Regulatory bodies across the globe are imposing increasingly demanding and prescriptive requirements for postmarket surveillance, calling for more proactive postmarket surveillance mechanisms, in particular. For manufacturers wishing to introduce or maintain distribution of devices in markets with new postmarket surveillance requirements, the importance of understanding and correctly implementing those requirements has never been more critical.
Fourteen million people worldwide were diagnosed with cancer in 2012, and experts predict 22 million people will receive a cancer diagnosis in 2030. Here, we examine how the processes used to broaden access to radiotherapy can readily be adapted by other members of the medical device community to improve the treatment of cancer patients and to create additional market value.
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.
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
Using egg whites, magnesium, and tungsten, university scientists have developed a component of electrical circuitry that could be used in dissolvable implants or advanced drug delivery. Their lab tests showed that the circuits were as stable and reliable as non-degradable circuits and could be dissolved in water within 72 hours.
Stryker Corporation added to its string of acquisitions this year with the recent purchase of Stanmore Implants, a United Kingdom-based manufacturer of reconstructive orthopedic devices for oncology patients, for $52 million (£35.6 million) in cash.
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.
NuVasive, Inc., a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, recently announced it will launch five new surgical solutions at the 84th American Association of Neurological Surgeons (AANS) Annual Scientific Meeting, being held April 30 – May 4, 2016 in Chicago, IL.
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.