Medical Device Link.

Late last month, as exhibitors and attendees prepared for the opening of the 94th scientific assembly and annual meeting of the Radiological Society of North America (RSNA; Oakbrook, IL), some industry analysts and observers expected a show climate even chillier than Chicago’s traditional cold-weather welcome to delegates. Initial forecasts suggested that this year’s RSNA show could take a serious hit because of a variety of challenges now shaking the radiology community. In support of their gloomy outlook, analysts pointed to recent Medicare reimbursement cutbacks, the numbing effect of the economic downturn on hospital plans for buying capital equipment, and the insistence of many public policy analysts that ‘overuse’ of imaging is a significant contributor to rising healthcare costs.

Yet, when RSNA released its audited registration figures, the show did remarkably well considering the current state of the economy. RSNA 2008 featured all the major players in the sector, as well as a solid representation of mid-size and smaller companies. Together, the exhibitors conveyed the impression of continuing vibrancy and commitment to developing the products, equipment, systems, and services that have made imaging one of the most technologically advanced sectors of the medical device industry. [More]   

CT Scans and Radiation Exposure: Emerging Legal Considerations for Imaging Manufacturers    

Rysavy

In hospitals, clinics, and unaffiliated radiologists’ offices throughout the world, computed tomography (CT) scans are increasingly the diagnostic tool of choice. But the unquestionable benefits of CT scans do not come without risks. The average effective patient dose from a single CT scan ranges from 10 to 250 times the dose received from a normal chest x-ray, with increasing doses for multiple scans.

Although there have been no reports in the legal press of lawsuits claiming radiation-induced cancers from CT scans, the issue has been attracting growing attention in that arena. And where public health risks emerge around a potentially toxic substance or medical procedure, entrepreneurial plaintiffs’ attorneys seem sure to follow. In this article, authors Charles F. Rysavy and Roger P. Shaw review the likely paths of plaintiff lawsuits involving CT scans, and what imaging manufacturers can do to guard against claims for radiation-related cancers. [More]

John

Shifting the Liability Load

In response to soaring U.S. medical liability insurance premiums that have periodically threatened to drive doctors out of business and harm patient care, many states have enacted reforms in the laws governing medical malpractice lawsuits. But in some instances, such civil liability reforms have also had an unintended consequence: they have shifted a larger share of the liability burden to medical device manufacturers.

Sommer

Van der Brugge

By now, leaders of private medtech companies should be intimately familiar with the terms of a new section of the Internal Revenue Code—Section 409A—which regulates company use of nonqualified deferred compensation. But executives who haven’t already taken action to bring their companies into compliance with the standards set up under these new regulations could find themselves struggling to meet the final implementation deadline of December 31, 2008.

Creation of IRS’s new regulations was prompted by the perceived abuses of deferred compensation arrangements that came to light during corporate scandals earlier in this decade. Simply put, the new rules regulate a wide array of nonqualified deferred compensation arrangements, including stock appreciation rights, restricted shares, phantom stock, and other deferred compensation programs. In this article, valuation services expert Bas van der Brugge explores the more-stringent standards brought into being under 409A, including safe harbor methodologies that can be used to determine the fair market value of stock options issued by private companies. [More]   

Technology Collaborations and Joint Ventures: Intellectual Property Rights Require Smart Planning  

Ferraro

Joining forces with another company or a university can be the best or only way to bring a new medical technology to market, especially in a weak economy. However, this approach requires company executives to make decisions on some important issues—especially with regard to the intellectual properties (IP) to be handled or developed by the partnering organizations.

 

In this article, Neil P. Ferraro looks at the key IP-related issues to be addressed when considering a joint venture, and how medtech executives can protect their companies’ interests while making the most of such partnering agreements. Common pitfalls arise when companies fail to carefully evaluate what types of organizations will make a suitable partner, the strength of the partners’ existing IP, whether each partner is free to use required technologies, what entity will own newly developed IP, or what rights the joint developers should have. Addressing these issues at the outset, says Ferraro, can avoid some of the problems of joint development and head off disagreements down the line. [More]