MDisrupt—building the gig economy for health industry experts

MDisrupt—building the gig economy for health industry experts

MDisrupt Podcast

MDisrupt—building the gig economy for health industry experts

Ruby Gadelrab, CEO and Co-founder of MDisrupt, the first-of-its-kind medical diligence company, discusses how they are helping health-tech startups demonstrate viability and bring health products to market faster and more responsibly. The company is also launching an on-demand health industry expert platform to connect a wide range of highly specialized medical and scientific professionals with emerging health tech companies that will most benefit from their expertise.

If you are a health industry expert join us!

MDisrupt One Year On—A Year of Transformation

MDisrupt One Year On—A Year of Transformation

The only constant in life is change. And nowhere is that more true than in your first year as a start-up.

As many of you know, MDisrupt was founded a year ago because we believed the healthtech world was lacking “medical diligence”. We believed this was the missing link in the market and the reason why so many healthtech startups were stumbling on the path to successfully commercializing their health products.

We originally created MDisrupt to identify healthtech companies who were at risk of becoming the next Theranos, or uBiome. Our hypothesis was that if investors undertook more rigorous medical diligence, they would be able to more easily identify and evade potential investments in companies that were not clinically or commercially viable, or who were not taking the appropriate regulatory path.

Like any start-up in its first year, we had ups and downs, learned a ton and we soon identified our true direction – to play an even more constructive role in the healthcare / healthtech industry than we had originally planned. Luckily we were small and nimble enough to be able to react quickly to the market dynamics and, while some of the changes were tough, they forced MDisrupt into a stronger, better place. I want to share with you the ways we have changed and the lessons we learned along the way. 

Changing Focus – Healthtech Investors Were Not The Primary Customers For Medical Diligence

It turned out that healthtech investors were not our primary customers. There is not really a ‘budget’ for medical diligence in an investment transaction. Tech funds source health subject matter experts from within their network to conduct diligence, whereas, bio and life sciences investors already have health domain expertise on staff.

We soon found that it was the bigger and more established health companies that had utility for our medical diligence services to provide an objective external third party view and address their needs in a range of fundamental areas such as: 

  • Benchmarking: 
    • “How do our clinical standards as a laboratory compare to other clinical labs?”
  • Mergers and Acquisitions: 
    • “We are considering an acquisition and want to understand the new market of the company we are acquiring.”
  • Market Sizing: 
    • “We are launching a new product in a new market and want an objective view of the market size and opportunity.”

Our True Market: Healthtech Truth Seekers Wanting Much More Than Medical Diligence Services

While we had limited traction with investors, one of the most inspiring parts of the last 12 months was meeting the healthtech founders who were determined to build their companies responsibly and cared deeply about building impactful, scalable and data-driven health products. But they did not just want our medical diligence assessments, they wanted access to us and other health industry experts to help them build their health products well in the first place. They were aware of how other healthtech companies had stumbled in their early days and did not want to make the same mistakes. 

These companies wanted our help to solve problems such as: 

  • Should my test be an LDT or an IVD?  Is it a health or wellness product?
  • What is the appropriate regulatory path I should take in the US?
  • How do I find a part-time Chief Medical Officer?
  • How do I access the self-insured employer channel?
  • What is the right strategy for engaging healthcare providers and payors?
  • Help me define a marketing strategy for reaching medical audiences.

Even the investors we engaged with in our early days, started to connect us to healthtech companies in their portfolios. Very soon we were overwhelmed with these types of requests and had to start tapping into our network of colleagues to help us on these projects. We quickly realized that our real market was helping the healthtech founding teams themselves.

Uncovering The Unmet Need: “The Gig Economy For Health Industry Experts”

As we began to reach out to our networks for help on these projects, and with all the press coverage we received when we launched, we were inundated with support from experienced health industry professionals and colleagues. The same key themes emerged: 

  • It is about time someone helped improve standards of health products. 
  • How can I help and get involved? 
  • Can I work for MDisrupt?
  • I want to work with healthtech companies and help them get to market quickly and safely.
  • How can I find the healthtech companies who could use my skills and expertise?

