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Articles from 2008 In March


Six Ways to Protect Your Company

Companies need to have serious training and supervision to ensure that companies understand and follow the rules. Make sure there are consequences when employees aren't compliant, too. 2. Make sure there is separation between science and sales. There's a place for science, and there's a place for marketing. 3. Be careful how hard you push the envelope. While some degree of risk-taking can be beneficial, companies also face the danger of coming too close to the line and then realize that the line isn't where they thought it was. By then, it's often too late and the government has taken enforcement action. 4. Investigate and remediate. Find out what the facts really are, and if you find that something is wrong, fix things before the prosecutor tells you to fix it. 5. To cooperate or not to cooperate? Litt advises, as a safe course of action, to always try to work with prosecutors but... (see #6) 6. Don't say too much too soon. In addition, don't take an aggressive posture. Hear what the prosecutor to say, and then educate him or her about the situation. Litt spoke at the Medical Device Congress held at Harvard University last week. -- Maria Fontanazza

DES Safe for Heart Attack Patients, Study Finds

Heart attacks caused by clots, deemed a risk from drug-eluting stents in earlier studies, were about the same in both groups. A second study, from Italy, found that major heart complications occurred half as frequently for patients with drug-eluting stents as compared to those with bare-metal stents. The key, however, is that DES patients take their anti-clotting medication as prescribed. These results mean that perhaps doctors have gone too far in cutting back their use of drug-eluting stents, based on previous findings.

Boston Scientific Sells Off Another Unit

Patient Expectations Higher for Technology

Blakeney, a registered nurse, is an innovations specialist at the Center for Innovations in Care Delivery at the Massachusetts General Hospital (Boston). When patients begin to weigh their options in choosing a device, adaptability is an important factor to consider. Patients ask themselves several questions--does this device fit into my lifestyle? Will it need to be replaced due to obsolescence that is built into the technology design? This ties into user-driven innovation--how a user can adapt technology to meet his or her specific needs. Then there's the issue of accessibility, at a reasonable cost. Will the device move in and out of a variety of environments as the patient moves? The device should, for the most part, remain unseen by people other than the user. Blakeney asked companies to expand who they currently have discussions with in terms of product design. (She implied that she wants manufacturers to go beyond talking to doctors.) She also wants them to think about what they can do with current technology to help prevent chronic diseases. -- Maria Fontanazza

Restore Medical Needs Cash Infusion to Stay Afloat

It disclosed yesterday that it may run out of cash by May because of investment in troubled auction-rate securities, reports the Star Tribune of Minneapolis. Companies holding these securities cannot cash out of them until an auction is successful, and the auctions have not attracted many buyers recently, because of the credit crunch and economic slowdown. This problem led the firm's auditor to write a dreaded "going concern" letter to the Securities and Exchange Commission; that is, it determined that at the present time, the firm doesn't have enough capital resources to fund future operations, which jeopardizes the existence of the company. Restore CEO Robert Paulson said the company will seek additional funds through equity or debt financing or through licensing its technology. It would be a shame to see that technology no longer be available to patients because of the financial climate.

New Combination Products Regulation Coming This Year, or Not

Transforming FDA LogoFDA's work on regulations and guidances specific to combination products has advanced very slowly, and recent turnover at the Office of Combination Products hasn't helped, reports a consultant who keeps close tabs on the OCP. Michael Gross, prinicpal consultant of Chimera Consulting and a member of the Combination Products Coalition, said OCP told him that a regulation regarding quality systems for combination products will come out this year. He spoke at the PharmaMedDevice conference in Philadelphia yesterday. Such a regulation is important because it is not clear when firms should follow quality-system practices for devices and when they should follow the ones for drugs. However, Gross said, the OCP once said it would come out in 2007, so nothing about the timetable should be taken for granted. Similarly, he said, OCP has said it will publish a guidance on safety reporting this year, but when it will actually appear is anyone's guess. OCP had four directors last year: Mark Kramer, who left in April after more than five years in the post; Joanne Less, who left in October; Patricia Love, who served as acting director from October to December, and Thinh Nguyen, who took over in December. It also lost Jim Cohen, an attorney who was instrumental in drafting its regulations and guidances, and Suzanne O'Shea, its product jurisdiction officer. This turnover is exacerbating the slowness of progress, Gross said.

Draft Guidance Calls for More DES Testing

These could make it longer for them to achieve FDA approval and cost their sponsors much more money. The recommendations include longer studies in humans, larger safety databases, and more postmarket studies, reports Bloomberg News. Also included in the document is guidance on assessing the toxicity of the drug used to coat the stent, both on its own and as part of the complete product. And it has draft recommendations for engineering tests, biocompatibility tests, and animal studies to assess the device's overall safety. The guidance was put together by both CDRH and CDER. A public workshop to gather comments about the draft guidance will be announced shortly.

A Pacemaker Made From Living Tissue?

According to an article on devicelink.com, Morad hopes his work will "unlock the complex system to proteins and electrical signals that keep the heart pumping at the right speed."

University Names Medtronic Veteran to Head Regulatory Affairs Program

Those who complete the program are prepared to work in a regulatory affairs department at a medical device company, in roles from design to quality assurance to marketing. The Star Tribune features a Q&A with Swanson.

Integra at Risk of Being Delisted

The firm says it is still reviewing accounts and that there are "material weaknesses" in its financial reporting. These may have to do with accrued liabilities, income taxes, and other things. The firm, which was named one of MD&DI's Medical Manufacturers of the Year in 2007, has requested a hearing before Nasdaq's Listing Qualifications Panel. That would at least delay a delisting until after the hearing. It would be a shame if something that happened on the financial side affects what the company is doing on the clinical side.