Speed-to-data determines go-to-market success for medical devices. You need to inform critical decisions with user data, technical demonstration data, and clinical data. We interview med tech leaders about the critical data-driven decisions they make during their product development projects.
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 …
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 i…
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. Thi…
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 therape…
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) monitor…
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, …
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. …
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…
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, t…
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 can…
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…
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 Mi…
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…
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 cou…
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…
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 co…
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 becomin…
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…