We heard from our client healthtech companies that they were struggling to access the experts they needed and here we were with hundreds of emails from passionate, experienced experts ready and willing to help. That was the moment we realized that the real problem we needed to solve was how we could provide easy access to experienced, vetted health industry experts. We knew then what we needed to build into the MDisrupt platform – a health expert two-sided marketplace. 

And so we did.  To date we have 58 consultant subject matter experts spanning the healthcare continuum, averaging 10 years’ experience in their discipline. Our expert consultants include:

  • MDs
  • Scientists
  • Market Access Experts 
  • Regulatory Experts
  • Commercial and Channel Strategists 
  • Lab Test Designers 
  • Clinical Trial Designers 
  • Health Economists

Many of these industry experts are still practicing and so are able to provide the most current perspective within their disciplines. They are able to assist healthtech companies in a variety of capacities including: 

  • Experts-in-Residence 
  • Part-Time Chief Medical or Chief Scientific Officer 
  • KOLs 
  • Medical or Scientific Advisory Boards 
  • Consulting Projects 
  • Expert Opinions

Engaging these health industry experts as consultants has enabled us to solidify our mission of helping to bring the most impactful health products to market faster and more responsibly by uniting the healthtech and healthcare industries – benefiting from the best of both worlds.

The Covid-19 Pandemic: An Unexpected Driver In Uniting The Healthcare And Healthtech Worlds 

As we entered 2020 the onset of the coronavirus outbreak changed the world for us all. Never has healthcare, healthtech and science been more in the spotlight than over the past 6 months. Very soon we started to see healthtech companies make significant shifts in their business models to help address the global pandemic. Some examples of these include:

  • Lab testing companies that wanted to shift into developing Covid-19 Testing 
  • Telemedicine companies that had to scale significantly 
  • Instrument companies that had developed products for adjacent industries wanting to move quickly into clinical lab testing 
  • Behavioral apps who pivoted to address mindfulness and stress-management issues arising from lifestyle shifts due to prolonged shelter in place mandates
  • Regulatory and clinical activities for “Back to Work” scenarios – how employers, colleges and schools can bring people back safely

Once again, we have been inundated with requests for health industry experts to help healthtech companies make these pivots and transitions. Increasingly, healthtech companies are seeing the value of having scientific and medical experts as core parts of their teams to help them navigate the new opportunities that the pandemic has brought to the industry.

As Start-Ups Evolve, So Do Their Teams 

Earlier in my career, while working for a start-up, a wise CEO told me that the people that found a company are not always the same people that grow the company, or scale it or take it public.  Teams evolve and different people and skills are needed for different stages of progression. 

MDisrupt was founded by myself and my close friend and colleague Jill Hagenkord, who I nicknamed the “Godmother of Precision Medicine”. We founded MDisrupt with the mission of helping bring the most impactful health products to market faster and more responsibly by uniting the healthtech and healthcare worlds. Today is the one-year anniversary of MDisrupt and, while that mission has not changed, it is bittersweet for me to announce Jill’s departure from MDisrupt. Jill was offered an incredible opportunity that she could not refuse and she is off to pursue her next amazing adventure. I don’t want to steal her thunder by announcing where she is going until she does, so stay tuned for her announcement. I am so incredibly grateful for the blood, sweat and tears Jill poured into MDisrupt working alongside me over the past year and how she helped turn a glimmer of an idea into a business that can truly make an impact for so many companies. Myself, and the MDisrupt community she helped to build, thank her for her dedication, passion and brilliance and we will be cheering her on as she embarks on her next journey.

We have also been lucky enough over the past few months to add some new and incredibly talented people to our team:

Ragan Hart, MS, PhD – Director of Operations and Business Development 
Ragan is an applied health economist, who evaluates clinical genomics and digital health technologies.  Learn more about Ragan Hart

 Dr Pamela Mehta – VP of Medical Affairs 
Dr. Pamela Mehta is a board certified, practicing orthopedic surgeon and the founder of Resilience Orthopedics. Read more about Dr Mehta 

Please join me in welcoming them to the MDisrupt Community!

