Author: imsta_master

The medical technology industry welcomes the vote on the consolidated medical device and in vitro diagnostics regulation texts by representatives of the Council and the Parliament on Wedneday 15^th June.

The Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament and Council’s Committee of Permanent Representatives (COREPER) voted to endorse the trilogue agreement. The texts can be downloaded and viewed on the European Parliament website – click here for more information.

MedTech Europe, the alliance of the medical device association Eucomed and the in vitro diagnostics association EDMA, continue to recognise the importance of these regulations towards the sector and the healthcare continuum at large.

“Medical technologies save lives, improve health and contribute to sustainable healthcare. Many of the proposed updates in the regulations are welcomed by our industry as they will enhance patient safety and facilitate access to new technology” says Serge Bernasconi, CEO of MedTech Europe.  “I believe that the new regulations are critical in filling in the gaps of the existing laws and in bringing a more harmonised set of guidelines across the region”, he added.

EDMA and Eucomed have already begun working on an in-depth analysis of the regulations to assess the overall impact towards the industry.  At the same time, EDMA and Eucomed are putting in place plans to provide active guidance and expertise for members to comply smoothly with the new regulations. IMSTA will put these Guidelines up on the members only section of our website in due course.

The consolidated texts are expected to undergo legal review and language translations in the coming months and are expected to be formally adopted at the end of 2016. The regulations would then apply to the medical devices and to the in vitro diagnostics sectors by 2020 and 2022 respectively.

Value-based health care is an emerging paradigm which has the power to change health care as we know it, but in order to achieve real impact, it must be applied to the key decisions that make up care delivery.

Several hospitals, procurement and even regional health authorities, have started including health care quality and longer-term cost impact considerations in their procurement decisions.  That’s seems reasonable given that the public health system is there to provide for maintaining the health of the population.  But what is meant by value?  Value is not just about cost, but also and principally about broader patient health and societal benefits.  Value is therefore a holistic concept.

One of the most critical decisions is the procurement of products or services by health care providers.  By choosing one product or service over another, procurement officials are de facto impacting the care being offered and incentivizing the industry and other health care stakeholders to act in specific ways.  Given this significant influence, procurement agencies should be one of the key players in health care leading the effort to focus on value.  Value in health care is not about getting three for the price of two.  This has enabled them to take health outcomes into consideration as well as other quality criteria, along with the total lifecycle cost and longer-term costs of care, so as to ensure best value for the patient, the medical staff, the entire hospital group and society.

It is further encouraging to note the increased focus the 2014 EU public procurement directive has placed on the quality criteria. This directive, which is currently being transposed into national legislations by the member states, puts clear focus on total economic value by making the most economic advantageous tender the default criteria and encouraging the use of best price/cost – quality ration i.e. the best value for money.

MedTech Europe in partnership with The Boston Consulting Group and international procurement experts, have been leading the way in developing a framework and tools to help health care providers evaluate the broader patient health and societal benefits when procuring health products or services.

At IMSTA’s Annual Conference ‘Embracing Technology in Value-Based Health Care’, Götz Gerecke, Managing Director and Partner of The Boston Consulting Group in Switzerland gave a presentation how BCG and MedTech Europe collaborated to create a framework and tool-kit to facilitate smarter procurement which will result in value and quality being included in tender evaluation in future. This will be a focus area for IMSTA in 2016 and beyond.

So, what does Value-Based Health Care actually mean?  See the BCG/MedTech document BCG-Procurement-Dec-2015.

We have mentioned many times before that the Health Products Regulatory Authority (formerly the Irish Medicines Board – IMB) is about to introduce fees for distributors of medical devices.  This will happen this year – 2016 – though the fees may only be payable from 1^st January 2017, we’ll have to wait and see.

The reason the HPRA gives for the imposition of fees on distributors is “the introduction of  fees at national level to recover the cost associated with our medical device regulatory activities”.   The new EU Regulations governing the manufacture, sale and distribution of medical devices finally comes into force this year, possibly by as early as June 2016.  The HPRA as the Competent Authority in Ireland is responsible for the monitoring of the safety and performance of medical devices throughout their lifecycle.  In it’s role as market surveillance authority, the HPRA monitors medical devices after they are placed on the market and currently conduct audits at medical device manufacturing facilities, amongst other regulatory activities in this area.   The Regulations will introduce new requirements and obligations for all economic operators, including distributors.  As such, the HPRA will be required to monitor the compliance of medical device distributors with the requirements laid down in the Regulations, which are anticipated to essentially constitute Good Distribution Practice (GDP) for medical devices.

What will this mean for distributors? Apart from the annual fee, distributors will be subject to having their supply chain operations audited by the HPRA.  So what will an audit entail?  HPRA conducted a Pilot Inspection Programme for Distributors of Medical Devices recently with a view to determining an appropriate inspections protocol when they go “live” with distributor audits in 2017.

IMSTA have invited HPRA’s Darren Scully to provide an update on the distributor pilot inspections programme for medical devices – key findings and recommendations in line with the medical device revision as the text currently stands – at a business breakfast briefing on 11^th May next.  This is really important so register early, we’re anticipating a huge turnout.   Confirm your attendance now by emailing admin@imsta.ie a.s.a.p.

We hope to be able to organise a follow-up business breakfast briefing shortly after the above which will be aimed at providing guidance on how members can comply with any recommendations the HPRA may have for distributors.

The IMSTA Annual MedTech Conference held on 6th April in the Crowne Plaza in Santry is one of only two flagship events that the medical supply industry puts on every year.  The event presents an opportunity to have industry issues publicly debated by recognised experts.  The participation of senior figures from the Irish health system and international thought leaders is testament to the high regard afforded to IMSTA events.

It was very encouraging to notice at this year’s event that the language has changed. Senior government officials and Chief Executives of our hospital groups are now talking of partnering with industry, consulting with industry, working together in an effort to deliver value-based healthcare. Even with the unfortunate last minute cancellation of the excellent Dr Rhona Mahony, we managed a programme that was interesting and relevant to delegates.

Many senior figures from government and it’s agencies attended and the feedback so far has been excellent. Commendations like “IMSTA conferences are always excellent”,  “A very good meeting and great speakers with lots of food for thought” and “another excellent IMSTA conference this week. I found it very useful . . “  are typical of the responses we receive, and they are not from members.

Finally, it is noteworthy that the Secretary General at the Dept. of Health, Jim Breslin, took the time to share the strategy and perspective of the department with us, he hasn’t gone to such lengths at other similar events. It must be good for members to hear what government’s thinking is, straight from the horse’s mouth.

Note that all the presentations are available below.

Mind Maps of the presentations areavailable at:  MIND MAPS 2016.

OPENING ADDRESS – Jim Breslin, Department of Health

VALUE-BASED HEALTHCARE, A NEW FRAMEWORK FOR SMARTER PROCUREMENT – Gotz Gerecke, The Boston Consulting Group AG

eHEALTH A CRITICAL ENABLER, Richard Corbridge, HSE (short version)

PRIORITISING VALUE IN A MAJOR INFRASTRUCTURE INVESTMENT OPPORTUNITY – Ms. Eilish Hardiman, Children’s Hospital Group

ROLE OF TECHNOLOGY IN DELIVERING HEALTHCARE – NO PLAN, NO MONEY, NO VISION – Prof. Barry McMahon, Tallaght Hospital and TCD

SBIR, GOOD FOR THE ECONOMY, GOOD FOR PATIENTS – David Connell, SBRI Management Board