 |
By Sherrie Conroy, Director of Content
The Subcommittee on Oversight and Investigations today held a hearing titled “Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs” to examine the state of the medical device industry and the impact regulations and policies at CDRH have on patient access, innovation, and job creation. The subcommittee addressed the following questions:
- Have review times for innovative medical devices increased?
- Has there been a lack of consistency in review and data requirements?
- Has it become more time-consuming and difficult to get approval for and conduct clinical trials?
- What has FDA leadership done to improve consistency and transparency in the device approval processes?
- What do these factors mean for patient access to innovative new devices and treatments
“Over the past few years I have personally been aware of many instances where product clearances were denied or significantly delayed by CDRH when the patient benefit clearly outweighed any potential risk to the patient,” said Robert Fischell, MD, and medical device inventor. “The inability for reviewers to be held accountable for their changing standards and increased risk aversion is something Congress must address if we are to improve patient care, promote innovation, and jumpstart our economy.
Full Article |
 Medical Design is now on Facebook!
Be sure to "like" us at Facebook.
|
Dr. Jeffery Shuren, director of CDRH will be the plenary speaker at AdvaMed 2011: The MedTech Conference on September 28. Conference highlights include a series of “CEO Unplugged” sessions, a biodiagnostics primer, executive workshops, company presentations, and medtech partnering meetings. President George W. Bush and Indiana Governor Mitch Daniels have already been tapped to speak. Shuren, who has been with FDA since 1998, took on his current role in 2008, managing the staff responsible for assuring the safety, effectiveness and quality of medical devices. He has played a key role in several policy initiatives, including the reauthorization of the Medical Device User Fee Act, and the creation of The Sentinel Initiative, which works toward establishing a national electronic system to monitor medical product safety. He has also participated in the development of the FDA’s Pandemic Influenza Preparedness Strategy, the Counterfeit Drug Task Force Report, and the interagency Food Safety Working Report to the President of the United States. AdvaMed 2011 will feature 39 educational panels. Once again, the Business Development Track will unveil the annual “Pulse of the Industry” report by Ernst & Young, accompanied by a CEO panel discussion, while the Emerging Growth Company Track will provide perspectives on the state of medical device and diagnostics funding from the angel, venture capital and private equity community.
Full Article |
FDA has issued a draft guidance for the development and implementation of mobile applications for smart technology devices. The guidance is intended to inform manufacturers, distributors, and other entities about how FDA intends to apply its regulatory authorities to select software applications intended for use on these mobile platforms. The guidance was issued on July 21. “Given the rapid expansion and broad applicability of mobile apps, FDA is issuing this draft guidance document to clarify the types of mobile apps to which the FDA intends to apply its authority” the agency says. “At this time, FDA intends to apply its regulatory requirements solely to a subset of mobile apps that it is calling mobile medical applications or "mobile medical apps." FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in agency guidances means that something is suggested or recommended, but not required.
Full Article |
An FDA Advisory Panel has voted to recommend approval of the Edwards Lifesciences Corp’s SAPIEN transcatheter heart valve for the treatment of certain inoperable patients. Edwards submitted a PMA application in the fall of 2010 based on data from the inoperable cohort of The PARTNER Trial. This cohort compared the outcomes of 358 patients after treatment with either standard therapy or the Edwards SAPIEN valve delivered transfemorally. "We are pleased with the panel's strong recommendation for approval, and would like to thank them for their comprehensive and thoughtful review of the data presented from The PARTNER Trial. This represents another important step on the path to what we hope will lead to FDA approval of SAPIEN," says Michael A. Mussallem, Edwards' chairman and CEO. "We would also like to thank the principal investigators and their heart teams at the PARTNER hospitals for their dedication to this clinical trial, and to their patients for participating in a study of a new therapy."
Full Article |
Colorants developed for healthcare, medical device, and pharmaceutical applications, now meet USP Class VI and ISO 10993 biocompatibility requirements when used with medical grades of Eastman Tritan copolyester. PolyOne’s OnColor HC Plus line of colorants has been pretested for the copolyester. Pretesting can shorter development times for medical device OEMs. PolyOne’s OnColor HC Plus colorants are global formulations with biocompatibility approvals (USP Class VI, ISO 10993) in both liquid and masterbatch forms.
Full Article |
A new white paper focuses on product development considerations for hydrophilic coatings. Biocoat, maker of lubricious hydrophilic coatings for medical devices, has released the eight-page technical white paper, which covers the general properties of hydrophilic coatings and the most commonly used types of medical devices that require high lubricity. The paper provides design engineer with in-depth guidance on understanding the applications, how to evaluate vendors, and the cost implications of coatings processes. The paper discusses the environmental conditions in which the device is to be manufactured, sterilized, and stored as well as the extent to which the device interacts with biological tissue.
Full Article |
Widex saves at least 10 man hours per model analyzed
|
 Widex, a hearing aid innovator, uses SpaceClaim 3D Direct Modeling to prepare models quickly and easily for performance-intensive analyses, without being bogged down in the complexity and compatibility issues inherent with traditional CAD systems. By using SpaceClaim, Widex is saving at least 10 man hours per model analyzed.
|
|
Intelligent control applications often call for multiaxis products to meet demanding performance requirements. Configuring a control solution in a mother board/daughter board array is a convenient and proven method of addressing these types of applications. Maxon’s EPOS2 36/2 motherboards are designed to make product development faster and easier, giving the designer either a standalone multiaxis motor controller or one that can be integrated into the final product as a subboard. Starting with 11 nodes connected together via CAN-Open, the snap-apart construction allows for quick multiaxis customization on a single board.
Full Article |
Hybrid Technology Powers Integrated Connectors
The Mini Hybrid Connector integrates air lines and electronics into a compact, single connection point for remote tools on medical devices and equipment, reducing misconnections and enhancing patient therapy outcomes.
www.colder.com
Boker's 2011 Washer Catalog
Boker's 2011 Washer Catalog features over 25,000 non-standard flat washer sizes, available with no tooling charges, outside diameters of 0.080" to 5.140" and over 2,000 material options for endless possibilities.
www.bokers.com/mee
What the heck is a hexa-kaleidocycle?
It's Protogami, a 3-dimensional folding object that showcases the interaction of materials and surface finishes – the newest, interactive design aid from Proto Labs. Broaden your knowledge of surface finishes, materials and design techniques by requesting one today. You'll learn, you’ll be endlessly amused, and you just might be inspired to come up with the next big thing. To get yours, register here.
Bishop-Wisecarver Corporation
Bishop-Wisecarver is a woman owned manufacturer specializing in v groove guide wheels and guided motion technologies -- Inventor of the ORIGINAL DualVee® guide wheel.
www.bwc.com
Phillips Plastics Corporation®
Medical OEM projects often require more that a custom part or a vendor with limited services. Learn more about the engineering services, materials support, clean rooms, quality control, packaging, sterilization, manufacturing technologies available from Phillips Plastics.
|
|
|
|
