Clinical Perspectives

Stephanie Stover

Clinical Perspectives is a medical device and MedTech podcast for the people building, selling and scaling healthcare technology. Host Stephanie Stover, CEO of Passionate Media Marketing, sits down with medical device founders, MedTech executives, surgeons, investors and healthcare innovators to unpack what actually works, from FDA clearance and reimbursement to KOL strategy, marketing, sales and funding. No jargon, no theory, just the real story behind the technology and the companies bringing it to market. New episodes every week. Follow the show if you are a medical device founder, a MedTech sales or marketing leader, or a clinician who wants to hear how this industry really operates. Watch the full video episodes on YouTube: https://www.youtube.com/channel/UC7upa8hmIqRS8ZNcW5gDDtA?sub_confirmation=1

  1. 4d ago

    Medical Device Sales Today, What Actually Closes Deals

    A surgeon can love your product and still never use it. Twenty five years ago a rep could get a new product into the next procedure with a nod from the surgeon. Today GPOs, IDNs, formulary committees and hospital CFOs decide, and Christopher J. Borsa, VP of Sales and Marketing at Vitasora, explains what it takes to sell into that system. In this episode Access has collapsed. Reps once needed only the surgeon, the OR director and materials management. Now GPOs, IDNs, formulary committees and hospital credentialing all stand in the way. No code, no sale. Christopher recalls Kyphon reimbursement shifting on whether a patient stayed 23 hours or went home the same day, and why products without a code are dead in the water. Employed physicians follow formulary. Many surgeons are now hospital employees who earn a bonus for staying on the approved product list. Hospitals want one or two vendors. Standardization, better pricing, fewer reps in the OR and volume rebates push systems to cut the shelf down. Cold outreach rarely works. For every thousand messages Christopher might get one or two leads. Warm handoffs from trusted connectors get the meeting. Distributors are deep, not wide. Large companies moved to direct sales forces for control, accountability and growth, and few distributors hold direct GPO contracts. AI is the axe, not the tree. Products that win will fit the hospital formula of outcomes, cost, reimbursement and length of stay. Chapters 00:00:05 Welcome and introductions 00:00:57 From Boulder runner to warehouse to regional VP 00:03:50 What changed in 25 years of MedTech 00:08:31 The user is no longer the buyer 00:10:40 Patient care, prehab and better informed patients 00:13:42 Exparel and getting patients off opioids 00:15:13 What creates commercial traction today 00:19:52 The changing role of distributors 00:22:30 Warm handoffs and connectors 00:26:24 Landing the first customers from zero 00:28:17 Where AI fits in MedTech 00:33:01 MedTech ten years from now 00:36:08 Final advice for listeners About the guest Christopher J. Borsa is VP of Sales and Marketing at Vitasora. He started in the warehouse of a durable medical equipment startup and worked up to sales rep and regional VP. He went on to roles at Stryker Endoscopy, in spine, at Kyphon and at Pacira Biosciences, and now works in remote patient monitoring. Follow Christopher J. Borsa LinkedIn: https://www.linkedin.com/in/christopher-borsa-b3530079/ Would you rather see Christopher and Stephanie talk it through? The video version is on YouTube: https://youtu.be/XLgn6ORKiew If your medical device company has a strong product but keeps stalling at formulary and value committees, book a discovery call with us here: https://api.leadconnectorhq.com/widget/bookings/md-pm-discovery

