MedTech Speed to Data

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 knowAmerica'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-grittyA practicing transplant surgeon and currently the Vice Chair of Innovation in the Department of Surgery at the Medical University of South Carolina, Dr. Scalea has seen a dramatic improvement in the efficiency and survivability of organ transplants.Operations that once took hours are now routinely completed within an hour. At the same time, complication rates are at all-time lows. Many technological advances made these improvements possible, but Dr. Scalea saw opportunities in the organ transplant system's operations.“We have about twenty-four hours to move a human kidney from the donor hospital,” he explains. This tight turnaround led Dr. Scalea to explore the potential for drone delivery. “We were watching the [transportation] time go up,” he recalls. “We hypothesized that using drones to seamlessly go from the donor to the recipient hospital might allow the recipient side more flexibility to get better outcomes.”Data that made the difference:Data drove MediGO's decision-making and ultimately led to a pivot from drone to supply chain technology. “We fundamentally believe that this problem is worth solving for the community,” Dr. Scalea says, “so what data are required to make this a business? It was through a combination of customer discovery, key informant interviews, and a ton of research into the space.”Identifying the actual customer was key. “We initially focused on the transplant centers,” Dr. Scalea says, “and then fundamentally recognized the organ banks responsible for moving the organs were the right customers. Organ banks didn't see as much immediate value in the biotelemetry. What they needed was logistics.”From there, the MediGO team could understand their customers' financial concerns. “We needed to understand funds flow — how those customers get reimbursed for the work they do.”As a practicing surgeon, Dr. Scalea inherently understood the customer's customers. “I was very fortunate to be an active transplant surgeon while standing up MediGO. Every day, I'd go to the hospital and ask myself, ‘Where's the organ?' This problem was real.”“As our colleagues around the country read the research we were publishing, it became clear there was a groundswell of interest in this problem being solved.”

Ohio-based Avation Medical has developed a bioelectric wearable device for at-home treatment of overactive bladder, promising improved quality of life for patients suffering from the most common cause of incontinence and urinary urgency.In Episode #38 of the MedTech Speed to Data Podcast, Andy Rogers discusses the Vivally System, entrepreneurship, and more with Avation Medical co-founder Jill Schiaparelli.Need to KnowBioelectric 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 GrittyAlthough 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 differenceAs a serial entrepreneur, Schiaparelli has learned that success requires understanding and meeting the needs of three key stakeholders: the patient, the physician, and the payer:Overactive bladder patients dissatisfied with traditional treatments are an enormous market. Most physicians can only offer prescriptions for imperfect drug therapies that do not generate revenue for their practices. Payers don't like either option since surgery costs reach $40,000 while drugs require lifetime prescriptions.“Every area we checked into, it made sense. This technology in this market checked all those boxes to say there's a need. We thought this was a real opportunity to disrupt the market.”But success requires addressing the needs of other stakeholders, including regulators and investors.Regulators' expectations, for example, drove Avation Medical's decision to implement quality control processes while starting its first clinical trial. “We knew that was going to be very important because we planned to use the clinical trial with our FDA submission.”Aligning Avation Medical's investors' expectations was just as important, with each investment round supporting the next stage in development and commercialization.Schiaparelli takes a holistic perspective on a Med Tech startup's data strategy.“It's speed, absolutely,” Schiaparelli says, “but it's also intelligent data that speaks to the needs of all the people that you'll need to demonstrate to down the line.”

Transforming Chronic Pain Treatment with a Lean, Data-focused Development StrategyBased 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 knowPain 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-grittyAlgometRx's technology platform emerged from research by the company's founder, Dr. Julia Finkel at Children's National Hospital. A pediatric anesthesiologist, Dr. Finkel must assess pain in children who lack the words to describe their experiences.“She wanted something that she could use in clinic to help better understand patients' pain,” Jackson explains. “Something that's simple enough that anyone could use in a variety of settings.”The Nociometer platform selectively activates nerve fibers and evaluates the patient's physical response — without causing additional pain.“We're able to identify the physiologic underpinnings of that pain experience, and that allows clinicians to better understand what's happening.”An objective assessment of the patient's pain lets the clinician make faster, better-informed decisions, but the real value will come from monitoring treatments. Rather than waiting three months to see if a treatment works, patients can return to the clinic a week later for a follow-up measurement. “That gives the clinician different information they wouldn't have had, Jackson says. “We can get right to the root of it, and you avoid six, seven, eight visits.”Data that made the difference:AlgometRx discussed this first-of-its-kind technology with the FDA before developing its proof-of-concept prototype. “We had this novel concept of a pain biomarker and device, so we wanted to know how we would even bring a device like this [to market].” FDA feedback informed a development strategy focused on gathering data from specific populations.AlgometRx leveraged partnerships to support this focused strategy. Working with Johns Hopkins researchers under an NIH Sprint for Women's Health grant, AlgometRx is developing pain response data sets for patients with systemic lupus and carpal tunnel syndrome. The startup is also a member of JLABS, Johnson & Johnson Innovation's life sciences incubator, where they get valuable insight into the Nociometer platform's potential role in pharmaceutical research.Running a lean operation lets AlgometRx prioritize data. Jackson is the startup's only full-time paid employee. Dr. Finkel, AlgometRx's board, and a network of consultants and contractors bring their expertise as needed. “We don't have a robust employee base, but we have a robust team,” Jackson says. “We've run this lean approach where we only bring in people as needed. Obviously, our investors love that idea because it's spending money on device development and data generation.”

Data drives MedTech growth, from the leanest startup to the world's most valuable pharmaceutical company. In Episode #36 of the MedTech Speed to Data Podcast, Key Tech's Andy Rogers discusses data-driven trends in medical technology with Anand Subramony, Eli Lilly's Vice President of Drug Delivery, Device, Connected Solutions & Innovation.Need to know·       Quarter-century perspective — After getting his PhD in chemistry and materials science from Purdue University, Subramony spent the next twenty-five years developing novel medical technologies for firms like Johnson & Johnson, Novartis, and AstraZeneca.·       Cutting-edge combination product development — Now at Eli Lilly, Subramony's team is responsible for combination product development, from early development through commercial development, for new delivery dosage forms.The nitty-grittySubramony 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. 

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 knowThree 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-grittyGiven 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 differenceThe 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.

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-grittyAs 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.

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 knowUTIs 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-grittyDr. 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 differenceWorking 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

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 knowBuilding 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-grittyBlackbird 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.”

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 knowCell 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-grittyCell 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.

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 knowChanging 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-grittyA 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 differenceResMed'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?”

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-grittyAlthough 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.” 

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. 

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 knowTube 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-grittyNeal'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:

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.

