MD&DI Associate Editor Maria Fontanazza just returned from the Medical Device Regulatory and Compliance Conference at Harvard University. Here is her report:
As the pace of medical innovation continues to accelerate, expect some changes from CDRH in the coming months. Scott Gottlieb, deputy commissioner for medical and scientific affairs in the Office of the Commissioner at FDA, said the agency is ready to tackle regulatory, product, and communication challenges. And with the cost of healthcare increasing, FDA needs to take steps to develop a more efficient approach, said Gottlieb. A broad initiative, complete with a guidance document, to improve CDRH’s premarket evaluation process could be coming soon. The agency is reevaluating its system for premarket review and will be working harder at monitoring the performance of products after approval. FDA also wants to communicate more effectively with the broader medical community and keep patients more informed about device issues. This includes a new approach to releasing information about recalls.
Guidant Corp. suffered yet another setback yesterday when it announced it would scrap its drug-eluting stent slated for introduction in Europe because of manufacturing defects. The New York Times reports that European introduction of the Xience V stent has been pushed back to the third quarter of this year, and the company has taken a $15 million write-off for the first quarter. The firm found that about 1% of the products made in its Temecula, CA plant were not meeting specifications, but did not specify the production problem that caused them. No patients were harmed. The move does not affect the acquisition of Guidant’s assets by Boston Scientfic Corp. and Abbott, and does not push back the timetable for U.S. market introduction. That’s not expected until 2008. What may be affected is how long until Guidant gets out of FDA’s doghouse.
In the latest chapter of the battle over stent technology, Medtronic Inc. has sued Guidant Corp., alleging two of Guidant’s stents infringe patents licensed to Medtronic. The suit, filed in the High Court in Dublin, Ireland, follows a similar action filed in North Carolina in February. evYsio Medical Devices, the Canadian company Medtronic licensed its technology from, has two separate suits against Guidant pending. Unfortunately, this is not the first time stent technology has caused messy lawsuits. With so much at stake in this market, chances of any firm relenting are slim. So the lawyers will battle it out.
CDRH’s Office of Science and Engineering Laboratories (OSEL) today released its annual report for Fiscal Year 2005. OSEL supports the scientific basis for FDA’s regulatory decision-making by developing independent laboratory information for CDRH. In addition, OSEL researchers are involved in mission-oriented science activities including test methods development, risk assessments, forensic investigations, product evaluations, and technology forecasting. The report does a nice job of showing how its functions support CDRH, and is worth checking out.
A medical device that could radically change how patients take their medications was featured in The Times of Trenton, NJ on Sunday. Trenton-based Chrono Therapeutics Inc. developed the Chronodose System, which feeds medication through the skin and allows caregivers to preprogram the exact times and dose amounts for a patient. Even variable doses can be accommodated. This is an advance over conventional transdermal technology, which also feeds medication through the skin but can only do so in a “prepackaged” format.
The Star-Ledger of Newark, NJ reports that an arbitration panel has ruled that Medtronic Inc.’s Driver stent technology did not violate patents held by Johnson & Johnson. This is a boon for Medtronic, as the Driver technology is its stent platform for the Endeavor drug-eluting stent, eliminating a hurdle for Medtronic to play in that lucrative market. Medtronic’s stent patent violation suit against J&J is still pending.
The June issue of MD&DI will spotlight 50 Companies to Watch, and we, the editors, want your suggestions as to who deserves to be recognized. We will consider any manufacturer of finished medical devices with an interesting story to tell, whether it has to do with technology, business strategies, market success, or contributions to healthcare. Nominees can be of any size. To send a nomination, please email mddi@cancom.com with the following information: your name, employer, email address, and phone number; the name, location, and annual revenues (if public) of the firm you’d like to nominate; a list of the firm’s key products (they may be on the market or in development); and a brief explanation of why this company is one to watch. Please send your nominations no later than Friday, April 7, 2006. We hope to see your suggestions, and if you have any questions, please contact us at mddi@cancom.com.
CMS and other payers are moving from the current reimbursement system, where they pay for medical services rendered, to a system that pays for quality. They are becoming increasingly interested in the choices that hospitals make about which devices and treatments they use. Steve Ubl, president of AdvaMed, pointed out some of the pros and cons of such a system during a Frost & Sullivan Medical Technologies session.
The Good: The medical device industry already has a leg up on other industries in terms of quality. The medtech industry consistently delivers high-quality products to the public.
The Bad: Such a system could promote incentives to use a cheaper treatment rather than the best treatment available.
The Ugly: Value-based purchasing could easily tie into gainsharing programs, which AdvaMed has vehemently opposed.
Ubl pointed to diabetes as an example of where an efficiency slide could occur. The New York Times recently published an article that discusses the high cost of treating diabetes. With a value-based purchasing system, physicians may be reimbursed for providing treatments that increase the quality of care for diabetes. However, if it standardizes product selection, substandard products may become the preferred devices. Industry must not allow substandard products to become the standard of care.
Medicare has decided to cover a test that could better indicate who should receive an implantable cardioverter-defibrillator. According to the Boston Globe, the test, made by Cambridge Heart Inc. (Bedford, MA), detects a tiny variation in heartbeat that is undetectable on a traditional heart chart but indicates whether a patient’s heart is at risk of stopping. It’s possible the test could eliminate a number of ICD candidates, which would be bad news for Medtronic, Inc., St. Jude Medical Inc., and Boston Scientific Corp., which is soon to acquire Guidant Corp. But it could also show that patients not considered as candidates for an ICD should have one. Either way, this should be a useful tool to help doctors and patients reach a decision.
An expert panel convened by Guidant Corp. last summer to review how the firm handled flaws in heart devices has issued a strong rebuke to the company’s approach. The 12-member panel concluded that defects posing significant risks to patients should have been promptly disclosed, regardless of how statistically insignificant they may be. The New York Times received an executive summary of the report yesterday. The full report has been posted on Guidant’s Web site. The crucial issue for the future is how to make such disclosures without causing unnecessary panic. Is the mainstream media capable of reporting the facts but showing restraint?
