HSBC Innovations is the global bank’s financing arm for American and European startups, especially in the healthcare and life sciences industries. The bank’s semi-annual Venture Healthcare Reports document trends in the investment market.

Key Tech’s Andy Rogers welcomes the report’s author, HSBC Innovation Managing Director Jon Norris in Episode 43 of the MedTech Speed to Data podcast.

Need to know

• · Four core market segments — HSBC Innovation’s Venture Healthcare Reports cover investments and exits in Biopharma, Dx/Tools, Med Device, and Healthtech.
• · Sourcing investment data — Norris enriches Pitchbook data with additional structure and analyses, making the report more relevant to these market segments.
• · Sourcing exit data — Norris supplements media and industry publications with market research and conversations with industry leaders.
• · An investment data tapestry — The reports provide “an honest picture of what’s going on in the market” so investors and innovators alike “can make targeted smart decisions.”

The nitty-gritty

Andy and Norris discuss the investment market’s recent history before exploring drivers of today’s investment headwinds.

“2021 was a record-setting year,” Norris recalls. “Every record that could be set for deals and dollars was set across all the sectors.” Things changed in 2022 as new BioTech IPOs struggled, prompting investment reprioritizations.

“VCs had done all these… frothy valuations,” Norris says. “They had to go back and look at their own portfolios and say, does this company have enough capital? How do you want to put money to work?”

Investments rebounded in 2024, but not the number of deals. Investors poured money into their existing portfolios to boost their exit chances, resulting in today’s nine-figure megadeals.

“Basically, they’re smooshing two rounds together and extending the investors coming in to support that round,” Norris says.

Headwinds stiffened in 2025 as tariffs, a more litigious competitive space, and other factors amplified business uncertainty.

Norris attributes this progression to the psychology of venture capital. “When you think about what makes these folks tick,” Norris explains, “they want to continue to raise new venture funds because they get paid management fees. But in order to raise their new venture funds, they have to show their investors that they’ve actually gotten returns.”

That means reaching an acquisition or IPO. “They’re very focused on getting to exit right now. That’s why they’re so focused on their existing portfolio. And because of that, they haven’t been doing as many new investments.”

New investments still happen, of course, but the criteria have changed. “While the dollars are actually up in some of these sectors, especially Med Device,” Norris says, “you’re seeing that being put to work on later-stage deals because they’d rather get a shorter time to exit.”

Data that made the difference:

Norris’ insights from the HSBC Venture Healthcare Report let him advise startups fighting today’s investment headwinds.

Adopt a megaround mentality. “Series B has been extremely difficult,” Norris says. “[Raising] sub two million, that’s one thing. But if you’re looking to raise five million, it’s almost better to raise twelve.”

Find investors outside the mainstream. “Traditional venture investors don’t want to write small checks.” Norris sees angel groups, innovation centers, and other small investors funding these early rounds.

Explore acquisition exits, but be careful. “On the device side, most of the corporates have been pretty darn active,” Norris says. However, some litigate to block emerging competition, especially in the Dx/Tools sector. Norris’ recommends researching potential acquirers before taking meetings.

Download the HSBC Venture Healthcare Report for Norris’ complete analysis, and watch the video below for insights into the Medical Device and Dx/Tools sectors, AI’s role in MedTech, and more.

In-utero procedures can yield better long-term outcomes for the baby. However, fetal surgery relies on instruments developed for other disciplines. An early-stage startup in Maryland is developing in-utero instruments to improve outcomes for both fetus and mother.

Fetal Therapy Technologies CEO Selena Shirkin joins Key Tech’s Andy Rogers for Episode 42 of the MedTech Speed to Data podcast to discuss startup innovation in fetal surgery.

Need to know

• Fetal surgeries carry risks — In addition to uterine damage complicating future pregnancies, 40% of surgeries have a risk of preterm birth.
• Few specialized tools are used — In the field’s forty-year history, the FDA has only approved the Karl Storz Fetoscope for use in fetal surgeries.
• Off-label device use is widespread — Equipment borrowed from adjacent fields like laparoscopy and neurosurgery weren’t indicated for use in the uterus.

The nitty-gritty

Shirkin and Chief Technology Officer Eric McAlexander founded Fetal Therapy Technologies as students in Johns Hopkins University’s biomedical engineering graduate program. While shadowing surgeons, they saw how off-label instruments complicated procedures.

“I watched a surgeon using a grasper and suture,” Shirkin recalled. “The suture was falling out of the grasper because they didn’t fit. It took time in the surgery to make sure that didn’t occur.”

