MedTech Speed To Data podcast

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Ep 39 Adapting to Market Needs: From Advanced Biotelemetry to Organ Transport Logistics 42:59

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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.”…

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Identifying the Need for a Wearable Solution to Overactive Bladder: Insights from Market Research with Patients, Providers, and Payers : 38 51:26

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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.”…

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Developing a Clinically Useful Pain Assessment Tool : 37 34:04

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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.”…

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End-to-End Responsibilities for Early Development : 36 38:17

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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.…

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Navigating the Challenges of Instrument Development in Cell Therapy Manufacturing : 35 42:52

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Cell therapy research and manufacturing are driving demand for automated high-throughput equipment to improve quality, reduce costs, and shorten the development cycles of innovative treatments that save lives. But what factors shape a startup’s journey from the lab to commercialization? In Episode #35 of the Speed to Data podcast, Key Tech Business Development Manager Kelly Parker leads a panel of industry experts who discuss high-throughput automation in cell therapy screening and manufacturing. Daniela Hristova-Neeley, Ph.D. , is a partner at the advisory firm Health Advances, where she is a leader in the diagnostics and life sciences tools practice. Blair Morad is Senior Director of Engineering at Cellino, a startup developing autonomous biomanufacturing technology for personalized cell therapies. Nova Syed is a founder and angel investor in the deep tech and healthcare sector. Most recently, Syed was the founding VP of Product at Mekonos, a developer of silicon nano-needles for cell therapies. Need to know Three factors drive requirements in cell therapy screening: · Customers are studying a huge variety of biological systems and drug targets. · Business requirements drive the need for faster and cheaper therapy development. · Meeting regulatory standards demands high-quality, reproducible data. In manufacturing, meeting GMP makes design requirements even more complex as the product must: · Improve flexibility and scalability. · Improve quality control and traceability. · Lower manufacturing costs. · Reduce human interaction to improve efficiency and quality. The nitty-gritty Given the many competing business, market, and regulatory requirements, the instrument design process inevitably forces developers to make tradeoffs. The panelists agreed that quality is table stakes, which means technologists and business leaders must balance time, cost, and scope. “You have to be ruthless when it comes to prioritizing your differentiator,” Hristova-Neeley said. In Morad’s experience, understanding the organization’s core competency is essential to focusing on the right problems. Data that made the difference The three panelists shared their lessons learned from hard experience in the healthcare technology business. Get early feedback from the market. “Product-market fit doesn’t just happen,” Syed explains. “Unless you get feedback directly from the users and the customers, you don’t have the data to iterate to the next cycle.” Hristova-Neeley agreed. “It’s always important to hear what the customers have to say. Automation is certainly important, but it’s not the only thing that is going to solve how we do cell therapy manufacturing or cell therapy development.” Look for outside expertise. “When you’re working with the right experts,” Morad said, “they know how to ask the right questions that are helpful to move forward.” A good startup employs many intelligent people, but they won’t know everything about everything. Find outside partners who have already built the assays, workflows, automation modules, and other elements outside your core competency so you can focus on your innovations.…

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Using Spatial Biology to Get Critical Data : 34 35:41

