Digital health startups can incorporate clinical expertise into business models – here’s how

Early indications show funding to digital health startups in Q4 2022 fell so much, they’re close to levels last seen in 2019.

But the dollar amounts don’t tell the whole story. How you grow as a digital healthcare company is just as important as if you grow at all.

A company built for the long term should have clinical experts as part of its leadership to ensure that care is always based on the patient’s medical needs as well as maintain quality control.

Here’s a framework that digital health startups can consider:

Bring clinicians into senior leadership

The best-case scenario for a digital health startup is to bring on a clinician as a co-founder.

I speak from experience. My co-founder is a triple-board-certified psychiatrist who brings clinical expertise to everything she does. From evaluating product roadmap decisions with our technology department to strategy discussions at board meetings and managing our entire clinical team, her contributions are vital to the health and direction of the company.

Dedicating resources and space to full-time providers allows them to focus more on patient care — the reason they got into medicine.

Outside the C-suite, hiring clinicians as senior leaders with responsibilities beyond clinical practice is invaluable. The key is to ensure clinicians know they will report to another clinician, not a non-clinical executive.

Non-clinical leaders, including founders and non-clinical C-suite executives, should practice what they preach. They should consistently loop in their clinical partners for business discussions even if they don’t have an obvious clinical impact.

The main benefits of taking this approach include:

  • The clinical and non-clinical partnership is more active from the jump;
  • Other team members and clinical staff will see and respect the inclusion;
  • Clinicians may uncover something that has an indirect but important clinical impact.

Beyond hiring clinicians in-house, startups should consider inviting clinicians to join their board of directors. Their presence on the board helps guide a company towards becoming an ethical and sustainable medical practice focused on helping patients rather than a technology company operating at the expense of patients.

This dedication to patient outcomes is a differentiator and should be reflected at every working level of a digital health startup.

Celebrate providers’ dedication

Dedicating resources and space to full-time providers allows them to focus more on patient care — the reason they got into medicine.

Digital health startups can incorporate clinical expertise into business models – here’s how by Ram Iyer originally published on TechCrunch

How to obtain FDA buy-in and unlock more funding for your health tech startup

Many years ago, oil from Chinese water snakes was successfully used to treat joint pain until peddlers made “snake oil” synonymous with fraud. Times have changed, but the medical industry continues to walk a fine line between optical illusions and real solutions.

Now, as venture capital funding within health tech has fallen 41.2% compared to the same time last year, it’s even more important for emerging technologies to present more than promises.

By reaching for the highest standards and obtaining regulatory certification from institutions like the U.S. Food and Drug Administration (FDA), startups can show investors and clients that they’ve gone through the necessary checks for safe use in healthcare, creating more opportunity to drive long-term success.

FDA breakthrough device designation

The influx of artificial intelligence in healthcare is exciting but often met with skepticism from the public, and rightfully so. The stakes for a poorly designed digital health product are higher than any other industry, and the costs of failure much more serious.

There are many regulatory organizations that offer credibility and validation to incoming healthcare solutions, but the FDA is the best place to start. Why? The large U.S. market and its reputation for a rigorous framework around approvals will make it easier to expand down the road. Also, the FDA is one of the few agencies that has created a distinct path for software as a medical device (SaMD) to gain approval.

Startups should view privacy, safety and clinical validation not as nice-to-haves but as key components of the user persona they are building for.

The FDA’s breakthrough device program focuses on technology that will meaningfully help an overly taxed system. It’s an increasingly well-supported pathway that makes it easier for innovators to bring products to market faster, and it’s one of the best examples across the world of how regulators are responding to and working with innovators.

Devices must meet two criteria to be eligible for breakthrough device designation. First, the device must provide effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition. Second, the device must meet at least one of the following: The device represents breakthrough technology; no approved or cleared alternatives exist; the device offers significant advantages over existing approved or cleared alternatives; and the device availability is in the best interest of patients.

While the FDA will give you an opportunity, it is up to your startup to test rigorously for efficacy and meet the highest standards when the time comes. The first criteria will be the most difficult bar to clear, as you must show clinical efficacy. The breakthrough device designation program is based on pilot studies done on the technology.

How to prove clinical efficacy

Recently, the Journal of Medical Internet Research analyzed over 224 venture-backed digital health startups that have raised more than $2 million in funding. The study rated each company on a scale of 0 to 10 for “clinical robustness,” 10 being the highest possible score. Of all the startups, 43.8% scored a zero. It’s no wonder venture capitalists are pulling back.

