Why Flex is betting on stretchtronics for medtech

The wearable lab at Flex (formerly Flextronics) reports it’s making strides when it comes to creating devices that are transparent and seamless. “Usually when you think about healthcare, you picture a person in a bed with wires running all around. We think healthcare should be as easy as putting on a T-shirt,” said Flex CEO John

EY, Evaluate are upbeat about the medical device industry: Here’s why

The medical device industry is growing at a healthy and steady pace, according to new reports that EY and Evaluate released today during AdvaMed’s annual Medtech Conference. “The results of this year’s report is a direct contrast to last year and tells a positive story about the future of the medtech industry,” said EY partner

This Dräger newborn incubator focuses on ‘intact survival’

The latest in incubator technology from Dräger focuses on long-term health and quality of life, as well as survival. One device paying particular attention to these trends is the Babyleo TN500 IncuWarmer beds from Dräger. Florida Hospital announced it’s the first in the United States to implement the Babyleo beds. The beds are being used in

The startup pivot: How to rethink your medical device company

In the medtech market, startups have to be flexible; the startup pivot is crucial. “Companies have to morph as they go,” said Maria Palasis, CEO of bioresorbable drug delivery system company 480 Biomedical. Palasis explained that startups, and even mature companies should expect to shift their technology in one way or another through the course of

What’s next in 3D printing prototypes

Tony Holtz, Proto Labs 3D printing is advancing, especially for medical device applications. Printer developers are making leaps when it comes to achieving finer resolution and prototypers are improving steps for secondary processes. The 3D printing technology has enabled improvements in micro resolution features and clarity for lenses and microfluidics. The improved secondary operations have created

Medtech innovation: Here’s how you speed it up

Here’s how medtech can speed up its processes and tap into innovation, courtesy of Peter Douglass, director of technical operations at Proto Labs. Innovation in the medtech space is what every company wants. And there are many theories on how to get there. One is that improving the speed at which you develop will naturally

FAIs: When do you use conventional versus digital inspection methods?

Tony Holtz, Proto Labs First article inspections (FAIs) can be time-consuming and costly, but they are a necessary step in getting medical devices from product design to production. Medical device manufacturers are likely familiar with the process, although most leave it to suppliers to handle. Even if that is the case, device makers should get

FDA’s medical gas guidance offers clarity to manufacturers

FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003. A review under FDASIA in 2015 noted that minor guidance updates and better inspector training would improve the regulatory […]

5 mistakes that can turn your product registration into a money drain

Medical device registration may seem straightforward but is actually prone to potentially costly mistakes.  Medical device organizations are required to register medical devices with notified bodies in all countries where they sell those products. This process is fairly well understood and expected. However, there are pitfalls in the practice of compiling the dossiers to register,

Insights into fastener torque auditing and certification

An improperly torqued screw can mean the difference between passing certification and product failure. A new technical article from Futek outlines the importance of gasket and seal integrity validation, as well as third-party repair certification, and standards compliance and traceability in this fastener validation process. Requirements for tool verification are similar, whether the end product is

Microinnovation: what paper towels have to teach us about medtech

How can you double the efficiency of a paper towel? Turns out you don’t need to reformulate or make the paper thicker. Instead, you find a simple concept that offers users a new way to think about the product. That’s what happened when paper towel manufacturers began producing the half-sized sheet. Roger Smith thinks the

What is the hardest thing about medtech IoT?

The medtech IoT space is fraught with decisions that can make or break a product launch. There are several points at which developers in the space might want to throw their hands up or put their head under the covers. We asked some device experts to share their toughest lessons from IoT in the medical

UDI laser marking: Here’s the key to making it durable

Optimized lasers and passivation can make the difference when it comes to creating durable UDI laser markings for medical devices, according to a new long-term case study. Tuttlingen, Germany–based Add’n Solutions, worked with FOBA Laser Marking+Engraving to test the marking processes. The results found that FOBA’s short pulse fiber making lasers worked better when optimized to adapt to

How Consensus Orthopedics added smarts to orthopedic devices

Consensus Orthopedics made headlines with its TracPatch this year. So how did an ortho company get a digital product to market? Let’s face it, orthopedic devices are dumb. That is to say, they are mute. Silent. And in today’s healthcare environment, the silent kind of dumb is dangerous. Consensus Orthopedics (El Dorado Hills, Calif.) wanted to

Abbott’s new contact ablation catheter: Here’s what you need to know

The new TactiCath contact ablation catheter unites EndoSense and St. Jude Medical technologies that Abbott acquired, marrying fiber optics, flexibility and 3D mapping. If you want your grilled cheese to cook faster, you press it into the pan with your spatula. That’s contact force, the principle behind Abbott’s TactiCath contact force ablation catheter, according to