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Pictorlabs is a California-based startup developing a cloud-based platform that uses artificial intelligence to improve tissue sample analysis through virtual histological staining. In Episode #34 of the Speed to Data Podcast, Key Tech’s Andy Rogers speaks with Pictorlabs Chief Product Officer Raymond Kozikowski about his company’s all-digital approach to tissue sample testing. Need to know · Histopathology — The visual analysis of stained tissue samples to diagnose cancer and other conditions. · Tests have long turnaround times — Selection, preparation, and imaging can take as long as a day to return one test’s results to the physician. · Tests are requested sequentially — The results of one test determine the next test in the decision tree, so physicians can’t order all the tests simultaneously. · Cancer patients must wait — On average, there is a forty-day gap between biopsy and first treatment. The nitty-gritty As Dr. Kozikowski explains, “Histopathology has traditionally been a chemistry-based testing paradigm. Every cancer case starts with a biopsy, and those tissues are transformed into data that inform the diagnosis and therapeutic options.” Pictorlabs’ solution uses one tissue sample to create a virtual stain that simultaneously generates results for dozens of tests within minutes. “What we’re doing is teaching AI algorithms the relationship between validated test results and the underlying signature from that unstained piece of tissue,” Dr. Kozikowski said. “From a single patient sample, you’re no longer limited to running one chemical-based test. You can run ten, twenty, thirty AI-based tests.” Although the company thought it faced a long march toward the clinical market, Pictorlabs found an opportunity in a different market. “There’s a really robust cancer research market, both the academic medical centers and the pharma companies. Where we really got traction wasn’t necessarily as a replacement [technology] but a complement to other kinds of tests.” Dr. Kozikowski cites spatial biology as an example. Cells express their genes and RNA differently depending on their location in tissue. Understanding this spatial relationship could yield new, more targeted therapies. “A challenge with interrogating RNA targets,” Dr. Kozikowski explains, “is that you often can’t also run traditional staining-based tests. With virtual staining, we’re actually able to complement those RNA-based tests with a pseudo-staining result. This is perfectly fit for purpose in those workflows.” Data that made the difference: The importance of data to AI development isn’t surprising, but Pictorlabs needs more than quantity. “There’s also a lot of nuance in the design of that dataset and making sure it’s fit for purpose,” Dr. Kozikowski says. “Has it seen the diversity of human disease in that training dataset to really make sure that it generalizes accurately and robustly?” Partnerships with the research community have helped refine Pictorlab’s technology. One of these relationships is with Dr. Michael Kallen, a pathologist at the University of Maryland’s School of Medicine. “Diagnosing lymphoma or leukemia can be very, very complex. You have the challenge of managing a complex workflow in the lab and the complexity of making sense of all those test results spread over weeks or maybe even a month.” “[Dr. Kallen] saw the opportunity. We’ve been partnered with that department for a while now, exchanging data to help train algorithms and get feedback from pathologists. We’ve just received an innovation grant to deploy our technology side-by-side with their existing workflows to look at the value.” Watch the full video below to learn more about Pictorlabs’ virtual staining solution and to hear Dr. Kozikowski’s advice to product managers and entrepreneurs.…

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Design as a Platform for Future Assay Tests : 33 35:46

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Astek Diagnostics is a Baltimore-based MedTech startup developing a platform for diagnosing urinary tract infections (UTIs) with unprecedented speed and accuracy. In Episode #33, Key Tech’s Andy Rogers and Lauren Eskew discuss this exciting development with Astek Diagnostics co-founder and CEO Dr. Mustafa Al-Adhami. Need to know UTIs are proliferating — Within thirty years, global cases rose 90% to over 400 million cases [CC1] , with over 8 million hospital visits in the US alone. Rapid tests are unreliable — Low-specificity dipsticks have high false-positive rates. Clinical tests are slow — Labs take up to three days to return results. Incorrect prescriptions are common — Physicians initially choose the wrong antibiotics in half of patients, delaying effective treatment. UTI complications are lethal — 25% of sepsis cases start as UTIs, leading to 68,000 deaths in the US [CC2] . Slow, inaccurate diagnoses breed resistant bacteria — Delaying the use of effective antibiotics contributes to the severe threat of antimicrobial resistance. The nitty-gritty Dr. Al-Adhami’s entrepreneurial journey began with a personal crisis two months before receiving his biomedical engineering Ph.D. when his grandfather developed a UTI. “It took the doctors four days to tell him what antibiotic he should be using,” Dr. Al-Adhami said. “In the meantime, he was in pain. He was delirious. He fell and broke his hip. I kid you not, he was a young 87-year-old. Within one week, he was a much, much older, bedridden 87-year-old. [While] helping with his care, I was like, if we were able to give him the proper antibiotic right away, we would not be here!” Such strong motivation led to a one-hour test for use in a urology or OB/GYN clinic. The system has two components: a single-use sample cartridge and a durable microfluidics fluorescent analyzer that characterizes antibiotic susceptibility [CC3] . Astek’s tabletop prototype already achieves 97% specificity and 94% sensitivity — results that would revolutionize UTI treatment worldwide. Data that made the difference Working with Key Tech, Dr. Al-Adhami’s team will soon have an alpha product ready to begin feasibility studies. Shortly afterward, the beta design will enter clinical trials with a planned FDA submission by the second quarter of 2025 — a remarkable four years after the company’s founding . “The patients are waiting, right?” Dr. Al-Adhami pointed out. “Luckily, my grandfather is still with us. The goal here is to help with my grandfather's situation, so I need to get this to market as soon as possible. ” While Dr. Al-Adhami and co-founder Kevin Tran saw the market need, they needed data from their first prototype to show potential investors. “We ran fifteen samples, and the device was spot on with thirteen of the fifteen . It was like, this works! This is not a bad idea! I was confident enough to raise a pre-seed round. To say, ‘Hey, angel investor, can I have 50K?’” Further market research helped shape pricing and reimbursement models that benefit the company and physicians. “More importantly,” Dr. Al-Adhami said, “ the patient is getting better. That makes it sustainable. The idea here is to shorten the [hospital stay]. We did a health economics study. If we shorten the stay [for all patients] by one day, we’re saving the hospital — per site — a million dollars a day .” Watch the full video below for more details and to hear Dr. Al-Adhami’s advice for MedTech founders. [CC1] From Key Tech/Astek press release [CC2] From Astek’s website [CC3] From Key Tech/Astek press release…