The National Institutes of Health spends about $42 billion on medical research each year, but less than one-eighth of that money is spent specifically on women's health. That may come as a bit of a shock, given that women make up a majority – about 51% – of the population. This underserved market is a huge economic opportunity for med tech companies.That's what Holly Rockweiler discovered as a Fellow at the Stanford Byers Center for Bio Design. So she put her background in biomedical engineering to work and started Madorra Medical, developing solutions to improve the vaginal atrophy and dryness that women experience after menopause or breast cancer. Madorra's flagship product is a handheld home-use device that uses ultrasound to rekindle the body's natural moisture-producing capability. The FDA has granted it breakthrough device designation The first randomized trial has been published, and a second one is on the way, and the company is now working toward the next set of data. Here in Episode #24, Madorra CEO Holly Rockweiler and Andy Rodgers talk about how that data is helping to blaze new trails in women's health. Need to know: There was a commercial about menopause in this year's Super Bowl (Astellas Pharma). That simple fact signals a new era in women's health.  Fundraising can be the most difficult part of bringing a new product to market, and it never goes away. Investors want to know what data has been collected, what payer requirements are, and to see a clear path to market. Piggyback on existing data when you can. For Madorra, there was substantial literature and technology using ultrasound in other therapies, data on vaginal blood flow from sexual arousal studies, and existing ultrasound devices that could be modified to show proof of concept. The nitty-gritty:Vaginal dryness resulting from vulvovaginal atrophy (VVA) affects over half of post-menopausal women and is also common among breast cancer survivors due to treatments that cause estrogen levels to drop. Symptoms include soreness, irritation, pain, increased urinary tract and yeast infection rates, and pain with sexual intercourse. Today, the standard treatment for menopausal symptoms is estrogen therapy. But that comes with risks: breast cancer, heart attack, and stroke. The quandary for doctors and patients alike is whether the benefits of pharmaceutical treatment outweigh the risks. For some patients, the risks are too significant and estrogen therapy is not recommended.   By putting data to work, Madorra created an ultrasound solution that stimulates natural moisture production and eliminates these risks. Madorra's hand-held external device, used on regular basis for 8 minutes, has been producing significant results in 1 to 3 weeks.  The device is shaped to be intuitive as possible to fit naturally and is used with disposable proprietary hydrogel. Safety is always a key issue, and the wide variety of literature on ultrasound therapies – including the fact that it's used on pregnant women – has instilled confidence in patients and clinicians alike. Data that made the difference:Market data from the Stanford BioDesign program helped Rockweiler learn to do an analysis of unmet needs, stakeholders, and market dynamics before taking the big leap.An Institutional Review Board (IRB) feasibility study helped in initial development.Pre-existing data on ultrasound showed that ultrasound therapy in other uses improved blood flow to treated areas. This key finding indicated that it might work on thin friable vaginal tissue as well.Patient data revealed how the condition feels to patients and what they wanted in a product.Bench studies and computer simulations proved invaluable in prototyping.This story is not only compelling because of the ingenious device itself, but it also reveals a broader story about opportunities in the underserved market of women's health.Interesting links:https://www.madorra.com/https://www.ispot.tv/ad/1VAi/astellas-pharma-super-bowl-2023-whats-vms

Surgery is not usually considered a spectator sport, but an OR is often filled with the surgical team, colleagues, residents, and medical device clinical representatives, in addition to a patient and equipment. Now Avail Medsystems, based in Silicon Valley, has created a way to increase learning, collaboration, and idea-sharing in the OR – while reducing the headcount – by connecting physicians and care teams to remote experts and device industry representatives during medical procedures. The Avail surgical telepresence platform is a hardware and software platform that enables instant, two-way audio/visual communication with high-definition video, surgical imaging views, and even telestration capabilities. In Episode #23, Andy Rogers of Key Tech talks with James Domine, CTO at Avail MedSystems, about how data-driven surgical procedures are facilitating collaboration and creating better outcomes. Need to know: Understand the rules of engagement – the surgeon in the OR is ultimately responsible, so assist without hindrance and design redundancies for reliability, such as battery backup for power failure, etc. Take a Silicon Valley approach – strive for a constantly evolving product driving toward a user benefit. Internalize security upfront and consider different vectors of attack – healthcare has experienced the largest percentage increase of cyberattacks (it currently ranks 3rd among industries) and is increasingly the choice of bad actors. Build a moat – Domine says Avail's best defense from the competition is being “the best platform on the market, with a custom system that integrates everything to provide the best intuitive UX, optimized for the OR environment.” The nitty-grittyThe Avail platform connects inside and outside the OR and allows viewers to customize their own experience. This way, clinical specialists, additional physicians, residents, and advisors watching the surgery can be remote but still actively participating and sharing with the surgical team. Med-tech research and development teams can sit in on the action, too, enabling collaboration on device development and creating faster product design cycles.The complete hardware and software package features a palette of high-tech features, including hi-def video, GigE Ethernet port, built-in dialing for calling remote contacts, and medical imaging. The system is on a wheeled cart, with a camera on a manual boom arm, so surgery can be viewed from various angles. The audio system streaming is custom-built for the OR to reduce background noise from machines and equipment.Avail is a data nexus – not only capturing real-time data from the surgical procedure itself – but archiving and enabling machine learning to help improve subsequent procedures and outcomes.Audiovisual data - the remote app works with an iPad or laptop. With two-way audio and video, it's like being in the room — even if you're thousands of miles away.Digital data – the system enables digitization of the OR to guide physicians and allow machine learning.Secure data - Avail is HIPAA-HITECH protected. To enhance security, designers purposefully avoided certain design patterns and third-party platforms.User feedback - user input ensures that any new feature added will be used, and Avail generates data on reliability, which is logged on Splunk, a data analysis platform that seeks, monitors, and analyzes machine-generated data via a web-style interface. Through collaborating in real-time, sharing knowledge about surgical techniques, and accelerating the development of new products and procedures, data is connecting a world of medical expertise.USEFUL LINKswww.avail.io/splunk.com

For most MedTech devices, the path to development starts with defining a market need, then creating a technology to fill that need. But sometimes innovation lies in finding a new application for an existing technology. And sometimes the inspiration can come from a totally unexpected place.Such was the case for Venk Varadan, indie film producer-turned MedTech CEO of Nanowear, a wearable diagnostic device for cardiac patients. Nanowear adapted a unique sensor technology originally designed to provide data-rich sonar for submarines and high-flying aircraft, to create a cloth nanotechnology, which captures and transmits 85+ dimensions of clinical-grade biomarker data from basic skin contact. The fabric has a suede-like texture, which comes from billions of tiny vertical sensors.Nanowear's SimpleSense™ is an FDA-cleared wearable A.I.-based remote diagnostic platform.  The non-invasive smart fabric collects a variety of metrics including ECG, heart rate variability, respiratory rate, actigraphy, impedance cardiography, thoracic impedance, and cardio-phonography. Nanowear is one of a handful of ways to track heart rate, blood pressure, and other vital signs for long periods of time. But the big plus is that it's non-invasive and can be used at home, facilitating patient compliance and, through telehealth, expanding the geography of high-quality care in rural markets. Andy Rogers of Key Tech gets to the heart of the matter as he talks with Venk about the journey from lab to marketplace.Need to know: Decide who you're going to be. Early on, Nanowear chose to go into MedTech, when they could have easily applied their technology to sports or wellness markets.  Don't be afraid to re-think. Nanowear was originally two products: a tank top for men and a bra for women. The realities of sizing and inventory forced a change to a unisex shoulder sash. Know what you don't know. Become an information sponge. Start small, stay small. After seven years, the Nanowear team is still only 30 people, recruited mainly from family (Venk's father, Vijay, developed the fundamental technology), friends, and colleagues. Look at the angles. Consider the viewpoints of all your stakeholders: investors, clinicians, patients, and your own staff.  The nitty-grittyThe primary factors that drive the application of nanosensors in healthcare are their non-invasive ease of use, high signal fidelity, and continuous monitoring capability.  Nanowear's shoulder sash is an easy-to-use multi-metric diagnostic system with state-of-the-art embedded wireless network devices that feeds data to a smartphone, a laptop, or directly to a remote server. This in turn enables a closed-loop digital system for specific machine-learning algorithms built on terabytes of patient data.Right now, Nanowear is focusing on monitoring congestive heart failure, which affects over 5 million patients in the U.S. With this versatile undergarment, doctors can remotely monitor patients and hopefully reduce expensive hospital visits. For patients, it's a comfortable, easy way to stay on top of their condition. The SimpleSense™ fabric is the first cloth that's FDA 510-cleared, but pioneering the cloth technology was only the beginning. The next challenge was dealing with the “firehose of data” that it generated.Collecting more data. Nanowear sensors capture 85+ medical grade biomarkers directly from the skin and provide accurate, continuous, real-time assessment of the heart, lungs, and upper vascular system: a more comprehensive picture of patient health. Managing more data. The cloth technology produces exceptionally high-quality raw signal data. To analyze millions of data points per patient per day, Nanowear had to create proprietary software. Retaining more data. With machine learning algorithms, Nanowear can track trends in a patient's cardiovascular health over time, providing clinicians with a tool that enables much more accurate decision-making.