Startups hoping to secure regulatory buy-in from the FDA must test to ensure the device is more effective at treatment or diagnosis for a serious illness. This means testing not just for a device’s efficacy but conducting studies that compare it to existing, approved treatments.

How to obtain FDA buy-in and unlock more funding for your health tech startup by Ram Iyer originally published on TechCrunch

8 investors discuss what’s ahead for reproductive health startups in a post-Roe world

One of the most pressing issues the U.S. has to prepare for, perhaps, is the future it faces after the toppling of Roe v. Wade.

Come the midterm elections, voters will weigh in on candidates and, consequently, measures that will dictate abortion access and other human rights issues. The role venture capital must play in all of this is becoming clearer: There has been a push to fund more reproductive health companies, include healthcare access in ESG investments and reevaluate the safest places to open a business for women employees.

To get a clearer picture of what lies ahead, TechCrunch+ surveyed eight investors and learned what they think venture’s role should be in a post-Roe world. McKeever Conwell, the founder of RareBreed Ventures, noted the tenuous relationship between venture money and ethics. He said although there are some who might not care about human rights issues in relation to investing, he wants to double down on funding startups focused on reproductive health.

Theodora Lau, the founder of Unconventional Ventures, said she believes more venture investors should take political stances on issues. “Access to healthcare is a right; it’s not politics,” she said. “These are existential issues that should concern all of us, regardless of our role.”


We’re widening our lens, looking for more — and more diverse — investors to include in TechCrunch surveys where we poll top professionals about challenges in their industry.

If you’re an investor who’d like to participate in future surveys, fill out this form.


“Where legislation continues to lag, it’s important for technology to take a proactive stance to bring transparency to current and future innovations and mitigate the kinds of risks we see today.” Hessie Jones, partner, MATR Ventures

Meanwhile, Hessie Jones, a partner at MATR Ventures, said the due diligence process needs to go deeper to identify the risks of developing new technology. “Due diligence needs to expand past the point of founder ‘intentions.’ We have to ask ourselves: What is the potential that this technology can be used for other use cases beyond its current intention? What is the impending risk to people or groups?”

Finally, nearly everyone we spoke to is keeping an eye out for change that could come in November. “Vote,” Lau said. “With your voice, with your action and with your wallet.”

We spoke with:


Hessie Jones, partner, MATR Ventures

What was your initial response to the overturn of Roe? What are other impacts the overturn of Roe has had on your firm and investment strategy?

I grew up in the Catholic system, which vehemently opposed abortion and the right of women to decide what to do with their own body. I am also a Canadian, and our laws regarding abortion and the rights of the mother are very different than the U.S.

The Dobbs v. Jackson’s Women’s Health decision implies the rights referenced under the 14th Amendment — specifically, a woman’s right to privacy under the “due process clause,” which affirmed her right to choose whether to have an abortion — leaves all civil right precedents vulnerable to being overturned.

The assumed misinterpretation of the 14th Amendment in this opinion turns back the clock when it comes to the rights women have been fighting for years.

Where legislation continues to lag, it’s important for technology to take a proactive stance to bring transparency to current and future innovations and mitigate the kinds of risks we see today: Exposure of personal information, data surveillance and the use of personal information that will ultimately inflict harm on individuals and groups.

This is already happening, and now it has found its way into communities where reproductive data is leveraged against the data subjects.

Will the Dobbs decision affect the criteria you use to conduct due diligence?

Absolutely! Apps that have been used to help women, like Flow, Glowing and Cue, can be weaponized with warrants to identify those who are or may be seeking abortions. The data collected by these apps and Big Tech can be sold, breached or acquired via government warrants without taking into consideration the rights of the subject.

Due diligence needs to expand past the point of founder “intentions.” We have to ask ourselves: What is the potential that this technology can be used for other use cases beyond its current intention? What is the impending risk to people or groups? As well, we must, at the very least, demand privacy-by-design standards and the security of the infrastructure acquiring any personal data.

We must scrutinize founders’ intentions, how the data will be used, who the partners are, to what extent data will be shared and for what purposes. We’ve come to a perilous crossroads where technology has contributed to harms, and we now must put the onus on founders to be more accountable for what they’re building.

8 investors discuss what’s ahead for reproductive health startups in a post-Roe world by Dominic-Madori Davis originally published on TechCrunch

9 ways founders can bring automation to healthcare

For years, automation has been a key driver of transformation across industries, changing the way companies and entire sectors operate. However, healthcare, a $4.1 trillion industry, has fallen behind.