Observations like these led the team to wonder why the field lacked optimized tools. “As biomedical engineers,” Shirkin says, “we asked ourselves what if we created those purpose-built instruments that actually make these procedures safer?”

They quickly ran into the commercial limits of a market as small as fetal surgery. With only one device FDA-approved for in-uterine procedures, surgeons have no choice but to use devices off-label. So Fetal Therapy Technologies is flipping the script by leveraging the broader applications of an instrument designed for fetal surgeries.

“In a way, our company solves two problems at once,” Shirkin says. “A company that creates a fetal innovation [that] also raises a much broader market of general microsurgery.”

Their first product is a uterine port. “Similar to laparoscopic surgeries,” Shirkin explains, “that involves inserting a port through the abdomen into the uterus. [The new] port is designed to leverage the elastic properties of the uterine environment to make entry safer than the current clinical standard.”

For broader commercialization, they aim to demonstrate equivalence to predicate devices and qualify as a 510(k) Class II device following benchtop and animal studies. Approval for fetal surgeries is a longer journey, but the company can build on its data before entering human trials.

Data that made the difference:

Shirkin offered insights for other students considering an entrepreneurial future in MedTech.

• Leverage university resources. “We work incredibly closely with the Johns Hopkins Center for Fetal Therapy,” Shirkin says. We’ve also gotten opportunities from Johns Hopkins Technology Ventures.”
• Build a network of advisors. “We are supported by a very broad variety of clinical, technical, and business mentors across the Johns Hopkins ecosystem and beyond.”
• Tap into local funding sources. “There’s a lot of collegiate business plan competitions that we’ve been very successful [raising] non-dilutive funds that way. There are also state-level grants. We just received a Baltimore Innovation Initiative grant.”

Epinephrine auto-injectors, first developed in the 1970s, are the most common emergency treatments for anaphylaxis, often deadly allergic reactions. The limitations of liquid epinephrine and the device’s decades-old technology have kept these life-saving devices out of patients’ hands. Austin-based startup Windgap Medical, Inc. plans to break these barriers with a more convenient, shelf-stable alternative.

In Episode 41 of the MedTech Speed to Data podcast Key Tech’s Andy Rogers and Thomas James sit down with Windgap’s co-founder and Chief Business Officer, Brent Buchine, to discuss the data-driven development of the company’s life-saving technology.

Need to know

· Epinephrine auto-injectors are big business — A $1.3 billion market at Windgap’s founding, sales of epinephrine auto-injectors exceeded $3.1 billion in 2024.

· Few eligible patients get these life-saving devices — Only 52% of American food allergy patients ever receive prescriptions, and epinephrine auto-injectors are only available in 32% of the world’s 195 countries.

· Traditional auto-injectors are relatively large and inconvenient — Only 55% of patients with prescriptions report having immediate access to their auto-injectors.

· Liquid epinephrine is thermally unstable — Doses lose their effectiveness with prolonged heat exposure, forcing patients to refill their prescriptions more frequently.

The nitty-gritty

Buchine and his co-founders saw an opportunity to make epinephrine delivery more convenient and accessible. “We developed a freeze-dried version of epinephrine to make it more stable and double, if not triple, the shelf life,” Buchine explains.

However, lyophilization introduces an extra step in the treatment process. The dried epinephrine must be rehydrated and mixed in a solution before injection.

“If you have a rescue product for emergency use, you have to get it very quickly,” Buchine says. “With modest training, you need to make sure people know how to use the product because their life is at risk if it doesn’t work.”

Windgap’s ANDI® platform is a small, highly portable single-dose auto-injector, Buchine explains. “Simply twisting the cap automatically rehydrates that dose in a couple of seconds — no shaking, no swirling required. It’s ready to inject by pressing the device next to the injection site.”

Windgap and its pharmaceutical clients are still in the commercialization phase, but the company is already looking at the future of complex injectables.

“We see that, fundamentally, formulation pipelines are getting more and more challenging,” Buchine says. “You have multiple injections, you have mixing, you have high viscosity/high volume. The conventional options out there are not as suitable anymore. We’re solving those problems specifically because we think there’s an opportunity to be best in class in that area.”

Data that made the difference:

Developing combination products is a multi-stakeholder problem. “It’s drug, it’s device, it’s patient, it’s prescriber, it’s payer. You’ve got to think about all of those stakeholders along your development.”

Get in front of stakeholders to understand the problem. “We did a lot of surveys and uncovered the opportunity. Patients weren’t getting prescriptions filled or weren’t even going to the doctor to get prescriptions. It was that segment that we spent a lot of time talking to.”

Listen to your customers. “We’ll talk to pharmaceutical companies [and ask] what are some of the biggest challenges you’re facing in your pipeline? And then you just listen. Over time, you look for that recurring theme. That’s what really drove our product strategy.”