Before any med-tech entrepreneur can bring a product to market, he or she must prove the technology will work reliably. Transforming a nascent technology like digital microfluidics into an intuitive product is not easy. But it doesn't take a seasoned engineer to understand that you'll need to evaluate multiple iterations of the device in order to develop a system that will work as intended.In Episode 21 Andy Rogers and Key Tech Senior Computer Engineer, and Partner, Lei Zong talk about creating test platforms that will collect essential raw data and turn it into useful information to speed up the product development process.Need to know:  Is this thing going to work? – the fundamental, elemental, do-or-die question. While de-risking, look ahead to the long-term - could the test bed lead to a potential system higher-level architecture, or just be a dead end? Be greedy about data. Get as much as you can with the test bed in order to understand system boundaries. You don't know what you don't know. So the flexibility of test beds is paramount. The nitty-gritty:Medical devices often have humble beginnings. Some may start out in pieces, with off-the-shelf components cobbled together into a benchtop system that simply demonstrates the proof of concept. This is a great shortcut that helps non-software engineers get up and running quickly. But as with any shortcut, there are caveats. Holding off for custom design and testing until later in development isn't always cost-effective.Consider this example: you have a PCR test fixture, like those used in COVID tests, to drive a thermal profile with a consumable, and you want to know what's happening within the platform itself, both with fluid and temperature. You need feedback from the system and software to capture the data. Generally, you have 3 options:1.      Off-the-shelf software, which may lack necessary functionalities or may not be compatible with certain test bed components.2.      A customizable solution such as Key# (Key Sharp), a solution that can drive the system and be configured to collect, process, and display the data you need.3.      Develop your own application, which requires time and deep, deep pockets. What's more, the PC app won't have any practical commercial use, since you'll likely need a custom UI to control the product.The customizable Key# solution gives you the most flexibility, budget-wise and performance-wise. Key# lets you quickly build the architecture you need with the functionality you want. It allows you to leverage a flexible framework with existing command libraries and gives you the ability to easily add new or custom commands. From there, the user can build scripts to run system protocols and collect data throughout the product development process.This customizable setup allows the user to easily adjust and test a variety of ranges and performance parameters to make testing fast, reliable, and easy. The user can tweak every parameter at a granular level: control modules, pumps, sensors, temperature ramp rates, and more.In addition to allowing users to control components at a granular level, the custom message protocol provides a clean and intuitive UI to enable more team members and manufacturing partners, to test devices.Let's say you need to control six motors and optical sensors – with Key#, you can set parameters and go! A program such as Key# can give users a graphic image of what the system looks like while collecting and processing hundreds of real-time data points from firmware (such as fluid movement, the temperature at various points in the system, and so on).As prototypes progress and include more custom features, programs like Key# can progress with the prototypes. Key# can provide pedigree verification along the way and can also continue running as the foundation for firmware while you enhance the UI. Core functionality remains the same, but the end-user interface is much “dressier.”To learn more about Key#, check out our blog “Key Sharp – Key Tech's Custom Software Tool” or contact us to discuss further.

Everybody likes to feel warm and cozy, but we all know someone that can't keep themselves warm. This is a particular problem for women who have undergone preventive or therapeutic mastectomies. The implants used in reconstructive surgery often feel cold, literally chilling women to the core.Kristen Carbone designed Brilliantly Warm, a wearable technology to solve a problem that she had herself: keeping warm following a preventive double mastectomy and implant reconstruction.A former museum curator, Kristen had no background in engineering or business, but she had a powerful idea. She started with a prototype that was connected to a drill battery, and now has a low profile, wearable technology that delivers safe, natural-feeling warmth to the body. The device slips easily into any bra and is controlled by an app, making it an almost invisible solution for women who want to feel warmer and more comfortable. Brilliantly Warm was initially designed for mastectomy patients, but since its launch, Kristen discovered it's also being used by nursing moms, for menstrual cramps, and people with chronic conditions who constantly feel cold.Here in Episode 20, Key Tech's Andy Rogers talks with Brilliantly Founder and CEO Kristen Carbone about the hows and whys of Brilliantly Warm and how data – or sometimes the lack of it – shaped the journey from idea to marketplace. Need to know: Feel the need. Kristen understood the need for the product from her personal experience. Get a lawyer and accountant you love. Find people who focus on start-ups, who can help you make deals, and help you stay compliant with regulations. Take the fastest track to the market. Brilliantly Warm is sold directly to consumers. For them, it was a quicker way to ROI. And because it's a consumer product, Brilliantly Warm is not subject to FDA med-tech regulations.  Work the web. Brilliantly has a robust website that sells the product and also offers content to help address some of the issues cancer survivors face: sexual dysfunction, medical bills, talking to kids about hereditary cancer, and living well after treatment. Start small.  Brilliantly began with small product runs, so the company was not sitting on large inventory. That gave them the flexibility to make improvements along the way based on customer feedback about product size, shape, and even color.  The nitty-grittyBreast cancer affects about 1 in 8 women in the U.S., and those women who have had a mastectomy and reconstructive surgery often feel cold because implants will actually act as a heat sink and pull heat away from the body's core.   Until now, women have had to create D-I-Y warming solutions, such as using chemical hand warmers or electric heating pads; these can result in discomfort, burns, and even melted implants, necessitating additional surgery. Therefore, safe temperature control was a critical product requirement for Brilliantly Warm. Once a setting is selected in the app, the wearable warms up, with three temperature settings and a built-in thermometer that ensures it never exceeds 111 degrees F. In the earliest stages of development, Kristen found herself in a data desert. There was virtually no market research about breast cancer survivors, no research to support the product for investors or even much research on women-founded businesses. * So she did what any enterprising entrepreneur would do: she built a database herself. Through what she terms “shameless networking,” Kristen talked to hundreds of women who had similar experiences and assembled enough anecdotal information to convince investors and customers and get the product off the ground. Turn anecdotes into science - by assembling a large body of anecdotal information and seeking constant feedback from the breast cancer survivor community, Kristen created compelling evidence of market need.Use what you got – among the few nuggets of data that Carbone could find was that women have a 30% slower metabolism than men, that 80% of people are willing to use wearable technology, and that feeling warm and comfortable improves productivity, all of which strengthened her case.Create a data feedback loop for your customers. Kristen talked to hundreds of breast cancer survivors and previvors. Through those conversations, she confirmed the need and recognized that the opportunity to help women feel better was much bigger than a single product. Through a wide range of content on the Brilliantly website, Kristen is connecting with the community of women navigating life after breast cancer with a curated resource of products, services, and information.After a jump-start into the direct-to-consumer market, Kristen and her team are now three years into R&D with its flagship product, Brilliantly Warm. Though the company is still in the VC stage, the product is approved for HSA and FSA expenditures. Now, they're exploring the efficiencies of the B2B market and insurance reimbursement.  And working on new applications for warming technology.This is an inspiring story of by-the-bootstraps entrepreneurship. Give it a listen here . You'll be happy you did. *According to a February 2021 article in Harvard Business Review, only 2.3% of venture capital funding goes to start-ups founded by women.

