IMSTA IVD Open Day
IMSTA is planning to provide a forum for discussion on building a new narrative for the value of IVDs. We are hosting an IVD Open Day on 12 October in the Clayton Hotel Liffey Valley. Registration is from 9.15 am. and we would welcome your participation – see Agenda below.
Please reply to firstname.lastname@example.org a.s.a.p. for the IVD Open Day to register for your place.
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.
IMSTA Annual Conference 2018 will be held on Wednesday 11th April in the CROWN PLAZA HOTEL, Northwood Santry, Dublin 9.
Registration will be avialable shortly on www.imsta.ie.
Sponsorship enquries to email@example.com.
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.
Provider of respiratory monitoring technology PMD Solutions has been selected to join the NHS Innovation Accelerator Programme.
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:
- Stopping Direct Sponsorship to Healthcare Practitioners (HCPs). As of January 1, 2018, it will no longer be allowed for companies to provide direct financial support to individual HCPs to attend either local or international Third Party Organised Events (e.g. congresses). Instead, support can be offered through Educational Grants provided to Healthcare Organisations (HCOs) or Professional Conference Organisers (PCOs). The message here was very clear that Education Grants can only be provided to Healthcare Organisations or PCOs, and member companies cannot themselves select the person who should be the recipient of this Grant. They can however suggest a specific area of expertise who should benefit from the Grant.
- Public disclosure by Member Companies of their Educational Grants: as of January 1, 2018, companies providing Educational Grants to HCOs will be publicly disclosing the aggregated amount of all Educational Grants, provided to HCOs over the year of 2017, on the Transparent MedTech system. The disclosure deadline is 30 June 2018, for publication in August.
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 firstname.lastname@example.org. 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 email@example.com .
|MOST INNOVATIVE PRODUCT AWARD IRELAND Sponsored by |
WINNER - HOSPITAL SERVICES LIMITED NisoBiomed - Endofaster
(ltor) Mark Coffey (Vice Chair IMSTA), AnnMarie Sanderson and Graham Stewart (HSL), and Deirdre Glenn (Enterprise Ireland).
|MOST INNOVATIVE PRODUCT MULTI NATIONAL sponsored by |
WINNER - JOHNSON & JOHNSON Neuravi / Cerenovus - Embotrap
(ltor) Mark Coffey (Vice Chair IMSTA), Judi O'Malley (J&J), Deirdre Glenn (Enterprise Ireland)
|BEST TECHNICAL SERVICES COMPANY sponsored by |
WINNER - WASSENBURG MEDICAL Technical support
(ltor) Brian Kearney (BEAI), Ronan Wright and Rob Vavasour (Wassenburg) and . Mark Coffey (Vice Chair IMSTA).
|BEST IMPROVEMENT IN PATIENT SAFETY sponsored by |
WINNER - MEDTRONIC IRELAND TYRX Absorbable Antibacterial Envelope.
(ltor) Mark Coffey (Vice Chair IMSTA), Lisa Dunne, Emma Gilmore and Gareth Townsend (Medtronic Ireland) and Stephen McMahon (Pact for Patient Safety).
|EDUCATION AND TRAINING AWARD sponsored by |
WINNER - BD Nexia Closed Catheter system
(ltor) Mark Coffey (Vice Chair IMSTA), Greg Quinn and Ceire Procter (BD) and Ms. Terry Hannon (RCSI) .
|eHEALTH/DIGITAL HEALTH AWARD sponsored by |
WINNER - SYNCROPHI KEWS 300
(ltor) Tom Byrne (Pathfinder), David Toohey (Syncrophi) and Mark Coffey (Vice Chair, IMSTA).
|HEALTHCARE INNOVATION AWARD sponsored by |
WINNERS - Belfast Trust VR MRI Team Radiological Sciences & Imaging
(ltor) Mark Coffey (Vice Chair IMSTA), Dr. Cormac McGrath (Belfast Trust), Darrin Morrissey (HRB)
|MOST COST EFFECTIVE PRODUCT OR SERVICE sponsored by |
JOINT WINNERS - SYNCROPHI and VIDEODOC KEWS 300 and online Doctor and eHealth platform
(ltor) David Toohey (Syncrophi), Dr. Tanya Mulcahy (HIHI), Brendan Curtriss (Videodoc) and Mark Coffey (Vice Chair IMSTA).
|BEST PRIMARY CARE/COMMUNITY SERVICE AWARD sponsored by |
WINNER - VIDEODOC Online Doctor and eHealth platform
(ltor) Alan Wallace (Mangan O'Beirne), Brendan Curtriss (Videodoc) and Mark Coffey (Vice Chair IMSTA).