A New Year, A New Look

As a health product marketer by blood, I believe it is important that a brand is not only representative of your company’s personality but also a critical communication vehicle for your target audiences. We serve both health innovators and our health industry experts equally. Our goal has been to create a brand that resonates with both sectors, keeping the modern feel that the healthtech industry is accustomed to, but enriching this with content written by our experts to address the real issues entrepreneurs may face as they take on the challenges of responsibly building scalable health products.  

 We also wanted to make it easier to showcase some of our experts’ skills and create simpler ways for health companies to find them. So we gave ourselves a rebrand – take a look at our new website, we welcome your feedback. I want to thank Paul Bohanna, our creative and technical director who has worked tirelessly over the past few months to reimagine our brand and build our website. 

A Company Is Only As Good As Its Network of Supporters – Thank You

As with any start-up, the first year is a year of learning, pivoting and identifying new opportunities. But one thing has been clear – we have been blessed with incredible support: from the clients that believed in us and trusted us to work closely with them on their projects, to the network of health industry experts that joined our platform and have been passionate about not only helping the healthtech companies but also helping us directly, advising us, writing amazing blogs for our website and evangelizing our message.

Finally, I want to acknowledge a few partners who have supported us and provided wisdom and guidance from our very first day.  

One year on, I am humbled and grateful for all the support and from the bottom of my heart I thank you all. 

Ruby Gadelrab
CEO

Bridging the Cultural Divide Between Healthcare and Healthtech

Bridging the Cultural Divide Between Healthcare and Healthtech

Bridging the Cultural Divide Between Healthcare and Healthtech 1

From Healthcare to Healthtech

Jill Hagenkord talks about her transition from Healthcare to Healthtech and shares the lessons she learned. In this podcast Jill shares some of the cultural differences she observed between the two industries and the ways that healthtech companies can collaborate with healthcare experts to create clinically and commercially viable health products that can scale.

jill hagenkord

Jill Hagenkord, MD

MDisrupt Guest Author

Jill is a board-certified pathologist with subspecialty boards in molecular genetic pathology and a fellowship in pathology/oncology informatics. She brings expertise in health product strategy, coding, coverage, reimbursement, medical and regulatory affairs, health policy, clinical laboratory medicine, population health, provider education and patient engagement.

Accessing the self-insured employer channel correctly takes special expertise. If this channel is key to your commercial strategy, talk to us—we can help.

8 Common Mistakes Healthtech Companies Make When Building Health Products

8 Common Mistakes Healthtech Companies Make When Building Health Products

Written by Ruby Gadelrab, CEO and Co-founder of MDisrupt

Most of us in the health industry want to get meaningful health products to market, and to the people who need them, as fast as possible.  Yet in the growing healthtech sector, despite over $50B invested since 2011, there have been relatively few successful exits.  

Over the past five years, since before we founded MDisrupt, we have worked with, advised, reviewed or consulted for over 100 healthtech companies.  We were surprised to find that the mistakes these companies are making are shockingly consistent. Even more striking is that many of these mistakes are completely avoidable.  Here are a selection of the most common things we have seen. 

1. Not Having the Right Product-market Fit 

Many of the health products we reviewed often just don’t solve a real problem in healthcare.  At best, some are nice to have, but for the most part many of the companies we talked to hadn’t actually understood the workflows and nuances of what their intended customers were trying to accomplish. Often it’s a case of trying to commercialize a technology by “backing into” a perceived problem. 

In many cases entrepreneurs start with a technology and then seek a market. In one case, an entrepreneur had built software for physicians of a particular type of medical specialty, but had never actually spoken to one of those physicians. She hadn’t engaged them at any point before building the product to check that it solved a real problem, or during the build to understand what features were important.  

Understanding your target audience—and especially where the user fits within the complex healthcare setting—is critically important when building health products. There are many nuances, stakeholders, workflows and dependencies that differ for each case and are critical to understand.  Involving healthcare experts from your target audience early and throughout product development is mission critical to building a clinically viable health product.

In short, no product-market fit = little or no scale. 