Each year, millions of people in the U.S. require some sort of neurosurgery due to injury, disease, or genetic condition. They often undergo multiple procedures and face long, painful recoveries. This inspired Jesse Christopher to start tinkering with his kid's toys in his garage, which was the beginning of Longeviti Neuro Solutions.Starting from this humble beginning, Longeviti pioneered the development of a low-profile intracranial device platform in 2016, in partnership with Johns Hopkins: the first customizable platform to address a growing need for patients undergoing complex brain surgeries. Today the company is pioneering new solutions for brain surgeries and has brought several FDA-cleared implants to market.In Episode 19, Andy Rogers talks with Longeviti Founder and CEO, Jesse Christopher, about the journey from garage to CEO's office, and the data that helped along the way.Need to know: Advocacy groups can guide innovation. Listen to physicians and patients to keep the user front-of-mind during development. Embrace the grind. Founding and operating a startup takes fortitude and trust. “Lean in” to the FDA. They're receptive to questions, and can provide great insights, and resources. Also, check out FDA preceptorship programs.  Plan. Plan. And plan some more. Set a calendar each year so that planning is visible to all, while being mindful of this wisdom from heavyweight Mike Tyson, “Everybody has a plan until they get punched in the face.” The Nitty GrittyLongeviti's Clearfit® disc implants are designed to reconstruct the skull's natural contour after surgery, and allow for post-operative imaging using ultrasound, instead of more costly MRI or CAT scan procedures. Their InvisiShunt™ supports location and orientation while restoring the natural contour of the cranium for patients with conditions such as hydrocephalus. InvisiShunt is a single-use, sterile implant made to fit different areas of the skull. These devices are “windows into the brain” that allow doctors to monitor tumors, observe fluid drain, and to use ultrasound instead of more costly MRI or CAT scans for diagnosis and easy access monitoring (ultrasound imaging is not possible on an adult because of the attenuation abilities of the skull).Of course, a lot of hard data went into the engineering and manufacture of these devices, including material selection, contour, and manufacturing specs. But the secret to Longeviti's success so far lies in how the company has been able to manage” soft” data.Market knowledge – before starting Longeviti, Jesse had 20 years' experience in the field with a Fortune 300 company.Company culture – in any start-up, you're flying by the seat of your pants. But establishing a culture that fosters creativity, accountability, and open communication helps build a strong cohesive team. Humility helps.Education – as with any new technology, real success lies in the ability to educate people about the use and the advantages of your device. Longeviti relies on several pillars: On-brand initiatives Physician courses, society meetings, and conferences Working with hospitals to “follow the dollars”  Patient advocacy groups, whose feedback can guide innovation It's a marathon run, gathering data to hit critical mass. But these grassroots efforts pay off in real-world terms: research that points to statistical significance, achieving standards, and getting all-important reimbursement codes. Investor relations – a start-up can't survive without regular infusions of capital. So keeping investors happy–and focused on a success that may be years in the making–is critical.  Communication and transparency are the rules. It's just as important to understand their need for revenue. Show them a path to profitability. Create multiple plans for success. Tell them where you see opportunities for growth. And toot your horn when you find pockets of success. Longeviti is a great story that truly captures the med-tech entrepreneurial spirit. And the discussion is chock-full of great info. Helpful Links:  www.longeviti.comwww.hydroassoc.org/hydrocephalus/

Coagusense developed the first point-of-care prothrombin time/Internationalized Normalized Ratio (PT/INR) monitoring system for cardiac patients to help them maintain warfarin dosage within a therapeutic range. In the latest version of their device, they actually removed connectivity features to accommodate the needs of their older, less-tech-savvy self-testers. Therefore, they had to go back to the FDA with more bench data for re-approval. Andy Rogers talked with Mike Acosta, EVP/Head of Compliance at Coagusense, and later recapped some of the lessons learned with Senior Electrical Engineer Jake Cowperthwaite. Andy and Jake have an informative discussion about how to define performance requirements when you're aiming for FDA approval.Need to know:Make sure the performance requirement is objectively verifiable by a measurable test result, functional demonstration of performance, simulation analysis, and/or visual inspection.Plan for the number of prototypes you'll need to create confidence in your statistics. Large companies may have their own internal mechanism to create a plan. Startups can consult with the FDA. Understand the regulatory considerations for seamless FDA approval.  It's a good idea to meet with the FDA prior to submission to outline your requirements. The earlier you have regulatory buy-in, the better.The nitty gritty:Rule Number One is to make sure that the performance of the device is objectively verifiable. For example, simply stating “the device shall be easy to use” is vague and subjective and won't cut it with the FDA. Write your requirement in a way that can be verified through: testing and measuring results, a functional demonstration of performance, analysis via calculations or simulations, or visual inspection. A well-written requirement is specific with clear criteria, for example if your product was a pump, a performance requirement could be: “the aspiration pump shall have X flow rate within Y bounds”. If it meets that requirement, you're ready to move on. Don't over-spec.Three things the FDA is looking for: Above all, efficacy and safety Accuracy Is your device novel technology or based on a predicate device? At the test bench, start with a good understanding of how many prototypes you'll need to have statistical confidence in your results. Sample size will depend on the data needed; an on/off switch won't require a large sample size, but testing with different operators – as with in-home devices – will need a substantial data set.In some cases, it's possible to short-cut the process early in development by testing multiple variables at once. This will yield a lot of data, which can then be analyzed. You'll find some variables meaningful and others not, but understanding these variables and their sensitivity early in product development has great value and can save money in producing fewer prototypes.USEFUL LINKShttps://coag-sense.com/about-us/https://www.greenlight.guru/

There's nothing like finding a partner with a map when you're exploring new territory.CoaguSense developed the first point-of-care prothrombin time/Internationalized Normalized Ratio (PT/INR) monitoring system for cardiac patients who have been prescribed warfarin. Their Coag-Sense® device monitors blood clotting rates and helps patients maintain rates within a therapeutic range. It's designed for both professionals and patient self-testers. As with any MedTech device, there were plenty of regulatory hoops to jump through. So they looked for outside help and found it with Greenlight Guru, a company that provides an out-of-the-box electronic quality management system specifically designed for MedTech companies. Listen in as Andy Rogers talks with Mike Acosta, EVP/Head of Compliance, CoaguSense, and Wade Schroeder, Medical Device Guru at Greenlight Guru, to learn how outsourcing can facilitate speed to data and get you to market more efficiently.NEED TO KNOW: Understand the market by getting users' feedback—what they want/need versus “if you build it, they will come.” Go out there and get that information. An outside partner can provide a built-in knowledge base. In the med tech industry, quality for the sake of compliance is no longer enough. COVID pandemic challenges have delayed FDA review time. THE NITTY-GRITTY:According to the FDA, about two million people in the United States take warfarin to prevent blood clots and to prevent stroke in people with atrial fibrillation, heart disease, or artificial heart valves. So CoaguSense was poised to capitalize on a large market. But as a small company with a new technology, the path to regulatory approval could have been long, tortuous, and costly. Greenlight Guru came to the table with a purpose-built platform that could manage all the quality, regulatory, clinical, and product development activities across the entire device lifecycle. And having the design control aspect upfront helps all the way.Coag-Sense is now a market leader, and they're working on a 3rd Gen simpler version to meet the needs of their older patients. Every step of the way, data drove the decisions.Fast data. The Coag-Sense® meter directly measures clot formation in seconds. Procedures and templates from Greenlight Guru were audit-ready to align with regulations, including ISO 13485 and FDA CFR Part 820, and provide a traceable source of truth. Independent diagnostic testing facilities (IDTFs) can be used to manage call-in results from self-testers, even if a device lacks connectivity. Developing a “downgraded” next-gen version without connectivity for elderly patients The Gen 3 version of Coag-Sense actually has fewer bells and whistles in response to the needs of older in-home self-testers who are less tech-savvy. Here are the hows and whys:Consider elderly patients' desire for simple devices - Many older people don't have computers at home or are not savvy with smartphones; they don't want or need connectivity. These patients are more commonly managed by IDTF's who can manage self-testers.  Build in time for FDA reviews - First, a Gen 3 FDA review is more challenging than a Gen 2  review. You'll need to show more performance data: FDA wants to see data comparing operator to operator. In addition, the classic 30-day review for 510k is now taking almost a year, with older reviewers retiring and new reviewers coming on board. Be ready with a plan for post-market surveillance - IVDR - Capturing post-market surveillance data is required now and will feed back for potential improvements.Find partners who continually evolve – CoaguSense partnered with Greenlight for an out-of-the-box solution for QMS & documents, but just as important for keeping up with what needs to be reviewed in international markets and traceability mapping too. It all adds up to one interesting discussion. Listen in. USEFUL LINKS:https://coag-sense.com/about-us/https://www.greenlight.guru/

