Each medtech company must consider carefully how its products and services fit its customers’ needs. Some may pursue (or continue) a category-killer approach, and dominate a narrow channel. Others may choose to be market disrupters and produce game-changing technologies. Most of today’s medtech companies have taken a blended approach, but the opportunities to partner with providers in the new outcomes-based healthcare paradigm are enticing.
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.
Med Device Online recently interviewed Dr. Ken Stein, SVP and chief medical officer at Boston Scientific CRM. Dr. Stein discussed his company’s yet-to-be-named, leadless micro pacer, where the device stands in development, and how Boston Scientific plans to combine its new pacing technology with its subcutaneous implantable defibrillator (S-ICD) to create a flexible modular system.
The new guidance on human factors requirements, issued by the FDA in February, answers some long-standing questions for the industry and raises a few new ones. What are the biggest changes and what do they mean for medical device manufacturers? Here’s a closer look at what’s new, what’s the same, and what manufacturers should be doing now.
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
Yoky Matsuoka, a Google X co-founder and former VP of technology at home automation products company Nest, is reportedly joining Apple to help the company with its healthcare initiatives. After a professional hiatus, the highly-regarded neuroroboticist is taking on a new challenge as Apple deepens its dive into healthcare with its mobile-based software frameworks.
Swiss-based Sonova has acquired Dutch-based audiological solution provider AudioNova in a $953 million deal that will more than double the company’s presence in the European hearing aid market. Senior executives said the combined companies will create the largest hearing aid retail service network in Europe, with 2,580 storefronts in 12 countries.
Siemens Healthcare announced that it has rebranded as Siemens Healthineers as it looks to add new offerings to its imaging and diagnostics portfolio. In explaining the name change, the German conglomerate emphasized its engineering and scientific expertise in creating healthcare applications.
WiTricity, the industry pioneer in wireless power transfer over distance, recently announced that Greatbatch, a global developer and manufacturer of medical devices and components, has extended its relationship with WiTricity to leverage its wireless energy transfer technology in the development of implantable medical device applications.
Royal Philips has set in motion its protracted plan to focus on healthcare by announcing that it will sell its traditional lighting business through an initial public offering (IPO).
Ligand Pharmaceuticals Incorporated announces the acquisition of economic rights to multiple programs owned by CorMatrix.
Sinocare, a Chinese medtech specializing in the development and manufacture of biosensor technology, has inked a deal to acquire U.S.-based PTS Diagnostics and its portfolio of point-of-care (POC) biometric testing devices. The $200-million deal expands Sinocare’s global foothold in the diabetes management market.
Medtronic plc announced recently the appointment of Karen L. Parkhill as executive vice president and chief financial officer (CFO), effective June 20, 2016.