2. Building Products With Economics That Don’t Work

Having product-market fit is one key to building a clinically viable health product.  Equally important is commercial viability, in particular, ensuring that your product creates value for its user. Does it come at a price point where the ROI of adopting it is clear? How much does it save compared to other technologies or to the status quo? How much does it cost to implement? Do the combined costs of the product and the implementation provide a compelling financial argument? 

To answer these questions (which stakeholders WILL ask) it’s essential to do a Health Economic Study or Health Economics Outcomes Research (HEOR).  This needs to be conducted by an experienced health economist and definitely not by the internal commercial teams. 

One type of Health Economic study is  a Cost Effectiveness Analysis (CEA). The CDC has a great definition and example here. 

“Cost-effectiveness analysis is a way to examine both the costs and health outcomes of one or more interventions. It compares an intervention to another intervention (or the status quo) by estimating how much it costs to gain a unit of a health outcome, like a life year gained or a death prevented.”

There are several different types of health economic models. Different stakeholders prefer one over the other and they are not easily converted. For example, self-insured employers may prefer a Budget Impact Analysis.   For either channel, you will absolutely be required to show these analyses as part of a BD negotiation before they would even consider a pilot.  

Beyond the healthcare setting, another mistake entrepreneurs often make is overestimating what consumers are willing to pay for a health product.   While it’s good practice to conduct price elasticity studies to gauge the value consumers perceive in your product and where the right price point may be, it’s important not to over-index on these results.  Consumers behave very differently in research settings than in a real world setting when they have to pay for health products. 

Even if you have the BEST technology that solves a REAL problem, if the economics don’t work, then there is no viable business. 

3. Under-representing Medical Expertise in Their Teams 

Many healthtech companies we spoke to, had no healthcare experts on their leadership teams at all. Very few had hired medical professionals as employees, consultants or advisors, and those that had them rarely involved or listened to them. This feels counterintuitive if you are building a health product.  As a marketer, I (Ruby) have been hired by multiple companies to consult because the founders know and freely admit that they don’t know marketing and so they hire an expert. However, rarely have we seen them say the same thing about hiring medical people.  

In one case, I met a founder who was building a clinical genetic test and seeking advice on his first hires and advisors. When I suggested that the first hire should be a medical geneticist, or a chief medical officer,  he was horrified and asked “Why would I hire that skill set now – what would they do? What value would they bring?” These questions are answered by Dr. Daniela Crandall in her blog The Critical Role of Medical Affairs in a Healthtech Start-Up

4. Undervaluing Medical Experts in their Teams

After we founded MDisrupt, we were overwhelmed with support from the healthcare industry. Hundreds of people reached out to say how glad they were that we founded the company and how much Medical Diligence is needed. As we started talking to them, they all told us similar versions of the same stories of their experiences in healthtech companies: 

  • Many were hired by healthtech companies for “optics” purposes only

  • Very few had a significant role or say in product development

  • When they suggested that certain mission-critical studies should be done they were often ignored or put on performance improvement plans for overstepping

  • Numerous medical professionals told us they were asked to join sales calls and state their name and credentials only and not speak beyond that 

  • When marketing material was created, it was rarely passed to the medical teams to review for accuracy of clinical claims.  On the rare occasions that it was, commercial interests often trumped medical truth. 

Most of the healthcare experts we met were talented, passionate and eager to be part of the creative disruption of health care. Although they had had bad experiences, they still had faith that if healthcare professionals could be given a real seat at the table and a significant voice in building health products, they could help accelerate the path to market in a responsible way.   

There is no doubt that health care needs to be disrupted and to become a better experience for all of us. Healthcare experts and healthtech founders are equally frustrated and united in the mission to make this happen quickly, but it needs to be done responsibly.  Healthtech entrepreneurs can save themselves years of time and millions of dollars if they engage health experts early and often in a meaningful way.  

5. Failing to Understanding the Difference between Scientific and Medical Expertise

Many of the founders we talked to mistook “scientific” advisors for medical ones. Often when we asked where they were seeking medical guidance, we heard “Prof. X from high profile institution Y is one of our founders/advisors/board members.”  We would say, “That’s great, but does Professor X have any medical training? Has he or she ever commercialized a health product?” Usually the answer was no. 

