About 10 years ago, there were a number of notable trends and market forces which began to, once again, change how the medical device manufacturing sector brought its products to market. They’re still shaping the market we have today. Andrew Potter, Bonifacio Consulting Services, and Chris Delporte Perhaps the true measure of a forward-thinking industry […]
FDA releases top 3 medical device regulation goals
FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paper that FDA’s CDRH released today. The agency said the priorities further its overall goal of providing Americans with more timely access to the latest high-quality, safe and effective medical devices. […]
Report slams European Union’s high-risk medical device approvals rate
A health economics and outcomes research group has concluded that the assessment for high-risk medical devices in the European Union is of low quality and needs improvement. The report appears in the December 2017 issue of Value in Health by ISPOR. Get the full story on our sister site Medical Design & Outsourcing.
What is the future of medtech in 2018?
Some of the largest medtech companies showed in 2017 that they are ready to grow through embrace the new healthcare ecosystem. Medical device companies are putting greater emphasis on value-based. They’re putting more attention to clinical and economic research and adopting digital products that incorporate machine learning and data integration. Questions, though, still remain as […]
These 5 surgical startups want to build the OR of the future
As with most medtech advances these days, a running theme among top surgical startups is value. Innovators presented their surgical platform products in various stages of development at this year’s AdvaMed MedTech Conference as part of the Medtech Innovator Program, offering a view of the future of ORs across the world. As mentioned, there are some running […]
Medtronic’s CEO thinks value-based care is really important: Here’s why
Value-based care is the future of healthcare, and according to CEO Omar Ishrak, it is the past, present and future of Medtronic. Ishrak spoke at OCTANe’s Medical Technology Innovation Forum (MTIF) this week about the opportunity and responsibility medical device companies have when it comes to adopting value-based care models. In this future, Ishrak sees […]
Who got picked for FDA’s digital health pre-cert pilot?
FDA has announced the names of the companies selected to participate in its digital health pre-cert pilot – a first-of-its-kind program aimed to revolutionize digital health regulation in the U.S. Dr. Scott Gottlieb, FDA’s commissioner, announced the nine participants of FDA’s digital health software precertification pilot program (FDA Pre-cert) last week during his keynote address at the AdvaMed MedTech […]
Should the medical device industry pay user fees to CMS?
Achieving reimbursement from payers has become a major challenge for medical device companies. Could the solution lie in having them pay user fees to CMS – the way they do to FDA? That was the question floated by Nadim Yared, president of CVRx and the current chairman of AdvaMed, during this week’s Medtech Conference powered by […]
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 John Carlson, president of health […]
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 […]
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 […]