Medical Device Link.

LEAD STORIES

Falco

“Starting a new company requires more than working 9 to 5. It’s about doing what is needed to get things done,” says Tony Falco PhD CEO and founder of Resonant Medical (Montreal). That effort includes putting together a “solid business team” blessed with tons of entrepreneurial talent, conducting an exhaustive patent search, and writing a strong business plan.

No amount of business savvy will compensate for a duff product, of course, and Falco believes Resonant has a clear winner in its Clarity System. Developed by Falco at Montreal’s McGill University Health Center, where he had completed a doctorate in medical physics, was teaching graduate courses, had an active research program and clinical responsibilities, the system uses 3-D ultrasound image-guided radiation therapy (IGRT) to treat prostate- and breast-cancer patients. Falco and his business partner, Fred Francis, founded Resonant Medical in 2000 after negotiating exclusive licensing rights with McGill, which owned . Falco’s technology patent.

Based on initial success with prostate cancer patients since 2004, the breast system is the first use of 3-D ultrasound technology for IGRT to help women and their doctors combat the disease. The Clarity System enables radiation therapists to compare a fused ultrasound-CT image taken during treatment planning with ultrasound images from each consecutive day of treatment. This breakthrough allows doctors to monitor the daily movement of tumor cavities so that the physicians can pinpoint the actual location of the lump for more focused radiation placement. This focusing capability can minimize radiation margins around prostate or lumpectomy cavities, according to the company. Cancer centers in the United States, Canada, and Europe are now using the Clarity System.

Falco discussed a range of topics about the start-up with MX, including the system’s genesis, the challenges of technology transfer, the demands of launching a company, the rigors of the clinical trial process, and what he’s learned from customer feedback. [MORE]

Elwell

Good documentation is an investment. If you need convincing, all you have to do is glance at FDA 483 warning letters, which cite documentation problems with alarming frequency. The good news is that these problems can be fixed after your company receives a warning letter. The bad news is that, until you fix the problems, they can cost you both time and money. When the FDA investigator shows up, he usually sequesters himself in a room with documents. If documents are the first line of inquiry, shouldn’t they also be the first line of defense? The best course of action, therefore, is to avoid 483 warnings altogether by putting in place a logical and comprehensive system of documentation before the FDA inspector comes around.

Considerable Costs
Suppose FDA appears at your door tomorrow, and suppose it finds cause to issue you at least one 483 warning that your company’s cGMP documentation is inadequate. How much will that cost you? No one seems to know for sure, not even as an average. This fact is due partly to the variables involved and possibly to hidden intangible expenses. Despite the lack of hard numbers, no one would dispute that the cost is considerable. Just having your corporate inadequacies made a matter of public record throws a lot of dirt on your company name; dirt that may take substantial effort—not to mention time and money—to remove.

Larry Elwell explains why your company should invest as much time and effort on its paperwork as it does making safe and effective devices. [MORE]

Sackman

Numeroff

Success in today’s rapidly changing and increasingly competitive device market requires two key abilities. The first is flawless execution of traditional marketing activities. The second is critical assessment of the product’s clinical and economic value proposition in the context of strategic marketing.

More and more, customers are expecting improved outcomes because of medical technology advances, new drugs, and rising healthcare expenses. These expectations come with costs that are at or below current pricing.

Many high-tech medical device companies have excellent reputations for product innovation and superior product features. But the feature and benefit orientation of many companies is no longer sufficient to keep pace with the continually evolving expectations of cost-conscious medical customers where superior clinical and economic outcomes are required to both maintain and drive premium pricing. In this article. Rita Numerof and Jill Sackman tell how your customers’ understanding of a product’s value drives market success. [MORE]

ECRI Institute (www.ecri.org), an independent nonprofit that researches the best approaches to improving patient care, has released a top 10 list of health technologies that hospital executives should have on their radar. According to the institute, the list takes into account the convergence of critical patient safety, economic, and regulatory pressures currently facing hospital healthcare executives.

The list includes technologies and technology-related issues across a variety of clinical and operational areas, including health IT, cardiovascular surgery, oncologic radiation, procurement, infection control, and imaging and radiology services.

The report contains easy-to-read overviews and the institute’s perspectives on the technologies and the processes. The new executive report is intended to help guide healthcare leaders in planning for capital expenditures. [MORE]

The MX Q&A: Novel Ultrasound Cancer Treatment Technology Delivers a Clear Winner

Avoid FDA 483 Warnings with Better Documentation

A Solid Sales Plan Requires Scrutiny of Device's Clinical, Economic Worth

ECRI Lists Top 10 Medical Technologies for Hospital Executives

INDUSTRY IN BRIEF

Devicor Medical Products LLC (Pleasant Prairie, WI) has named Jonathan Salkin to serve as executive vice president, corporate development and strategy. Salkin was most recently a managing director at the Royal Bank of Scotland, where he launched the bank’s first healthcare investment banking group globally. Prior to that, Salkin was vice president of corporate development for Cardinal Health, responsible for strategic planning, mergers, and acquisitions for Cardinal’s $10 billion medical products and services group. At Devicor, his responsibilities will be to work to secure an initial platform acquisition in interventional medical devices, as well as other mergers and collaborative efforts. Salkin will also serve on Devicor’s board of directors.

Covidien (Dublin) and VNUS Medical Technologies Inc. (San Jose) announced that Covidien has reached a definitive agreement to acquire VNUS, a developer of medical devices for minimally invasive treatment of venous reflux disease. In 2008, VNUS had revenues of $101 million. The boards of directors of both companies have unanimously approved the transaction, which specifies that a wholly owned subsidiary of Covidien will pay $29 in cash per VNUS share for a total of approximately $440 million, net of cash acquired. The transaction, which will take the form of an all-cash tender offer followed by a second-step merger, is subject to customary closing conditions, including receipt of certain regulatory approvals, and is expected to be completed by June 30, 2009.

FDA has approved the Carpentier-Edwards Perimount Magna East aortic valve by Edwards Lifesciences Corp. (Irvine, CA). The device is designed to ease implantation into the heart. The valve, made from bovine pericardial tissue, has a low profile and smooth commissure posts for insertion through small incisions or small aortic roots. The company has also introduced the Port Access EndoDirect System, which enables surgeons to stop a patients heart and keep it at rest during valve insertion, without requiring a incision down the middle of the chest.

Two Johnson & Johnson executives have joined to work at an endovascular neurosurgical start-up firm. Eric Milledge, former company group chairman of J&J’s LifeScan division, and Robert O’Holla, former vice president of regulatory affairs, medical devices have taken leading roles at Nfocus Neuromedical Inc. The firm is working on noninvasive surgical devices that have the potential to cure aneurysms, among other neurovascular problems.

CALENDAR

July 14: Invest in Spain: Business Opportunities in the Biotechnology, Pharma, and Life Sciences Sector, Web seminar

July 17-19: Discovering Openness in Health Systems, Washington, DC

July 20-21: Competitive Technical Intelligence, Pasadena, CA

July 24: 510(k) Submissions: Getting to Market 2009, Anaheim, CA