Medical Device Link.

The MX Q&A: Craig Turner

Craig Turner

The estimated number of annual needlestick injuries in the United States varies. The National Institute for Occupational Safety and Health (NIOSH) has cited studies showing that between 600,000 to 800,000 healthcare workers incur injuries yearly. Founded in 1995 by Craig Turner, MedPro specializes in passive technology designed to reduce the risk of accidental needlestick injuries. Turner calls MedPro Safety “a nimble and emerging company.” It went public in 2007, and in 2008 the company signed two agreements with European-based Greiner Bio-One for manufacturing and distribution of the tube- and skin-activated blood collection and safety needle devices. Turner shared his thoughts with MX on these business developments, the impact of the federal needlestick safety legislation, and MedPro Safety’s transition from needle destruction to its current focus on passive technology. [MORE]

Ten Steps to Speeding Product Development While Meeting FDA Mandates

Noel Sobelman

The path to successful product development for medical device companies is rife with roadblocks. The recession has only added to the pressures of mounting regulatory requirements, particularly those from FDA. And then there is the skyrocketing number of product recalls, which reached an unprecedented 845 recalls in 2008—up 43% from just a year earlier. Device manufacturers are attempting to navigate the convoluted path of regulatory compliance while facing extraordinary pressures for growth. Many of these companies recognize the need to reevaluate their current processes and implement a development approach that meets the requirements for both design control and a fast flow of successful new products. Yet more than half of the firms interviewed in a recent study conducted by Kalypso admitted that they were falling short of their new product development (NPD) success goals. The author explores how companies can smooth the road to market by improving process definition, workflow, project team structure, and related device development practices. [MORE]

Take a Hybrid Partnership Out for a Spin First

Kevin Quinley

As anyone who has paid above-sticker price for a Prius knows, hybrids are in hot demand. In the life sciences, hybrids that blend elements of medical devices and pharmaceuticals are also hot-ticket items. Such combination products or convergent technologies often marry the best innovations of drug development with highly sophisticated delivery systems. Convergent technologies include innovative products such as drug-eluting stents, bone graft scaffolding/sponges coated with growth protein, implantable pumps that deliver drugs or biologics, transdermal patches, and implantable polymer wafers for chemotherapy. Companies developing convergent medical technologies can mine veins rich with opportunities, but, as you can see, they also face steep product liability perils if products cause patient injuries, have defects,
or fail to perform as intended. These outcomes can trigger lawsuits that financially drain companies. Expert Kevin Quinley examines due diligence and risk-management assessment as keys to avoiding product liability in convergent medical technologies. [MORE]

IVD and Pharma Alliances Fuel Growth of Personalized Medicine

Personalized medicine is becoming more fact than fiction with advances in genetic testing technologies. Pricewaterhouse Coopers (PwC) points to an emerging trend of increased alliances between diagnostic companies and pharmaceutical firms. In its report, “Diagnostics 2009: Moving Towards Personalized Medicine,” the advisory firm speaks to this trend and its implications.

During the past year, industry saw significant mergers and acquisitions in the diagnostics sector, says Doug Mowen. He is managing director, health industries advisory, pharmaceutical and life sciences at PwC. He believes that this signifies more partnerships between diagnostics and pharmaceutical firms. “Payers are interested, the pharmaceutical companies know they need it, and the government is driving a requirement to take cost out of the healthcare system. All these elements are motivating diagnostic alliances.” [MORE]

MD&M Minneapolis · October 21–22, 2009 · Minneapolis Convention Center, Minneapolis, MN

eCardio (The Woodlands, TX) was named among America’s fastest-growing private companies by Inc. magazine. The Inc. 500 placed eCardio at #117 with a three-year sales growth of 1424%. The 2009 Inc. 500 measures revenue growth from 2005 through 2008. To qualify, companies must have been founded and generated revenue by the first week of 2005, and therefore able to show four full calendar years of sales. Additionally, they must be U.S.-based, privately held, for profit, and independent—not subsidiaries or divisions of other companies—as of December 31, 2008. [MORE]

PerkinElmer (Waltham, MA) agreed to pay $63.7 million for Sym-Bio LifeSciences, a Chinese maker of diagnostic products. PerkinElmer plans to close the acquisition by the end of September through its Singapore unit. The agreement contains representations, warranties, and covenants and provides for indemnification by each of the parties in the event of a breach of representation. [MORE]

Abbott Laboratories (Abbott Park, IL) has announced an agreement to acquire the outstanding equity of Evalve Inc. (Menlo Park, CA). The acquisition provides Abbott with a presence in the area of nonsurgical treatment for structural heart disease, in which physicians use catheter-based devices to repair or replace basic structural components of the heart such as mitral and aortic valves. The agreement includes an upfront payment of $320 million in cash, plus an additional payment upon completion of certain regulatory milestones, for a total of up to $410 million. Under the terms of the agreement, Abbott will acquire the remaining 90% of outstanding equity of Evalve Inc. [MORE]

BioClinica Inc. (Newtown, PA), a global provider of clinical trial services, has acquired the CardioNow unit of Agfa HealthCare (Ridgefield Park, NJ). With this addition, BioClinica now offers streamlined electronic transport systems to facilitate the blinding, sharing, tracking, and archiving of medical images for multicenter clinical trials as part of its suite of imaging services. Imaging information will also be integrated with BioClinica Express electronic data capture to further simplify and enhance the clinical trial process for life science companies. [MORE]

October 26-28:
BioInterface, San Mateo, CA

November 9-11:
Medical Device Regulatory, Reimbursement, and Compliance Congress, Washington, DC

November 6:
New Healthcare Paradigm: Technology, Value, Emergence, New York City

November 8–10:
Customer Contact Europe: Proven Methods for Providing Excellence in Global Customer Contact, Dublin, Ireland

November 12:
Health Technology Summit: Evidence and Reform—Healthcare Policy and the Challenges of Health Technology Research, Washington, DC