Use data to convince investors. “There was a vastly underserved market. Our ability to communicate that to investors and help them understand the opportunity of taking [at the time] a $1.3 billion business to something substantially above that.”

Hundreds of approved devices use artificial intelligence to help physicians diagnose patients faster and more accurately. Brooke & Associates is a legal and regulatory advisory firm that helps medical device makers get AI-powered devices through FDA pre-market approval.

In Episode #40 of the MedTech Speed to Data podcast, Key Tech’s Andy Rogers and Lei Zong speak with the firm’s managing member, Jason Brooke, about the FDA’s latest guidance to medical device developers for integrating AI into their products.

Need to know

• AI’s role in MedTech — AI identifies otherwise undetectable data patterns that humans can apply in clinically meaningful ways.
• FDA’s AI staffing surges — The agency accelerated hiring to develop internal AI applications and support pre-market reviews of new AI-powered devices.
• Radiological imaging leads the pack — More than half of 900+ FDA-approved AI-based products are in radiological imaging.
• Other fields are catching up — Cardiology and neurology applications are more recent entrants in AI-powered devices, but their numbers are growing.

The nitty-gritty

The FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” in early 2025 to explain how it will address AI’s adaptive nature in medical device regulation.

“This guidance is really focused on a total product lifecycle approach,” Brooke explains.

Good management practices govern traditional medical device development, so documenting the development process in pre-market submissions is not as critical. AI model development is different because the model can evolve once in service.

“There’s a level of information that’s necessary in submissions for AI-based technologies that we haven’t had to provide to the FDA before,” Brooke says. “They want a lot of information,” Brooke says. “That’s an area I think may be problematic because a lot of that is somewhat trade secret.”

AI-specific guidance touches almost every aspect of a company’s submission, from risk assessment to labeling to cybersecurity. Brooke highlighted how the FDA’s approach to AI data management could change development practices to ensure the independence of training and validation data sets. For example, companies must separate their clinical sites geographically and temporally.

“This guidance gets into the weeds,” Brooke says. “It’s important for companies to understand this if they’re developing an AI-based product.”

Data that made the difference:

In addition to discussing the FDA’s proposed AI regulations, Brooke discusses the challenges companies face in bringing AI-powered medical devices to market.

“If you take away anything from this podcast,” Brooke says, “it’s that there’s a lot of burden associated with developing an AI-based medical device. If you don’t need to, then I wouldn’t recommend doing it.”

Slow and steady wins the race. Do your homework, plan for the FDA review, and then engage the agency at the right time to get them on board.

Thoroughly characterize your data sources. Devices like ECGs can vary by vendor, model, site location, patient, and many other factors. The FDA wants to know how this variability could affect the downstream AI model.

Develop a strong clinical validation plan. The FDA will limit claims and require disclosures when a device that performs well overall underperforms among certain patient groups.

Successful organ transplants depend on quickly getting donor organs to their recipients. MediGO, now part of CareDx, pioneered logistics technologies that help make these life-saving procedures more successful than ever.

In Episode #39 of the MedTech Speed to Data podcast, Key Tech’s Andy Rogers and Lauren Eskew speak with MediGO co-founder Dr. Joseph Scalea about how data led the startup to solve challenges in the organ donation supply chain.

Need to know

America’s nationwide organ donor network — From Hawaii and Alaska to Puerto Rico, patients are on a nationwide waitlist for compatible donor organs.

Organ donation used to be local — As recently as the 1990s, most organ transplants came from local Organ Procurement Organizations (OPOs), so long-distance transport was rare.

Today’s organ logistics are complex — Every organ donation requires a singular supply chain combining private or commercial aircraft and ground vehicles to link fifty-six OPOs with hospitals.

The nitty-gritty

A practicing transplant surgeon and currently the Vice Chair of Innovation in the Department of Surgery at the Medical University of South Carolina, Dr. Scalea has seen a dramatic improvement in the efficiency and survivability of organ transplants.

Operations that once took hours are now routinely completed within an hour. At the same time, complication rates are at all-time lows. Many technological advances made these improvements possible, but Dr. Scalea saw opportunities in the organ transplant system’s operations.

“We have about twenty-four hours to move a human kidney from the donor hospital,” he explains. This tight turnaround led Dr. Scalea to explore the potential for drone delivery. “We were watching the [transportation] time go up,” he recalls. “We hypothesized that using drones to seamlessly go from the donor to the recipient hospital might allow the recipient side more flexibility to get better outcomes.”