For an industry that constantly innovates, evolves and adapts, the reticence to embrace automation is frustrating, but ultimately, unsurprising. Healthcare remains in a constant tug-of-war among patients, payers, providers and pharma. This push and pull drives unnecessary costs, impacts clinical quality and leads to patient and provider dissatisfaction.

We cannot solely lay the blame on regulations. In other highly regulated industries such as financial services, automation has redefined high-friction processes. For example, automation transformed mortgage underwriting by providing consumers, brokers and banks with relevant information, rules and real-time transactions. As incumbent banks embraced startups, investors leaned into novel ways to reduce friction and improve accuracy, increasing annual mortgage origination by nearly 40% compared to the last decade.

There’s immense opportunity for similar gains in healthcare, but long-term success requires healthcare incumbents to truly commit to automation.

The ongoing COVID-19 pandemic has exposed significant cracks in our healthcare system. As healthcare systems and payer executives contend with ballooning labor costs tied to The Great Resignation and reduction in patient mindshare from the explosion of digital-native startups, they will need automation to stay competitive.

Friction created by prolonged implementation cycles, lack of adequate clinician involvement and difficult to measure ROI has left us with a healthcare system skeptical of technology.

Automation is the key to a more resilient and efficient healthcare system, but increasing meaningful adoption remains challenging. Entrepreneurs trying to navigate these waters should consider the following go-to-market tactics to increase their odds of success:

Focus narrowly on a specific “starter” problem

Even if your platform can do multiple things, you should focus on helping “onboard” prospective customers with one thing you do really well that has short go-live times, minimal customer resource requirements and clear success metrics.

Clearly define success across measurable metrics

ROI is often both qualitative and quantitative in nature, so it’s important to define the framework for your offering and weight KPIs differently based on prospective customer nuances instead of creating bespoke ROI frameworks that are impossible to keep track of.

Deliver 1x-2x ROI within a year of launch

Having clearly defined success metrics should enable automation platforms to demonstrate value within six to 12 months of launch. Ideally, companies should target 1x-2x ROI for the initial deployment to avoid underpricing. Showing ROI within a budget cycle will position companies well for future expansion.

Finger on your pulse: API-first startup Vivanta hopes to be Plaid for health

API-first companies are on the rise, not just in fintech but also in sectors like healthcare. This diversification is boosted by the fact that employees who have earned their chops on banking APIs are now applying their skills to other problems.

Healthcare is one of the sectors that could benefit from API solutions. While there is value in knowing your heart rate or glucose levels, an API can help companies give its end users a much more global view of their well-being, allowing them to take the right steps to stay healthy.

Mexico-based startup Vivanta lives at this intersection of healthcare and APIs. Its focus is health data, with an eye on the fact that wearables are becoming ubiquitous. But its co-founders Alex Hernandez and Jorge Madrigal previously worked together at fintech companies: Arcus, acquired by Mastercard last December, and Belvo, which is API-led and sometimes described as “LatAm’s answer to Plaid.”

This API-centric track record was key for the startup to raise a $300,000 pre-seed round even before launching its product — Vivanta is doing a private launch next month.

“We invested in Vivanta because Jorge and Alex have a successful track record of pushing new API products into the market,” said 99startups managing partner Alejandro Gálvez, who participated in the funding alongside Guadalajara’s Redwood Ventures, Monterrey’s Angel Hub MTY and Mexico-focused syndicate Lotux.

Vivanta’s founders also invited a dozen individuals to participate in the round, with a focus on operators with relevant expertise. “Being able to ask questions to people who’ve done it before is invaluable,” Madrigal told TechCrunch. “We wanted to have a strong network of people that we can lean on.”

Some of Vivanta’s angel investors are founders themselves, such as Arcus’ Edrizio de la Cruz, Madrigal’s and Hernandez’s former boss. But the pair also made a deliberate effort to reach out to technical profiles that are perhaps less common on cap tables — including female engineers and CTOs currently building APIs.

For mental health startups, happiness is in niches

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Last April, Alex and I reported CB Insights data showing that venture investment into mental health startups had dropped sharply in Q1 2022 compared to the preceding quarter. But in the last couple of weeks, I have heard about several venture-backed deals into the subsector of health tech. They got me curious: In which areas of mental health are VC firms still willing to invest? Let’s explore. — Anna

Mood swings

The more the pandemic seemed to subside, the less venture capital investors seemed willing to commit to companies and sectors that had initially benefited from strong tailwinds when most of the world started staying at home. On public markets, the pandemic trade is over, with former darlings like Peloton and Zoom experiencing whiplash. Similarly, we saw a net decline in private investment into telehealth and mental health startups.