As medical devices keep advancing, the consumables used in testing and therapeutics are moving forward as well, far beyond grandpa's diabetes test strips. New semiconductors, circuitry, and sensors, along with automated production, bring a whole new spectrum of functionality within reach for consumables. The burgeoning at-home market is driving demand and the growth of body-worn therapeutics and delivery devices. But with new functionality comes new risks, and among the biggest risks is human error. To paraphrase Murphy's Law, “Anything that can be misused, will be misused.”  Complex consumables are our topic du jour. Mechanical Engineers Will DeMore and Andy Rogers engage in a far-ranging discussion of the ins and outs of consumables development, how to avoid pitfalls, and how to engineer your way to success.Need to know: The critical importance of interfaces How to “goof-proof” your system Why user experience drives design Common pitfalls that slow development and increase costs The nitty-gritty:Consumable products, whether they're for in-home or clinical use, fall into two categories: single-use, such as blood-test strips, or multiple-use, such as CPAP masks. Each has its own special considerations. But regardless of whether your device is single-or multiple-use device, a therapeutic device, testing device, or drug delivery system, interfaces are the areas where your product will succeed or fail. Interfaces are where you'll encounter the most constraints and most complexity in design. For example, a body-worn consumable in a home setting has an interface between the device and user, the device and electronics, the device and its physical space, as well as the device and the digital world, i.e., smartphone app. Keep the user experience topmost in your mind and your design. It pays to put some time into “poka-yoking” your product. (Poka-yoke is the Japanese term for "mistake-proofing.") It can be as simple as a “This side up” sticker, color-coding, or creating a plug-in that only works one way, a la Apple.Consider number and types of sensors needed. If you're dealing with gases or liquids, you'll need a reliable seal to prevent backflow and cross-contamination – preferably with haptic feedback – so your user knows when the connection is secure. For multi-use consumables, factors like ingress protection, cleanability, and durability, come into play. Depending on the type of device, you can upgrade interfaces at development or add them later. The important thing is to take a risk-based approach in your design. Think ahead and design to assembly to reduce time and scrap. Think about the cost vs. benefit of upgrades. And, of course, safety first. The bottom line on complex consumables, whether starting from scratch or adding new functionality to an existing device, is to look for places to add value. Optimize the user experience. Add new data or new connectivity.  Prompt the user when it's time to re-supply.  The more you succeed in simplifying a complex consumable for the user, the more successful your product will be.HELPFUL LINKS:https://sixsigmadsi.com/poka-yoke/

When you're trying to add new functionality to existing technology, the data you need won't be presented on a silver platter. Sometimes, you don't even know what the right data is until you find it. This was the case with RevMedica, a start-up that's developing a new hybrid robotic laparoscopic stapler technology.Following Andy Rogers' talk with RevMedica, he and electrical engineer Rachael Scott discussed the search for data when designing new functionality into existing platforms. Need to know: Cost is a driver in a hospital environment. Look at the competitive field and at other technologies that could enable your technology. Understand what your customers want and how they work; function and features define your architecture. Be ready to demonstrate the added value of the features you've designed in. The nitty-gritty:Clinicians want it all when it comes to medical technology, but they don't want to pay for it all, especially in the highly competitive hospital market. So when you're adding new functionality to existing systems – or even developing a disruptive new technology – you must pick and choose features that will make your product stand out without breaking the bank. There are a few ways to find and evaluate the data you need to successfully bring your product to market.  Understand your customers. Listen to what they want and need, and understand how your product affects their workflow. Get user feedback throughout the development process. Clinicians perform many different tasks, so big changes can lead to non-compliance, which reduces efficacy. Know when to hold 'em and when to fold 'em. Consider how far along the development path you can go before you pivot by setting milestones. And look to the data to make the “go or no-go” decision. For example, RevMedica's original idea was to develop a full-on robotic technology. Months into development, it became apparent that a hybrid model was the way to go, and they had the smarts to make the switch. Look for savings in manufacturing. Costs can be amortized for durable components, so deciding which components are durable and which are disposable is a critical decision. Seek ways to design multiple parameters into one sensor. This also affects the sustainability of your product – an increasingly important issue. In addition to opening up a new world of ideas, sustainability can be a competitive advantage in the marketplace. Design for the outcome you want. Consider what happens when the task you're enabling is performed correctly, and design to that outcome. Once again, this is where user data is invaluable. This helps you evaluate your feature set and ensures that you're creating the right architecture for the platform.  Above all, remember, there's power in the data, and collecting the data as you develop new products helps inform another generation of technology.Helpful Links:https://www.revmedica.comHome | revmedica

Following the data leads to a breakthrough idea in laparoscopic surgery.Sometimes a technology starts off in one direction, but the data leads developers somewhere else entirely. This is the case for RevMedica, an early-phase medical device company, and manufacturer.  The first product in development at RevMedica is a cybernetic laparoscopic surgical stapler. The development of this device may transform the $4.5B surgical market by matching a reusable power module with a disposable sterile body. But it didn't exactly start that way. Recently, Tom Wenchell CEO, and Robert Satti CTO, of RevMedica talked with Andy Rogers of KeyTech about how a venture to create a full robotic surgery platform turned into an even better idea, by following the data path. Need to know:·    Sometimes data can lead you in a new direction. Follow it.·    Start-ups must learn to do more, with fewer prototypes·    Data mapping puts performance on view for users and investors·    There's a balancing act between development and marketing The nitty-gritty Surgical stapling is a workhorse technology. Staplers are used every day to dissect and/or ligate soft tissue in abdominal and thoracic cavity surgery. Surgical staplers are nothing new. But the mechanical devices – and even the powered devices – have well-known drawbacks. They don't fit every hand, can be tiring to use, create waste, and rely on the surgeon to feel his or her way around inside the soft tissue. RevMedica's technology is designed to effectively bridge the gap between the instrument and the surgeon's hand. It's a hybrid device, not a full robotic system. It's designed to give surgeons a tool to make better decisions in the OR and create better patient outcomes. Different types of data have shaped each step of the development: Market data drove initial development. As RevMedica Interviewed surgeons, their original concept for a full robotic stapling device fell by the wayside, and the hybrid model began to emerge. Competitive data helped refine and develop the hybrid concept. They looked at entire systems to find inefficiencies in mechanical and powered devices. It became apparent that a hybrid architecture enabled better articulation, smart firing, and a significant competitive advantage: the durable component can remain sterile for multiple procedures. And durable components reduce the waste of “one-and-done” mechanical staplers. This way, RevMedica can provide more value, at a lower cost, without all the bells and whistles or full-on robotics. Ergonomic data from workflows and job functions surrounding the device as well as the way the device works with tissue provided valuable insight. Different aspects of workflow in OR were scored and ranked, then aggregated in spreadsheets and graphs. By making the data visual, RevMedica developers created a useful tool to define user needs, evaluate performance, and demonstrate the viability and value of the technology for investors. Give the episode a listen!Learn more about RevMedica: https://www.revmedica.com/

Get feedback early to fast-track your robotics design.Start-ups that inherit robotic prototypes from universities or research labs often get caught up trying to get a product out the door. Instead, they should focus on designing a product that will be competitive in the market. Following a chat with Dave Saunders, CTO at Galen Robotic, Andy Rogers sat down with Key Tech Sr. Mechanical Engineer, Danica Mackesey, to discuss the challenges and pitfalls of designing medical robotics.Need to know: Get frequent feedback from end-users. If they don't have complaints, get nervous. View the system as a whole. It's all too easy to get lost in the weeds. Make sure that your designs are manufacturable. This may seem obvious, but it's as big as the difference between theory and practice. The nitty-gritty:The first step in designing for quality is to determine the requirements of the robotics system, including the when, where, and how the system will be used and what features are needed. Once the features have been determined, it's time to consider how well they work for the end-user. This is the audience participation segment of product development, where user input can save you lots of time and trouble. In robotic surgery, surgeons need to feel comfortable and confident with the device. For example, consider the ergonomics of handles and the effects of repetitive motions. Monitors should be easy to view. Of course, a high-voltage robotic system must be safe (Your mantra is, “IEC 60601, IEC 60601, IEC 60601…”), and it also must fit into the environment of the operating room without danger of tipping over or dangling cables, and out of the way of surgical drapes. The earlier you tackle these issues, the better.Temper your forward-thinking design with some down-to-earth risk management. For instance, what happens if the robot stops working in the middle of a procedure? That kind of thinking leads you to designing-in overrides and safety systems.Finally, the answers to many of your design questions (and challenges) are often as near as the phone or email. Ask your end-users. Ask your component manufacturers – they have almost as much riding on your success as you do, and they can provide valuable advice.Give it a listen!