Data that made the difference:

Data drove MediGO’s decision-making and ultimately led to a pivot from drone to supply chain technology. “We fundamentally believe that this problem is worth solving for the community,” Dr. Scalea says, “so what data are required to make this a business? It was through a combination of customer discovery, key informant interviews, and a ton of research into the space.”

Identifying the actual customer was key. “We initially focused on the transplant centers,” Dr. Scalea says, “and then fundamentally recognized the organ banks responsible for moving the organs were the right customers. Organ banks didn’t see as much immediate value in the biotelemetry. What they needed was logistics.”

From there, the MediGO team could understand their customers’ financial concerns. “We needed to understand funds flow — how those customers get reimbursed for the work they do.”

As a practicing surgeon, Dr. Scalea inherently understood the customer’s customers. “I was very fortunate to be an active transplant surgeon while standing up MediGO. Every day, I’d go to the hospital and ask myself, ‘Where’s the organ?’ This problem was real.”

“As our colleagues around the country read the research we were publishing, it became clear there was a groundswell of interest in this problem being solved.”

Ohio-based Avation Medical has developed a bioelectric wearable device for at-home treatment of overactive bladder, promising improved quality of life for patients suffering from the most common cause of incontinence and urinary urgency.

In Episode #38 of the MedTech Speed to Data Podcast, Andy Rogers discusses the Vivally System, entrepreneurship, and more with Avation Medical co-founder Jill Schiaparelli.

Need to Know

• Bioelectric medicine is an alternative to pharmaceuticals and surgery — Selectively stimulating the nervous system can enhance, control, or fix a function without the tradeoffs of other treatments.
• Overactive bladder is a prime candidate for bioelectric solutions — Forty-five million Americans have overactive bladder, with nine million preferring adult diapers to traditional treatments.

Nitty Gritty
Although not fully understood, overstimulation of nerves in the bladder wall produces spasms, creating an urge to urinate as often as thirty times a day in extreme cases.

Few sufferers choose sacral nerve stimulation, the gold standard treatment, which requires a device implanted near the spine to stimulate nerves regulating bladder behavior.

“The moment you say surgery, it complicates things.” Schiaparelli explains. “You need a physician who knows how to do it, you need a patient who’s willing to have what could be a very extensive surgery, and you need a payer who’s willing to pay for the surgery.”

Drugs for overactive bladder have unwelcome side effects that cause most patients to drop out of the care pathway.

“When you look at those dynamics,” Schiaparelli says, “it screams a need. Patients want something that takes surgery out of the equation, doesn’t have the side effects of drugs, and is convenient.”

Avation Medical’s Vivally System is an ankle-worn device that indirectly stimulates the sacral nerve through the tibial nerve without surgery. The device measures responses to adjust its stimulation automatically in real-time.

“This physiologic closed loop allows the patient to have personalized, effective therapy in just thirty minutes once a week,” Schiaparelli says.

Data that made a difference
As a serial entrepreneur, Schiaparelli has learned that success requires understanding and meeting the needs of three key stakeholders: the patient, the physician, and the payer:

• Overactive bladder patients dissatisfied with traditional treatments are an enormous market.
• Most physicians can only offer prescriptions for imperfect drug therapies that do not generate revenue for their practices.
• Payers don’t like either option since surgery costs reach $40,000 while drugs require lifetime prescriptions.

“Every area we checked into, it made sense. This technology in this market checked all those boxes to say there’s a need. We thought this was a real opportunity to disrupt the market.”

But success requires addressing the needs of other stakeholders, including regulators and investors.

Regulators’ expectations, for example, drove Avation Medical’s decision to implement quality control processes while starting its first clinical trial. “We knew that was going to be very important because we planned to use the clinical trial with our FDA submission.”

Aligning Avation Medical’s investors’ expectations was just as important, with each investment round supporting the next stage in development and commercialization.

Schiaparelli takes a holistic perspective on a Med Tech startup’s data strategy.

“It’s speed, absolutely,” Schiaparelli says, “but it’s also intelligent data that speaks to the needs of all the people that you’ll need to demonstrate to down the line.”

Transforming Chronic Pain Treatment with a Lean, Data-focused Development Strategy

Based in Washington, DC, AlgometRx has developed a technology platform that will let clinicians perform objective pain assessments to improve treatments for chronic pain.

In Episode 37 of the MedTech Speed to Data Podcast, Key Tech’s Andy Rogers and AlgometRx Chief Operating Officer Kevin Jackson discuss how collecting the right data sped the Nociometer platform’s development.

Need to know

Pain diagnosis is challenging — Patients self-report their experience, which is inherently subjective and variable.

Pain treatment involves trial and error — Finding the right treatment plan often requires a months-long iterative process.