Market corrections after a period of hype are part of the investing game. But it would be hard to argue that mental health needs have decreased. According to the World Health Organization, incidents of anxiety and depression increased by 25% in the first year of COVID-19. Just because we are now hopefully leaving the worst of the pandemic behind us doesn’t mean everyone is suddenly feeling better — which is why a few recent funding rounds in the mental health space raised my attention.

Of course, a few mental health–related deals are anecdata. And since we are talking mostly about early-stage deals, this doesn’t mean that the investment decline has been reversed. In aggregate, we will only have more clarity once Q2 numbers are available. But what’s interesting is that these startups hint at some novel approaches to mental health in which VCs are still willing to invest. Or, dare I say, show us where their mind is at.

No longer underserved?

VCs might have no headspace left for the next Headspace. The broad-ranging mental health-focused platform and its most direct competitor, Calm, seem to have captured most of the mainstream market for bite-sized mindfulness. But there are still gaps in the mental health market to address — at least, some startups think so.

Digital biomarkers are healthcare’s next frontier

Blood pressure, body temperature, hemoglobin A1c levels and other biomarkers have been used for decades to track disease. While this information is essential for chronic condition management, these and many other physiological measurements are typically captured only periodically, making it difficult to reliably detect early meaningful changes.

Moreover, biomarkers extracted from blood require uncomfortable blood draws, can be expensive to analyze, and again, are not always timely.

Historically, continuous tracking of an individual’s vital signs meant they had to be in a hospital. But that’s not true anymore. Digital biomarkers, collected from wearable sensors or through a device, offer healthcare providers an abundance of traditional and new data to precisely monitor and even predict a patient’s disease trajectory.

With cloud-based servers and sophisticated, yet inexpensive, sensors both on the body and off, patients can be monitored at home more effectively than in a hospital, especially when the sensor data is analyzed with artificial intelligence (AI) and machine-learning technology.

Opportunities for digital biomarkers

A major opportunity for digital biomarkers is in addressing neurodegenerative diseases such as mild cognitive impairment, Alzheimer’s disease and Parkinson’s disease.

Neurodegenerative disease is a major target for digital biomarker development due to a lack of easily accessible indicators that can help providers diagnose and manage these conditions. A definitive diagnosis for Alzheimer’s disease today, for example, generally requires positron emission tomography (PET), magnetic resonance imaging (MRI) or other imaging studies, which are often expensive and not always accurate or reliable.

Cost savings and other benefits

Digital biomarkers have the potential to unlock significant value for healthcare providers, companies and, most importantly, patients and families, by detecting and slowing the development of these diseases.

‘Move fast and break things’ is a bad idea for health tech startups

It may seem counterintuitive, but one of the reasons some entrepreneurs are drawn to healthcare are the regulations. No industry outside of defense is as heavily scrutinized, and for good reason: When you deal with people additional caution is essential.

Rules, requirements and regulatory complexity may be barriers to entry in the world of digital health startups, but they also present opportunities.

Founders often find creative ways to reconcile the additional oversight, like saying that their launch is merely a proof of concept, or that they can’t justify the cost of spending hundreds of thousands of dollars a month on advertising to attract new users.

When venture funding was scarce, there was a compelling need to prioritize speed and maximize the runway provided by smaller seed rounds. The environment, however, has changed — burgeoning investor interest and ample available capital have meant that there’s an even greater need to allocate significant budget to compliance.

Speed and efficiency may be essential for startups, but regulatory compliance need not be a bottleneck or a financial drain.

If compliance isn’t a consideration from the start, founders will sooner or later end up in a situation where they have to scramble to fix things behind the scenes, spending huge amounts of money on legal fees — and that’s the best case scenario. In the worst case, a deal can blow up.

It is understandable how these concerns can be overlooked at the beginning. There’s a certain amount of creativity and dissatisfaction with the status quo necessary for founders to conceive of building something that doesn’t already exist.

But when you’re building a digital health company, the ultimate end user is a person in need of medical care. The stakes are higher than creating the next puzzle game or food delivery app.

The Kindbody TC-1

It’s telling of our maturity as a society that infertility is a concept approached rarely with anything but awkwardness and uncertainty.

The ability to have children is integral to our society, but when someone faces infertility, support systems can prove scarce, fertility services can make patients feel adrift, mental health support is rare, patient education is abysmal and costs are obfuscated; the list goes on and on.

Fear, uncertainty and doubt rule in the realm of reproductive healthcare, and it’s beyond any one person or company to remedy this.

Kindbody, however, is trying. The women behind this startup know first hand how harrowing the fertility journey can be, and they have put together a platform that confronts and addresses its problems head-on.