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Where to Focus De-Risking : 32 39:28

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Blackbird Labs is a life sciences accelerator with a mission to develop Baltimore’s biotech startup ecosystem. Funded by the owners of the Baltimore Ravens, Blackbird’s focus is on bridging the gap between research labs and clinical trials. In Episode #32, Andy Rogers of Key Tech talks with Blackbird Labs CEO Matt Tremblay about Blackbird’s integrated initiative to foster life science and biotech research in Baltimore. Need to know Building Baltimore’s biotech infrastructure — The Baltimore area is home to some of the nation’s top biotech research institutions with lots of mid-career talent, but a relatively underdeveloped investor ecosystem compared to Silicon Valley. Building a thriving ecosystem — With a mission to foster entrepreneurship and reduce Baltimore’s opportunity gap, Baltimore Ravens owner Steve Bisciotti’s family foundation wants to develop the region’s biotech innovation. Blackbird Labs gets innovations out of the lab — A $100 million founding grant will let Blackbird Labs accelerate life sciences innovation by helping promising research cross the gap separating the lab from the market. Blackbird Bioventures moves startups towards the market — Making seed-stage investments and cultivating a network of investors, advisors, and leaders will help biotech startups shift from research to clinical trials. The nitty-gritty Blackbird Labs and Blackbird Bioventures address a significant hurdle preventing novel therapies and technologies from reaching the market. A laboratory discovery is too risky for investors. There are too many open questions concerning safety and efficacy. “When a new therapeutic is identified,” Tremblay explains, “we can’t just immediately go into a clinical study.” Blackbird Labs attacks the problem from one end by funding research at universities and contract labs that no longer fits within the academic systems of publications and grant-making. “What you may need is another one to two years of very focused research to create the data that will then draw in investors that can support the development of this technology all the way to market.” That is when Blackbird Bioventures enters the picture. Startups need capital to prepare for and enter clinical trials, which Blackbird’s early seed investments and investor networks help provide. Since its launch last November, Tremblay’s organization has already awarded grants to six research teams and invested in four existing startups. Data that made the difference: “An important element of our business model is syndicating with other investors but also strategic partners like Big Pharma,” Tremblay says. “We have a few different layers of challenges to overcome. We’re not just looking at… commercial potential, but we also have to look at the feasibility on a one to three-year timescale .” The goal is to generate what Tremblay calls “prudent principal data” to excite potential investors . This data must meet two criteria. First, is there a strong mechanistic underpinning for therapy’s efficacy? Second, can the project generate clinical data on a meaningful timescale to show that the therapeutic works? Blackbird’s data and investments, Trembly explains, “is a signal to the market that this is an important technology . The goal is then to bring investors from within the Baltimore ecosystem — but importantly from outside of the mid-Atlantic —folks that are investing in very high-quality companies in Boston and San Francisco to look at what we’re building here.”…

