Medsider

“Startups are like sharks. They’ve got to keep swimming. They’ve got to keep moving. If you run out of capital and have to pause things, it does more than pause things.” Dan Rose, former CEO of LimFlow SA “Find an actual problem, and don't just invent one. Find a problem that you can solve and that has either an existing market, or a market that you can create and grow.” Marissa Fayer, CEO of DeepLook Medical “It almost sounds blasphemous because everybody wants the 510(k) or the CE mark when you can get it. I'm just simply pointing out that pre-commercially, they're expensive to maintain.” Trent Reutiman, CEO Mercator MedSystems, Inc. Medsider Mentors are book volumes we publish a few times a year, summarizing the best Medsider interviews from the last few months. Here’s the last of our #medtech rockstars from Volume VI of Medsider Mentors, authored by our host Scott Nelson, who is also the co-founder and CEO of FastWave Medical. Here’s more to chew on: 🌞 In the early development phases, design for the average user to maximize adoption rates. Keep it simple and don’t be afraid to pivot. 🔓 Identify a genuine need and develop a product that enhances efficiency and outcomes while fitting into existing workflows. 🤹🏼♂️ Be intentional about the balancing act of demonstrating your technology’s efficacy by gathering data for regulatory purposes while consistently improving upon the design and usability of your device. Available for premium members for free, check out the full edition of Medsider Mentors - Volume VI (link in comments) to learn from founders and CEOs of the hottest #medicaldevices and health technology startups in the world. For non-premium members, individual volumes can now be purchased separately.

“The biggest learning for me and the biggest excitement with the community round is every time somebody invests, there's a little box where they get to put in information about why they're investing. Some folks don't say anything, but a lot of them do. It's been so rewarding for me to read through those comments and just hear the stories about family members and loved ones who see how they could use our technology.” Meet Conor Cullinane, PhD, an aeronautical engineer by training who went from designing NASA space suits to developing novel #medicaldevices. Conor has an impressive resume that includes Harvard Medical School, Massachusetts Institute of Technology, and NASA - National Aeronautics and Space Administration. He, along with two other rocket scientists, co-founded Pirouette Medical, a startup developing Quicpush, a disk-shaped autoinjector that delivers medicines with just the push of a button. Here’s a sneak peek into Conor’s conversation with Scott Nelson: 📐 Be selective with where you innovate. Disrupt where it matters most, but don't reinvent the wheel unnecessarily. By aligning with established practices and industry standards, you can streamline your development processes, reduce costs, and ultimately leave room for creative freedom where it counts. 🔄 Although less common in medtech, community fundraising rounds may offer benefits like brand awareness and direct engagement with potential end users. View all investors as valued partners to foster a strong community and feedback loop around your product. 👓 Everyone in the healthcare supply chain, from payers to providers, needs a reason to choose your product. To successfully launch a #medicaldevice, it's crucial to understand the needs of all stakeholders. Check out the full interview link with Conor in the comments below. This Medsider episode was brought to you by FastWave Medical, a hot IVL startup in the cardiovascular space. Don’t miss out on their next fundraise (more details in the comments). P.S. - We just launched Medsider Mentors Volume VI, which is packed with insights and learnings from founders and CEOs of some of the most dynamic medical device and health technology startups in the world. Click the link in the comment section for this latest edition now available exclusively to our premium members.

We love it when Scott Nelson, our host and co-founder of FastWave Medical, puts together these op-eds for MD+DI! His recent article explores five unconventional approaches for #medtech success. Big shoutout to our past guests featured below for sharing their stories and insights. Click on the link ⬇ to check out the full article.

