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MedTech Speed to Data

MedTech Speed to Data

Auteur(s): Key Tech
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Speed-to-data determines go-to-market success for medical devices. You need to inform critical decisions with user data, technical demonstration data, and clinical data. We interview med tech leaders about the critical data-driven decisions they make during their product development projects.© 2024 Key Tech Inc. Science Sciences biologiques Économie
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  • MedTech's 11 Year Exit Problem— and What It Means for Raising Capital
    Dec 11 2025

    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.

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    52 min
  • From Lab to Clinic: Building Safer Tools for Mothers and Babies: 42
    Oct 29 2025

    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.”
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    26 min
  • Spotting An Opportunity, Crafting A Solution : 41
    Jun 24 2025

    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.”

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    37 min
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