Could you be limiting the sales of your medical device by not considering self-care users within your design process and IFUs?

by | May 19, 2021 | IMed Consultancy

Could you be limiting the sales of your medical device by not considering self-care users within your design process and IFUs


The combination of the increasing prevalence of chronic diseases and working through the challenges which the COVID-19 global pandemic presented for patient care, has without question highlighted the need for increased self-care. But who is going to support this? There are many potential beneficiaries from widening self-care in our communities, but who is going to drive this change? Patients? GP’s? Community care providers? Hospitals? Occupational Therapists? Healthcare managers? Or maybe medical device companies themselves?

The truth is that everyone must play their part if it’s going to work – improving patient outcomes, reducing healthcare & transport costs, cultivating better information transference and minimising virus exposure. However, I think that Medical Device manufacturers are mostly still scratching the surface of the potential clinical impact they could make in improving patient knowledge and self-care results. So, I’d like to urge them to keep focusing their teams on real clinical benefits when considering how their device will be used and how key information could be provided to key stakeholders.

Patient and carer-friendly medical devices can and do undoubtedly increase patient compliance, improve disease management and positively impact our health care service providers. Greater awareness of the general population regarding self-care management potential is needed, however the medical device industry has a responsibility to work with clinical services to ensure the right product is used for the right patient at the right time. Many larger medical device manufacturers do have scientific and clinical specialist teams, providing clinical tools, clinical and patient education and product innovation supporting best practice. However, economic factors and adjustment to a new ‘normal’, could tempt some manufacturers to shed these teams. Perhaps they simply don’t have the funds to maintain this kind of specialist overhead? Everyone understands the grim realities of cost – but it’s so important to keep using the services of clinical specialists as part of the sales organisation, even if it’s outsourced, at critical lifecycle pinch points.

In 2019 the NHS Long-Term Plan stated that prevention and proactive working are the priorities to keep patients well for longer. This polarised as the pandemic saw clinics and health centres close and the vulnerable isolating, making it all the clearer that self-care has become critical for sufferers of long-term conditions AND their health care service provision.

As a Clinical Nurse Specialist managing and treating lower limb conditions, self-care is high on my agenda and involves teaching patients and their families to manage their own leg wounds as well as preventative action to avoid recurrence. As a clinical educator, I’ve had to adopt a completely different approach; using simplified definitions, a holistic view of what can be achieved, whilst also developing a plethora of educational material to enhance patient and carer empowerment.

A patient who feels empowered with their own care is more likely to follow effective treatment and preventative therapies. Even patients with complex comorbidities that make assessment, management and healing difficult, can still be competent to self-care, BUT they do need tools to help them.

An example of this could be using digital or printed patient support such as patient passports. These are personalised medical documents, which explaining a patient’s conditions, treatment programs and management therapy, in a simple and understandable language. It’s an evolving treatment tool and can be carried and taken to GP reviews and Hospital check-ups, maintaining vital client history and methods of treatment ensuring all health professionals involved are as fully informed as the specialists and the patient themselves. They can even reference affiliations and support networks for patients, to minimise isolation and encourage peer support. Many clinical teams are challenged both in the time it takes to produce these valuable materials, as well as the printing and distribution cost.

Long Term Plan

Post-pandemic, self-care is set to grow further over the coming months, laying strong foundations for the impact that personalised care can make in supporting people to look after their own health and wellbeing; way beyond the immediate context of Covid-19.

Sure – the virus has highlighted the importance of long-term self-care management and the need for simple but effective treatments, but effective educational support will continue and not diminish in value, even after the current crisis is over. This builds on the confidence that’s developing in this area and will become an important part of the health care mix for the long term.

Supporting Self-Care

There is a need for clarity in defining self-care, when its appropriate and when it’s not, what is expected and what is not. Many people use the terms self-care and self-management interchangeably, but there are important distinctions;

Self-management will usually be used in relation to long-term chronic health conditions such as Diabetes and Heart Disease. It offers patients a more sustainable way of living with their health condition without the day to day support of a health care professional.

Self-care however, potentially incorporates supported physical self-treatment by the patient and ongoing management, which could include:

  • Delivering their own skin and wound care
  • Applying their own dressings
  • Monitoring their condition
  • Implementing a supported treatment programme.

This style of care is set to grow and grow and will continue to support, educate and empower all patients to treat and management common conditions more independently, so that the NHS can deliver a more streamlined, effective and efficient health care service for the 21st Century.

So – How can medical device manufacturers help deliver self-care?

Naturally, all medical device manufacturers will align their service to the MHRA standards, with an aim to protect and promote public health and patient safety. Medical devices play a key role in patient care, which is vital for diagnostics, treatment, monitoring, management and rehabilitation; all of which incorporate self-care. Effective management of these is required to deliver evidence based best practice, clinical and financial governance, including the minimising of risk of any adverse events.

Working with service providers, manufacturers have a professional duty to ensure their own skills, knowledge and training remain up to date. Clear responsibilities should exist for ensuring that the manufacturer’s IFUs are clear for all types of users and, where appropriate, these should align to the needs of carers AND patients. IFUs may need to be supplemented on an ongoing basis, with training and updated improvements to ensure an increasingly effective and efficient delivery. The type and delivery of the training will depend on many factors and will be device dependent. This should involve an approach for all types of potential end-users including clinical professionals, healthcare providers, patients and their carers.

Working in collaboration, medical device manufacturers, service providers and patients can all improve the effectiveness and delivery of our healthcare now and for the future of our NHS. So please make sure that your initial design, sales process and post market surveillance and feedback maintains a real focus on clinical and home healthcare settings. It’s a supply chain to be proud to contribute towards.

Andrew Kerr

Andrew Kerr

Director, Lower Limb Consultancy Services Ltd, UK; Honorary Tissue Viability Clinical Nurse Specialist, Sandwell and West Birmingham Hospitals NHS Trust, UK

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