Risks of inappropriate drug treatments increase — Poor understanding of pain’s causes leads to the over-prescription of the wrong drugs, a contributing factor to the opiate crisis.

The nitty-gritty

AlgometRx’s technology platform emerged from research by the company’s founder, Dr. Julia Finkel at Children’s National Hospital. A pediatric anesthesiologist, Dr. Finkel must assess pain in children who lack the words to describe their experiences.

“She wanted something that she could use in clinic to help better understand patients’ pain,” Jackson explains. “Something that’s simple enough that anyone could use in a variety of settings.”

The Nociometer platform selectively activates nerve fibers and evaluates the patient’s physical response — without causing additional pain.

“We’re able to identify the physiologic underpinnings of that pain experience, and that allows clinicians to better understand what’s happening.”

An objective assessment of the patient’s pain lets the clinician make faster, better-informed decisions, but the real value will come from monitoring treatments. Rather than waiting three months to see if a treatment works, patients can return to the clinic a week later for a follow-up measurement. “That gives the clinician different information they wouldn’t have had, Jackson says. “We can get right to the root of it, and you avoid six, seven, eight visits.”

Data that made the difference:

AlgometRx discussed this first-of-its-kind technology with the FDA before developing its proof-of-concept prototype. “We had this novel concept of a pain biomarker and device, so we wanted to know how we would even bring a device like this [to market].” FDA feedback informed a development strategy focused on gathering data from specific populations.

AlgometRx leveraged partnerships to support this focused strategy. Working with Johns Hopkins researchers under an NIH Sprint for Women’s Health grant, AlgometRx is developing pain response data sets for patients with systemic lupus and carpal tunnel syndrome. The startup is also a member of JLABS, Johnson & Johnson Innovation’s life sciences incubator, where they get valuable insight into the Nociometer platform’s potential role in pharmaceutical research.

Running a lean operation lets AlgometRx prioritize data. Jackson is the startup’s only full-time paid employee. Dr. Finkel, AlgometRx’s board, and a network of consultants and contractors bring their expertise as needed. “We don’t have a robust employee base, but we have a robust team,” Jackson says. “We’ve run this lean approach where we only bring in people as needed. Obviously, our investors love that idea because it’s spending money on device development and data generation.”

Data drives MedTech growth, from the leanest startup to the world’s most valuable pharmaceutical company. In Episode #36 of the MedTech Speed to Data Podcast, Key Tech’s Andy Rogers discusses data-driven trends in medical technology with Anand Subramony, Eli Lilly’s Vice President of Drug Delivery, Device, Connected Solutions & Innovation.

Need to know

· Quarter-century perspective — After getting his PhD in chemistry and materials science from Purdue University, Subramony spent the next twenty-five years developing novel medical technologies for firms like Johnson & Johnson, Novartis, and AstraZeneca.

· Cutting-edge combination product development — Now at Eli Lilly, Subramony’s team is responsible for combination product development, from early development through commercial development, for new delivery dosage forms.

The nitty-gritty

Subramony drew upon his career-spanning perspective to discuss significant data-driven trends that impact the entire industry, not just Eli Lilly.

One topic he raised in his conversation with Andy was using data to monitor disease state progression. Already an important element of fields like neurology and oncology, extensive data collection will become essential to a wider range of treatments. For many conditions, Subramony explains, disease state is a binary evaluation.

“You can really understand disease state progression using digital biomarkers and collecting data throughout [the treatment],” Subramony said. “I think these are areas where there is a lot of potential.”

Another data-driven trend Subramony discusses is the adoption of direct delivery therapies. When treating tumors and other conditions, off-target toxicity can cause unfortunate side effects. Genetic medicines, such as mRNA therapies, can target the cell surface, protect the cargo, and prevent endosomal escape.

“It’s going to disrupt the way we look at drug delivery from macroscopic pen auto-injector deliveries to microscopic, targeted deliveries where you need to take the therapeutic moiety into the site of action,” Subramony said.

Data that made the difference:

This episode’s wide-ranging conversation covered many additional topics of interest to the MedTech community, including:

GLP-1 treatments are “really transformative” for individual patients who can afford them. However, bringing costs down will depend on data demonstrating how lower obesity and healthier lifestyles reduce the overall burden on the healthcare system.

For sensors and connected devices to go beyond “bells and whistles,” the industry must drive value from how we use that data. Relating compliance to efficacy, for example, makes moving patients from less effective to more effective therapies easier and faster.

Continuous monitoring can improve healthcare outcomes but requires new data management practices to govern how much data is collected, who is collecting and viewing the data, and what are the privacy rules protecting patients.