The data you need to design a multi-use surgical robotSurgical robots can do all sorts of things better than humans. But human doctors have a breadth of experiential knowledge and instinct robots cannot replicate anytime soon. Understanding that difference is the key to designing a successful robotic platform. Galen Robotics is expanding the benefits of minimally invasive surgeries by enabling precise surgical maneuvers through human-machine cooperation. Andy Rogers of Key Tech and Dave Saunders, CTO at Galen Robotics, discuss the challenges of designing surgical robots and the importance of collecting key data early in the design process.Need to know: Identify a clinical application that has value for the surgeon Get feedback early and often More prototypes yield more data  Multiple applications help justify cost Converting qualitative data to kinematics is key to optimizing performance The nitty-gritty:Robots are transforming surgery, making it faster, safer, and less invasive. But the majority of surgical robots on the market today are one-trick ponies. Galen has a unique technology for delicate ear, nose, and throat (ENT) procedures that could have many applications. Leveraging different types of data gave Galen Robotics an advantage in the market.A priori knowledge. Galen recognized an unmet need in the marketplace and licensed a concept that was initially developed at Johns Hopkins, so they didn't have to start from scratch. The robot is not the surgical tool; it is a stabilizing platform that holds and manipulates an ordinary surgical tool similar to power steering in a car. Galen Robotics engineers capitalized on the fact that surgeons know how to use the tools of their trade; they just need a helping hand to use the tools more effectively.  This collaborative approach enables surgeons to focus on what they do best –analyze the situation and decide on a course of action– because the surgical robot stabilizes the instruments and facilitates the procedure. Observational data. Engineers went into the OR to see which aspects of specific procedures surgeons found the most challenging to see first hand the scale of motion delicate ENT procedures require. This information proved valuable in driving components choices and materials.Qualitative data. Surgeons have performed head and neck surgeries for decades, so they know what a successful surgery “feels” like. They already have the touch. In this case, engineers were able to use kinematics to turn this trove of anecdotal information into Quantitative data.Quantitative data. Engineers then quantified surgical movements to adjust the “feel” and “tune out” normal hand tremor. This made surgical motions performed by the surgeon feel more natural. They also added in range-of-motion safeguards to help prevent accidental damage to surrounding tissues.Prototyping is essential throughout the whole development process . The more, the better– because no matter how crude– each prototype yields valuable user feedback. For example, one Galen Robotics prototype was modeled on the children's game “Operation”. Doctors at a conference tried to beat the robot, picking a small part out of a slot. Only one succeeded. And Galen Robotics' concept was validated.But ultimately, one of the most innovative ideas Galen Robotics is developing may not be their engineering, but a unique go-to-market plan. A plan that helps hospitals avoid the capital-intensive cost of adding another surgical robotic platform, by licensing a Galen Robotics device once it's approved.Give it a listen.HELPFUL LINKS:https://www.galenrobotics.com/

Clinical and in-home trials are different, but the essentials are the same –solid data, foresight, and flexibility.Clinical trials are understandably rigorous, but in-home trials add a few wild cards into the mix. Andy and Jake spoke with Steve Schaefer, CEO of CoolTech, about this exact topic in the previous episode. Here, Andy and Jake dig into in-home trial design and execution from a product development perspective.Need to know: Approach trials with confidence in your device, backed up by data Know your user: clinical users are different from home users Evaluate the device against all applicable standards, and verify, verify verify. Stay lean, stay simple The nitty-grittyBy now, it's pretty clear that the future growth of med-tech points towards in-home testing and therapy. But you have to jump through more hoops from prototype to commercialization for in-home devices. As the Boy Scout motto says, “Be prepared.”Plan for change. Start with a change control process in place so that you don't make changes that could negatively affect performance down the road. Evaluate your device against all applicable standards at appropriate milestones. Know your user. Clinical users are different from your home user, and each will need different training to use and evaluate the device correctly. Keep it simple. A clinical device may not need all the bells and whistles of a commercial device, so keep it as simple as you can. With in-home trials, you don't have trained clinicians and engineers on hand to monitor the process, so once again, make it simple for users to get it right the first time. For example, with the MiHelper in-home trials, CoolTech used disposable tubes and masks to simplify use and facilitate the trials; commercial products will be multiple use.To get from trial to commercial success, you need to: Connect the dots. Make sure your core parameters match Lock down the software Review features and edit if needed Perform a gap analysis Understand impact of all changes Trace data back to clinical device There are more details and more insight in the podcast. Check it out.

CoolTech Part 2: Get through trials faster, with fewer tribulations.Here, Andy Rogers and Jake Cowperthwaite continue their talk with Steve Schaefer, CEO at CoolTech, about the quest for data with MiHelper: a new in-home therapy device.MiHelper is a drug-free way to treat migraines, cooling the patient with air. The design for the device was piggy-backed (pun intended, as they used a porcine animal model for the original device) onto an existing cooling platform –CoolStat– used for a totally different type of therapy. Even though the platform itself was proven, MiHelper still had to go through the twists and turns of trials because it was a de novo device in this application.Need to know: Understand the commercial product requirements before you start To get from clinical trials to home trials as quickly as possible, develop platforms concurrently Drive value every step of the way Essentials to bridge the gap from trial to commercialization: market, pricing, and reimbursement models The nitty-gritty:Oxygen therapy has been used to treat migraines in the past, but devices were too bulky and complex for at-home use, until a prototype study at Johns Hopkins indicated that room temperature air could do the job. When CoolTech worked with their engineering partner to adapt their existing CoolStat evaporative cooling platform, the objective data panned out, and patients reported relief from migraines using the device. So MiHelper was born. That was the easy part, relatively speaking.The thorny path is the road to clinical trials, in-home trials, regulatory approval and ultimately, commercialization.  For clinical trials in this case, a subject had to develop a migraine, travel to the hospital, receive the therapy, and then report about relief – a lag time of several hours. At-home trials require an additional level of device confidence, which is being achieved through design verification, biocompatibility testing, and electrical safety & EMC testing.  There are more wild cards, starting with shipping the device to test subjects. (CoolTech found a contract manufacturer who could drop-ship and re-process them). Recruiting test subjects was done through social media, and because the data is digital, the study center doesn't have to be local, allowing for larger sample sizes.  Data tracking and security is another big issue that CoolTech solved with a one-way app. To speed the whole process along, CoolTech developed the trial device and in-home platforms concurrently. To support at-home trials, CoolTech is using a “small-but-mighty” team of in-house people and contractors, which allows for flexibility and quick response. This way, they can channel resources into generating high-quality evidence and driving value. The MiHelper trials have yielded a couple of valuable tips for any start-ups going into home trials.1. Try to partner up with emerging companies using convergent technologies. 2. Partners could range from privately funded research to oversight by a clinic, or anything in between.  2. When evaluating data, it's the quality of the evidence, not the name on the paper, that counts. The market for in-home therapy is growing by leaps and bounds. And the profit potential is huge. But get your ducks in a row before you jump into the pond. That way, the path from drawing board to commercialization will be smoother and more straightforward. There's more. The whole story is right here, and well worth a listen.HELPFUL LINKS:https://www.cooltechcorp.com/https://www.nih.gov/