    Medical Device Sales Today, What Actually Closes Deals
  2. 4d ago

    Ultrasound AI Built in a Basement Won FDA De Novo Approval

    Ten years ago, Robert Bunn was using AI to find oil. After his wife suffered numerous miscarriages, he built a supercomputer from parts in his basement and trained it to predict a baby's actual delivery date from routine ultrasound images. Doctors told him it was impossible, and then the FDA granted it a de novo. In this episode Why predicting the actual delivery date, rather than the date a baby turns 40 weeks old, gives clinicians the warning they need to decide who gets progesterone or bed rest. How a peer reviewed paper with the University of Kentucky turned skeptical doctors around and supported the FDA submission. What a de novo means: the FDA issues about forty a year, for technology with nothing like it in FDA history, and Bob got one starting from his basement. Why Brazil, through ANVISA, approved Ultrasound AI about a year and a half before the US, and how the company is also operating in Chile. How labeling shapes the pitch: US indications do not allow preterm birth claims, so the early use case is getting high risk patients in obstetric deserts near a high level NICU in time. How Bob handles disbelief by inviting doctors to send blinded patient studies, and why he compares adoption to the four minute mile. Why cash is the bottleneck for Ultrasound AI and nearly every women's health company he knows, even as investor interest grows. Chapters 00:00:00 Welcome and introductions 00:00:39 From oil industry AI to miscarriage research 00:02:53 What doctors can do with early warning 00:06:24 Doctors push back and the University of Kentucky study 00:07:38 Earning an FDA de novo 00:08:50 What kept him going when doctors said impossible 00:10:07 How Ultrasound AI works 00:11:09 Adoption in Brazil, Chile and the US 00:12:52 Physician stories and obstetric deserts 00:14:56 A goal of access for every woman on earth 00:15:39 Beyond pregnancy, including ovarian cancer 00:18:17 The neglect of women's health 00:20:43 Cash as the biggest challenge 00:22:27 You can just do things 00:23:38 Where to follow Ultrasound AI About the guest Robert Bunn is the founder and CEO of Ultrasound AI. Before starting the company, he used AI in the oil industry, and he describes himself as an AI researcher and data scientist with no medical background. His technology predicts delivery dates from routine ultrasound images, has FDA de novo approval and is in use in Brazil and Chile. Follow Robert Bunn LinkedIn: https://www.linkedin.com/in/robertbunn/ Ultrasound AI website: ultrasound.ai LinkedIn: https://www.linkedin.com/company/ultrasoundai/ Would you rather see Bob tell this story? The full conversation is on YouTube: https://youtu.be/yolEo4zxT2A If you lead a medical device company facing skeptical buyers or a long regulatory road, book a discovery call with our team: https://api.leadconnectorhq.com/widget/bookings/md-pm-discovery

    Ultrasound AI Built in a Basement Won FDA De Novo Approval
  3. 5d ago

    Can a Genetic Test Predict Your Addiction Risk?

    Physicians told James J. Piacentino something he did not expect: cutting back on opioids may be leaving patients in pain, stalling procedures and costing hospitals revenue. The co-founder of Thrive Genetics explains how an addiction risk score built from a genetic swab and 25 behavioral questions turns that problem into an ROI case for hospital CFOs. In this episode Why addiction is roughly 50% genes and 50% behavior and environment, so most risk is passed down through habits rather than DNA. How the test works: a genetic swab plus 25 behavioral and environmental questions, a seven day lab turnaround, and an addiction risk score. It supports the physician's decision and does not diagnose, prescribe or suggest. The revenue leak: when a patient stops partway through a 36 treatment head and neck oncology course, booked anesthesiology, medication and resources go unrealized. Why Thrive sells to the CFO's office in oncology and orthopedics on return on investment, while billing codes are still in process. How hospital data sets drew inbound interest from pharmaceutical companies that want to stratify clinical trial cohorts for non opiate products. Know your regulatory swim lane early: clinical decision support, pharmacogenomics, diagnostics and therapeutics face very different paths, and former FDA consultants should document which lane you are in. His three question test for any idea: is it a gap in care, is it a have to have, and is there a customer willing to pay for it? Chapters 00:00:00 Welcome and introduction 00:00:28 What Thrive Genetics does 00:01:16 The origin story on the drive to Maine 00:04:19 Why addiction is hard to predict 00:07:03 How the test works 00:09:41 Who pays and the revenue leak 00:12:17 Reaching hospital decision makers and pharma 00:14:15 The biggest challenge, slow is the new fast 00:15:58 Advice for founders before FDA approval 00:18:45 Staging growth without overselling 00:20:23 The opioid crisis and underprescribing 00:23:34 How physicians react 00:25:52 The magic wand, orchestration 00:26:57 Three questions for anyone with an idea 00:28:09 Where to find James About the guest James J. Piacentino is the co-founder of Thrive Genetics, which identifies addiction risk in patients before they are prescribed highly addictive pain medications. He spent about twenty five years in tech, corporate and startups building and inventing products, and helped build venture funds. He lectures at Northwestern and Kellogg School of Business on his idea to action to impact model. Follow James J. Piacentino Thrive Genetics website: ThriveGenetics.ai Personal website: jamespiacentino.com LinkedIn: https://www.linkedin.com/in/jamespiacentino/  Would you rather see James and Stephanie talk it through? The full conversation is on YouTube: https://youtu.be/jq2xCK1Np74 If you are a medical device founder or commercial lead working out how to sell hospitals on ROI, book a discovery call with our team: https://api.leadconnectorhq.com/widget/bookings/md-pm-discovery