The startup’s clinics are modern and inviting, its doctors eschew traditional white coats to meet their patients eye-to-eye, it builds mental health plans for every patient, its website is clean, informative and actually has prices clearly outlined so patients can plan for the expenses. Kindbody’s desks even sport rounded corners in an effort to remove hierarchy from the care.

The company is attacking the fertility market from many angles, but its focus is clear: making the patient feel acknowledged, cared for and comfortable. And that approach has paid off — the company has raised $154.7 million so far, and its business is booming at its facilities across the United States.

Kindbody’s valuation comfortably gives it unicorn status, but in the realm of fertility, the company may truly be a unicorn.

TechCrunch’s writer and analyst for this TC-1 is Rae Witte. She has written extensively on technology, business and culture for publications like TechCrunch as well as the Wall Street Journal, Vogue Business, and our corporate sister publication, Engadget. The lead editor of this package was Ram Iyer, the series editors were Henry Pickavet and Alex Wilhelm, the copy editor was Richard Dal Porto and original illustrations were created by Nigel Sussman.

Kindbody had no say in the content of this analysis and did not get advance access to it. Witte has no financial ties to Kindbody or other conflicts of interest to disclose.

The Kindbody TC-1 comprises three main articles numbering 8,200 words and a reading time of about 30 minutes. Here’s what’s in the bank:

We’re always iterating on the TC-1 format. If you have questions, comments or ideas, please send an email to TechCrunch+ Editor-in-Chief Alex Wilhelm at alex.wilhelm@techcrunch.com.

How compassion and inclusivity are helping Kindbody change the fertility industry

When the topic of fertility comes up, we often hear hushed tones discussing someone else’s or their own journey through infertility. Sure, celebs have begun talking about it, but we’re rarely taught about it in health class. Nor is it typically a topic of discussion over holiday hors d’oeuvres.

At a time when the world is fighting inequities around health and welfare, reproductive healthcare continues to be largely ignored in the conversation. The science and medicine around fertility are presented with an air of complexity that, more often than not, leaves patients feeling lost, scared and alone.

To change a system that’s reactionary instead of proactive is far from simple. To even make marginal improvement, one would need to thread the needle of education, accessibility and perhaps place compassion over profits and growth.

Kindbody appears to be one of the few startups in the space well on its way to tackling this behemoth of a challenge. Its approach is also drastically different from most fertility service providers — it has savvy, intelligent marketing; a tech-enabled and fully virtual care facility; a focus on compassion; and ample customer education to help patients feel involved and understood.

The company today has 12 outlets in ten cities in the U.S. and is fast ramping up its scaling efforts with over $154 million raised so far. Aiming to be a one-stop shop for fertility, gynecological and wellness services, Kindbody provides services to heterosexual couples, single mothers by choice and members of the LGBTQ+ community.

Gina Bartasi launched Kindbody, her third fertility startup, in 2018, after her own journey helped her understand just how broken and antagonistic the system is. With an eye toward inclusivity, holistic care and reducing the friction in the patient process, Bartasi and her team have created one of the few companies in healthcare making a difference.

The first thing I noticed on my fertility journey was that every physician I saw in the fertility industry was an older white male. Gina Bartasi, founder of Kindbody

In this first part of this TC-1, we’ll explore Bartasi’s journey, the problems in the fertility space, the difference that clear pricing and communication can make, and how eliminating the white coats and display of degrees around the offices has helped Kindbody become one of the preferred destinations for fertility treatments.

Addressing how we approach fertility

Bartasi originally ran a media company in Atlanta, but sold it after getting married and relocating to New York City to be with her husband. When she was 38, she and her husband decided to start trying to have a baby, and, like many women a decade ago, were met with an experience that was far from the warmth and care one would expect at such an intimate time.

“The first thing I noticed on my fertility journey was that every physician I saw in the fertility industry was an older white male,” she told me. “I was treated as a subordinate, like the doctor was all-knowing and our mission was to do exactly what he said, even though I was paying $25,000, whether or not I had any success.”

Gina Bartasi, founder of Kindbody

Gina Bartasi, founder of Kindbody. Image Credits: Kindbody

This experience prompted her to launch her first fertility startup in 2008, Fertility Authority, a content platform and fertility clinic review website for those facing infertility.

A few years later, in 2015, the company was renamed Progyny after it was bought by Kleiner Perkins and TPG Biotech. The content platform was maintained, but the company’s focus pivoted to selling fertility benefits to self-insured employers.

While a fertility insurance solution seemed like a great idea, the reality of how healthcare is set up in the U.S. made for some significant roadblocks.