Medical Device Blog – QA & Regulatory Updates from Emergo Group

The UK Department of Health has undertaken a campaign to expand the use of mobile medical devices and services to cover three million patients over the next five years.

Launched in collaboration with the National Health Service, industry and professional partners, the campaign entails deploying mobile medical devices to three million patients through 2016. The campaign’s work plan remains in early stages of development, however, according to E-Health Insider.

Because the capital investments required for establishing telehealth systems can be prohibitively high, according to the NHS, the Department of Health will consult industry to identify ways to address cost issues.

The campaign follows an effort the Department of Health began in 2008 to assess how telehealth would impact the NHS and British social care services; that assessment concluded that proper implementation of telehealth systems could result in 15% fewer A&E visits, 20% fewer emergency admissions, 14% fewer routine or elective health care visits and 14% fewer inpatient hospital stays.

If those predictions hold up, the case for governmental involvement in driving adoption of mobile medical devices becomes compelling. 

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.

A new report examining European in vitro diagnostic (IVD) market performance in 2010 sees flat or negative growth across most major EU member states due to cost containment measures and worsening economic conditions.

According to the European Diagnostic Manufacturers Association’s (EDMA) study, the European IVD market totaled €10.5 billion last year, with revenue growth of only two percent from 2009. Cardiology testing and diabetes-related IVD sectors as well as products for managing hospital-acquired infections showed the strongest growth rates in 2010, but all other testing areas showed flat or negative growth.

EMDA attributes these rates to European governments’ placing of limitations on IVD testing volumes and reimbursement to balance budgets. (Efforts by governments to implement ill-conceived austerity measures are also not helping.)

Germany remains Europe’s largest IVD market, but IVD revenue growth there was -0.01% in 2010 following a decision by the Federal Joint Committee to end reimbursement for some diabetes-related tests via statutory health insurance.

In France, new laws allowing consolidation of private laboratories also boosted procurement consolidations in 2010. Growth in the glucose self-testing segment totaled 6.4%, but all other IVD segments remained flat over the same period. Price decreases, Cost per Reportable Result (CPRR) efforts and more demanding customers all affected poor growth rates overall, according to EDMA.

The Italian IVD market showed modest growth (1.1%) last year, but late payments of as many as 700 days plagued the region; the market in Italy will likely face greater challenges as the country’s economy worsens.

Spain’s IVD market also grew slightly in 2010, by 0.5%, but EDMA expects pricing pressures to make Spanish market conditions more challenging for IVD manufacturers.

The UK has no official IVD reimbursement system in place, but cost containment efforts there have nonetheless driven laboratory consolidations. Efforts to contain the National Health System’s budget are also drawing more private-sector providers into the British IVD market.

It is difficult to see European IVD growth rates improving substantially going forward, as Continental governments large and small continue tightening health care-related budgets under the questionable assumption that austerity will stave off recession. 

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.