    Can a Genetic Test Predict Your Addiction Risk?
  4. 5d ago

    They Squished Cells at High Speed and Changed Cell Engineering

    Portal.bio staffs its field team with PhD scientists, splits it by application instead of territory, and counted two pharmas among its first three customers. CEO and founder Armon Sharei explains why he keeps ignoring the playbook, and why he believes a startup's average outcome is it's going to die. In this episode Why Portal.bio hires PhD scientists as partnering reps, since most scientists hate talking to salespeople and a typical rep cannot speak their language. The case for organizing a commercial team by application area, such as drug screening or immune cell therapy, instead of a Northeast rep and a California rep. How Portal.bio works with 10 pharma companies at three years old, against the assumption that you sell to academics first and wait for publications. The probability math behind his doubts on in vivo cell therapy: a nanoparticle that reaches 20% of T cells gets two cargos into only 4% and three cargos into 0.8%. What an $8 million DARPA award is funding: a point of care machine prototype, and why a box that never touches a patient means nothing. Why he keeps promoting high potential people who are early and unproven over outside hires who check the boxes. The messaging problem of a broad platform: the PROTAC pitch that excites one researcher means nothing to a T cell engineer, and how conferences and LinkedIn ads help narrow it. Chapters 00:00:05 Welcome and introduction 00:00:26 From an MIT PhD to SQZ and then Portal.bio 00:02:56 Who Portal.bio is built for 00:03:55 Reaching conservative researchers 00:05:14 The myth of in vivo cell therapies 00:07:52 What nanoparticle experts say privately 00:09:10 Success over the next six to twelve months 00:10:57 Structuring the commercial team 00:14:55 Testing a strategy with no control arm 00:16:33 Advice on defying the average outcome 00:19:42 The magic wand: the right message to the right scientist 00:22:35 Where to follow Armon About the guest Armon Sharei is CEO and founder of Portal.bio, a platform for putting materials into cells. During his PhD at MIT, where Bob Langer was one of his co-advisors, he worked on the technology that led to SQZ, a company that went public in 2020. Portal.bio is three years old and already works with 10 pharma companies. Follow Armon Sharei LinkedIn: https://www.linkedin.com/in/armonsharei/ Portal.bio website: newsletters available through the site Boba & Biotech: the podcast Armon's team hosts on biotech's problems and exciting developments Rather see the conversation than hear it? The full video is on YouTube: https://youtu.be/fJ_SyU68g9g If you lead a medical device company and your commercial plan feels like it was copied from someone else's playbook, book a discovery call with us: https://api.leadconnectorhq.com/widget/bookings/md-pm-discovery

