MICK MacCLANCY’S STORY
See how Irish Medics and Medtech saved Mick’s life ….
As you may have heard at IMSTA’s Annual Conference, the Minister for Health Simon Harris TD welcomed the HSE PCRS’s decision to reimburse Freestyle Libre for children and young adults
Minister Harris said “Almost 190,000 people in Ireland have diabetes. This is a chronic disease that takes a lot of management, but we have made huge strides in treating and managing diabetes here and I’m very happy today to welcome the HSE’s decision to reimburse Freestyle Libre for children and young adults.”
“This innovative device will allow blood glucose levels to be monitored without invasive finger prick testing, which will be very welcome news for both parents and children. I know that some patients have to test their glucose levels up to ten times a day and I hope that inconvenience and discomfort can be minimised for as many children and young adults as possible.”
“This is another very positive step in the management of diabetes, along with the Diabetes Cycle of Care, which is a great example of how joined-up primary care and expanding the scope of general practice can be so effective in reducing hospital visits and admissions. The Cycle of Care allows adult patients with Type 2 Diabetes, who hold a medical card or GP visit card, to be managed in the community, by their own GP and practice nurse, rather than in a hospital clinic.”
“We know from the National Healthcare Quality Reporting System (NHQRS) that hospitalisation rates that have decreased substantially for diabetes, and I want to see that downward trend continue. My Department is progressing more work in the area – the National Clinical Effectiveness Committee (NCEC) prioritised the development of a Diabetes Type 1 clinical guideline for adults during 2017. The HSE’s National Clinical Programme for Diabetes plan to complete this guideline and submit to the NCEC for quality assurance early this year, and I hope to see it published soon after.”
“The HSE will now make arrangements for the reimbursement of Freestyle Libre on an individual basis where specific criteria are satisfied in line with the recommendations of the Health Technology Assessment Group and I look forward to its being available for patients in the coming months.”
An Expert Group, under the auspices of the HSE’s Health Technology Assessment Group (HTAG), considered the Free Style Libre application by Abbott for addition to the Reimbursement List in line with the Health (Pricing and Supply of Medical Goods) Act 2013.
The Health Technology Assessment Group recommended that reimbursement for the device should be considered, subject to certain conditions (see here for further information).
The HSE has accepted its recommendations in principle and will be developing an application suite for hospital clinicians to use when proposing suitable patients for consideration of individual reimbursement support.
This will be confined to children and young adults who require multiple dose injections of insulin in the first instance, with a review after twelve months. The HSE has indicated that it will take some months to build the application suite for reimbursement support which will be endocrinologist / Hospital Clinic initiated.
See Abbott winning their IMSTA AWARD here https://youtu.be/A3Nj85O6PTc
The Board of MedTech Europe has issuing the following recommendation to IMSTA/its members:
If you have any business interaction with the UK, consider this as a critical and urgent situation requesting all your attention. Anticipate business continuity plans including a “hard Brexit” scenario that should include no recognition of your UK CE marked products in the EU27 after the end of the transition period. This includes not only products originating in the UK but products from other countries who used UK Notified Bodies to gain CE marking, e.g. BSI (Italics added by IMSTA).
These plans need to take into consideration the possible delays in product re-certification by Notified Bodies due to the transition into the new Medical Device Regulation (2020) and IVD Regulation (2022).
The dynamic of the negotiations will evolve as we get closer to the end of the transition period and to a possible “cliff”. Rest assured that MedTech Europe will continue to put all their effort in advocating their proposition up to and even after the end of the transition period. We will keep you informed on the evolution of the situation, which is fully monitored by the Board of MedTech Europe and its dedicated Brexit Task Force.
Following our very successful Annual Conference 2018, the following presentations are now available:
Measuring outcomes in Ireland – Prof. Charles Normand, Trinity College
Slaintecare and Value-Based Health Care – Dr. Thomas Kelley ICHOM
HTA as a driver: HIQA’s Health Technology Assessment of Mechanical Thrombectomy in Strokeusing – Dr. Máirín Ryan, Director HTA and Deputy CEO HIQA
Appllying Value Based Health Care to MedTech – Yves Verboven, Director Market Access & Economic Policies, Medtech Europe
CASE STUDIES- How value-based health care strategies are delivering better outcomes
2 Examples from MedTech Europe’s Value-Based Procurement pilot studies
(a) HCB MEAT TAVI Pilot – Ameer Ally Edwards UKI
(b) UniHA – Hypothermia – Kevin Bellenger
Value Based Health care in Wales – Alan Brace, Director of Finance, Health & Social Care, Welsh Government
Assessing the Value of Medical Devices in the HSE – Dr. Anne Dee, Health Technology Assessment Group Lead and Specialist in Public Health Medicine, Department of Public Health
Collaborative approach to Procurement – John Swords, Head of Procurement, Health Business Services, HSE.
