Vicki Anastasi, Senior Vice President of Aptiv Solutions, sat down this past week with Brett Johnson of OneMedRadio to discuss innovative approaches to trial design. Vicki touched on adaptive trial designs as well as risk-based monitoring, and explained the benefits offered by these advanced investigatory techniques. Listen to the full interview below for an in-depth look at where the future of clinical trial design is headed.
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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 area of research and development, as each branch of the armed forces is continually on the lookout for new technologies that will help reduce both the human and material costs of waging war. (more…)
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 industry from a regulatory, economic, and demographic perspective.
Several interesting points were made within the "Pulse of the Industry" report that indicate the direction in which the medical device business specifically, and healthcare in general, is moving. [...]
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 States. The 2.3 percent excise tax would be charged directly to medical device manufacturers, based on the gross sale price of each affected product.
A 2.3 percent excise tax on its own sounds innocuous, which was no doubt by design on the part of the [...]
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 need to bring their product to market.
Funded by the John Adams Innovation Institute, M2D2 offers companies, researchers, and inventors a broad range of services that are critical to the development of new medical devices. The main goal of M2D2 is to [...]
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 as to when the situation might improve.
Using the dramatic phrase “perfect storm” to sum up the issues currently facing medical device companies and regulators, Dr. Shuren outlined a number of different market problems which have no easy [...]
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 how the ministry has been protecting public safety.
Specifically, the Auditor General’s office has leveled charges that Health Canada has been remiss in providing market surveillance and inspection services at the level necessary to [...]
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 it is working with several different developers to produce apps for its Sync in-car vehicle interface.
Ford is most interested in medical monitoring apps that are designed to help improve the quality of life for drivers, as well as protect their safety. Currently, Ford is working with SDI [...]
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 requirements associated with the permission to sell devices within that country. This includes procedural documentation, handling of complaints, storage and delivery of devices, and installation and servicing of devices (where [...]
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 no surprise that quality system activities are often the the last aspects of FDA regulation to be implemented.
A quality system is always most effective when it is implemented from the ground-up as part of the natural progression of medical device design and production. [...]