    They Squished Cells at High Speed and Changed Cell Engineering
  5. 5d ago

    How an Early-Stage Startup Made Its Way Into the NFL

    Shiva sold 15 plus units of Hydrawav3 to customers before the company was even incorporated. That came after a first startup where three years went into building a product before anyone asked who would pay for it. This time, the team went straight to sports practitioners who never asked about reimbursement. In this episode Ask who pays first. Shiva built a newborn care product for home use for three years before asking a customer if it was viable, feasible and sustainable, and calls that the biggest lesson of a first startup. Sell where reimbursement is not the question. Hydrawav3 went to sports practitioners who were already paying for hot packs, cold packs and dry needling. Let customers fund the start. Therapists and the people of Sedona funded the company in a crowdfunding style model before incorporation, with only an idea and a basic prototype. Why not a medical device. Shiva says a medical device would have made it harder to build the ecosystem and understand the customer so early, while a wellness platform let the team sit with customers before they had a usable product. Demos on the toughest case. Prospects get a two week trial with no promises, and live pitches start with the client nothing else has worked for. Pick one market. After starting broad, from massage therapists to med spas, the team narrowed to sports and now faces the chicken and egg problem of funding manufacturing for demand. Door to door still works. Shiva and teammate Danielle knocked on physical therapy offices in Phoenix, Scottsdale and Vegas, then built word of mouth through five conferences. Chapters 00:00:05 Welcome and meet Shiva 00:01:00 The origin story of Hydrawav3 00:03:08 Water, polarity and nature 00:03:53 How the product works 00:05:56 New clients in the NFL and college sports 00:06:49 CES launch and the 900 unit goal 00:07:30 Lessons from a first startup 00:11:19 Focus and the chicken and egg of scaling 00:12:35 Door to door sales and live demos 00:15:22 Pricing and home use leasing 00:18:00 The body as a battery About the guest Shiva is a biomedical engineer from the southern part of India who lives in Sedona, Arizona, where Hydrawav3 is based. Before Hydrawav3, Shiva developed medical devices for newborn babies and was a supervisor at one of the biggest spas in the country. Hydrawav3 launched at CES in Vegas, where a technology sponsor gave it a Best Tech Award, and it now manufactures in Arizona. Follow Shiva LinkedIn: https://www.linkedin.com/in/sivakumarpal/ Hydrawav3 website: hydrawav3.com Free two week trial: hydrawav3.com/trial Order page: hydrawav3.com/buy Instagram: @hydrawav3 Rather see this conversation than hear it? Watch it on YouTube: https://youtu.be/qnOINAvU4WM If you lead a medical device company and still cannot say who will pay for your product, book a discovery call with us: https://api.leadconnectorhq.com/widget/bookings/md-pm-discovery

