Medical Device Blog – QA & Regulatory Updates from Emergo Group

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.

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.

Nine medical device industry associations have signed on to the Global Compliance Statement on Interactions Between Medical Technology Companies and Healthcare Professionals (HCPs), a document intended to promote ethically sound interactions between the groups’ member firms and health care providers.

The Advanced Medical Technology Association (AdvaMed), Eucomed and the European Diagnostic Manufacturers Association (EDMA) first signed on to the document in 2010; six additional groups—the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR), the International Medical Devices Manufacturers Association (IMEDA), MEDEC, the Medical Technology Association  of Australia (MTAA), the Medical Technology Association of New Zealand and the South African Medical Device Industry Association (SAMED)—signed the document during the 2011 International Medical Device Industry Compliance Conference in London, according to a Eucomed press release.

Specific efforts the associations have agreed to undertake include pushing their respective members to adopt compliance policies and procedures in line with industry codes; providing guidance to industry regarding ethical business conduct when engaging with health care professionals; keeping members informed of relevant laws, regulations and professional codes that impact how firms interact with health care professionals; and collaborating to increase adoption of ethical codes of conduct on a global scale.

Buy-in of the global compliance statement among a significant number of trade groups representing various medical device markets no doubt reflects a more advanced and nuanced level of maturity of the industry as a whole—but also the need for member companies to establish adequate processes and procedures in the face of growing regulatory interest.

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.