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.

New Study Identifies Five Principles of Effective Medical Device Procurement

A new study published in the Journal of Medical Marketing lists five key principles necessary to develop sound medical technology procurement strategies and avoid costly long-term consequences.

The study, “Global Best Practices in Medical Device Procurement—A Road Map to System Success,” examined research on health care cost containment efforts across 10 countries, and gathered input from government officials, health care providers and medical device industry officials.

First, the study found that procurement decisions and policies should be developed and evaluated in terms of impact on total cost rather than solely on initial product price.

Second, adequate clinical input into tendering processes is necessary to protect patient access to a proper array of treatment options, and to ensure that clinical requirements are satisfied as well.

Third, procurement officials should have the flexibility to implement provisions for new product adoption in order to improve access to new, superior medical technologies.

Fourth, procurement systems should develop strategies that spur competition among suppliers to help prevent market stagnation.

Fifth, procurement systems should ensure transparency of processes in order to improve efficiencies and prevent wasteful allocation of resources to administrative processes.

Markets: WorldwideTags: Journal of Medical Marketing, medical device, procurement

Author: Stewart EisenhartDate: May 20, 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.

Markets: EuropeCategories: Regulatory ComplianceTags: EHTI, EU, European Health Technology Institute, Health Technology Assessment, HTA, medical technology, procurement, reimbursement

Author: Stewart EisenhartDate: April 11, 2011

Eucomed Proposes Wider Adoption of Remote Cardiac Device Monitoring Tools

European medical device trade association Eucomed has made adoption of technology to remotely monitor implantable cardiac devices a key element of its four recently submitted proposals to the European Commission Innovation Union Strategy’s Active and Healthy Ageing Innovation Partnership program.

Eucomed has advocated greater use of remote monitoring of cardiac devices among EU health care providers in order to both improve chronic cardiac care and reduce costs by potentially more than €5.6 billion annually. But facilitating widespread adoption of remote monitoring devices will require setting up permanent reimbursement mechanisms, Eucomed argues, as current models do not properly account for these capabilities.

The other three proposals Eucomed has submitted to the European Commission include:

Developing procurement systems such as those in the UK and Sweden that prioritize innovative products
Facilitating research on the influences of national and local procurement decisions
Establishing more effective community care in lieu of hospitalization for conditions such as stoma, wounds and incontinence