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Take a Holistic View to Define Your Cell & Gene Therapy Product : 31 46:08

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MicrofluidX is an early-stage developer of cell and gene therapy manufacturing platforms that aims to streamline the transition from laboratory research to large-scale GMP manufacturing. In Episode #31 of the Speed to Data podcast, Key Tech hosts Andy Rogers and Director of Strategy Lei Zong speak with Dr. Lindsey Clarke, MicrofluidX Vice President of Commercial, about the company’s solution to advanced therapy commercialization. Need to know Cell and gene therapies are revolutionizing medicine — Since the 1990s, these therapies have opened new avenues for curing once-terminal conditions like cancers and heart disease. However, the field is far from industrialized — Skilled operators produce these living medicines in small batches using systems sourced from a complex supplier ecosystem. Scalable manufacturing is part of the solution — MicrofuidX is developing a scalable bioreactor that speeds time to insight and accelerates commercialization. The nitty-gritty Cell and gene therapies allow the patient’s body to cure itself with a single dose. “When I first started in this industry,” Dr. Clarke explains, “we didn’t know if these therapies were going to work, then they started working, and then literally in the last five years, we started saying ‘curing.’ To have seen that in my career is incredible for me.” Researchers are now developing therapies for chronic conditions like epilepsy, rheumatic diseases, and diabetes. “I think that’s hugely exciting if, from a technology perspective, slightly concerning that there’s really big numbers of patients at the end of these. Do we have the tools that will enable us to get to that scale?” R&D pipelines translate manual laboratory processes into automated, scalable commercial production. A challenge for chemistry is more complex for cell and gene therapies that depend upon living cells where, as Dr. Clarke points out, small changes can have big impacts. She contrasts feeding cells in production, where automated incubators maintain perfect conditions, to a lab where a human operator moves a flask to a hood, removes the cap, adds media through a pipette, replaces the cap, and returns the flask. These steps introduce stresses and temperature variations that won’t exist in manufacturing. “We don’t measure it,” Dr. Clarke says, “We don’t know what impact it really has, but it could be having an impact. So you’re having to go through an optimization phase that is involving large scale technology.” Data that made the difference: MicrofluidX balances complexity with simplicity. The company’s core technology is a bioreactor with automation, control, and sensor layers that let this single platform scale from milliliters in the lab to liters in production. Dr. Clarke explains, “It means that you can really start to optimize processes in small volume, understand it, and then drive it to where you need it for manufacturing.” Listen to the market early. Letting potential customers shape the development path can optimize your product-market fit. “If you’ve already got something that’s ready for the market, it’s too late,” Dr. Clarke says. Qualitative discussions identify issues when you have time to change. Make engineers talk with people. Asking engineers, whether they want to or not, to join these customer conversations is “really good for them,” Dr. Clarke says. Engineers ask different kinds of questions that directly impact development.…

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Creating an Inclusive Culture : 30 37:29

