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. Jos…

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,…

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 O…

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 …

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…

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 appr…

Astek Diagnostics is a Baltimore-based MedTech startup developing a platform for diagnosing urinary tract infections (UTIs) with unprecedented speed and accuracy. In Episode #33, Key Tech’s Andy Rogers and Lauren Eskew discuss this exciting development with Astek Diagnostics co-founder and CEO Dr. Mustafa Al-Adhami. Need to know UTIs are proliferat…

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 integra…

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…

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…

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 r…

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 A…

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 abou…

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 wi…

By Key Tech

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 companie…

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 re…

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-tur…

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 d…

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 tec…

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 …

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…

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 …

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 dem…

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 R…

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 surgic…

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…

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 benef…

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 …

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 pigg…

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 ab…

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 Develop…

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 an…

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 th…

Focus on The Assay to Improve Overall IVD System Development Assay 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 wha…

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 clin…

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 …

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 desi…

Understanding Risks, Tradeoffs, and Prioritization in Your Next Automated Assay Development Program: 1. Product Strategy Working 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…

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.By Key Tech