The complexity and size of the life sciences industry in the UK is often underestimated, and is much larger than many people realise. This quickly evolving and growing sector makes it extremely challenging for healthcare organisations to keep up to date with the latest products.
‘The life sciences industry employs 248,400 people in the UK. Approximately 127,400 (51% of the industry total) are employed in the Med Tech sector comprising the Core Med Tech and the Service & Supply segments. The Core Med Tech sector is the largest in the industry by employment and number of businesses with a total employment of 97,600 (39% of the industry) and 2,730 businesses (45% of the industry)’. (HM Government, 2017)
Hospitals mainly deal with the ‘Core Med Tech’ sector in terms of the products and services they buy. When looking at the ‘Core Med Tech’ companies in the UK, one can easily see that dealing with this business sector is fraught with difficulty due to its size, complexity, and the investment required by healthcare organisations to keep up to date with the latest technologies and services. In healthcare organisations, choosing what to buy, and who to buy from is a difficult process in itself.
‘Core Med Tech’ includes all businesses whose primary business involves developing and producing Med Tech products (ranging from single-use consumables to complex hospital equipment, including digital health products). In the UK, there are 25,649 people across 448 businesses employed in the manufacture of medical equipment and supplies with an annual turnover of £4,675 Million. (Vanlint, 2019)
Considering this complexity, it makes it very challenging for healthcare executives to create a medium to long term plan. The plan requires the input of many different stakeholders from different levels within the organisation, and it must be financially and operationally sustainable. This strategic plan must have executive ownership to ensure that ongoing operational business plans are aligned with the technology replacement and purchasing plans, if they are to achieve the organisation’s vision for the future.
According to the Medicines and Healthcare Products Regulatory Agency, MHRA DB 2015: Managing Medical Devices (Medicines & Healthcare products Regulatory Agency, 2015), it states:
Section 2.1
Management Responsibility
Managing Medical DevicesMHRA DB 2015
- Healthcare organisations should appoint a director or board member with overall responsibility for medical device management.
- The management structure for medical devices should have clear lines of accountability up to board level.
- Healthcare organisations should set out a long-term approach and objectives for the management of their medical devices.
Section 2.6
Monitoring and Audit
- An Audit Report should be submitted to the board examining policies and procedures for the safe acquisition, use, maintenance and repair, decontamination and disposal of medical devices.
This board report will give the executives confidence that their organisation meets the regulatory requirements for:
Managing Medical DevicesMHRA DB 2015
- External monitoring and audit by the Care Quality Commission (CQC).
- The CQC will inspect against their ‘Essential standards’ of quality and safety, and
- Policies and systems of management for medical devices.
In 2014, I spoke at the National EBME Conference and Exhibition about my doctoral thesis ‘Achieving a Best Practice Model for Medical Devices Management Policy’ published by Middlesex University. (Sandham, 2014) This was the culmination of 4 years of work, where the main argument stated that planning procurement of medical devices plays a vital part in the strategic decisions that need to be made by the executives within any healthcare organisation, NHS or private, when it comes to medical equipment management. That’s obvious isn’t it? Apparently, it is not obvious because time after time, I go into healthcare organisations that are struggling with medical devices management and procurement planning.
After many years of promoting strategic medical equipment replacement planning, I am still seeing a widespread lack of executive understanding on how to sustainably link replacement of their technology to the organisations five-year business plan.
I keep getting asked the same questions:
- How does the organisation create a longer-term sustainable strategy for medical equipment asset management?
- What technology needs should be bought to meet their strategic goals?
Poor equipment procurement and management impacts both on the clinical outcomes for patients and the organisational efficiencies. In many healthcare organisations, lower tier managers are expected to buy and manage medical equipment assets without any knowledge of the organisations plans for the future. Five-year strategic plans are being drawn up by the executives, who often don’t review their plans with the medical technology asset managers or buyers, and then wonder why they do not achieve their operational business targets on time, and they go over budget.
