FDA cuts could threaten medtech innovation: Here’s why

The Trump administration’s proposed federal budget could hurt the speed and quality of FDA review times, says a top expert at Musculoskeletal Clinical Regulatory Advisers (MCRA). Glenn Stiegman, MCRA Innovation is a vital element of success for medical device companies. More than 6,500 U.S. companies are developing technologies that improve patient outcomes. This represents a

Why high-speed machining demands a high-end toolholder

In high-speed machining for medical equipment manufacturing, choosing the right toolholder is the key to greater precision, longer tool life and decreased machining costs. Jeff Elliott, for Collis Toolholder As any machinist will tell you, when it comes to precision machining, the importance of a toolholder cannot be overstated. The quality of the toolholder plays

China wants to dominate medtech: Here’s how

Under its “Made in China 2025” plan, the Chinese government seeks explosive growth in biomedical and high-end medical device manufacturing. Grace Fu Palma, China Med Device In 2015, the China State Council issued a 10-year manufacturing plan called “Made in China 2025.” The  goal is to elevate the “giant but weak” Chinese manufacturing industry into

3D printing can give your medtech startup a competitive edge

You need to be fast and nimble to compete. A strong maker culture enabled by 3D design and 3D printing could be the way to do it. Derek Mathers, Worrell It can be a lonely world for medical and biotechnology startup entrepreneurs during the early days. Despite their deep desire to introduce and scale novel life-extending

How to work with the new FDA

Here’s how medical device makers can capitalize on the strategic priorities and transparency initiatives at FDA’s CDRH. Lisa Olson, RCRI Scott Gottlieb has now settled into his role as FDA’s new commissioner and is putting his stamp on the agency. Interestingly, he has started with some very specific points of focus that have bubbled to

Long Island IEEE section to host power electronics exposition

Lee Teschler, EE World The IEEE section in Long Island, N.Y. will host the first-ever power electronics symposium to be held in that area on Thursday, Nov. 9, 2017. Organizers say they plan on having at least four technical lectures and expect to host 25 to 50 exhibitors and over 200 attendees. Organizers expect a

The U.K. wants to speed up medtech approvals: Here’s how

The U.K. is in the midst of changes to the appraisal pathways for assessing and funding health technologies, according to RTI-HS staff attending the recent  National Institute for Health and Care Excellence (NICE) 2017 conference. Caroline Ling and Jessica Costello, RTI-HS We and other RTI-HS staff recently attended the National Institute for Health and Care Excellence (NICE) 2017

Webinar: 3D printing at Medtronic – Sept. 5, 2017

Tuesday, September 5, 2017 2:00pm EDT / 11:00am PDT     Learn how 3D printing empowers medical device manufacturer Medtronic to bring products to clinical use faster, develop better therapies and personalize patient care. With functionally accurate, 3D printed prototypes, Medtronic can complete more design revisions in less time, empower physician feedback through an improved

Could this new assay reduce the need for animal tests?

American Preclinical Services has developed a novel assay that its creators think could replace the thromboresistance animal tests for medical devices – which use dogs, sheep and pigs. Mark E. Smith, American Preclinical Services Blood-contacting medical devices and the materials from which they are constructed must meet stringent safety criteria prior to regulatory approval for

Fluoropolymer medical tubing: What you need to know

Here are some important considerations when it comes to extrusion equipment and safety related to processing fluoropolymer medical tubing. Steve Maxson, Graham Engineering Corp. Medical tubing processors are showing more interest when it comes to venturing into the world of fluoropolymers – and for good reason. Materials such as FEP, PFA, PVDF and ETFE are

How FDARA is making a difference for industry and patients

Drs. Peter Marks, Jeffrey Shuren, and Janet Woodcock, FDA For decades, user fees paid by the medical products industry have provided critical resources needed to conduct product reviews in a timely fashion and to help ensure the safety and effectiveness of medical products that American patients depend upon. Since passage of the first medical product

How plasma treatments are driving up the value of plastic labware

By altering the surface properties of polymer labware through plasma treatments and coatings, manufacturers are improving the quality of test results while increasing value of products they create. Jeff Elliott, for PVA TePla America Each year, billions of multi-well plates, pipettes, bottles, flasks, vials, Eppendorf tubes, culture plates and other polymer labware items are manufactured for

How to ensure adhesion on hard-to-bond plastic substrates

Medical device companies are increasingly using plastic substrates that are tough and sterilization/chemical resistant. But they also come with adhesion challenges. Michelle Gumbert and Patrick Vaughn, Dymax  For medical devices such as catheters, prefilled syringes, vials, test tubes and injector pens, many manufacturers are turning to plastic substrates that are specifically formulated to resist harsh

How glass-sealed connectors increase medical device longevity

As medical instruments and technologies grow more sophisticated and complex, it is increasingly important to guard sensitive components from the autoclaving process while supporting their longevity. Glass offers a solution. Jochen Herzberg, Schott Electronic Packaging In today’s era of rapid technological advancement, medical devices have become more complex and capable than ever thanks to the

Intellectual property: How medtech startups can protect it

All companies begin with an idea. The details of protecting intellectual property, however, can be daunting, especially if your idea is in the field of medical technology. N. Scott Pierce and Alexander Adam,  Hamilton, Brook, Smith & Reynolds PC Starting a medical device company requires a vast array of knowledge, including knowledge about almost every