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Diversity and inclusion (D&I) are essential to sustainable business cultures, nowhere more so than in the MedTech industry, where a product’s success can depend on its acceptance within a variety of communities. In Episode #30, KeyTech’s Andy Rogers and Senior Mechanical Engineer Danica Mackesey sat down with Sarah Hassaine, ResMed’s Head of Global Inclusion and Diversity, about fostering environments where multiple voices get heard. Need to know Changing lives globally —ResMed is a global manufacturer of CPAP systems for at-home sleep apnea treatment and ventilator solutions for out-of-hospital care settings. Diversity as a strategy — Hassaine’s team coordinates ResMed’s efforts to bring diversity and inclusivity to the employee experience, business practices, and product development. Giving ResMed communities a voice — ResMed employees participate in Employee Resource Groups where women, veterans, neurodiverse, and other communities contribute their perspectives to the company’s D&I strategies. The nitty-gritty A large part of Hassaine’s role is fostering D&I within ResMed — quite a challenge, considering the company has over ten thousand team members supporting customers in over 140 countries! At the same time, the core challenges will be familiar to small companies and startups. “The first part is for people to understand themselves,” she explains. “People have their own intrinsic opinions, thoughts, biases…. Building in that ability to understand and find value in people’s differences is the hardest part.” Diversity and inclusivity also need to be part of the product development cycle. “Some communities are not comfortable talking about sleep,” Hassaine says. “It is a very personal experience. We have seen that struggle with getting some communities to even get sleep-tested.” People from disparate communities — Women, people of color, veterans, older people — have differing attitudes towards doctors, the healthcare system, and personal health in general. These differences, however, are not well understood. “Our medical affairs team is doing more research on the social determinants of health and access to health care. We're making sure that everyone gets access to a sleep test if needed.” Data that made the difference ResMed’s D&I team collects qualitative and quantitative data to understand the state of diversity and inclusion within the company. In addition to surfacing perspectives through Employee Resource Groups, her team generates quantitative insights from hiring, promotion, and attrition data as well as from employee surveys. “It does take time, especially in the inclusion space, to address data and see improvement,” Hassaine says. “I’m finally now having a story to tell three years later.” Hassaine and Danica addressed how diversity data plays is crucial in medical device development. Danica brought up the “importance of understanding who’s going to use the device because there’s some really potentially dangerous impacts.” “We're really taking that into consideration,” Hassaine agreed. The success of sleep apnea treatments often depends on the fit of a CPAC system’s mask. A key question Hassaine brought to ResMed’s product teams: “Are we making sure we have enough diversity to test our products so that we're… accommodating all face types or all heights or all body types?”…

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Exploring New Applications in Collaboration with BARDA : 29 49:29

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Rivanna Medical is a Virginia-based developer of ultrasound imaging technologies. Accuro, the company’s first product, is a “stud finder for the spine” for more accurate needle placement during spinal and epidural procedures. In Episode #29, Andy Rogers of Key Tech talks with Rivanna’s Chairman, CEO, and Co-founder, Will Mauldin, Ph.D., about the role of data in his company’s AI-powered product. Need to know Three million vaginal and caesarian births in the United States require anesthesia injected into the epidural space around the spinal cord. Twenty million patients receive epidurals during surgery or as part of a treatment program for chronic pain. However, there are complications. For example, post-dural-puncture headaches occur when a needle punctures the dura and fluid leaks from the spinal canal. First-attempt success rates are around forty percent in challenging populations, such as obese patients or those with spinal abnormalities. Success rates with Rivanna’s Accuro ultrasound imager approach seventy-five percent. The nitty-gritty Although physicians have used general-purpose ultrasound imagers to scout needle placement, most anesthesia providers don’t have the skills to make it common practice. By focusing on one indication, distinguishing epidural tissue from bone, Rivanna designed a simple handheld device that uses AI-powered software to streamline needle placement. Accuro’s small size and integrated screen make identifying and marking the needle insertion site easier. In addition, the device’s transducers interact with bony tissue better than general-purpose devices designed to image soft tissue. A focused value proposition also lets Rivanna use neural network algorithms to automate the identification of bone and epidural tissue and guide needle placement more accurately. Data that made the difference: Conversations with obstetrics anesthesia providers let Mauldin identify the value proposition. “It became pretty clear from those qualitative market research interviews,” Mauldin says, “that the problem is just where do I place the needle to begin with and on what trajectory?” Rivanna launched Accuro in 2015, but medical societies like the American Society of Anesthesiologists need more data to recommend ultrasound image-guided epidural procedures. Mauldin explains that Accuro’s next iteration requires identifying “what kind of endpoints would move society guidelines to point to an image-guided standard of care? What clinical evidence do we need to support in order to allow the societies to make that determination?” A new product line required gathering even more data. Today, seven percent of emergency department (ED) patients have suspected wrist or ankle fractures. The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) is concerned that terrorist attacks could overwhelm EDs with hundreds of fracture patients. Rivanna received BARDA funding to design a portable ultrasound bone tissue imager. “We made it through the base segment,” Mauldin explains. “That was about gathering data. We interacted with 180 different emergency physicians, emergency department directors, orthopedists, and radiologists to answer the question: is there a market here for the indication of bone fracture bedside assessment? Fortunately, the answer was yes.”…

