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 Position Paper Urges Greater Industry Role in HTAs

In a new joint position paper, European medical technology associations are arguing for greater industry participation in the health technology assessment (HTA) process to promote more efficient decision-making and resource allocation.

Associations including Eucomed, COCIR and EDMA argue that increased health care industry involvement in HTA processes used to assess safety, effectiveness and value of medical devices would facilitate system and method improvements. Managing scale, costs and predictability of HTAs requires more substantial input from manufacturers to support regulatory agencies, according to the associations. Medical technology developers have also gained substantial understanding of local and international HTA systems through their compliance efforts; as such, including industry perspectives going forward would make for more robust HTA processes, argue Eucomed and its cohorts.

Medical technology manufacturers produce or sponsor most evidence used to inform HTA processes, according to the position paper, and their “sophisticated” understanding of their products enables them to more effectively interpret clinical evidence crucial to HTAs as well.

The paper furthermore identifies the following stages of the HTA process where industry can play a larger role: overall agency governance of the HTA process; specific technology assessments including data gathering and evaluation of evidence; and reviews of new clinical evidence as it emerges.

Industry desires to affect European medical technology regulation from within is understandable, but may not pan out—consider the Global Harmonization Task Force’s recent move to reform itself into the International Medical Device Regulators’ Forum and reduce input from industry representatives. European regulators may show similar inclinations.

Markets: EuropeTags: Eucomed, Europe, Health Technology Assessment, HTA, medical device

Author: Stewart EisenhartDate: December 12, 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: Ease Regulatory Requirements for Smaller-tier Medical Device Makers

European medical device industry trade group Eucomed has issued four major recommendations to the European Commission regarding easing regulatory requirements for small and medium-sized enterprises (SMEs) in order to foster innovation.

Eucomed has published a position paper, European Health and SMEs: Big Challenges, Small & Medium Sized Solutions, following a survey the group conducted over the course of 2010 of 12 European national medical technology industry associations to pinpoint major regulatory barriers to SMEs. Based on those survey findings, Eucomed has made four broad recommendations to EU regulators that the group argues will reduce unnecessary compliance requirements for smaller-tier medical device manufacturers.

First, Eucomed suggests a coordinated and transparent market surveillance program able to target specific product groups for both domestic and imported devices.

Second, the trade group argues for faster commercialization of “novel technologies” in order to expedite patient access to cutting-edge treatment and products.

Third, easier application processes for research and design funding programs should be established so that SMEs can more effectively access those funds.

Fourth, Eucomed urges broader information sharing among member state competent authorities pertaining to market access models and distribution channels to increase the overall size of the European medical device market.

On a related note, the trade association has suggested more transparent and predictable purchasing processes across the EU to clear up persistent questions about reimbursement and procurement; Eucomed also recommends scaled down Health Technology Assessment procedures be made available to SMEs with limited resources. (Eucomed plans to issue a separate document more fully discussing these two suggestions at a later, unspecified date.)

Furthermore, Eucomed has requested that the European Commission conduct a comprehensive survey of SMEs in the medical technology industry in order to more fully identify these firms’ operational needs and characteristics.