It appears that many healthtech entrepreneurs don’t know the difference between scientific and medical expertise. It’s important to have the right type of expertise for the task. Jill broke this down in her blog where she defined the differences between scientific and medical expertise.  

Even scientific discoveries which are peer reviewed in high profile journals  and widely cited need to be successfully translated into products that can be used on patients. Great science doesn’t always translate into great health products‚ the discovery may fail on some other aspect of its clinical or commercial viability (see the point about product economics above, for example). There is a difference between scientific validation and clinical validation.   Most scientific publications are not designed to demonstrate the clinical validity of a medical test or health-related claim. (We will address this in a future blog.)

Sometimes healthtech founders are not even aware that there is a scientific or medical discipline well-matched to the task they are trying to accomplish. An example of this is where a health product is designed to incentivize behavior change. I have met numerous founders who gave the role of creating these products to their Head of Product, typically a person with a commercial background. It comes as big news to them that behavioral science is an actual scientific discipline and there are specific scientifically proven methodologies for incentivizing behavior change.  In her blog, Dr. Gina Merchant, who has a PhD in behavioral science, describes why engaging a behavioral scientist is so important when building health products. 

6. Not Conducting the Appropriate Studies or Generating the Right Type of Evidence 

When building a health product, the bar for evidence that it ACTUALLY WORKS and is SAFE to use on real humans is much higher than when building consumer products.  

The studies aren’t a “nice to have”—they are mission critical for  building clinically and commercially viable health products. The studies that need to be conducted are an essential part of the formula for successfully building a health product.  This formula isn’t magic or a secret sauce: It is well known by healthcare professionals and is a standard series of studies and activities that every company building a health product has to do.    

We outlined these essential steps here in our blog The Formula For Widespread Adoption of Health Products that Every Healthtech Investor and Entrepreneur Needs to Know. As we talked to healthtech companies over the past few months, we realized that this formula seemed to be unknown to them. Many hadn’t planned on doing these studies simply because they didn’t know they had to. 

8 Common Mistakes Healthtech Companies Make When Building Health Products 2

7. Being Vague about a Product’s Intended Use 

The first step in health product development is to define the intended use statement (also called the intent of use). This statement informs the regulatory risk category and determines the types of studies that will be needed. Failure to optimize the test for its intended use will result in an unacceptable number of false results. But done properly, the intended use statement will serve as the “North Star” for product development, medical and scientific affairs, marketing, and financial forecasting. 

Many variables can influence the performance of a test, such as population characteristics, the prevalence of the target condition of interest, the setting, and the type of test, among others. Thus, it is important to design the performance evaluation studies to match the intent of use.

The intended use of a test describes:  

  • The clinical purpose of the test: e.g. screening, diagnosis, prognosis, risk prediction, therapy or treatment selection for patients

  • The type of technology used: e.g. next generation sequencing, spectrophotometry, or electrophoresis

  • The target condition e.g. disease, disease stage, or any other condition of interest

  • The analyte being measured  e.g. DNA, HbA1c, LDL, Vitamin D

  • The type of specimens acceptable for testing e.g. whole blood, plasma, serum, tissue 

  • The location where the test is conducted e.g. clinical laboratory, point of care, home use

  • The type of results: e.g. quantitative, continuous, ordinal, or qualitative

  • The population for which the test is intended e.g. adults over age 50, adults with a diagnosis of major depressive disorder who have had an inadequate response to at least one psychotropic drug, high risk pregnant women

  • Skill level needed for interpretation of the test the need for a trained or skilled user of the test or test interpreter

In our experience, founders often don’t understand the concept of intended use. When we ask them who  the product is created for, they often answers “Everybody,” or a very wide subset of the population. Usually the reason founders are keen to maintain a broad intended use is for commercial purposes; they don’t want to limit their TAM and SAM projections, particularly when fundraising. However, the fastest path to market is usually the simplest, narrowest intended use. The intended use can be expanded over time as additional studies are completed to substantiate the claims.

8. Misunderstanding What is Required to Access a Particular Channel 

I (Ruby) have consulted for about 35 companies over the past two years.  Almost all of them ask me one or more of the following questions: 

  • How do I get a deal with a self-insured employer (SIE)? 