“What I like to do in the moments of critical decisions is to expunge myself of any bias with respect to money that's been spent, and try to make a decision with fresh eyes." Benjamin Sexson, CFA, CEO of Monogram Technologies “Talking to the partners, members, and clients really helps me decide what's next. You’ve got to be out meeting with folks and getting feedback on an ongoing basis.” Bill Snyder, CEO of Cylinder “If the nurse doesn't like your product or the scrub tech doesn't like your product, your product isn't going to be used in the OR no matter how much the surgeon loves it.” Ahmed Zobi, EMBA, CEO of Syntr Health Technologies, Inc. Here's our next set of guests featured in the latest edition of Medsider Mentors, a book summarizing the best Medsider interviews from the past few months. These three #medtech entrepreneurs from our previous Medsider episodes have now returned as mentors, making an appearance in Volume VI, authored by our host Scott Nelson, who is also the CEO of FastWave Medical. Here are a few more takeaways from these featured interviews: 👓 Don't let past investments cloud your judgment about a project's present viability. Regularly reassess the viability of your idea based on current conditions, not past investment. 🌐 You have to know where your product or service fits in the overall healthcare ecosystem. That way you can connect the dots for your providers and consumers about the precise role you play in the benefits they receive.  🛣️ Focus on meeting FDA’s core requirements first. Don't get tied down trying to add extra features to early prototypes. Submit ASAP to pave the road to market. Available for premium members for free, check out the full edition of Medsider Mentors - Volume VI (link in comments) to learn from founders and CEOs of the hottest #medicaldevices and health technology startups in the world. For non-premium members, individual volumes can now be purchased separately.

“Everything we build should be self-explanatory. It's just like your phones, they make it so you pick it up, turn it on, and you don't have to have an IFU to teach you how to use it.” (Dr. Ananth Ravi, CEO of MOLLI Surgical) “If you haven't built a relationship over a long time and you have no traction and I haven't seen you progress, it's really hard for me to judge if this is something really differentiated.”  (Dr. Anish Kaushal, Healthcare investor Amplitude) “It's surprising how far you can get with nothing, and how little progress you can make with all the money in the world. Both things are true. It does take some creativity.” (Dr. Steven Mickelsen, CEO of Field Medical) Get a front-row seat to our entrepreneur roundtable as you read Medsider Mentors Volume VI, our latest book summarizing the best interviews from the previous several months. This edition includes highlights from interviews conducted by Scott Nelson, who is also the co-founder and CEO of FastWave Medical. Here are three more ideas from these interviews: 💉 Immerse yourself where your product will be used. Then build products that minimize risk, maximize patient benefit, have a fast learning curve, and are clinically effective. 🗺 Clearly define the gap, the solution, the regulatory process, and reimbursement. Show VCs that you're not improvising and that you have a clear roadmap with achievable milestones. 🦾 Scarcity can breed creativity, so use that to your advantage. Build prototypes with readily available parts and focus on nailing your narrative to convince investors. Available for premium members for free, check out the full edition of Medsider Mentors - Volume VI (link in comments) to learn from founders and CEOs of the hottest #medicaldevices and health technology startups in the world. For non-premium members, individual volumes can now be purchased separately.

“You now need to think more about how your device is going to be used and how it's going to be incorporated into the practice of medicine. So first and foremost, if your technology converts an in-hospital to an out-of-hospital procedure, or it allows earlier discharge or in some way, shape, or form shortens that episode of care within the hospital, that's really, really important. Even if your technology is better but it adds a two-day stay, that may be a tough sell.” Meet the CEO of Canary Medical Inc., Dr. Bill Hunter, who was previously instrumental in the development of #medicaldevices like the TAXUS drug-eluting coronary stent, paclitaxel-eluting balloons, and the Zilver PTX peripheral drug-eluting stent. Bill’s extensive career as a practitioner and notable successes in the #medtech space are truly impressive. After spearheading the successes of companies Angiotech Pharmaceuticals and CORREVIO PHARMA CORP., he’s now at the forefront of bringing novel digital solutions to healthcare. At Canary, Bill and his team are developing smart implants that empower patients by providing real-time insights during their recovery journey after implant surgeries. Here’s a taste of Bill’s interview with Scott Nelson: 🔍 Identify market opportunities by examining trends and structural gaps. Bill, for example, noticed the demand for personalized patient care and the strain on healthcare providers, leading him to develop digital solutions. 🏥Innovation in medtech requires a superior, not just an alternative, product approach framework. Consider how your idea streamlines processes, reduces hospital stays, and empowers both patients and physicians. 🩺 If you’re a physician contemplating a full-time move to a startup, embrace your entrepreneurial spirit by leveraging the stability of your medical career. Start small, experiment, and be honest with yourself about your priorities. Check out the full interview link with Bill in the comments below. This Medsider episode was brought to you by FastWave Medical, a hot IVL startup in the cardiovascular space. Don’t miss out on their next fundraise (more details in the comments). P.S. - We just launched Medsider Mentors Volume VI, which is packed with insights and learnings from founders and CEOs of some of the most dynamic medical device and health technology startups in the world. Click the link in the comment section for this latest edition now available exclusively to our premium members.