Organisational leaders need to understand that the medical equipment assets are inextricably linked to their longer-term operational efficiencies and clinical outcomes. If the productivity and clinical outcomes are part of their five-year operational strategy, then investment in the ‘right’ medical equipment assets must be part of that plan. Connectivity of these assets into the IT infrastructure, such as the EPR, will also plays a key function, as data becomes vital part in regard to assisting clinical decision support.
The Secretary of State for Health and Social Care, Matt Hancock MP, recently gave a keynote address to the Healthtech Alliance UK and said to the delegates:
“If you work in the NHS, in any part of the service, far too often old, out-of-date 20th century technology gets in the way of your ability to do your job, so when people say that better technology is a ‘nice to have’ that costs too much, I say wrong again. Better technology is vital to have and embracing it is the only way to make the NHS sustainable over the long term”.Better tech: not a ‘nice to have’ but vital to have for the NHS Hancock, 2020
A Strategic Approach to Change
I can go on the internet and read many NHS Trust ‘strategic plans’ which talk about using technology to improve outcomes for patients, but reading between the lines, it is clear to me that many of these ‘plans’ are superficial and unlikely to deliver their goals within the time frame set, because there are gaping holes around technology procurement and project management.
Many healthcare organisations are in the process of creating sustainable financial models, but these models require a five-year technology replacement strategy that underpins the five-year operational strategy.
During the covid pandemic of 2020, many healthcare practitioners have been using online consultations to avoid contact and the spread of the disease. This enables a more dispersed clinical model, but for this to be more effective long term, it will require investment in both the medical equipment and IT infrastructure. This not only requires an investment in hardware and software, but also in skilled people who understand the complexity of connecting medical equipment assets into the Electronic Patient Record (EPR), and managing those assets.
As discussed previously, delivering an organisation’s strategic plans will also require a strategic asset management and replacement strategy that is aligned with that ‘future state’ sustainable business plan.
In summary:
1. Organisational policies must be the driving force to change practice. These policies should be led by the board, working with the appropriate stakeholders to ratify and then implement changes in management and operational practice.
2. Once implemented, the strategy should deliver a programme that connects medical equipment into the EPR. Clinical evidence shows that this will deliver better clinical outcomes, and create a more sustainable and efficient organisation.
3. When the data is readily available, it can be integrated into other patient surveillance systems to carry out automated clinical decision support, which allows for prompt changes in treatment, or earlier discharge.
4. Once the organisation has bedded in policies and processes, the next step is telehealth, offering ‘remote clinical services’ such as ‘hospital at home’ where equipment at home can be connected directly into the EPR, giving the benefit of freeing up hospital beds.
5. Once all these systems are connected and fully operational, the next logical step would be investment in artificial intelligence (AI) software algorithms to monitor the data coming in and assist by supporting clinical decision stakeholders, ultimately improving patient outcomes.
The five-year asset management strategy shown below is indicative of how changing organisational policy and practice can deliver 21st century clinical outcomes for patients, and also deliver financially sustainable plans.
Five Year Asset Management Strategy
References
Hancock, M., 2020.
https://www.gov.uk/government/speeches/better-tech-not-a-nice-to-have-but-vital-to-have-for-the-nhs. [Online]
[Accessed Feb 2020].
HM Government, 2017. Strength and Opportunity, London: Office for Life Sciences.
Medicines & Healthcare products Regulatory Agency, 2015. Managing Medical Devices. [Online]
Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/421028/Managing_medical_devices_-_Apr_2015.pdf
[Accessed August 2020].
Sandham, J., 2014. Device Management Policy. [Online]
Available at: https://www.ebme.co.uk/seminar/transcriptions/device-management-policy
[Accessed 2020].
Sandham, J., 2014. Middlesex University Research Repository. [Online]
Available at: https://eprints.mdx.ac.uk/19157/1/JSandhamThesis.pdf
[Accessed August 2020].
Dr. John Sandham CEng.
