MedTech Speed to Data

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: k...

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 dev...

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 t...

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 fo...

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...

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...

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...

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, D...

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 pr...

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...

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 an...

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...

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/P...

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...

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 de...

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 what the assay needs to do, then figuring out how to...

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...

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...

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. B...

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 of Use Identify which areas of the eventual produ...

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.