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 15th 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.
Following IMSTA’s AGM on 6th April last, we are pleased to announce that Mark Coffey, Country Manager, Johnson & Johnson Medical, has been elected to Council.
David Duffy, Prospectus, and Paul Mullaly, B. Braun, have retired from Council and we would like to extend our thanks to David and Paul for all their work on behalf of the members of IMSTA.
Mark is the Country Manager for our Medical Devices business in Ireland, with responsibility for the commercial operations both North and South of the boarder. He has 14 years’ experience in the medical devices industry and has worked for Johnson & Johnson for the last 4 years. Prior to Johnson & Johnson, Mark spent 3 years with Synthes Medical Ireland Ltd as Managing Director and 7 years with Boston Scientific in various sales management & marketing roles across the UK & Ireland.
The Johnson & Johnson family of companies have been operating in Ireland for 80 years, employing in excess of 2850 people across three business sectors; Medical Devices, Pharmaceuticals & Consumer Healthcare.
Mark has significant experience in dealing with key stakeholders such as government officials, semi state bodies and health insurance companies. This experience, along with his broad understanding of the NHS in England, could be beneficial to IMSTA as the Irish healthcare landscape continues to evolve towards a Money Follows The Patient / DRG model.
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.
IMSTA is pleased to announce an extension of our partnership with TenderScout to provide up-to-date medical and surgical supplies government opportunities on our own IMSTA website.
Members can now browse the list of open tenders and click through to gain more details on those of interest, or to browse through TenderScout’s global database of qualified government contracting opportunities.
Members can additionally add their email to TenderScout and gain access to a rich set of features that reduce the likelihood on missing out on the best opportunities to win business.
TenderScout finds winnable tenders by sifting through thousands of tender opportunities daily and automatically qualifying those that are right for you. Rather than searching multiple websites to find tenders, which you then have to qualify using incomplete information, use TenderScout to find the few that are the most winnable for you.
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 1st 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 11th May next. This is really important so register early, we’re anticipating a huge turnout. Confirm your attendance now by emailing firstname.lastname@example.org 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.
Mark Keating has just returned from an almost four month Walk For Their Lives expedition through six countries in the Balkans. He under took the walk to raise funds for two special beds that are needed in St John’s Cancer Ward in Our Lady’s Hospital for Sick Children in Crumlin, and similar requirements for a children’s cancer ward in Belgrade, Serbia.
Alone with his dog, Pajo, Mark– who is the CEO of Sandyford-based company Whitewater – went on a voyage inspired by a journey taken 100 years ago this year by his great grandfather and his grandfather-in-law.
His Irish great grandfather was with the London Irish Regiment and his grandfather-in-law was from Serbia. Their stories came together as they had to walk for their lives on the same side during the First World War, and, incredibly, survived.
In October 1915, the last survivors of the Serbian army, government, civilians, and some 30,000 boys were evacuated from their homes and country as they were chased by the German, Austrian and Bulgarian armies out of their homeland.
Some 450,000 people – comprising soldiers, refugees, families and young boys – set off to escape capture by walking over the high mountains of Montenegro and Albania to the relative safety of the tiny island of Corfu.
Mark and Pajo walked 1,990km for 103 days across 6 countries: Serbia, Bosnia, Montenegro, Albania, Greece and Macedonia, and managed to raise €12,000 for the cause, so far.
S p e a k i n g t o us he said: “My great-grandfather fought and survived and he gave me life and my wife’s Grandfather was the same, so this was a walk to remember the living rather than the dead, and to remember how tough the fight was to live.”
Mark’s quest drew from the “similarities of my great grandfather’s walk for life and the children today who are fighting for their lives to rid themselves of cancer, and that’s where the connection came in and how the story evolved”.
This is not Keating’s first adventure for the cause. In 2013, he undertook a solo charity cycle from Dublin to Belgrade and back to Dublin – a total of 6,080km across 12 countries, to raise €60,000 to buy critical lifesaving equipment for Temple Street Children’s University Hospital, Our Lady’s Children’s Hospital, Crumlin and The Mother and Child Hospital in Belgrade.
Mark wants encourage anybody at all to support the cause and help the children by donating to www.whitewaterfoundation.org.
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.
