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

Push for Med-tech Innovation Policy Underway in Germany

The German government has formed a committee of industry and regulatory experts charged with developing a national innovation policy for medical technology.

According to German medical device manufacturing trade publication DeviceMed, Germany’s ministries of Education and Research, Health, and Economics and Labor are spearheading the initiative to boost innovation and competitiveness of German medical technology developers, as well as improve patient care and speed up time to market for cutting-edge devices.

The committee will examine issues including funding and regulatory frameworks as well as specialist workforce shortages, cooperation models, clinical trial requirements and alternative funding options.

Committee findings are expected to be available in late 2012.

Markets: EuropeTags: clinical trials, germany, medical device

Author: Stewart EisenhartDate: November 3, 2011

BVMed Annual Report: Healthy Returns, but Stronger Regulatory Support for Innovation Needed

In its latest annual report, German medical device industry trade group BVMed (Bundesverband Medezintechnologie) stakes out the group’s positions on German health policy, financing issues and medical device legislation, and also provides results of BVMed’s annual membership survey.

According to the survey, the German medical technology sector saw 5.5% sales growth in 2010, and 80% of respondents expect higher sales rates this year; profits will be challenged, on the other hand, by more expensive raw material costs and higher rates of outstanding debt.

In light of European economic challenges as well as increasing prices for raw materials, BVMed members expressed tempered optimism regarding 2011 results—48% of firms expect better returns this year, while only 17% anticipate lower returns.

Although respondents generally rated Germany highly as a medical device market, they also identified political and financial issues they believed should be improved in order to boost efficiencies in their view. To wit, 60% of firms cited reduced bureaucracy and faster decision-making processes as their top concern, and less than a quarter of respondents expressed satisfaction with the current German reimbursement system.

BVMed also used its annual report lays out positions the organization argues are necessary to better support innovative medical technologies in Germany. Among the group’s suggestions:

Formation and proper funding of an “innovation pool” to support independent assessment of medical devices’ benefits
Allowance for greater industry participation in the deliberations of the Joint Federal Committee overseeing Germany’s health care system
Expansion of innovation-friendly practices applied to the German inpatient sector to the outpatient sector as well
Keeping the Medical Devices Directive’s “New Approach” to regulating medical devices in place as the EU considers its MDD Recast

Give the size of the German medical device market—as well as the degree of influence Germany wields within the EU—how successfully BVMed pursues its goals will no doubt shape relationships between regulators and industry across Europe.

Markets: EuropeTags: BVMed, European Union, germany, MDD, medical device, Medical Devices Directive

Author: Stewart EisenhartDate: April 18, 2011

40-year EU Patent Impasse at an End?

The European Patent Office (EPO), the European Commission body theoretically responsible for evaluation of patent applications, appears closer than at any point in the last 40 years to achieving a more streamlined, less costly and truly centralized process for patent approval.

In a December 13, 2010 post on the blog medtechinsider.com, UBM Canon Editor in Chief Norbert Sparrow notes that medical technology developers accounted for the largest number (more than 12%) of patents filed with the EPO in 2009; according to Sparrow as well as recent Financial Times news (registration required), 10 countries including heavyweights Germany and France have appealed to EU internal market commissioner Michel Barnier to allow those countries to pursue a centralized patent approval system without the involvement of other member states, if necessary (much to the chagrin of Spain and Italy).

If the EU can successfully instill final approval authority within the EPO and do away with the current country-by-country patent granting and approval process, the ramifications for medical device and IVD manufacturers should prove quite beneficial. Caveats regarding the sometimes glacial pace of EU reform processes must of course be emphasized, but nonetheless progress—even if in slow motion—is progress.