Ltor: Michael Collins, Irish Ambassador to Germany, Dr Tom Kelly – Head of Industrial, Lifesciences and Consumer Division at Enterprise Ireland, Sean Kinsella, PMD Solutions CTO, Anne Dorney, PMD Solutions, CFO, Pat Breen, Minister for Trade, Employment, Business, EU Digital Single Market and Data Protection and Myles Murray, PMD Solution CEO.
The NHS Innovation Programme is a partnership between England’s 15 Academic Health Science Networks (AHSNs) and is focused on working with healthcare innovators.
The announcement from the world’s largest healthcare conference Medica, where PMD Solutions was showcasing its RespiraSense product, a device which can continuously monitor patients’ respiratory rates. The device can help detect patient deterioration up to 12 hours in advance of an adverse patient event, allowing healthcare professionals to intervene faster.
PMD Solutions was invited by Enterprise Ireland to be part of the Irish pavilion where they represented alongside some of the world’s leading medtec organisations.
The NHS will rapidly adopt the company’s RespiraSense product to help improve the standard of care throughout the UK. The device is currently being piloted in Portsmouth, Bradford and London hospitals as part of the Innovation Programme.
RespiraSense is currently awaiting FDA clearance but PMD Solutions expect it to be available for sale within the US sometime next year.
Minister for Trade, Employment, and Business, Pat Breen TD said: “I am delighted but not surprised with PMD Solutions’ recent successes. I had the pleasure of visiting them at this year’s Medica event and was extremely impressed by their high levels of innovation and entrepreneurship. It is wonderful to see an Irish company at the forefront of medical technology advances. They serve as a great example to all Irish companies with ambitions to trade internationally.”
Sheila O’Loughlin, senior market adviser, Enterprise Ireland said: “PMD Solutions has achieved significant traction in the UK market, further strengthened by its recent acceptance on the prestigious NHS Innovation Accelerator Programme. We will continue to support them as they expand in to European and global markets.”
Speaking about the company’s recent successes, Myles Murray, CEO, PMD Solutions said: “We are most grateful to Enterprise Ireland for giving us this fantastic opportunity to showcase RespiraSense to the global healthcare industry. We have created an innovation that is set to change the face of in hospital monitoring at a global scale, improve patient outcomes and generate substantial cost savings for healthcare providers.”
Murray continued: “We are a young company with big ambition. The recent NHS announcement, coupled with Medica has allowed us to engage with global leaders and positioned PMD as an international clinical differentiator in the patient monitoring market.”
With the implementation deadline for the updated MedTech Code of Ethical Business Practice less than 1 month away, IMSTA hosted a Breakfast Briefing to inform members of the two major changes which they should be aware of. Melanie Robertson (Siemens Healthineers), Chairperson of the Code of Ethics Group, kindly updated members of the following changes:
IMSTA Members can avail of templates etc which are available on the Med Tech Europe website by following the link here. Melanie also included some useful information which should assist the smooth adaption of the changes in her slide presentation available on request from email@example.com. This included information on how to navigate the MedTech Europe Conference Vetting System (CVS). This Conference Vetting System is an independently managed system that reviews the compliance of third-party educational conferences with the MTE Code of Ethical Business Practice, based on clear and objective criteria. For more information on this please see Med Tech Europe link above.
If any member would like more information or have any comments to make on the changes to the Code of Ethical Business Practice, please email firstname.lastname@example.org .
|MOST INNOVATIVE PRODUCT AWARD IRELAND Sponsored by |
WINNER - BEATS MEDICAL Health Exercises for Parkinsons Patients.
(ltor) John Carew and Ciara Clancy (Beats Medical) , and Tom Kelly (Enterprise Ireland).
|MOST INNOVATIVE PRODUCT MULTI NATIONAL sponsored by |
WINNER - ABBOTT DIABETES CARE for their FreeStyle Libre Flash Glucose Monitoring System.