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Lessons Learned in Innovation & Launching Products : 28 32:23

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Uterine cancer rates in the United States are rising. Yet uterine exams rely on expensive, difficult, and painful procedures developed decades ago. North Carolina-based Luminelle has developed an office-based alternative that could revolutionize women’s health. In Episode 28 of the MedTech Speed to Data podcast, Andy Rogers of Key Tech talks with Allison London Brown, Luminelle’s Chief Executive Officer, about her company’s innovation journey.…

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Don't Obsess About the Solution, Obsess About the Problem : 27 37:55

för 2 years sedan37:55

37:55

Sometimes, it takes direct experience to understand the value of innovation. Born out of personal crisis, Luminoah is developing a solution to enteral nutrition, or tube feeding, that will dramatically improve patient quality of life. In Episode #27 of the MedTech Speed to Data podcast, Key Tech’s Andy Rogers talks with Luminoah CEO Neal Piper about bringing much-needed innovation to in-home care. Need to know Tube feeding is extremely common — Every year, half a million new patients, from infants to geriatric patients, can’t swallow solids or liquids and require an alternate means of nutrient supply. Enteral nutrition lets patients live at home — A patient with long-term needs has a gastric feeding tube inserted through their abdomen into their stomach so they can leave the hospital. Yet the current standard of care is bulky — Patients must manage an IV pole, peristaltic pump, replaceable nutrient bags, and two meters of tubing. Slow pumps limit freedom further — Patients become defined by their illness, unable to go to work or school. Current products do not track data — Because tracking nutrient consumption is difficult, many patients are readmitted to the hospital for malnutrition. The nitty-gritty Neal’s decision to enter the enteral nutrition sector was not the result of market analysis or laboratory research. “It came out of a personal need for my wife and I when my son, Noah, turned three years old. He started choking on his saliva and food.” Doctors at the UVA Children’s Hospital discovered a tumor in the base of Noah’s skull that prevented him from eating or drinking. Noah rang the bell and ended his therapy after 18 months of chemotherapy. “Fortunately for us, we had a really positive outcome,” Neal said, but the experience opened his eyes to the challenges kids and adults face in similar situations. “Everyone says, don’t obsess about the solution, obsess about the problem, and that’s what we did.” After interviewing GI surgeons, nutritionists, distributors of feeding solutions, and many patients, Neal confirmed that Noah’s experience was not unique. “The major challenge that patients are dealing with is a lack of portability, an unintuitive approach, and not being able to track and be empowered with data.” Data that made the difference: Understanding the problem can justify a research program, but it does not explain how Luminoah could raise $1 million seed and $6 million Series A rounds in a tough investment climate. Noah explained how his team pressure-tested what he calls the 5 P’s of business development: Product Validation: Can you design a manufacturable product that solves the problem? Plan: What’s your go-to-market strategy? What does the financial model look like? Patent strategy: Can you protect the technology? People: Can you find experienced people to drive the project forward? Pathway: Can you get from development through 510(k) approval? “Three and a half years in, we’re about a month away from design three,” Noah explained. “We’ve got a working device we’re submitting to the FDA for 510(k) approval with clearance anticipated in 2024.” Learn how the Charlottesville, Virginia, biotech ecosystem and a community of enteral feeding patients supported Luminoah’s journey in the full video here:…

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Consider the Input- Ryan Myers : 26 31:38

för 2 years sedan31:38

31:38

Many conditions can elevate or depress the intracranial pressure (ICP) of fluid pushing on the brain, potentially seriously impacting patient health. However, the only ways to measure ICP require specialized invasive techniques that are too risky for most patients. In Episode #26 of the MedTech Speed to Data podcast, Key Tech’s Andy Rogers talks with Ryan Myers, CEO and Co-founder of CranioSense, about developing portable, non-invasive ICP measurement technologies.…

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"Be Obsessed with the Journey not the Outcome" - Joe Mullings : 25 52:20

för 2 years sedan52:20

52:20

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