Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

German Med-Tech Industry Reports 5% Growth

Germany’s medical technology industry has seen sales rates grow by more than five percent according to a survey by the German Medical Technology Association (BVMed).

The BVMed survey had 117 participants, and was released before the 2011 Medical tradeshow in Düsseldorf last month. Key results:

Nearly 80% of respondents expect 2011 sales to eclipse their 2010 results, due primarily to growth in exports
Despite sales growth, German medical device manufacturers are having to deal with rising costs of raw materials and transportation, as well as late payments—all of which are impacting profits
Half of all survey respondents have created new jobs in 2011, and 35% of respondents have maintained current staff levels over the same period; BVMed estimates that its entire membership of firms has created 3,000 new jobs in Germany within the last year
A majority of respondents indicated favorable views of Germany as a business location, citing high levels of patient care, good infrastructure, efficient market approvals and high standards of clinical research as strong points
Respondents perceived weaknesses in Germany’s reimbursement system, including increasing pricing pressures from purchasing groups, low reimbursement levels and statutory health insurance policies “hostile” to innovative products

Steps respondents would like to see taken in order to address weaknesses in the German medical device regulatory system include shorter decision-making timeframes by the Federal Joint Committee, as well as reforms for self-governing bodies.

A key question based on the survey results is which export markets are providing the most sales growth for German medical device manufacturers. Are these markets primarily other European Union member states, or they primarily overseas markets in Asia and the Americas? As the European economic crisis continues to unfold, these firms may find it harder maintain sales rates in their closest markets.

Markets: EuropeTags: BVMed, EU, germany, medical device, medical technology, reimbursement

Author: Stewart EisenhartDate: December 1, 2011

Eucomed Unveils Five-year EU Healthcare Strategy

European medical technology trade association Eucomed has published a five-year strategy for improving the EU healthcare system by more closely aligning medical technology with health care delivery and reimbursement models.

Citing ageing populations, growing labor shortages and other demographic trends posing challenges to the current European healthcare system, Eucomed proposes a focus on “value-based innovation” by medical technology manufacturers in order to improve both cost efficiencies and health outcomes. It is incumbent upon industry, according to the Eucomed plan, to develop a collaborative model with healthcare providers and regulators whereby industry will:

Establish the value of medical technology and product innovation
Develop and share evidence-based arguments that medical technology can support health ageing
Prove medical technology’s cost efficiencies
Expand innovative practices to address looming healthcare labor shortages
Increase the medical technology industry’s value within the broader EU economy

Eucomed also recommends changes in healthcare spending practices, noting that currently only five percent of such spending in the EU goes to medical technology, whereas 70% of spending goes to medical care delivery. Investing in medical technologies to boost prevention as well as efficiencies within healthcare systems will require major adjustments to those spending percentages, Eucomed argues. In addition, the group contends that silo-based funding and reimbursement of healthcare in the EU should be phased out in favor of value-based pricing to incent medical technology innovation as well as better longer-term health and economic outcomes.

Eucomed members will be required to sign on to its plan by 2015. Demonstrating value-based evidence of medical technology can improve healthcare systems could drive European regulators to more fully support the group's recommendations--depending on how convincing that evidence is.

Markets: EuropeTags: EU, Eucomed, medical technology, reimbursement

Author: Stewart EisenhartDate: October 13, 2011

New Guidelines for Medical Technology Issued in the UK

The National Institute for Health and Clinical Excellence (NICE), an organization providing health care-related guidances and standards in the UK, has published guidelines explaining the process and methods of its Medical Technologies Evaluation Programme (MTEP) designed to promote efficient and consistent uptake of medical technologies within the National Health System (NHS).

The NICE guidelines should prove especially relevant to medical device and technology manufacturers interested in adding their products to the program, according to the organization. NICE developed the guidelines through consultation with the NHS, industry representatives, academia and patient advocates.

Markets: EuropeTags: medical device, medical technology, MTEP, NICE, UK

Author: Stewart EisenhartDate: April 25, 2011

EHTI Research Takes Aim at “Innovation Paradox” in EU Medtech Procurement Policy

New research by the European Health Technology Institute for Socio-Economic Research (EHTI) puts forth five recommendations to address the impact of more centralized medical technology procurement policies among European health systems on product innovation.

The EHTI’s report, Resolving the Innovation Paradox of MedTech Procurement: Five Lessons from Research Outcomes, argues that moving toward centralized procurement processes has enabled health systems to reduce short-term costs at the expense of longer-term cost effectiveness via innovative treatment regimes. In order to get beyond this mindset prevalent among procurers, medical technology providers should carefully consider issues such as value perception, innovation models and barriers to new product adoption.

First, EHTI recommends providers more clearly articulate the value their innovations offer—rather than just list technical features and expect clients to infer value—in order to successfully commercialize their products.

Second, providers should identify communities of practice most relevant to their products, and deploy their marketing and sales efforts accordingly.

Third, better recognition of barriers to adoption related to increasing use of cost-control measures and more difficult product differentiation would allow managers to plan earlier and more effectively to overcome those barriers.

Fourth, the EHTI identifies the growing use of Health Technology Assessments (HTAs) across the EU as a challenge to manufacturers of innovative medical technologies and devices, primarily because HTAs in their current form have been designed largely for pharmaceutical products. As such, providers should persistently and constructively suggest HTA bodies develop new methodologies to address significant differences between pharmaceutical and medical technology products.

Fifth, successful product commercialization includes not only initial adoption rates but also sustained ones, particularly as development costs grow and product lifecycles shrink. Accordingly, providers should include analysis of product sustainability in their launch plans.