    How an Early-Stage Startup Made Its Way Into the NFL
  6. 5d ago

    Red Light Therapy Explained by the CEO of THOR Photomedicine

    James Carroll left school at 16 with no qualifications. Today Thor Photomedicine is on target for 16 million in revenue with no investors, and its light emitting lollipop is becoming a standard of care for oral mucositis. He explains how he got there, including the time investors crashed the company and he bought the assets back. In this episode Why James says most light therapy products tested by academics do not deliver what the manufacturer claims, and why he is writing a PhD proposal on measuring and reporting dose. How a medical CE mark was granted in the late 1990s after he faxed over cell studies, mouse studies and a paper on four human cases. How a new CEO installed after an investment round fired everybody and crashed the company within 18 months, and how James restarted Thor alone on January 1, 2008. The oral mucositis results: Texas Children's Hospital extrapolated $1.3 million in savings, Christie Hospital calculated £530,000, and tube feeding hospitalization fell by 88.7 percent in one hospital. Why pediatric cancer hospitals are now one of Thor's biggest customer groups, and why the lollipop currently tastes of plastic. How the dry age related macular degeneration indication now has FDA clearance, a procedure code and a temporary T code for reimbursement. His goal of 100 cleared indications for use in 100 countries by the time he is 100 years old, with fibromyalgia next. Chapters 00:00:00 Welcome and introduction 00:00:35 Leaving school at 16 and an electronics apprenticeship 00:03:52 Lecturing at Harvard and 42 academic papers 00:04:58 Why light dose measurement is a mess 00:06:10 Resilience and the early days 00:07:31 Hospital demos and a CE mark by fax 00:09:36 FDA 510(k) and the lawsuit 00:12:28 Investors, a new CEO and a crashed company 00:13:22 Restarting Thor with no investors 00:14:49 100 indications in 100 countries by age 100 00:15:10 NovoThor and how the light works on mitochondria 00:18:16 The light emitting lollipop for oral mucositis 00:21:41 Photobiomodulation versus red light therapy 00:23:14 Macular degeneration, fibromyalgia and unmet needs 00:25:35 Could it help endometriosis 00:28:34 Final advice and where to find James About the guest James Carroll is the CEO and founder of Thor Photomedicine, which he started with two engineers after leaving school at 16 with no qualifications. He has co-authored 42 academic papers, eight of them with Harvard Medical School, and has lectured at Harvard, Stanford, NYU and the University of Pennsylvania. Thor has installed about 5,800 systems and is on target for 16 million in revenue without any investors. Follow James Carroll LinkedIn: https://www.linkedin.com/in/jamesdcarroll/ Thor website, including training courses and webinars: thorlaser.com NovoThor whole body system: novothor.com You can also watch this whole conversation on YouTube: https://youtu.be/WbgGQkTzkEc Founders and commercial leads who want hospitals to act on their medical device evidence can grab a discovery call slot here: https://api.leadconnectorhq.com/widget/bookings/md-pm-discovery

    Red Light Therapy Explained by the CEO of THOR Photomedicine
  7. 5d ago

    This Technology Could Change What Surgeons Know Before Leaving the OR

    Xeos can show a surgeon where cancer sits in a removed tumor in about 10 minutes, and a Vanderbilt publication matched its measurements to final histopathology within one millimeter in 15 of 16 cases. Selling it is still hard. Guy Albalancy, US sales director at Xeos, explains why evidence, budgets and awareness decide the pace of a $400,000 capital launch. In this episode Why frozen sections, the standard of care for decades, can take 15 minutes to several days, and how the Aura 10 returns a PET CT image of the specimen in about 10 minutes. The orange peel analogy: why surgeons need healthy tissue around the full circumference of a tumor, about five millimeters in head and neck cases. What early US adoption looks like: three sites and six or seven surgeons over the last year, across head and neck and breast cases. The two wave go to market plan: academic medical centers first for their research bandwidth, then non-academic and community hospitals for volume. The two objections that travel together, lack of evidence and budget, and how to answer the surgeon who says "I don't have a positive margin problem." Pricing at about $400,000 list, with a rental option at a fixed monthly payment and unlimited use. Why Guy believes in-person selling still beats remote, and why his magic wand would produce a 500 patient study. Chapters 00:00:00 Welcome and introduction 00:00:38 From insurance to Stryker 00:01:51 Capital sales at Accuray and the move to Xeos 00:03:18 The problem with incomplete tumor removal 00:05:42 Frozen sections versus a 10 minute PET CT image 00:08:38 Early US adoption and the Vanderbilt data 00:09:56 Go to market, academic centers first 00:11:17 The evidence gap and surgeon pushback 00:13:57 Pricing and the rental model 00:14:28 Myths about medical device sales 00:17:12 What 2026 looks like for Xeos 00:18:45 The magic wand, a 500 patient study 00:19:17 Where to find Guy and Xeos 00:19:56 Advice for patients facing cancer surgery About the guest Guy Albalancy is the US sales director at Xeos, a Belgian company founded in Ghent that makes the Aura 10, an intraoperative PET CT imaging system for cancer surgery. Based in Philadelphia, he has spent more than ten years in medtech, starting as an orthopedic trauma rep at Stryker and moving into capital equipment sales at Accuray, the company behind CyberKnife. Follow Guy Albalancy LinkedIn: https://www.linkedin.com/in/guy-albalancy/ Xeos website: xeos.care, with clinical cases for head and neck, breast and urology Published work: publications from Xeos clinical partners in the Head & Neck Journal, JAMA and Wiley Prefer to watch Guy walk through it? The full conversation is on YouTube: https://youtu.be/THz3wnPKL6c If you are a medical device founder or commercial lead trying to turn early clinical data into closed deals, book a discovery call with our team: https://api.leadconnectorhq.com/widget/bookings/md-pm-discovery

