MediBeacon (St. Louis) recently announced that it has won FDA breakthrough device designation for its Transdermal GFR Measurement System (TGFR). TGFR is one of several products granted breakthrough status, FDA’s expedited path outlined in the 21st Century Cures Act. The product measures glomerular filtration rates (GFRs) in patients with impaired or normal renal function. TGFR is considered […]
4 historical medical devices that will horrify you
The history of medical devices is fraught with misguided ambition, shots in the dark, and, of course, quackery. It is also full of unbelievable invention. When we look back at our medical past, we might see the early iterations of technologies today. There were mistakes, but there were also the early seeds of progress – […]
FDA to revamp medtech cybersecurity — with your help
FDA recently announced that it is taking additional steps to boost medtech cybersecurity, and it’s seeking outside help to do. The agency will soon release a new draft of its premarket guidance document to combat the growing threat of cyber attacks. In addition, the agency announced multiple partnerships with manufacturers, hospitals and more — as […]
When product development goes sideways (and how to fix it)
Product development going wrong? You may need a tiger team. Jeff Champagne and Eric Claude, MPR Associates, Inc. We would all like for product development projects to go smoothly and predictably, but you know what they say about “the best-laid plans.” Robert Burns aside, when needed technologies do not integrate as easily as planned, hardware or […]
Medtech should think more deeply about the problems it’s trying to solve
Medtech can improve by thinking more about the problems it is trying to solve and looking outside of normal avenues for inspiration. [Photo by Sinan Helfenstein on Unsplash] Jeff Karp, Brigham and Women’s Hospital, Harvard Medical School. For companies and academics aiming to innovate in the medical space, we often don’t spend enough time thinking about the problem […]
How suppliers are taking drug-delivery tech to the next level
Medical device industry suppliers and outsourcers are helping to enable the latest drug-delivery tech. Drug-eluting technologies are moving beyond stents, thanks in part to the development of polymeric hydrogels engineered to respond to a range of different physical and chemical stimuli. Medtech innovators have figured out how to use hydrogels as components of micro-shells or […]
4 ways medtech contractors are evolving (and why)
The present and near future for medtech contractors will rely on specific strategies such as tiered partnerships and consolidation, an emphasis on speed, and owning therapeutic and technology spaces. Andrew Potter, Bonifacio Consulting Services, and Christopher Delporte In the first article in this series, we examined some of the important trends during the last 10–15 years […]
Drug delivery needs better human factors
Adopting neuroscience-based human factors methods could yield better outcomes for patients, improved communication design and engineering teams, and maybe even help companies build IP. The methods behind assessing human factors in medtech are outdated—and they’re due for an upgrade, said Charles Mauro CHFP, of Mauro Usability Science. “The type of research employed to determine if […]
ResMed is disrupting connected health: Here’s how
Here’s how a respiratory firm took control of the connected health and the medtech digital revolution. When you think powerful digital connected devices, the first thing to pop into your head probably isn’t a CPAP. Continuous positive airway pressure has been shown in numerous studies to be effective in improving sleep apnea and preventing a […]
7 digital health startups you need to watch in 2018
If you want to see where the big money is going in healthcare these days, digital health products are the place to look. Digital health startups raised $11.5 billion in 2017, up 27 percent over 2016, according to the StartUp Health Insights Year End Report. Digital health startups are doing everything from enhancing patient-provider relationships to […]
Expect high acquisitions, possible bidding wars in 2018, medtech expert says
Look for another strong year for medtech acquisitions in 2018 — and even potential bidding wars — predicts patent attorney David Dykeman. The wave of mergers and acquisitions in the medical device industry should continue this year, both in terms of value and volume, according to patent attorney David Dykeman. “Many large medtech companies are […]