You don't know where test data will lead, but you can follow it if you plan aheadA few weeks ago Andy and Jake Cowperthwaite spoke with Steve Schaefer, CEO of CoolTech, about designing your device as a platform. Steve's company was able to use their temperature management platform to develop two devices, for two distinct applications.They were able to achieve this by designing enough flexibility into the initial design, which is what Andy and Jake discuss in depth this time around.Need to know: Design the device as a platform with flexibility to facilitate future changes Let the end user tell you what the ideal architecture should be The more data logging, the better Four critical areas to allowroom for improvements: software, electronics,, mechanical modules, and service access  The nitty-gritty:When thinking about flexibility, there are four core elements to keep in mind.Flexibility in Software DesignPlan for software upgrades and how you will deliver them. Plan to log as much data as possible, because you never know what data you will need.Flexibility in Electrical DesignEnsure your power supply can support new features. Include hooks on circuit boards for future sensors and actuators.Flexibility in Mechanical DesignFocus on modularity, so you can change parts of the hardware without impacting the entire device.Flexibility in ServiceabilityFocus on easy access to internal components, and make disassembly and reassembly as easy as possible. While you can't plan for everything, doing preformative testing early, and letting your prospective end users tell you what the ideal product architecture and use case should be. This way, once you get into a trial, the development changes are very technical in nature, rather than being due to the device not being easy to use.For a great example of how to do this, take a listen to our interview with Steve Schaefer. HELPFUL LINKS:https://www.cooltechcorp.com/https://www.nih.gov/

How to get from “data” to “device”: one cool story.What data you need, where you get it – and most importantly – what you do with it, all determine whether a medical device will be successful. Of course, every technology has its own set of caveats, but it always helps to hear from people who have been there.In this episode, VP of Business Development Andy Rogers, and Senior Electrical Engineer/Partner Jake Cowperthwaite, both of Key Tech, talk with Steve Schaefer, CEO at CoolTech, about the quest for data with CoolStat: a new way to manage patient temperature in fever that can develop following a stroke, traumatic brain injury, seizure, or metabolic encephalopathy. There are other technologies that manage patient temperature, but CoolTech partnered with a engineering team to build a way build a better mousetrap. CoolStat generates filtered air that's delivered to the patient via a nasal mask air tubing set. It cools through evaporative cooling, using room temperature air. CoolStat is smaller and lighter than existing devices; it reduces side effects like shivering which can lead to complications – and shortens treatment time. Need to know:●       Understand the commercial product requirements before you start●       Your regulatory path depends on your specific device●       Go where the data leads The nitty-gritty: The initial data that drove CoolStat's development was collected from tests on pigs, who have similar physiology to humans.  In this case, because they were seeking objective data – rate of cooling, rate of air flow and efficiency of cooling – CoolTech was able to save time by using existing temperature probes and storage software.  The first results were okay, but less than optimal. For many companies, this can be a go/no-go point, where you decide to fish or cut bait. CoolTech opted to pause the study, make changes, and go back to the FDA with an improved device. Finding human subjects for testing was another challenge. Patients are typically unconscious in the ICU, so getting family consent is laborious, especially during the COVID pandemic. Patient data is recorded on CRF's and validated within 24 hrs. so engineers can quickly make changes based on this real-world info.   CoolTech found that partnering with outside resources, such as the National Institutes for Health (NIH) university hospitals, and end-user associations can help to expedite development. Clinical studies will be completed soon. Now the critical numbers for CoolStat are the savings that hospitals can reap using this exciting new technology.  Listen in for more data. And more details. HELPFUL LINKS:https://www.cooltechcorp.com/

Managing Blood When Evaluating Consumable / Durable Medical Devices“Blood is thicker than water” the old saying goes. There's truth in that adage, especially when it comes to designing and running de-risking experiments of blood processing systems.Whole blood is a two-phase fluid, comprised of both cells and plasma. Under pressure, it's fickle and unpredictable. And those unique fluidics present distinctive challenges in designing medical devices.Blood management is the central concept in cardiac care, the largest segment of the medical device market. As the home care market continues to grow and devices become smaller, blood management becomes a more and more critical design issue.This month, Mechanical Engineer Katie Goetz and Andy Rogers of Key Tech talk blood: how it poses problems in medical device design, and how to get blood to do what you want it to do.Need to know:Why blood fluidics are differentHow to engineer your device for optimum flow controlHow storage methods, freshness of samples, and interactions can affect test resultsHow to deal with bubblesThe nitty-gritty:A blood analog may work fine in the early stages of testing, but nothing replaces testing with the real thing. Whole blood is thick and complex, and the viscosity varies due to many factors. That makes for some challenges when you want to make blood flow the way you want it in a complex consumable. Blood differs from person to person too, so medical devices must be capable of dealing with a wide range of conditions. Blood also interacts with metals, plastics, and air differently, which can also skew test results, so proper cleaning of prototypes is critical. And then there's foaming, which adds risk and time to your test planning.Even the logistics of blood are complex. Anyone who's doing testing needs to be trained how to work with blood and clean it up. Ordering blood takes a few days, and sample blood may need to contain additives like EDTA or other anticoagulants, so when you are designing and running experiments, you have to take this into account.As we said, blood is complicated.  But if you take it step-by-step, and follow the protocols, you can make blood behave the way you want it to. And you'll make your device all that more robust.Helpful linkshttps://www.iso.org/standard/38421.html

Decrease Time-to-Market by Developing Medical Device Software “In the Spirit” of IEC-62304Getting any new medical device to market is a race against time, and it's so tempting to jump in and start coding from the get-go. But hold your horses –  you'll save time in the long run, and potentially improve the valuation for your company, by following the spirit of IEC-62304 throughout each stage of development.This standard impacts the entire software development lifecycle: from initial requirements and coding to release and maintenance. Understanding when and how IEC-62304 applies can potentially save you months of backtracking in the race to get your device to market.Check out this video as Computer Engineer Jamie Kendall and Andy Rogers lay it all out and explain how “working in the spirit” of the standard can keep you on track, on time, and in compliance, particularly when developing non-regulated devices.Need to know: How to define the right architecture The trade-offs of building documentation as you go vs. retrofitting How existing code libraries and re-using compliant modules built to the IEC-62304 standard can keep you from “re-inventing the wheel” What tools can make the process smoother? How 62304 compliance can affect company valuation. The nitty-gritty:IEC-62304 lays out a unified process for evaluating safety in medical devices sold in the US and EU. The software safety classification, Class A, B, or C determines the safety-related processes you'll need to use. With non-regulated medical devices, you're working within a highly-structured environment, without the formalized legislative pressure. Choosing to focus on specific areas of IEC-62304, even without the requirement, balances the key factors of time and risk management. And when you understand precisely how the regulations apply, you can stay in compliance without going for all-out unit testing at each stage of development. It's important to identify interfaces from the very beginning. Think through what goes where: for instance, what should be firmware and what should be PC-based software. You can use pre-engineered software or existing code/ libraries for things that are not unique to the system (stepper motors, pump etc.) so you're not reinventing the wheel at each stage.For example, using a single micro-controller on your platform gives you a good reusable framework for low/mid-level modules, especially when these are designed to IEC-62304. In addition, you can use a methodology like AGILE project management, tools like ReSharper, or static analysis techniques to help you maintain quality and compliance.Keeping within “the spirit” of 62304 at each stage of development allows you to focus on key parts of the system and make needed changes in days versus weeks. By adding value to your device in this way, you're building value for your entire company.Helpful linkshttps://www.iso.org/standard/38421.html