A pioneering partnership between private sector companies and the health service to develop groundbreaking Irish healthcare products and research and use them to benefit Irish patients has been set up by the Government.
Minister for Jobs Richard Bruton and Minister for Health Leo Varadkar have announced €5 million in funding over five years for the Health Innovation Hub. The Hub has already shown its value and fostered a number of innovative healthcare products and services since it was set up on a pilot basis in 2012 based in University College Cork.
The Health Innovation Hub will be a win-win for businesses, the health service, and for job-creation:
- Innovative Irish healthcare companies will for the first time be able to easily access the health service to test their products and services, increasing the chances of developing commercial ideas and creating jobs;
- The health service will have easy access to innovative companies who can provide solutions to the problems that it faces, making it cheaper and easier to deliver better health-care to more patients.
The initiative has massive potential for Ireland’s burgeoning healthtech sector, and for improving healthcare services and outcomes for patients. It has already supported 23 projects involving 27 companies including:
- an online tool for GPs to monitor the physical activity of patients via a smartphone or wearable devices;
- scheduling services to improve patient flow;
- infection control and hygiene management systems.
And it has helped Irish-based companies to sell their technology abroad:
- Abtran, who were testing an electronic GP referral system were able to use the knowledge gained to tender for a similar service in a UK Trust;
- Radisens, who were validating point of care testing equipment, have now closed a contract with a Tier‐1 strategic customer for Troponin development. Radisens secured a significant ESA contract valued at €1m to develop an innovative blood testing device for use by astronauts on board the International Space Station and on various human spaceflight missions;
- Lincor Solutions tested bedside units to provide entertainment, education and access to clinical data. Access to clinical data provides the clinical team with more information at patient bedside and can improve patient satisfaction.
Speaking at the announcement, Minister Bruton said: “The Health Innovation Hub was identified as a Disruptive Reform in the Action Plan for Jobs and I am delighted that we have now progressed to establishing the Hub at the national level. We have combined exports from our lifesciences and ICT sectors of over €140 billion annually and the strengths of our enterprise base can be leveraged to deliver much needed innovation into our health system and at the same time sustain and create more jobs in these sectors.
“The commitment by Government to a facility such as the Health Innovation Hub also sends out a very strong message to international companies considering investing in Ireland that we are committed to developing even stronger links between the health and enterprise sectors and the high level R&D driving each sector. As part of our long term plan this will help turn good ideas into good jobs and ultimately make a major contribution in a drive towards full employment. ”
Minister Varadkar said: “Often when we talk about health, the discussion only focuses on the cost to the Exchequer. If you look at things in the round, health actually makes an enormous contribution to the economy. More than 100,000 people are employed in the public health sector and as many again with private healthcare providers, insurers, pharmaceutical companies, medical devices, and in research and development. The life sciences sector accounts for a lot of our export revenue and is a major source of inward investment. The Health Innovation Hub is an opportunity to build on this by creating linkages between the health service and industry to develop new products and services that we can use to improve our own health service at home and sell as products and services abroad. It’s also a good example of joined-up Government as it involves two Government Departments, two Government agencies and the universities.”
The Health Innovation Hub had been funded as a pilot project and following evaluation of the pilot, the Government decided to scale the project up to the national level with direct financial support being provided by Enterprise Ireland and in-kind support being provided by the Health Service Executive including dedicated staff. Following a competitive process a consortium led by University College Cork, with partners including Cork Institute of Technology, Trinity College Dublin and the National University of Ireland Galway, was appointed to host Health Innovation Hub Ireland.
A new Hub Director will now be appointed, who will guide the Hub through the next five years. The first call for proposals will be made later this year. A Stakeholder Advisory Group will also be set up to act as a forum between suppliers and users.
Julie Sinnamon, CEO, Enterprise Ireland commented: “Ireland’s strengths in ICT combine well with expertise in traditional healthcare and medical technology and many of our indigenous medtech businesses are leading international players in their areas of specialist expertise. Enterprise Ireland is committed to supporting collaboration opportunities between the health system and enterprise sector in order to innovate and internationalise healthcare technologies. The Health Innovation Hub will improve the efficiency of the commercialisation process of new technologies, products and services, benefitting the health sector and society as a whole”.