FDA funds a handful of pediatric device innovation groups around the United States. But Dr. Gwenyth Fischer, director of The Pediatric Device Innovation Consortium at the University of Minnesota, thinks there’s something that sets the seven-year-old group apart. The Minnesota group, Fischer said, is focused not only on funding but on getting doctors and other academics
Medical device startups: Here’s how you handle verification and validation
April 13, 2018 By Leave a Comment
The two “Vs” — also known as V&V, verification and validation — serve to link the medical device product that has been developed all the way back to the initial customer needs and product requirements. Bill Betten, Betten Systems Solutions While many think that verification and validation only occur at the end of the medical device development
Webinar: How Boston Scientific selected its PLM medical device software solution
April 5, 2018 By Leave a Comment
Thursday, May 3, 2018 2 p.m. Eastern time / 11 a.m. Pacific time As a global medical device manufacturer, Boston Scientific must balance quality, innovation, compliance, and profitability. This panel discussion provides insight into how Boston Scientific supports those needs. Listen to Tina Kunshier, Boston Scientific and Michelle Boucher, VP of research for
Genae acquires Hilbert Paradox
March 30, 2018 By Leave a Comment
Medical device contract research provider Genae (Antwerp, Belgium) recently acquired the digital health data management platform Hilbert Paradox. The financial details of the deal were not disclosed. Hilbert Paradox (HPX) captures and correlates digital health data by using different computing power, AI and data analytics. The company’s goal is to increase health data equity to improve
Why partnerships between medtech companies and doctors are so important
March 30, 2018 By Leave a Comment
As new devices and technologies are being developed in the medtech industry, doctors and physicians have to learn about the devices on platforms that are different from what they know. One way to help make the healthcare provider’s transition into using new devices easier is to forge a partnership between the industry and the physician,
Is 3D printing going to replace injection molding?
March 28, 2018 By Leave a Comment
3D printing and injection molding each have their own benefits and limitations when it comes to making medical device parts, according to experts from PTI Engineered Plastics, Carbon and Protolabs. Medical device parts makers are increasingly turning to 3D printing, but additive manufacturing has yet to reach the tipping point where it could supplant injection molding
Why you need to care about marketing requirements to develop a medical device
March 22, 2018 By 1 Comment
Marketing requirements are actually a critical part of the medical device creation process. They establish a solid foundation for product development. Kit Gianforte, Product Creation Studio Developing a new product can be an exciting and overwhelming time. You have observed an unmet need in the world and have a great idea for a new product that will
Medical device startups: Here’s how you handle regulatory and reimbursement
March 19, 2018 By Leave a Comment
The two “Rs” — regulatory and reimbursement — are critical elements of the environment in which a medical device product is developed. Bill Betten, Betten Systems Solutions This is the fourth in a series of articles that discusses the design of innovative products in the highly regulated medical environment. But the “environmental” factors of regulatory and reimbursement actually
The most disruptive medical device innovations of all time
March 2, 2018 By 2 Comments
When it comes to disruptive medical device innovations, it’s easy to lose the perspective of history. Here are devices through history that definitely made a difference. Chris Newmarker, Managing Editor and Danielle Kirsh, Assistant Editor Whether you’re talking about surgical robotics or efforts to bring more value to healthcare, the word “disruptive” seems to get
How self-serve medical devices could make patients feel in control
March 1, 2018 By Leave a Comment
Intimidating medical devices can cause anxiety for patients — in the same way that people can experience “white coat hypertension” when seeing a doctor. Devices that are smaller and more patient-centered could help patients feel better about their treatment and make them feel like they’re in charge, according to Leslie Trigg, CEO at Outset Medical (San
Designing for healthcare robotics: 2 things you need to consider
February 26, 2018 By Leave a Comment
Have an idea for an innovative healthcare robot? Here are a few design principles to help you avoid common pitfalls. Ken Haven, Acorn Product Development When people think of robotics, they often think about warehouses or manufacturing lines, where robots automate multiple processes. But robotics has the potential to reshape the way healthcare is delivered in a
NN Inc. acquires medical device developer, manufacturer Bridgemedica
February 22, 2018 By Leave a Comment
Diversified industrial company NN Inc. (Nasdaq: NNBR) announced today that it has completed its acquisition of Bridgemedica — which provides design, development engineering, manufacturing and packaging services to the medical device industry. Financial terms of the deal were not disclosed. Mansfield, Mass.–based Bridgemedica on its website describes itself as a “medical device turnkey concept-to-supply partner providing
Icon reports more expectation-beating results
February 15, 2018 By Leave a Comment
Medtech, pharma and biotech development outsourcer Icon continues to beat the Street when it comes to its results. Dublin, Ireland–based Icon (Nasdaq:ICLR) said today that it earned $78.5 million, or $1.43 per share, off $455.1 million in sales for the fourth quarter ended Dec. 31, 2017 – up from $74.3 million, or $1.33 per share, in
Webinar: Where should medical device companies launch products first?
February 8, 2018 By 1 Comment
This webinar was presented live on Tuesday, Feb. 27, 2018. Click below to watch on demand. The regulatory environments are changing, particularly in Europe. In the next few years, we are expecting a complete overhaul of the regulatory standards practiced by the E.U. These events will dramatically change how (and where) medical device
Webinar: How a 3D printer’s versatility enables medical innovation
February 5, 2018 By Leave a Comment
This webinar was presented live on Wednesday, Feb. 21, 2018. Click below to watch on demand. View this webinar to learn how 3D printing’s versatility has paved the way for medical advancements by Cardiovascuar Systems. To help fight the battle against CAD and PAD, CSI works continuously to advance their devices and develop