(ltor) Colm McNulty and Barbara Scott (Abbott Diabetes Care), Tom Kelly (Enterprise Ireland) and Mark Coffey (Vice Chair IMSTA)
|BEST TECHNICAL SERVICES COMPANY sponsored by |
WINNER - OXYGEN CARE Technical support
(ltor) Brian Kearney (BEAI), Andie Healy, Maurice Moran and David Moran (Oxygen Care).
|BEST IMPROVEMENT IN PATIENT SAFETY sponsored by |
WINNER - SMITH & NEPHEW PICO NPWT System .
(ltor) Barry Heaton and Nigel Clancy (Smith & Nephew) with Mark Coffey (Vice Chair IMSTA).
|EDUCATION AND TRAINING AWARD sponsored by |
WINNER - BD PosiFlush™ Pre-Filled Saline Syringe training and staff efficiency programme.
(ltor) Ms. Mary Jacob (RCSI), Greg Quinn (BD) and Mark Coffey (Vice Chair IMSTA).
|eHEALTH/DIGITAL HEALTH AWARD sponsored by |
WINNER - CAREFOLK Integrated care platform.
(ltor) David Cass (Pathfinder), Owen O'Dohety (Carefolk) and Mark Coffey (Vice Chair, IMSTA).
|HEALTHCARE INNOVATION AWARD sponsored by |
WINNER - HSE Primary Care Project Development and introduction of the Risk-Sentience Auxiliary Framework.
(ltor) Mark Coffey (Vice Chair IMSTA), Jerry Selvaseelan (HSE) and Dr. Mairead O'Driscoll (HRB).
|MOST COST EFFECTIVE PRODUCT OR SERVICE sponsored by |
WINNER - VICLARITY Healthcare Solution
(ltor) Dr. Colman Casey (HIHI), Ogie Sheehy (VICLARITY) and Mark Coffey (Vice Chair IMSTA).
|BEST PRIMARY CARE/COMMUNITY SERVICE AWARD sponsored by |
WINNER - CAREFOLK Integrated Care Platform.
(ltor) Alan Wallace (Mangan O'Beirne), Owen O'Doherty (Carefolk) and Mark Coffey (Vice Chair IMSTA).
Justin Carty, CEO of IMSTA spoke with Irish Times journalist Sylvia Thompson
The cheapest product rarely gives customers the best value, according to Justin Carty, the CEO of the Irish Medical and Surgical Trade Association. Representing products ranging from bandages to CAT scans, Carty has to navigate a careful route when promoting the medical device industry to public and private hospital purchasers keen to get the best value for money with limited budgets.
But, as luck would have it, Carty’s agenda fits completely with the new EU public procurement directive. This 2014 EU directive presents a holistic analysis of value based health care which evaluates the entire life cycle, safety and effectiveness of products and not just the purchasing price. It also encourages the industry to define best price-quality ratio and to collaborate more closely with purchasers at the pre-tendering phase.
A recent report from the Boston Consulting Group, commissioned by Med Tech Europe (of which IMTSA is a member) presents a clear picture on how things need to change. Currently, most health care providers purchase medical products on the basis of the up-front purchase price, which, the consultants argue cloud the true cost of care.
The report includes insightful examples of what happens when broader criteria are used to purchase equipment. Take for instance, the Karolinska University Hospital in Sweden whose foutreen year tender for imaging services which included MRI, ultrasound and CT scanners; by tendering for imaging services rather than equipment, the contract included maintenance of technical standards, upgrades and replacement during the fourteen year period. Similarly, when the Stockholm County Council (which runs most of the city’s hospitals) sought tenders for wound care products, it asked suppliers to include calculations for the number of dressing changes, staff and transportation costs for changing these dressings. The winning bid was from the highest priced products which showed a lower cost of care over time.
The Boston Consulting Group report argues that smarter procurement such as these examples embraces a value-based framework that is aligned with the new EU directive. To include all the hidden costs of the equipment in terms of its durability and suitability to patient’s needs, the group suggests a calculation based on patient outcomes divided by the costs of achieving these outcomes.
Carty hopes this more holistic approach to procurement will be embraced by healthcare providers in Ireland. “This new procurement process focuses more on how to achieve better patient outcomes,” he says. Carty also suggests it would encourage clinicians to work more closely with the medical technology industry rather than leaving procurement decisions to those with their eyes firmly placed on the purchase price alone.