“The FDA is going to object and question our science. The payers are going to question the efficacy and the health economic outcomes of what we're doing. The clinicians actually should question and test as well. Of course, this happens with the investors who question and test us on everything. It's just part of the job that we need to be able to answer all of the questions. We're looking to create things in the world that have never existed before. It's contingent on us to be able to explain it and to be able to address all open questions from all angles.” Meet Beth Rogozinski, CEO of Oncoustics. She’s held a variety of leadership roles in the field of digital medicine, including the development of the first FDA-cleared prescription digital therapeutic for Pear Therapeutics. She advises numerous startups and accelerators and has consulted with organizations like Stanford University, UnitedHealth Group, and the National Mental Health Innovation Center, and serves on the board of Biotechnology Innovation Organization’s Digital Health Committee. Oncoustics is developing affordable, non-invasive AI solutions for disease monitoring and treatment. Their OnX platform – a device designed to be used in conjunction with readily available handheld ultrasound devices – uses AI to analyze sound waves from ultrasound devices to monitor and quickly detect unhealthy liver tissue. In this Medsider interview, Beth and Scott Nelson discuss: 🏥 Clinicians, regulatory bodies, and commercial stakeholders may have different requirements. Address each of them as soon as feasible in the development process. 🔍 Consider FDA a part of your team. However, before approaching the agency, evaluate whether clearance is necessary for your product based on the value proposition vs speed to market. 📝 Fundraising for startups requires persistence and having a clear narrative about your technology. Engage with investors even if they typically invest in later stages. And don’t limit yourself to investors strictly within your niche. Check out the full interview in the comments below. This Medsider episode was brought to you by FastWave Medical, a hot IVL startup in the cardiovascular space. Don’t miss out on their next fundraise (more details in the comments). P.S. - We just launched Medsider Mentors Volume VI, which is packed with insights and learnings from founders and CEOs of some of the most dynamic medical device and health technology startups in the world. Click the link in the comment section for this latest edition now available exclusively to our premium members.

“When thinking about your go-to-market strategy, think about how you position yourself. What is your frame? What are you asking your users to compare your product to? Help them understand that.” (Tess Isabelle Cosad, CEO of Béa Fertility) “It's super easy to make things more complicated than they are. Just keep it simple. If you had to explain it to your mother or to your father or your grandmother, what would you say?” (Patrick Anquetil, CEO of Portal Instruments) “I think of capital raising as a friend-raising process, not a fundraising process. Because if you start working to raise capital only when you need it, then you're just going to be meeting people, and it takes months, if not years, to get checks.” (Harlee Sorkin, CEO of InterShunt Technologies, Inc.) Medsider Mentors Volume VI is here! It’s our latest book summarizing the best of the best Medsider interviews from the last several months. Dig in for insights from Scott Nelson and 3 incredible #medicaldevice entrepreneurs: 🌸 Prioritize design, especially if you are targeting the consumer market. Be as simple as possible. Don't leave room for your audience to infer or make assumptions about your product. ⚖  The right collaborations are golden. Beyond money, they offer insights, resources, and access to new markets. Every collaborator has their own agenda, so find a sweet spot where your goals align. ⭕ Prioritize ruthlessly during the capital-scarce initial phases. It’s a cycle of setting and achieving milestones that prove potential and help you secure further capital so you can move onward. Available for premium members for free, check out the full edition of Medsider Mentors - Volume VI (link in comments) to learn from founders and CEOs of the hottest #medicaldevices and health technology startups in the world. Non-premium members can now purchase individual volumes separately.

