The Future Lies in Value-Based Healthcare: Why we need to encourage our customers to base procurement decisions on more than the purchasing price

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

RCSI/IMSTA HealthCare Industry Representative Credentialing Programme

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.


“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  

Next  Dates

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: 

  1. Log onto the RCSI Faculty of Nursing and Midwifery’s website 
  1. Download and complete the Employer Verification Form. This is available on the website. This form contains a section, which must be completed by the employer, signed, and dated. 
  1. Pay the programme fee. This can be done on the website by clicking on the “Apply Now” button. This button takes the applicant to the following secure link:

On completion of this step, a receipt is issued containing a Transaction Number. 

  1. Email a copy of the completed Employer Verification Form, a copy of the receipt for payment and your name and contact details to referencing ‘HCIR Programme’ in the email subject line.

Further Information on this Programme

Ms. Catherine Clune Mulvaney

Operations & Education Manager

Faculty of Nursing & Midwifery

123 St. Stephen’s Green,

Dublin 2

T: 01 402 5172  M: 087 6374002



HPRA Introduction of fees for medical devices from January 2017

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 with the necessary contact details or go to the following website:

HPRA Medical Devices Information on Fees

HPRA Medical Device Letter to members

HPRA Medical Device Forms Appendix

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

IMSTA Joins Eucomed


IMSTA joins Eucomed

Eucomed is an organisation advocating for the interests of the medical device industry in Europe. It represents directly and indirectly 4,500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and management of disease and disability.  Eucomed represents a total of 11,000 legal entities in Europe.  It is part of MedTech Europe, an alliance with EDMA, the European Diagnostics Manufacturers Association.

Among its members, there are 24 national medical technology associations and 62 medical technology companies, comprising approximately 70% of the European market.  Eucomed has over 65 expert groups. These groups deal with regulatory, economic, public affairs, international and legal affairs topics.  Eucomed represents several sectors within medical technology such as ophthalmology, cardiovascular medicine, orthopaedics, advanced wound care and Community Care.

Eucomed’s main mission is to advocate for the medical device industry at the European level.  It engages with policymakers in European institutions and EU member states, patient groups, and medical associations.  Eucomed regularly organises meetings and workshops for members and stakeholders.  It lobbied extensively for the interests of the European medical device industry in the revision of the European medical device directive and advised IMSTA and IMDA in this regard.

IMSTA has been in touch with Eucomed since 2010, developing relationships with key personnel who have shared information on key trends and emerging position papers.  John Brennan, Director of Technical & Regulatory Affairs, has been a good supporter of IMSTA.  Prior to joining Eucomed John spent five years at the European Commission, having previously worked in and managed the Irish Notified Body, NSAI, where he gained extensive European and international experience in the design approval of high-risk medical devices and quality management systems.

IMSTA did not join Eucomed before now as the cost of membership was prohibitive relative to its’ value to IMSTA. We did however adopt Eucomed’s Code of Ethical Business Practice in 2011 and made it mandatory in 2013.

IMSTA’s CEO will spend the next 18 months engaging with Eucomed’s expert groups with a view to identifying how they can support the work of IMSTA nationally.  It may be possible for Chairpersons of IMSTA’s working groups to engage with and participate in appropriate expert groups such as the Procurement Working Group or on Reimbursement.  We intend to take full advantage of our membership and pass on the benefits of membership to our members.

New regulations that will enhance patient safety and facilitate access to new technology welcomed

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.


What does Value-Based Health Care actually mean?

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.

Gotz Gereke (Boston Consulting Group) on PodiumAt 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.


HPRA focuses on distributors

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 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.

“Another excellent IMSTA conference this week. I found it very useful . .”

Mark McIntyre (Boston Scientific) seated with Speakers

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.

Jim Breslin (Dept. of Health) at podiumFinally, 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


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








€5m allocated to Health Innovation Hub Ireland to foster links between Irish health service and vital new technologies

Health Innovation Hub




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”.

National Medical Device eAlert System






A newly developed National Medical Device eAlert System designed to streamline the management of medical device safety notices within the public health system was launched at the Royal College of Physicians in Ireland on November 30th.  Developed by the HSE National Medical Devices Equipment Management Committee, in collaboration with the Quality Improvement Division (QID) and with assistance from the Health Products Regulatory Authority (HPRA), the aim of the eAlert system is to provide each HSE or HSE-funded voluntary service location assurance in the management of medical device safety or quality related notices issued by the HPRA.

The occasion also saw the launch of a HSE Medical Device Management ‘Quality Assessment and Improvement Tool (QA+I tool)’ to facilitate assessment against the HSE Medical Device Equipment Management Policy and Best Practice Guidance.  A key component of the medical device vigilance system is the dissemination of information, which may be used to prevent recurrence of an incident or to alleviate the consequences of such incidents.  As the national competent authority for medical devices, the HPRA publishes notices relating to the safety and/or quality of medical devices on its website The majority of these notices are for the attention of health professionals including those working in hospitals, community healthcare organisations and other health facilities.

The national eAlert system receives notification directly from the HPRA of all safety notices or any internally generated HSE safety notifications for distribution.  A priority level is assigned to each alert in accordance with the HPRA traffic light system of red (Priority 1, most urgent), amber (Priority 2) and green (Priority 3, least urgent).  The medical devices eAlert system has been implemented and is available throughout the HSE and voluntary hospitals. T he web-enabled system is hosted by the HSE’s ICT centre and will facilitate the nomination of a ‘designated person / vigilance officer’ within hospitals, community healthcare organisations and other health facilities to take responsibility for the receipt of the medical device alert notifications. The ‘designated person / vigilance officer’ will ensure the further internal facility distribution to the relevant personnel for implementation of the recommended actions where applicable.  An automated response timescale (associated with the priority level) is also assigned by the HSE to each notification within which the relevant action must be reported back by the designated person / vigilance officer to the central ICT system as having been completed, or not being applicable, or some other outcome was required.  The eAlert system provides for an extremely efficient method of disseminating safety information to key medical device users and will contribute to enhanced patient safety across all the health facilities involved.

Healthcare professionals and medical device users are reminded to remain vigilant for field safety notices issued by medical device manufacturers as these will not be circulated via the eAlert system. The HPRA will continue to upload a monthly summary of field safety notices known to affect the Irish market on the website As part of its ongoing work to encourage user reporting, the HPRA in collaboration with the QID and Medical Device Equipment Management Committee developed a Step-by Step guide to facilitate users in reporting medical device adverse events.  This guide was also launched on November 30th and will be circulated to all users in the Acute Service and the Community Healthcare Organisation in early 2016.  Relevant guidance is available for download from