When investigating potential funding sources for medical device development, few companies consider exploring the opportunities offered by the military. Even in times of economic hardship when other classes of investors are reluctant to part with capital and most federal agencies cut back on spending, military funding is rarely affected. This is particularly true in the … continue reading
The Ernst & Young “Pulse of the Industry: Medical Technology Report 2011” was released last month, bringing with it a host of data, recommendations, and insight applicable to medical device manufacturers of all sizes. The report, which was presented at the Advamed 2011 conference, aims to offer a global analysis of the entire medical device … continue reading
Industry-specific taxes are nothing new on the American business landscape, but the upcoming excise tax to be levied against medical device manufacturers has caught many companies by surprise. In an unprecedented move, Congress has tucked a medical device tax into legislation that is designed to help pay for expanded health care coverage in the United … continue reading
Medical device startup companies in the state of Massachusetts have access to an important resource in the form of the Medical Device Development Center (M2D2). Managed by UMass Lowell and UMass Worcester, this business incubator is specifically geared towards providing those making their first forays into the medical device field with the support that they … continue reading
Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health (CDRH) recently had some alarming words of warning for medical device manufacturers operating in the United States. According to Dr. Shuren, a number of different factors have come together to place unprecedented pressure and strain on the medical device industry, with no clear indicators … continue reading
Medical device companies operating in Canada should be aware that the country’s Office of the Auditor General recently released its findings that Health Canada’s performance in regulating medical device products in that country has been deemed “unsatisfactory.” The revelation comes on the heels of findings of two previous audits which pointed out similar shortcomings in … continue reading
The question of FDA regulation of medical device applications, also known as “apps”, intended for use on mobile devices such as smart phones and tablets is an open-ended one that MDCI has tackled in previous blog posts. A new frontier for medical device apps appears to have opened up, with the announcement by Ford that … continue reading
Health Canada has changed its rules and requirements concerning Medical Device Establishment Licensing (MDEL), which provides a regulatory framework for selling or importing medical devices into Canada. Specifically, it serves as the method by which medical device companies active in the Canadian market prove to Health Canada that their product meets all of the regulatory … continue reading
It is a scenario that MDCI encounters on a regular basis when working with medical device startups: the lack of a quality system governing the medical device development. The many responsibilities that must be juggled at typically lean startup companies, coupled with the intense focus on growth and bringing a device to market, it is … continue reading
Customer feedback after your medical device has been placed on the market can be your first indication of a performance or safety issue. Yet, developing and maintaining a complaint handling system can be challenging. In fact, it is frequently a source of deficiencies in quality system assessments to ISO 13485 and CE Marking. As a … continue reading