    This Technology Could Change What Surgeons Know Before Leaving the OR
  8. 6d ago

    This MedTech Startup Is Moving Ear Tube Procedures Out of the OR

    For years, ear tubes meant anesthesia, a day of fasting, separation from parents and about two days off work for the family. David Carey, CEO of Preceptis Medical, explains how Hummingbird TTS moves the procedure into the office as a five minute topical procedure. He also shares how the company reached about 50 customers with a single salesperson and why reimbursement took longer than he expected. In this episode Why ear tube procedures were done in the OR, and what that cost families in anesthesia exposure, fasting and roughly two days of missed work How surgeons who are boxed out of ASC block time by cardiac and complex spine cases are turning to office based procedures Why an ENT's first procedure with a family matters when patients may need an ENT six or seven times in their lives How a limited market release brought on about 50 customers with one well traveled salesperson before a US expansion with new sales leaders and distributors Why reimbursement was the biggest challenge, from state by state Medicaid decisions to securing a separate code that covers the medical device The three tier awareness effort across ENTs, referring pediatricians and parents How the upcoming Parent Resource Center will help parents compare office and operating room options and find a doctor Chapters 00:00:00 Welcome and introduction 00:00:35 From sales associate to CEO 00:02:03 What Hummingbird TTS does 00:03:15 The impact on parents and families 00:04:31 How surgeons are responding 00:06:18 Limited market release and 50 customers 00:07:07 The reimbursement challenge 00:08:08 The magic wand, parent awareness 00:09:29 Building the Parent Resource Center 00:10:49 Sites, users and growth 00:11:28 Where to follow Preceptis 00:11:51 Advice on joining a startup About the guest David Carey is the CEO of Preceptis Medical, whose lead product Hummingbird TTS allows ear tube procedures to be done in the office instead of the operating room. He has spent about 30 years in the medical device industry at companies including Stryker, Medtronic and startups, focusing on commercialization, sales and marketing leadership. He has worked in roles from sales associate to CEO. Follow David Carey Preceptis Medical website: preceptismedical.com Hummingbird website: hummingbirdeartubes.com LinkedIn: https://www.linkedin.com/in/david-carey-1a1223/ LinkedIn: https://www.linkedin.com/company/preceptis-medical-inc-/ Would you rather see the conversation than hear it? Catch the full interview on YouTube: https://youtu.be/MNnw9BCFGto If you are a medical device founder asking clinicians to change how they work, book a discovery call with us: https://api.leadconnectorhq.com/widget/bookings/md-pm-discovery

About

Clinical Perspectives is a medical device and MedTech podcast for the people building, selling and scaling healthcare technology. Host Stephanie Stover, CEO of Passionate Media Marketing, sits down with medical device founders, MedTech executives, surgeons, investors and healthcare innovators to unpack what actually works, from FDA clearance and reimbursement to KOL strategy, marketing, sales and funding. No jargon, no theory, just the real story behind the technology and the companies bringing it to market. New episodes every week. Follow the show if you are a medical device founder, a MedTech sales or marketing leader, or a clinician who wants to hear how this industry really operates. Watch the full video episodes on YouTube: https://www.youtube.com/channel/UC7upa8hmIqRS8ZNcW5gDDtA?sub_confirmation=1