledge as a consultant, client advocate, and marketplace spokesperson. He is an industry thought leader in employee benefits and health and productivity.

Specialties: Medical Costs, High Cost Claimants, New Medical Technologies, Employee Benefits, Heath and Productivity, Population Health Data Analytics, Global Workforce, Generations in the Workforce, Financial Wellness, Thought Leadership, Public Speaking.

If you are interested in exploring the Self Insured Employer channel for your healthtech product, MDisrupt has a network of experts that can help. Talk to us—we can help.

We wouldn’t make drugs without chemists. So why make digital health products  without behavioral scientists?

We wouldn’t make drugs without chemists. So why make digital health products without behavioral scientists?

Humans are complicated, and changing our behavior is hard. 1, 2 Despite all the hype about artificial intelligence and personalization, most consumer-facing behavior change tools are incredibly unsophisticated, relying on basic self-tracking and superficially-tailored feedback to change behavior. Techniques known to be highly effective, such as such as disrupting habit streaks, and linking contextual cues to behavior, 3, 4 are noticeably absent in most digital health products. Maybe this is why most of these products don’t actually work.

Using science to sell apps—but not to build them

Most consumer-facing apps are not scientifically informed. 5, 6, 7 And even when they are based on evidence, implementation of the science into the product is often poor. 8, 9 This lack of science, however, does not prevent companies from using science to sell apps. On the contrary: A recent review found that over 40% of the most popular mental health apps invoked scientific language to support their effectiveness claims yet just one of these apps linked to published literature. 10

Many of the solutions being pitched or sold to us are behavior change solutions – buy this, wear that, ingest these insights about yourself, and you will be freed from pain, sleep better and lose weight! But peel back the marketing claims, and investors and consumers alike may bristle to find out that—to mention just a couple of examples— sleep-tracking apps can make insomnia worse, 11 and the published benefits of a daily blood pressure monitoring app (whose makers just raised $12 million 12) were based on just 2% of those sampled. 13

An alarming number of companies are publicizing results using inappropriate statistical techniques. For example, conducting what is known as a completers- only analysis involves selectively analyzing only those data from people who completed the trial/experiment, and ignoring the data from people who quit. This approach makes it way more likely you will conclude your product is amazing, because the people who make it to the finish line are inherently more motivated. We want to see your intent-to-treat results, which include the people who dropped out. It is also worth pointing out that the same statistical rules apply to both big and small data. Yet amid the promise of big data, many people have grown increasingly comfortable eschewing the fundamentals. 14, 15, 16 We need to remember that methods matter too: Applying the right statistical analysis can’t overcome bad execution or study design.

The mainstream media, investors, consumers, and industry players have been sold on the idea that behavior change is one appropriately timed nudge away and that we can educate our way toward healthier living. The expectation that exists in the space is wrong: You cannot simply click ‘like’ to change your behavior. 17

So how do you change behavior?

Behavioral science can help us design for behavior change, and build technologies that not only spark change but sustain it. 18

Behavioral science is the empirical study of human behavior across the lifespan. It encompasses fields such as psychology, cognitive science, public health and economics. Behavioral science emphasizes how context, and the social and physical environments, play profound roles in behavior, beliefs, and decision- making. People are different, context matters, and things change. 19 This table lists some behavioral interventions shown to effectively address common health problems.

  Links for references below correspond with number bubbles above.

Links for references below correspond with number bubbles above.

20 21 22 23 24 25 26 27 28 29 30 31 32 33 34

Behavior change science can tell us what works and what doesn’t. 35 If digital health technology companies ignore behavior change science, they will fail to produce meaningful, long-lasting results. 36

Behavioral science + 21 st century technology

Behavioral science has undergone radical transformation in step with the technological revolution. No longer must we rely on humans to self-report what they are doing—now wearables and sensors can passively detect behavior throughout the day. And in instances where we must ask people questions, new technology-enabled methods can illuminate the behavioral context, such as what the person is doing while sedentary, having cravings, and feeling blue. 37

The data accrued from these newer methods are reinforcing long-held (but previously untestable) hypotheses about the non-linear nature of change. 38, 39 They also enable us to intervene at the right time. 40, 41 In other words, we can get closer to automating human support than ever before. These new data also provide strong evidence that conclusions drawn from group-level data are extremely imprecise for individuals. 42 Fortunately, we can now optimize interventions at the individual level and realize the power of behavioral phenotyping. 43

For example, let’s consider how people react differently to self-tracking. We know that some people reject it because of waning motivation – they get negative feedback and stop tracking themselves. Measuring individuals’ determination, resilience, and/or coping style can provide insight into who will benefit from consistent tracking and feedback. For those who respond poorly to consistent tracking, reframing failure as within one’s control can overcome the tendency to avoid. 44

Wellness apps: A behavior change opportunity

Historically, our focus has been on helping people once they get sick, focusing our investment dollars, product pipelines, and healthcare reimbursement strategies toward treating disease. On its face, this makes sense: There is a lot of sickness to treat. Six in 10 US adults have at least one chronic disease, and four in 10 have two or more. 45 By 2030, the number of adults with three or more is estimated to almost triple from 31 to 83 million. 46 Including lost productivity, the economic burden of chronic disease is estimated to be a staggering 20% of our gross domestic product or $3.7 trillion. 47

But, what if we helped people before they got sick? What if we could recoup some of that $3.7 trillion, and pump it back into our economy? Lifestyle behaviors drive most chronic disease incidence, morbidity, and mortality. 48 These behaviors include smoking, excessive alcohol consumption, insufficient physical activity, and poor sleep habits. 49 With the help of science, these behaviors can be changed. And while there exists a dizzying number of consumer-facing wellness apps that claim to change these behaviors, very few have published evidence to indicate that they do so in any meaningful way. 50

Shockingly, even highly valued healthcare startups do not publish peer-reviewed evidence on their apps’ effectiveness. 51 If we are to move the needle on health, this indifference toward evidence and limited use of science must come to an end. We simply cannot afford to fall victim to the illusory truth effect whereby we accept evidence to be true based on how often we hear it repeated.

Digital health won’t advance without behavioral science

Digital health companies should have behavioral scientists embedded in their product development teams from the very beginning. Companies should also include behavioral science in their medical affairs departments, for both evidence generation and strategic leadership. The most forward-thinking companies will have chief behavioral science officers. 52

Within product development, behavioral design should operate in concert with user- experience design. 53 Behavioral design involves translating science into products and services. In addition, behavioral science should be positioned to work alongside analytics and data science. Establishing behavioral-data science architecture is necessary for many reasons, including planning experiments and interpreting users’ engagement data. Digital health companies need to go beyond a focus on the number of monthly or daily active users and ask themselves, what effective engagement looks like. 54, 55

Four questions for evaluating a product’s behavioral claims

  • What evidence supports these claims?

  • How was this evidence generated?

  • How is behavioral science informing product/service design?

  • Who is responsible for pilot tests/experiments?

Remember: Behavior change is hard. Science helps.

We wouldn’t make drugs without chemists. So why make digital health products  without behavioral scientists? 5

Dr. Gina Merchant, PhD, MA

MDisrupt Guest Blogger

Dr. Gina Merchant is a behavioral scientist specializing in digital health. She is an expert in user/patient engagement, how our social networks influence our health, and behavior change design. Gina has a PhD in Public Health, and an MA in experimental psychology.

Disrupt has a network of behavioral scientists; If your company needs this type of expertise to help you build your health product, talk to us—we can help.