MedTech Speed to Data

The Advantage of Rapid Prototyping in Wearable MedTech Development

Modern cancer treatments are getting better at targeting specific forms of cancer. However, this improved effectiveness often introduces lethal side effects. Skribe Medical is developing wearable technologies to help oncologists monitor and manage these side effects and ultimately improve cancer survivability.

In Episode 45 of the MedTech Speed to Data podcast, Key Tech’s Andy Rogers has a conversation with Ryan Neely, Skribe Medical’s CEO and co-founder, about the startup’s approach to rapid prototyping, clinical trials, and wearable technology.

Need to kno...

Design for Security from the Start: Making Medical Device Cybersecurity More Resilient

MedTech innovation is revolutionizing healthcare but is also introducing new cyberattack vectors that can put manufacturers, hospitals, and patients at risk.

In Episode 44 of the MedTech Speed to Data Podcast, Key Tech VP of Business Development Andy Rogers and Senior Computer Engineer Jamie Kendall discuss the FDA’s latest cybersecurity guidance.

Need to know

HSBC Innovations is the global bank’s financing arm for American and European startups, especially in the healthcare and life sciences industries. The bank’s semi-annual Venture Healthcare Reports document trends in the investment market.

Key Tech’s Andy Rogers welcomes the report’s author, HSBC Innovation Managing Director Jon Norris in Episode 43 of the MedTech Speed to Data podcast.

Need to know

In-utero procedures can yield better long-term outcomes for the baby. However, fetal surgery relies on instruments developed for other disciplines. An early-stage startup in Maryland is developing in-utero instruments to improve outcomes for both fetus and mother.

Fetal Therapy Technologies CEO Selena Shirkin joins Key Tech’s Andy Rogers for Episode 42 of the MedTech Speed to Data podcast to discuss startup innovation in fetal surgery.

Need to know

Epinephrine auto-injectors, first developed in the 1970s, are the most common emergency treatments for anaphylaxis, often deadly allergic reactions. The limitations of liquid epinephrine and the device’s decades-old technology have kept these life-saving devices out of patients’ hands. Austin-based startup Windgap Medical, Inc. plans to break these barriers with a more convenient, shelf-stable alternative.

In Episode 41 of the MedTech Speed to Data podcast Key Tech’s Andy Rogers and Thomas James sit down with Windgap’s co-founder and Chief Business Officer, Brent Buchine, to discuss the data-driven development of the company’s life-saving technology.

Need to...

Hundreds of approved devices use artificial intelligence to help physicians diagnose patients faster and more accurately. Brooke & Associates is a legal and regulatory advisory firm that helps medical device makers get AI-powered devices through FDA pre-market approval.

In Episode #40 of the MedTech Speed to Data podcast, Key Tech’s Andy Rogers and Lei Zong speak with the firm’s managing member, Jason Brooke, about the FDA’s latest guidance to medical device developers for integrating AI into their products.

Need to know

Successful organ transplants depend on quickly getting donor organs to their recipients. MediGO, now part of CareDx, pioneered logistics technologies that help make these life-saving procedures more successful than ever.

In Episode #39 of the MedTech Speed to Data podcast, Key Tech’s Andy Rogers and Lauren Eskew speak with MediGO co-founder Dr. Joseph Scalea about how data led the startup to solve challenges in the organ donation supply chain.

Need to know

America’s nationwide organ donor network — From Hawaii and Alaska to Puerto Rico, patients are on a nationwide waitlist for compatible donor...

Ohio-based Avation Medical has developed a bioelectric wearable device for at-home treatment of overactive bladder, promising improved quality of life for patients suffering from the most common cause of incontinence and urinary urgency.

In Episode #38 of the MedTech Speed to Data Podcast, Andy Rogers discusses the Vivally System, entrepreneurship, and more with Avation Medical co-founder Jill Schiaparelli.

Need to Know

Transforming Chronic Pain Treatment with a Lean, Data-focused Development Strategy

Based in Washington, DC, AlgometRx has developed a technology platform that will let clinicians perform objective pain assessments to improve treatments for chronic pain.

In Episode 37 of the MedTech Speed to Data Podcast, Key Tech’s Andy Rogers and AlgometRx Chief Operating Officer Kevin Jackson discuss how collecting the right data sped the Nociometer platform’s development.

Need to know

Pain diagnosis is challenging — Patients self-report their experience, which is inherently subjective and variable.

Pain treatment involv...

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...

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 sc...

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 phy...

Astek Diagnostics is a Baltimore-based MedTech startup developing a platform for diagnosing urinary tract infections (UTIs) with unprecedented speed and accuracy.

In Episode #33, Key Tech’s Andy Rogers and Lauren Eskew discuss this exciting development with Astek Diagnostics co-founder and CEO Dr. Mustafa Al-Adhami.

Need to know

Blackbird Labs is a life sciences accelerator with a mission to develop Baltimore’s biotech startup ecosystem. Funded by the owners of the Baltimore Ravens, Blackbird’s focus is on bridging the gap between research labs and clinical trials.

In Episode #32, Andy Rogers of Key Tech talks with Blackbird Labs CEO Matt Tremblay about Blackbird’s integrated initiative to foster life science and biotech research in Baltimore.

Need to know

Building Baltimore’s biotech infrastructure — The Baltimore area is home to some of the nation’s top biotech research institutions with lots of mid-career t...

MicrofluidX is an early-stage developer of cell and gene therapy manufacturing platforms that aims to streamline the transition from laboratory research to large-scale GMP manufacturing.

In Episode #31 of the Speed to Data podcast, Key Tech hosts Andy Rogers and Director of Strategy Lei Zong speak with Dr. Lindsey Clarke, MicrofluidX Vice President of Commercial, about the company’s solution to advanced therapy commercialization.

Need to know

Cell and gene therapies are revolutionizing medicine — Since the 1990s, these therapies have opened new avenues for curing once-terminal conditions like cancers and heart disease.

Howe...

Diversity and inclusion (D&I) are essential to sustainable business cultures, nowhere more so than in the MedTech industry, where a product’s success can depend on its acceptance within a variety of communities.

In Episode #30, KeyTech’s Andy Rogers and Senior Mechanical Engineer Danica Mackesey sat down with Sarah Hassaine, ResMed’s Head of Global Inclusion and Diversity, about fostering environments where multiple voices get heard.

Need to know

Changing lives globally —ResMed is a global manufacturer of CPAP systems for at-home sleep apnea treatment and ventilator solutions for out-of-hospital care settings...

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

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 know

Tube feeding is extremely common — Every year, half a million new patients, from infants to geriatric patients, can’t swallow solids or liquids and require an alternate means...

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 vagi...

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 imagi...

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...

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...

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...

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 pi...

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 i...

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 syste...

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 consumable...

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:

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...

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:

The data you need to design a multi-use surgical robot

Surgical 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 t...

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:

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 thro...

You don’t know where test data will lead, but you can follow it if you plan ahead
A 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:

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 pa...

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 s...

Decrease Time-to-Market by Developing Medical Device Software “In the Spirit” of IEC-62304

Getting 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...