Medical Device Posts

PMA Submission Helps Medtronic Win Lawsuit

Mark Crawford

After a five-day bench trial in February, Judge Mark Davis, U.S. District Court-Eastern Virginia, rejected a lawsuit brought by W.L. Gore & Associates against Medtronic. Gore claimed that Medtronic violated a patent it holds on the manufacturing process for making intraluminal stent grafts used for treating aneurysms. (more…)

Are You Ready for the Medical Device Excise Tax?

Mark Crawford

Most people say it’s really going to hurt—especially for small- to mid-sized medical device manufacturers, possibly even driving them out of business. Companies will likely have to cut jobs and reduce R&D budgets to have enough cash on hand to pay the tax, which goes into effect January 1, 2013. (more…)

Notified Bodies and Clinical Evaluations

Mark Crawford

Nancy J. Stark is president of Clinical Device Group, a medical device clinical consultancy based in Chicago. Recently she has noticed an increase in requests for clinical evaluations and offers advice about how to write clinical evaluation reports to meet the requirements of notified bodies. (more…)

Thinking about Brazil? Here’s what You Need to Know

Mark Crawford

If you aren’t already there, maybe you should think about Brazil.

With a population of about 200 million, Brazil is one of the largest medical-device markets in the world. It has a well-developed, evolving, and fairly reasonable regulatory system in place that is similar in many ways to the EU (although it has some significant differences, too). (more…)

Pilot Program for ISO 13485 Audits Sounds Promising

Mark Crawford

On March 19, the FDA announced guidance for a medical device ISO 13485:2003 voluntary audit report submission program. The document provides a strategy for responding to Section 228 of the Food and Drug Administration Amendments Act of 2007, which states that:

“For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality system standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.” (more…)

Breast Implant Fiasco in France Could Have U.S. Ramifications

Mark Crawford

On February 9 European Health and Consumer Policy Commissioner John Dalli called for immediate action from the EU to ensure stringent implementation of the current legislation on medical devices. This was in response to the fraudulent use of non-medical grade silicone in breast implants manufactured by the Poly Implant Prothèse (PIP) Company inFrance. The European Commission is now scrambling to tighten controls on the approval of medical devices and restore patient confidence. (more…)

Chinese Market Gets Hotter for Medical Devices

Mark Crawford

Citigroup Global Markets recently surveyed nearly 400 Chinese hospitals (about two percent of the country’s total) from 29 provinces and cities about attitudes toward the medical equipment market, medical consumable market, hospital construction cycle, and county-level hospital market.

Among the key findings:

“We estimate the total market size of the 11 medical equipment segments we surveyed to be about U.S. $5 billion in 2012, and expect the Chinese medical device market to grow about 17% in 2012 on 12% annual growth in medical equipment and 25% annual growth in medical consumables, largely driven by: 1) purchasing budget growth in Class-3 hospitals; 2) county-level hospital upgrade and expansion driven by government investments; and 3) a solid hospital construction cycle in 2012-15,” wrote Citigroup. (more…)

Pre-IDE Meetings Can Be Helpful in Understanding FDA Expectations

Mark Crawford

There are many pressures on medical device companies today—reduced venture capital investment, changing health-care reform, smaller and more complex devices, advanced materials, and the ever-present push from OEMs to keep costs down but get products to market faster, to name a few—all while increasingly managing their supply chains and meeting FDA regulations. (more…)

Mobile Medical Applications Are a Challenge for the FDA

Mark Crawford

In July 2011 the FDA released its draft guidance on the use of mobile medical applications. This first effort is regarded by many as long overdue; it also only addresses a restricted segment of the applications market. The comment period ended October 21 (view the guidance at Draft Guidance for Industry and Food and Drug Administration Staff–Mobile Medical Applications). (more…)

FDA and CMS Team up to Review Innovative Medical Devices

On October 7 the FDA and the Centers for Medicare & Medicaid Services (CMS) on announced a “parallel review” pilot program for reviewing medical devices for FDA approval and Medicare coverage.

Both organizations have agreed on guiding principles that are designed to streamline the processes and reduce the time span between marketing approval or clearance decisions and national coverage/payment determinations.

“By reducing the interval between FDA marketing approval and Medical coverage, this process will facilitate the development of innovative products and shorten the time it takes to bring these important products to patients,” states the FDA. (more…)