Focus on The Assay to Improve Overall IVD System DevelopmentAssay performance should be the priority when developing complex cartridge and instrument systems. The Assay is King! As assays are becoming more complex, taking an “inside-out” approach to IVD System Development is optimal for project success.This approach starts with first defining what the assay needs to do, then figuring out how to automate that process on the cartridge, and only then focusing on what a commercially viable instrument will look like. This leads to reduced costs, shortened timelines, and superior diagnostic performance. Put another way, the assay team should be the customer when architecting and developing IVD Systems—the chemistry should drive the project.How to implement the inside-out approachDefine the Assay FirstThe assay is where the magic happens and is where the intellectual property lies. That IP is what drives future acquisitions by global diagnostic players. For example, Roche recently acquired GenMark along with the ePlex system that Key Tech helped develop, to broaden its molecular testing portfolio.At the end of the day, the instrument serves the cartridge and the cartridge serves the assay. Before starting any product design work, you need to understand whether the chemistry is locked down. Is the benchtop assay working? If not, it may make sense to wait until it is, to avoid costly rework later.Our CEO and Co-Founder, Jenny Regan, stresses the importance of solidifying assay performance before instrument design:“Anyone can design a beautiful instrument that doesn't work. It's easy to do because it is a tangible milestone for investors and developers alike. The pressure to do that and make something that looks great before doing the nitty-gritty, difficult work of making a working assay is all too easy to fall into.”Collaborate on Menu Planning EarlyIt is critical to not only understand the lead assay, but also what other assays are being planned so that both cartridge and instrument can be planned accordingly. Early collaboration with the assay team will ensure that fewer changes and post-market updates need to be made. This approach also affects speed of regulatory approval, since most changes that need to be made to the cartridge or instrument, to support a new assay, will require applying for re-approval.For example, consider reagent quantity. If your lead assay requires eight reagents, but a few others need ten onboard, you need to ensure that the planned cartridge design takes that extra requirement into account and leaves space for the additional two.Sample type is another consideration. If the lead assay is going to work with a saliva sample, but a future panel will use a stool or blood sample, you need to ensure the cartridge is designed to be able to handle the future, additional sample types.De-Risk and Validate Assay Automation EarlyBecause a working assay is the end goal, it's critical to get working automated cartridge/instrument prototypes to the assay team early so they can validate that the chemistry is still working, and to design a workflow for their assay. It needs to be easy for the assay team to collect data and interact with these early prototypes.Often, this means developing test fixtures for each critical step in the assay process. When translating an assay from the bench to the cartridge, there could be steps that only work part of the time on the bench. These must be confirmed to work 100% of the time on the cartridge. Or there could be steps that always work on the bench, but are extremely complex to automate, requiring validation to see if that specific step is even practical in an automated instrument.At Key Tech, we have a proprietary software platform for hardware interaction, called KeySharp, that allows the assay team to control a prototype instrument while seeing a graphical engineering view of what the cartridge and instrument are doing. With this tool, they have a way to interact with the prototype, adjusting and testing variables, and designing a workflow for their assay.Constant Collaboration for Real-Time FeedbackThe “assay is king” approach requires an ongoing conversation between the engineering team and the assay team, and a consistent feedback loop.The traditional outside-in approach often creates unnecessary constraints on the assay team by forcing them to operate within an engineered product that was developed without them in mind. If the assay team has tweaked the bench assay to generate a better or quicker result, the design may not be able to support it.Pivots and updates in the bench assay are commonplace, so constant communication is the only way to anticipate and adapt the development effort in a timely way.Parallel Development of Cartridge and InstrumentOftentimes, three teams are working on a project – assay team, cartridge team, and instrument team – which makes efficient development exponentially more difficult. Especially if coordinating across multiple organizations.On the other hand, parallel cartridge and instrument development by a single interdisciplinary team eliminates conflicting priorities and incentives between vendors. This integrated approach helps your IVD system get to market faster, as both instrument and cartridge are developed under one roof toward a common goal. Ultimately serving the assay, designing the cartridge and instrument in parallel reduces your overall development process time and cost.Not all design and development firms offer both IVD cartridge and instrument design expertise to support a successful assay. Ben Lane, our Director of Engineering, shares,“Our claim of integration is truly the case. We have cartridge designers and instrument designers who are literally sitting next to each other and talking to each other all day long.”In SummaryAssays are becoming more and more complex, and ensuring that platform development actually serves the assay is critical. Placing your assay and engineering teams in constant collaboration and tackling de-risking, menu planning, and validation early in the process will lead to project success.

The market for medical devices for home use is projected to grow more than 20% to over $7 billion by 2027, driven by increased awareness of the importance of self-monitoring, an increase in lifestyle-driven diseases such as diabetes, and – in no small part– infectious diseases such as COVID.But the home environment is a far cry from the usual clinical setting, and it presents unique challenges in product design. Key Tech's Rachael Scott, Sr. Engineer, and Andy Rogers, VP of Business Development, talk about the challenges and provide valuable insights.What you need to know: How to work within the regulatory frameworks (FDA ANSI/AMMI 60601 -1 safety standards HIPAA, and more) Why the home environment is more demanding than a clinical setting When is the best time to test and de-risk Where your design can go wrong and how to prevent it The nitty-gritty:Begin with a good understanding of the home environment. These considerations affect your choices in electrical safety, screen size, GUI design, portability,  and durability. Expect the unexpected; untrained users, children, and pets are just a few wild cards that should figure in your design.  Make sure you have a way to offload and disseminate results in a user-friendly way. Interfaces are always critical, especially where HIPAA compliance is required.. Above all, get your prototypes into a home environment early in the design stages, and give them this reality check frequently.Helpful links:https://www.fda.gov/media/84830/download

A successful pharmaceutical device takes the entire drug journey into consideration - from manufacturing to packaging, to shipping, and finally patient administration. As drug delivery moves from the hospital to the home or other remote environments with untrained users, you need to consider end-user challenges along with technical fluidic control challenges to provide accurate dosage and delivery. Pharmaceutical devices are becoming more powerful., moving higher volumes of fluid over longer periods of time, all while remaining small, inexpensive to ship, and simple to use - often in remote settings. Empathizing with all users along the drug journey is key to balancing these often competing interests and, ultimately, commercial success. Hear Key Tech's engineers discuss how to solve these seemingly unsolvable drug delivery challenges.

At Key Tech we specialize in end-to-end product development for medical, industrial and consumer products, but the largest segment of our business is in vitro diagnostic (IVD) platforms. So we understand what it takes to take an IVD device from bench to market. Over the years, we've built an interdisciplinary team of scientists, engineers, and designers to partner with companies large and small. But for many companies, it makes sense to develop product development capabilities in-house. So here are a few tips about putting your own team together, from people who have been there before.

Understanding Risks, Tradeoffs, and Prioritization in Your Next Automated Assay Development Program:1. Product StrategyWorking backwards from the commercial goal, the purpose is to understand key drivers of product architecture and identify technical risk. Driving decision-making throughout development: intended price target and use case.2. Ease of UseIdentify which areas of the eventual product are most valuable to automate, and which are better left as manual user steps. Understand the risks and tradeoffs between the complexity of automation and the likelihood of human error.3. Sensitivity AnalysisBreak down assay steps and establish clear technical requirements for each step, as well as their interdependencies. Allow the engineering team to know what variables need further study to accurately assess technical risk.4. Consumable/Durable InterfaceFocus on device functionality and where features will reside in the system: what belongs on the cartridge and what belongs on the instrument to achieve performance and system requirements?5. Reagent HandlingConsider how reagents will be introduced to the assay: through durable containers at large runs or on the consumable in small doses. Reagent handling dictates high-level architecture decisions, best addressed early for optimal product architecture.6. Fluidic ControlPrecise liquid handling is a core challenge in assay automation. Identify how liquids, and typically air, will be controlled in a reliable, repeatable way, consider automation solutions for fluidics control, and address contamination sensitivity.7. Temperature ManagementDevelop methods for measuring and controlling temperature by understanding the effects on the instrument, cartridge, and assay performance.8. Algorithm DevelopmentThe data processing algorithm is often the core value proposition and differentiator being brought to market. Two factors ensure a clinically actionable test result: understanding the limits and constraints of the algorithm and recognizing the instrument requirements that the algorithm demands.9. Tech De-Risking MethodsIdentify what risks need to be mitigated and where various de-risking methods should be deployed. Methodology options include creating testbeds, modeling and simulation, and subcomponent specialist consulting.10. ScaleThe framework bookend considers the impacts of high quantities and long-term use on the instrument and cartridge reliability, cost, and performance. Understand whether the device can work in large numbers and what strategies should be employed to improve reliability and performance while containing cost.

Welcome to med tech speed to data, a key tech podcast, where we interview med tech leaders about the critical data-driven decisions they make during their product development process.