DOUG'S LATEST COLUMNS
I spoke with Craig Thompson, MD, SVP/CMO of Boston Scientific’s Interventional Cardiology unit, about TAVR costs, benefits, and market drivers, as well as Boston Scientific’s Lotus valve system.
Factors driving the adoption of human factors engineering include market demand for intuitive products, the world’s growing, aging population, mass customization of products, and greater patient engagement. User preference now is almost as important as clinical efficacy, as customer feedback and performance metrics affect how hospitals and other providers are compensated by insurance companies and Medicare.
After countless hours putting together your 510(k) submission, the last thing you expect is to get a rejection letter from the FDA. However the odds are against you — between January and June of 2015, 69% of 510(k) applications were rejected their first time. Here are four reasons why your submission might get rejected, and tips to avoid making these mistakes.
As part of the outsourcing and offshoring community, we collectively take a lot from local communities, and often forget what enables us to reap such financial and strategic benefits. Giving back to the communities in which we live and work should be a cornerstone of the outsourcing/offshoring relationship.
As the FDA’s next deadline for the unique device identification (UDI) of Class II devices draws closer, medical device manufacturing companies are looking to further their UDI implementation, whether they are well on their way to success or they haven’t even started. Barcoding, or identifying products via GS1 regulatory standards, is essential for companies wishing to be up to date on UDI implementation. Unfortunately, companies may be delaying UDI implementation because they view the new regulations as something an organization can address quickly. This is not the case. This article discusses the importance of viewing UDI implementation as process that encompasses the entire company rather than just as a “quick fix.”
The industry must be able to demonstrate that it has been able to use the tax suspension to innovate and grow in order to avoid the tax’s reinstatement. The ability to show results will be paramount, creating a need for more efficient online reporting.
Radio frequency (RF) ablation uses RF energy to ablate or destroy unwanted tissues. When delivered via a catheter, it offers a minimally invasive treatment for a wide variety of conditions, including atrial fibrillation (AF). These systems typically include a peristaltic pump to provide cooling or temperature control, and this pump must be able to produce and control the high pressures (up to 130 psi) required in this application.
Shifts in healthcare have essentially changed suppliers’ role in the industry – especially when it comes to infection prevention. And, they’ve greatly impacted how both providers and suppliers think about the use of antimicrobials.
Labels often are an afterthought, because they don’t directly affect the capabilities of a medical device. However, they certainly affect the functionality of the device and users’ ability to effectively utilize all of its features. Consider these factors — and their importance — as you design your medical device overlay or inventory stickers.
As demands in customer packaging and pouching grow in sophistication, ATL has kept pace by expanding our packaging capabilities. We have the engineering expertise to go beyond typical "cookie-cutter" type packaging modes in order to accommodate your one-stop supplier needs.
The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.
Medtronic’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.
Protomold’s rapid injection molding process is a very useful option for prototyping lenses that need to be tested for fit and structural integrity in optical systems. Optical component prototypes produced using the rapid injection molding process can cost up to 90% less than parts produced with traditional tooling methods.
Zeus offers the FluoroPEELZ™ peelable heat shrink designed with quick and easy peel away capabilities to improve product efficiency and safety, and to accelerate catheter production.
The A6700sc and A6750sc are high sensitivity thermal imaging cameras with long-wave and mid-wave models. Short exposure times and 640 x 512 resolution allows for freeze motion and accurate temperature measurements, making these cameras ideal for high-speed thermal events and fast moving targets in electronics inspections, medical thermography, manufacturing monitoring, and non-destructive testing applications.
The Tech Group, a West company, is a leading global contract manufacturer of pharmaceutical packaging & drug delivery, diagnostics, and medical device products. With over 40 years of experience and eight facilities located throughout North America and Europe, The Tech Group is focused on serving the needs of healthcare companies by providing a single-sourced solution from product conceptualization through manufacturing and final packaging. Capabilities include; concept design, engineering development, prototyping, production scale up, validation and commercial manufacturing.
Heatron was founded in 1977 and established a solid business in heating component design and manufacturing. Our mission to help our customers accelerate their product development process by offering high performance products that differentiates them. With expertise in a multitude of key thermal technologies, our products are engineered to withstand the extraordinary demands placed on them.
FDA has approved Abbott’s Freestyle Libre Pro System for professional continuous glucose monitoring (CGM), which provides clinicians with 14 days’ worth of patient data so they can make more informed clinical decisions regarding diabetes management.
Medtronic says the U.S. Food and Drug Administration (FDA) has cleared the company's TrailBlazer angled support catheter, which is used in endovascular procedures to support a guidewire and deliver solutions and diagnostic agents as part of the treatment of peripheral artery disease (PAD).
Galway, Ireland further solidifies its position as a global center for medical technology as it opens CÚRAM, the Centre for Research in Medical Devices, based at NUI Galway. The facility will provide Irish and foreign scientists and entrepreneurs support in developing basic research ideas — in glycoscience, biomaterials science, regenerative medicine and tissue engineering, drug delivery, and medical device design — into commercially viable clinical applications.
Boston Scientific has announced a $210 million deal to acquire EndoChoice Holdings, an Atlanta-based medtech specializing in endoscopic imaging systems, single-use devices, and infection control products.
GE Healthcare is earmarking $50 million to fund five.eight, its first healthcare accelerator, which will support startups that develop promising, low-cost medtech technologies specifically designed for emerging markets.
BrainScope — a medtech specializing in traumatic brain injury (TBI) diagnostic technology that is backed by the U.S. Department of Defense (DOD)— has announced FDA clearance for Ahead 300, a hand-held medical device capable of objectively assessing the likelihood of TBI.
Medtronic plc, the global leader in medical technology, recently announced that Sugar.IQ with Watson, the first-of-its-kind cognitive app that helps detect important patterns and trends for people with diabetes, is now in live use for the first time.
The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) announced recently its top ten regulatory science priorities for 2017. As they were in 2016, "Big Data" and medical device cybersecurity remain as focus areas, with precision medicine and clinical trial design joining the list of priorities for next year.
