A new In Vitro Diagnostic Devices Regulation (IVDR) has been proposed to replace the existing In Vitro Diagnostic Devices Directive. Mapping out your path ahead of time, including preparing to be flexible, will equip you to respond to this new paradigm.
The first and second Unique Device Identification (UDI) compliance dates have passed, and successfully understanding the difference between the “letter of the law” and the “spirit of the law” not only ensures compliance, but also determines that your UDI solution was right for your firm. Here are several key considerations for firms embarking on a UDI compliance program for Class I and II devices.
To learn more about how the IoT will impact medtech as a whole, and drug delivery in particular, I interviewed Stephen Wilcox, principal and founder of Design Science, Inc. We discussed his thoughts on trends in the drug delivery device market, how he sees the evolution of the IoT transforming healthcare technology, and what implications the technology holds for device developers.
The second article in a two-part series examining the past, present, and future of the U.S. transcatheter aortic valve replacement (TAVR) market, this installment examines what it will take for TAVRs to become the standard of care for low-, intermediate-, and high-risk patients with severe symptomatic aortic stenosis. It also looks at major competitors in the space and emerging opportunities.
In order to better understand the different types of sterilization for medical device components we refer to the Center for Disease Control and Prevention for a definition; "sterilization is the use of a physical or chemical process that destroys all microbial life including the bacterial endospores that are so highly resistant". By Rena Ivory, Crescent Industries, Inc.
In the manufacture of healthcare products and medical materials, especially ceramic materials like zirconia (used as an implant material) and hydroxyapatite (synthetic bone replacement material), there is often a stage in the manufacturing process involving a powder suspension. By Matthew Cantelo, Lucideon
It seems like the clinical research world is often thought of in terms of pharmaceuticals. Clinical trials are often referred to in Phases, such as “a Phase 2 study of a new drug” or “a Phase 3 randomized clinical study with a placebo control.” By Brandy Chittester, IMARC Research, Inc.
Human-centred designs have become a driving trend in the development of next-generation inhalation devices, making them more useful, usable, and desirable than current inhalation devices. By applying design research, industrial research, and human factor disciplines in cooperation with design for manufacturing and assembly philosophy, patients are able to receive inhalation devices that minimize opportunities for error, and support greater adherence to their prescribed therapy.
This white paper describes Phillips-Medisize’s approach to human-centered design in producing the next generation of smaller and smarter inhalation devices.
The best part of my job is helping medical device manufacturers use molded silicone components in their innovations. By Phil LaRoy, Vesta
Abbott will acquire St. Jude Medical for $25 billion in cash and stock to significantly enhance its medical device business and cope with increasing price pressure from consolidating hospital clients.
Dexcom CEO Kevin Sayer spoke candidly about his organization’s recent growth and the associated “growing pains” as he laid out the company’s strategy moving forward. Despite what he calls the “most complicated product launch in our history” — the G5 continuous glucose monitor (CGM) — Sayer reported a 60 percent bump in Q1 diabetes management system revenue, gleaned by far outperforming market competitors, including Medtronic, J&J, and Abbott.
Building on a strong showing during the preceding quarter, and based on increased adoption in the United States, transcatheter heart valve (THV) therapies drove up first quarter sales of Edwards Lifesciences, the company announced recently.
Boston Scientific has achieved double-digit growth in four of its seven businesses for a total of 11 percent Q1 growth overall, its best quarterly performance in over a decade, according to senior executives. Analysts attribute the growth in part to the company’s ability to diversify in lesser known markets and the successful launch of several new products.
Royal Philips is starting to reap positive results from its strategic pivot into healthcare, with its HealthTech business expanding by 5 percent during the first quarter, helping drive comparable sales growth up 3 percent to €5.5 billion. Continued investments, deal-making, and product launches contributed to the strong performance of the unit, which will be the sole focus for the company after it sells its Lighting business.
Elekta today announced that its leading-edge high-field MR-guided linear accelerator (MR-linac) platform will be the focal point of seven scientific presentations at ESTRO 35, the annual meeting of the European Society for Radiotherapy & Oncology, taking place April 29 - May 3.
Stryker's Performance Solutions (SPS), the business unit of Stryker's Reconstructive Division that partners with hospitals and physician practices to improve quality outcomes, patient satisfaction and profitability in the orthopedic segment, is launching a new digital patient engagement and education platform to help improve the overall care delivery and experience for patients undergoing joint replacement surgery.
Baxter CEO Jose Almeida — the former CEO of Covidien — is making good on his promises to drive growth by cutting costs and investing in innovation, as the company announced a worldwide 4 percent increase in revenues in the first quarter of 2016. Baxter also will host an innovation hall at its 2016 Investor Conference, which will showcase the company’s recent R&D efforts.