  • How do I get physicians to buy and use my product?

  • How do I get a deal with a health system?

  • How do I acquire consumers?

I will save consumer acquisition and health systems for future blogs, since they are entirely unique channels. Here’s what’s important to know about self-insured employers and physicians. 

Self-insured employers 

Often entrepreneurs choose to access this channel as they believe it’s a way to accelerate commercialization and revenue before the necessary studies are done to get into medical society guidelines and reimbursement.  This assumption is often not the case, SIEs also have a minimum bar of clinical evidence required. SIEs may consider small pilots that are usually funded by the healthtech company without seeing the studies. But ultimately, the final decision for adopting a health product widely in this channel will be made by a CMO (Chief Medical Officer). She will often ask for the same level of clinical evidence as required in a healthcare setting.  

In addition, the ROI analysis is also critical for this channel (see product economics section above). Again, if the economics don’t work, there is no opportunity for scale. Our physician consultant and expert Dr. Ron Leopold covers this in his blog How Healthtech Companies Can Successfully Access the Self-insured Employer Market.

Physician adoption 

When it comes to achieving widespread adoption in a healthcare setting by physicians, there are two additional critical steps (assuming all the other steps have been done correctly). These are 

  • Incorporation into medical society guidelines 

  • Reimbursement

Healthcare professionals and scientists are the most skeptical audiences. Glossy marketing material alone isn’t going to convince them of much; in fact it will barely get their attention.  

The biggest influencers of these professionals are their peers. For them, convincing content needs to be in the form of credible data and evidence. And the most effective communication medium is medical society meetings. 

For healthtech companies, a critically important part of entering this channel involves developing a KOL (Key Opinion Leader) program. KOLs will help to generate the data and evidence necessary to get into medical society guidelines, convince payers to reimburse for their products and will also create “medical influencers” who can educate their peers. How a KOL program works and its purpose will be addressed in a future blog. 

We have often heard from healthtech companies, “We don’t have time to do all these steps; these studies take years; we need to get there faster – what can we skip?” The reality is that when it comes to health products, there are no shortcuts. 

So how does a healthtech company in a rush to commercialize get there?  Well, the easiest way is to engage healthcare experts early, listen to them and follow the formula to avoid making costly missteps. The hard way is to try to skip a few steps and waste years of time and millions of dollars trying to recover.


How Can We Help?

The path to getting your health product widely adopted may be longer than for a consumer product, but it doesn’t have to be hard.  At MDisrupt, our goal is to help healthtech companies create clinically and commercially viable health products. We have built up a network of experts from across the healthcare continuum and they are all passionate and eager to help healthtech founders get the most impactful products to patients faster. If you need a healthcare expert, talk to us


Why Investors Need to Do More Rigorous Medical Diligence as a Core Part of any Healthtech Investment

Why Investors Need to Do More Rigorous Medical Diligence as a Core Part of any Healthtech Investment

Yesterday’s big news, reported by Chrissy Farr of CNBC, was ‘“Gut health start-up uBiome files for bankruptcy five months after FBI raid.”  In other words, yet another health tech company is making headlines for avoidable, costly—or dangerous—missteps. The troubles of uBiome, Theranos, Nurx and 23andMe have been high profile enough to make the press, but they are by no means unusual. In fact, similar missteps are happening all the time with smaller health tech companies, usually unbeknown to their investors. 

It’s time that we in the industry, who are creating the health products of the future, ask ourselves why these problems keep  happening and what we need to do to fix them. A heated debate erupted on Twitter in response to the latest uBiome headlines, questioning what role investors play in enabling missteps and whether they are doing an appropriate level of medical diligence when they fund health tech companies.

Investing in early-stage companies is always risky particularly in the unproven health tech sector. In every investment transaction, investors conduct a process of due diligence to confirm the accuracy of claims about the company’s finances, business model and teams. The due diligence process is intended to help identify the potential winners, elucidate key risks, and develop a risk mitigation plan with the management team. Common areas of review during the diligence process include finances, operations, legal, and, when appropriate, technical. Although the investors and entrepreneurs need to be aware of diligence issues, the actual assessment is typically done by professionals—accountants for financial diligence, lawyers for legal diligence, and so forth.This is because these individuals do a far better job of identifying potential pitfalls or risks.