A natural extension of this approach would, according to Carty, be for healthcare providers to seek solutions to ongoing problems through industry competitions. This already happens in some countries such as the UK where the Small Business Innovation Research (SBIR) mechanism is used. There, NHS England’s SBRI Healthcare has worked with companies to come up with new solutions to problems in diverse areas such as diabetic foot ulcers, child and adolescent mental health and brain injury. The key element of effective SBIR programmes is that clinicians and front-line staff are the ones to identify the unmet need.
In his role as CEO of IMSTA, Carty proposed the SBIR model to a cross-departmental committee at Government level in 2015.
“We proposed that one to two per cent of the HSE non-pay procurement budget of €500 million could be ring-fenced to find solutions to identified healthcare problems,” he explains. The proposal was repeated in the IMSTA submission to the Oireachtas Committee on the Future of Healthcare in August 2016. As yet, the model hasn’t been embraced by the Health Services Executive.
Now, in 2017, Carty is keen to move the agenda forwards. To that end, Value-Based Healthcare Strategies is the theme of the IMSTA Annual Conference in the Crown Plaza Hotel, Santry on March 22. Confirmed speakers include Dr Tom Kelley from ICHOM, the International Consortium for Health Outcomes Measurement, Bill Maher, the CEO of the Bons Secours Hospital Group and Frank Sullivan, Adjunct Professor in Medicine and Director of Prostate Cancer Institute, NUIG. Throughout the conference, delegates will hear about the role of healthcare innovation in improving patient and clinical outcomes. Proposals for a new economic evaluation framework for medtech will also be discussed.
Ultimately, Carty is keen to spread the message about the role of medical technology companies in helping people live longer, healthier and more productive lives. “These life changing innovations also bring savings across the health care system by replacing more expensive procedures, reducing hospital stays and allowing people to return to work and home more quickly,” says Carty.
However, he adds a note of caution. “In order to understand the value and benefits of medical technology and ensure continued leadership of this industry, we must have the right public policies to support investment, innovation and patient access.”
Article for IMSTA Newsletter, Spring 2017
The Faculty of Nursing & Midwifery, Royal College of Surgeons in Ireland and IMSTA are delighted to announce a new innovative Credentialing Education Programme for Healthcare Industry Representatives (HCIRs) entering healthcare facilities for the purpose of conducting business. The programme aims to enhance the standards of training for HCIRs visiting healthcare organisations, provide assurance to health service and hospital staff and support public and private health service providers fulfil their duty of care to protect patients and ensure safe outcomes. Patient health, safety and confidentiality are the primary focus of the programme.
This bespoke blended-learning programme entitled: “HealthCare Industry Representative Credentialing Programme” will be delivered over 12 hours. The first four hours of the programme will be delivered, in one face-to-face in the RCSI at 9am, and finishing at 13.30pm.
A further 8 hours of content will be delivered on-line via the Faculty’s online “Moodle” Platform. These can be undertaken at a time and location convenient to the participant. Participants will be required to complete a short Multiple Choice Quiz (MCQ) on completion of the programme.
FEEDBACK FROM MEMBER WHO ATTENDED MARCH CREDENTIALING PROGRAMME:
“From an Industry Representative perspective, I feel it is very important to attend the course and attain the Credentialing Card, as our industry and the people we engage with on a daily basis require us to be ethical, compliant and, above all, be competent to ensure better patient care and patient outcomes.”
John Donovan, Sisk Healthcare /MED Surgical
The next HCIR Credentialing programme date for 2018 will be advised shortly.
New Programme Registration Process for Individual Applications:
Registration for the programme can be completed in four steps:
On completion of this step, a receipt is issued containing a Transaction Number.
Further Information on this Programme
Ms. Catherine Clune Mulvaney
Operations & Education Manager
Faculty of Nursing & Midwifery
123 St. Stephen’s Green,
T: 01 402 5172 M: 087 6374002
Dear Medical Device Stakeholder,
Your industry representative body has kindly agreed to distribute the attached letter (attachment I) on behalf of HPRA.
The purpose of the letter is to inform stakeholders of the new fees that will be implemented from 1 January 2017 and to request contact information so that HPRA can contact organisations directly on the matter of fees.
We could be grateful if you could respond to devicefee@HPRA.ie with the necessary contact details or go to the following website:
Human Products Authorisation & Registration Dept
Health Products Regulatory Authority | An tÚdarás Rialála Táirgí Sláinte
Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2.
Tel: +353 1 676 4971
Fax: +353 1 676 7836