Medical device manufacturers routinely design products that, even a few short years ago, were the stuff of science fiction. And let’s not even mention the amazing research underway today that will animate tomorrow’s medical products, from Tricorder-like devices performing on-the-spot diagnostics to 3-D printers producing replacement body parts. But there’s a problem: money. To succeed in today’s marketplace, medical device original equipment manufacturers (OEMs) must take into account funding and reimbursement pathways, the critical role that health technology assessment (HTA) can play, and other factors that may have little to nothing to do with how well or how safely a device performs its intended task. The three-day conference at MEDTEC Europe 2012, which returns to Stuttgart, Germany, from 13 to 15 March, is designed to bring clarity to this fragmented and muddled process.
The opening full-day session smartly sets the tone. “Market access hurdles for the MedTech” industry convenes a distinguished group of experts offering insights on everything from health technology assessment agendas and funding riddles to the vagaries of procurement and reimbursement practices. Their informed opinions are especially valuable in the current economic climate, where healthcare budgets are increasingly under siege. In a post published on the Eucomed blog last year, Joerg Kruetten, Executive Vice President at Simon-Kucher & Partners, described the knock-on effect that financial constraints are having on healthcare systems.
“Stricter reimbursement controls by payers, which are increasingly often combined with formal health-technology assessments and/or case-based funding across the EU, are putting significant budgetary pressure on caregiver institutions,” wrote Kruetten. “In response to cost pressure, many caregivers are focusing on the procurement side as a comparably easy area to cut operating costs. This has led to higher procurement professionalism and to an overall decreasing influence of the clinical staff on product and therapy choice.”
As has been noted at several industry events over the last few years, notably at Eucomed-led meetings, the MedTech business model is changing dramatically. A fundamental part of that transition involves the determinant role that financial gatekeepers play in access to innovative medical technology. HTAs and outcome-based research are being stretched beyond their intended functions to declare winners and losers in the marketplace, while procurement and reimbursement mechanisms are gamed to excessively favour the payer. More than ever, medical device manufacturers must acquire a sufficient level of expertise in such matters to allow them to anticipate these roadblocks early during the development cycle and find pathways to overcome them.
To my mind, a good place to start building that expertise is by attending the MEDTEC Europe conference. In particular, the daylong session on 13 March features a host of well-informed speakers addressing these issues and, more importantly, suggesting solutions.
But that is not it. On day two, the conference focus shifts to the largest and most lucrative medical device market in the world—the United States, which accounts for approximately 40% of global healthcare spending. “Bringing your innovative device to the US Market: what you need to now” addresses a number of key issues that aspiring exporters must master if they seek success.
The impending revision of the medical device directives will be front and centre during day three of MEDTEC Europe. Among other speakers, Eucomed’s John Brennan, Director Regulatory and Technical Affairs, will share the medical technology industry’s views and positions on the revision.
Other tracks running in parallel with the aforementioned sessions will emphasis design, engineering and quality issues by focusing on the application of human factors engineering, the tenets of risk management and the ever-evolving principles of medical device design.
The full schedule and speaker list can be accessed at www.medteceurope.com. The conference is supported by Eucomed and media partner Spectaris. It is part of MEDTEC Europe, the largest European tradeshow devoted to medical manufacturing, which is organised by UBM Canon and sponsored by EMDT and Qmed.
I am sure the conference will produce many interesting discussions so head over to Stuttgart and join in the debate!
– Norbert Sparrow Editor in Chief, EMDT – medtechinsider