CONTRIBUTORS
Strong performance in the medical device industry requires strong executive leadership. In this issue, MX takes a look at key issues in business planning and corporate governance for medtech manufacturers, and contributors provide essential information for executives looking to stay on top of all areas of their businesses.
Industry Associations
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Thompson
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Kendall
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In late 2007, the Combination Products Coalition (CPC; Washington, DC) began to plan its 2008 advocacy agenda. As it did, the organization's diverse group of member companies identified a need to step back and take the industry's pulse on existing combination product policies and guidance. In "An Uncertain Path", Bradley Merrill Thompson and Leah R. Kendall present the findings of a CPC-sponsored survey designed to gauge industry priorities for guidance and rulemaking activities in the converging worlds of medical devices, pharmaceuticals, and biologics. Thompson is a member in the healthcare and life sciences practice of Epstein Becker & Green PC (Washington, DC). There, he counsels medical device and drug companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. For trade associations, Thompson serves as counsel to AdvaMed for payment issues, as general counsel to the Combination Products Coalition, and as counsel and secretary for the Indiana Medical Device Manufacturers Council. Kendall is an associate in the healthcare and life sciences practice of Epstein Becker & Green, where she advises clients on FDA and CMS regulatory requirements. Thompson can be reached at 202/861-1817 or via e-mail at bthompson@ebglaw.com. Kendall can be reached at 202/861-4197 or via e-mail at lkendall@ebglaw.com.
Finance
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| Cohen |
Concerns about a recession and the upcoming election—which could have an impact on budget and FDA regulatory matters—are likely to weigh down mergers and acquisitions (M&A) activity in 2008. Although the aphorism that healthcare is recession-proof still applies, prospects for a particular medtech sector, company, or deal must be evaluated according to their specific circumstances. In "The State of Medtech M&A", Richard S. Cohen takes a look at top 2007 medtech deals, as well as the M&A outlook for 2008. Cohen is president of the Walden Group Inc. (Tarrytown, NY), a strategic investment-banking firm specializing in the healthcare industry. He has provided strategic, operating, financial, legal, and tax expertise in numerous mergers, acquisitions, and other healthcare transactions. Cohen can be reached at 914/332-9700 or via e-mail at rsc@waldenmed.com.
Business Planning & Technology Development
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| Thoma |
As with many business ventures in today's globalized economy, medical device companies see lower costs and increased efficiency as major benefits of taking clinical trials overseas. At the same time, there are potential drawbacks to conducting clinical trials overseas that must be weighed against the benefits. In "Clinical Trials Go Global", Michael Thoma explores potential stumbling blocks for overseas trials, including the myriad regulations that may trip up unwary companies with unfamiliar requirements. Thoma is assistant vice president for global technology underwriting at Travelers (St. Paul, MN). He is responsible for determining segment strategy and appetite and supporting field offices in product development and underwriting training. Thoma can be reached at 651/310-5061 or via e-mail at mjthoma@travelers.com.
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| Maines |
Public concern about corporate conduct and influence has been growing steadily over the past four decades, and medical device firms are far from immune to the rising tide of public scrutiny. Although there is no one-size-fits-all approach for company leaders looking to create an organizational culture that promotes ethically responsible behavior, there are frameworks that can help executives think about how they should approach this undertaking. In "Creating Cultures of Responsible Conduct", T. Dean Maines focuses on an approach that has proven useful for two decades. Maines is president for the SAIP Institute at the University of St. Thomas Opus College of Business (Minneapolis). The institute fosters ethically responsible business conduct through the Self-Assessment and Improvement Process (SAIP), a method that enables organizations to appraise and enhance their performance on questions of corporate ethics, governance, and social responsibility. Maines can be reached at 651/962-4261 or via e-mail at tdmaines@stthomas.edu.
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Kadamus
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Bates
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Companies are discovering that managing their carbon footprint and determining their impact on the surrounding environment is not just good environmental stewardship—it is also good business. Although consumer-based markets have been the primary proponents of this business model, the medical technology industry could benefit greatly from embracing the notion of sustainability. In "Greening Medtech", Chris Kadamus and Wayne Bates, PhD, PE, examine the various drivers that are beginning to coax the medical technology industry toward more sustainable design and operation practices. Kadamus is a principal design engineer with Cambridge Consultants Inc. (Cambridge, MA). During his 10-year career in the medical device industry, he has designed products for a variety of industry sectors, including drug delivery, endoscopy, general surgery, cardiac critical care, and in vitro diagnostics. Kadamus has worked to implement sustainable design methods such as design for disassembly, part count minimization, and use of recyclable or biodegradable polymers. Bates is engineering manager at Capaccio Environmental Engineering Inc. (Marlborough, MA). Bates has more than 20 years' experience in the environmental field and specializes in providing design solutions for projects involving water conservation, industrial wastewater treatment, and product life cycle assessments. Kadamus can be reached at 617/532-4700 or via e-mail at chris.kadamus@cambridgeconsultants.com. Bates can be reached at 508/970-0033 or via e-mail at wbates@capaccio.com.