“The key, for entrepreneurs, is to think about what is the highest impact thing that I can do, what is the critical milestone that I can achieve to get to the next point where I can raise some additional capital.” Meet Timothy Boire and Geoffrey Lucks, co-founders of VenoStent, Inc., who are tackling a major challenge in dialysis access. Tim is a biomedical engineer who discovered the Achilles heel of vascular surgery during his time as an entrepreneurial lead at National Science Foundation (NSF) I-Corps. Geoffrey, on the other hand, has a Master's in Bioethics from the University of Pennsylvania and an MBA in Finance from Vanderbilt University, where the two met. Their product, SelfWrap, is a bioabsorbable wrap to improve the success rate of vascular surgeries. It could mean fewer complications, better outcomes, and longer-lasting access points. Here’s an inside peak at their conversation with Scott Nelson: 👍🏽 In medtech, the first task is to prove your concept. Thoroughly research your space, seek feedback from clinical experts throughout the entire process, and engage with partners who can offer the expertise that you need in your product development. 📐 Showcase your market savvy by demonstrating a real problem, a working solution, and a sizable market. Then build early prototypes, learn from them, and continuously improve. Get your device into the hands of potential users as soon as possible and seek early feedback. 👨🏻🤝👨🏽Forging a collaborative relationship is the golden rule for navigating regulatory interactions. Understand FDA’s perspective, follow their guidance, and foster transparency. At the same time, make sure you capitalize on the advantages of your chosen regulatory pathway and position your device accordingly. Check out the full interview in the comments below. This Medsider episode was brought to you by FastWave Medical, a hot IVL startup in the cardiovascular space. Don’t miss out on their next fundraise (more details in the comments). P.S. - We just launched Medsider Mentors Volume VI, which is packed with insights and learnings from founders and CEOs of some of the most dynamic medical device and health technology startups in the world. Click the link in the comment section for this latest edition now available exclusively to our premium members.

“Focus, focus, focus. There are many things competing for your attention. Fires burning everywhere and 25 people clamoring for your attention. Being able to be disciplined on how I spend my time and the team's time is critical.” (Ken Mariash, CEO of Sinaptica Therapeutics) “I should have introduced myself to every VC possible over the course of a year, put them on a mailing list, give them regular updates, become familiar, and become an everyday brand that they're watching.” (Daniel Powell, CEO of Spark Biomedical Inc) “When you're playing chess, it's not your next move that you should be thinking about, or your opponent's next move that you should be thinking about. Rather, think about the move you’ll make after your opponent's next move.“ (Carla Spina PhD, CEO of Noa Therapeutics) For those of you who are not familiar with Medsider Mentors, these are book volumes we publish a few times a year, summarizing the best Medsider interviews from the previous several months. We recently launched Medsider Mentors Volume VI, curated by our host Scott Nelson, who is also the co-founder and CEO of FastWave Medical. Over the next few weeks, we’ll be sharing a few memorable quotes from our past guests.  Here are today’s lessons from the 3 featured #medtech CEOs of the day: 🪜 Take incremental, manageable steps toward your goals. Consider which variables will add more value to your company’s current position and be maniacally focused on achieving those. 🧤 Let go of your ego and rigorously test whether you have product-market fit. Focus on creating a minimum viable product (MVP) and explore ways to outsource design and development. 🛒 Being capital efficient during the early stages is both about where you spend the money and where you secure it. Available for premium members for free, check out the full edition of Medsider Mentors - Volume VI (link in comments) to learn from founders and CEOs of the hottest #medicaldevices and health technology startups in the world. For non-premium members, individual volumes can now be purchased separately.