Yet in health tech, the process happens in a different way. When it comes to the medical diligence required to evaluate a company, tech investors usually rely on their associates instead of on professionals with medical industry expertise. 

Medical Diligence Is Missing

We would hope that by simply presenting the above sentence to the investor world, the logical disconnect would speak for itself. In case that’s not convincing enough, the proof of the problem is in the numbers: Over $50 billion has been invested in health tech in the last ten years, but with very few successful exits. Clearly, most medical diligence that has been done to date has not been rigorous enough. For the most part, it has failed to separate those companies who are creating a clinically and commercially viable health product from those who are not. And it has failed to detect the ones making the egregious missteps we are seeing in the headlines.

Tech entrepreneurs are famous for solving problems with rapid iteration and learning. However, they can often take far too long—five years or more—to discover certain requirements for success in health tech: Specifically, that: 

  • There is a formula for achieving widespread market access in health care 

  • They need team members who are part of the healthcare industry 

  • Credible evidence presented in the right places is necessary before widespread adoption of a new health product can happen. 

Proper medical diligence that takes these principles into account can save entrepreneurs years in opportunity cost and save investors tens of millions of dollars per company.  

Investors Need to Lead

The investment community has the power to propel the health tech industry forward and accelerate the disruption of health care by identifying the most viable health products faster. In order to do this effectively, investors need to know that a company’s business practices and financing are sound. But they also need to know if a product or service is actually clinically useful, solves a real healthcare challenge, and whether the company has data or is conducting studies that support its claims and stated value propositions. The timeframe to investors’ return on investment is overtly tied to the answers to these questions. Rigorous medical diligence is ESSENTIAL to investor success and to the creative disruption of healthcare.

While the elements of medical diligence are well known to traditional healthcare investors, we believe it’s important for all investors to obtain an assessment of these criteria when considering an investment in a health tech company.  We have outlined these essential parameters in our blog The Formula for Widespread Adoption of Health Products that Every Investor and Health Tech Entrepreneur Needs to Know.

At MDisrupt, we believe that an obvious solution to the problems in health tech is to engage healthcare professionals and market access experts to assess the viability of health tech investments. As with legal, financial, and technical diligence, medical diligence, when conducted by experienced professionals, can save time and money, avoid embarrassing missteps, and set appropriate revenue timeline expectations. 

MDisrupt works with investors and health tech entrepreneurs to do an independent, transparent, and objective assessment of the clinical and commercial viability of health-related products and services. We can identify red flags early on as well as work with companies to bridge any gaps they may have. Our assessment includes: 

  • Clinical Viability

    • Intended use and product-market fit

    • Analytical and clinical validity

    • Clinical utility and health economic models

    • Prospective outcomes studies

  • Commercial Viability 

    • Coding, coverage, and reimbursement, if appropriate

    • Clinical dossier development

    • Key opinion leader strategy and eventual inclusion in professional society guidelines

    • Channel optimization and market access strategy

  • Regulatory Strategy

  • Privacy and Security

As an industry, we need to do better. We need to combine the best business philosophies of the tech industry with the best practices of the healthcare industry to help get the most impactful products to patients faster. This is MDisrupt’s mission.  

If you are an investor considering an investment in a health tech company, talk to us. We are happy to outline and explain the essential elements of medical diligence and why they are important to successful investments. Medical diligence can help keep you and your portfolio companies from making headlines for the wrong reasons.

jill hagenkord

Jill Hagenkord, MD

MDisrupt Guest Author

Jill is a board-certified pathologist with subspecialty boards in molecular genetic pathology and a fellowship in pathology/oncology informatics. She brings expertise in health product strategy, coding, coverage, reimbursement, medical and regulatory affairs, health policy, clinical laboratory medicine, population health, provider education and patient engagement.

Every health tech company wants widespread adoption for its health product. There is a community of healthcare experts who would love to help you. Talk to us—we can help.