The Patient Protection and Affordable Care Act (ACA) is the broadest change to the U.S. healthcare system since the creation of Medicare and Medicaid. Although the act is phased in over eight years, the dramatic increase in access—more than 32 million new lives and 15 million better insured beneficiaries—will overwhelm the system, causing a prolonged funding crisis starting in 2015.

Fredrick W.K. Brown

I see a window of opportunity for the medical supply, device, and diagnostics industry to benefit from the ACA by implementing targeted strategic programs before the massive influx of new beneficiaries.

Half of the 32 million newly insured will be covered under Medicaid; competing successfully in the Medicaid market...

April 15th, 2011

Senator John Kerry sent a letter to FDA Commissioner Margaret Hamburg (pdf), expressing his concern over the IOM's proposed revisions to the 510(k) clearance process. 

Kerry's main criticism is that members of the medical device industry have not been included in the Institute of Medicine's assessment of the clearance process. The senator urged Hamburg "to establish a deliberative and transparent process for reviewing the IOM recommendations that ensures adequate opportunity to solicit substantive and meaningful input from all stakeholder groups before any recommendations are filed"

The letter came as a direct result from a meeting the Massachusetts senator had with MassMEDIC, says the association. MassMEDIC says that Senator Kerry intends to invite Commissioner Hamburg to Boston in the coming months to meet...

April 15th, 2011

Stereolithography (SL or SLA) is one of the many tools used in rapid prototyping. Use of the technology can lead to reduced product development times (sometimes from months to days). But OEMs need to know the risks, the costs, and the latest in the technology to make the best decision as to whether SL is the right choice for their application.

A FREE Webcast "Discover How Advances in Stereolithography Technology and Resins Can Speed up Your Product Development," is designed to help medical device makers assess the performance and test capabilities of functional prototypes created by SL. Experts include Jon Spragg and Dr. Beth Ficek from DSM SOMOS.

The Webcast is April 19, so its...

April 15th, 2011

Remember back in January 2009 when the Government Accountability Office (GAO) admonished FDA for allowing too many high-risk (Class III) medical devices to be approved through the 510(k) process? The GAO remembers. And it's not too pleased with what FDA's done since.

The GAO's Marcia Crosse testified at a hearing in front of the Senate Special Committee on Aging on Wednesday, and she criticized the agency for continuing to approve high-risk devices via the 510(k) pathway. The GAO wanted FDA to either reclassify Class III devices or put them through the stricter premarket approval (PMA) process, but the watchdog group found the agency's progress lacking. From a statement released by the GAO:  

Since then, FDA has set strategic goals to address these device types, but has issued a final rule regarding the classification of only one device type. As of April 1, 2011, FDA’s action on the 26 remaining types of high-risk devices was incomplete...

April 14th, 2011

Steve Beversluis, director of quality assurance and regulatory affairs, business development, at Precision Medical Products Inc. recently sat with MPMN to provide guidelines for OEMs as they work with a molder.

Beversluis said that the molder's expertise should be specific to the product and the OEM's needs (e.g., Six Sigma, cost optimization, and manufacturablity). He also warns OEMs not to be lured by promises of lowered tooling costs from overseas vendors without considering that other costs, such as shipping, could rise.

When it comes to materials expertise, Beversluis says the molder should be able to provide advice from the design and tooling phase to the process development phase. He says a partner should "stay abreast of materials trends and have experience in molding such difficult materials as thermoplastic urethanes."

Read the full interview "...

April 12th, 2011

FDA investigators do get trained to the regulations as well as to FDA’s guidance on design controls. They do not necessarily have experience with a medical device firm that has done good design and has fully compliant design control processes and procedures. Their understanding of good design is learned primarily by inspecting medical device firms. They may not always have an objective or unbiased understanding of good design. They will be able to determine whether your procedures appear compliant. From your post-market data (complaints, production non-conformances, MDRs, recalls or corrections and removals and your design and manufacturing changes) they will be able to determine whether you do or do not...

April 11th, 2011

If the federal government shuts down tonight (which is looking more and more likely) how will the device industry be affected?

As with every sector, one can debate the degree to which the government impacts device makers, but the feds do interact with industry in two key ways: as a regulatory authority via FDA and as a source of funding via the NIH.

Those who receive funding from NIH will not notice much of a difference, at least for a little while, according to the American Association for the Advancement of Science's ScienceLink blog. The NIH's intramural funding would be severely limited, and research done directly by the agency will be dramatically reduced. But extramural funding, which is what goes to researchers at universities and institutions outside of the NIH, would not be hampered in the immediate future. A...

April 8th, 2011

Two undergraduate biomedical engineering students at Ryerson University have developed a prosthetic arm that can be controlled by brain signals. Powered by pneumatic pumps and valves, the arm offers a wide range of movement. The prosthetic limb, which is the brainchild of Thiago Caires and Michal Prywata (both of whom are pictured on the right), draws most of its power from compressed air.
To control the device, a user wears a headset that picks up brain signals. The information from the signal is transmitted wirelessly to a computer in the mechanical arm. After the computer interprets the data, a signal is relayed to the pneumatic system to initiate movement.
The device has a cost that is 25% of other functional prosthetic arms, which generally use microelectronics or motors
to initiate movement. In addition...

April 7th, 2011

You have to get up pretty early here in the United States, but if you do, you could find a wealth of knowledge at our upcoming virtual event.

This dynamic event " Developments in Materials for Medical Applications" features a virtual conference and trade show devoted to developments in materials for medical applications. The day is filled with a keynote address on materials insights, and discussions on orthopedic materials, product design, and emerging innovation.In addition, materials experts and suppliers will be onhand to discuss your materials needs and challenges.


Developments in Materials for Medical Applications
From European Medical Device Technology, MD+DI...

April 7th, 2011

To better understand the implications of changes for clinical operations in the medical device and diagnostic industry, PRTM is teaming up with MD+DI to conduct a survey.
This brief survey is designed to reveal the challenges and opportunities medical device companies face as they align their clinical operations with changing market requirements and business strategies.

Critical questions cover several relevant areas, including clinical organization spend and structure, clinical evidence trends, clinical trial performance and productivity, business practices in planning, trial portfolio, and execution management, and clinical trial outsourcing.

Survey participation will require about one hour of your time. All individual company data will be kept confidential—only aggregate industry data will be summarized in the report. Companies that desire

April 6th, 2011