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Grassroots medical device innovation in the NHS: a new model pioneered at a DGH

Dr Peter Young, consultant in critical care at The Queen Elizabeth King’s Lynn NHS Foundation Trust, and Dr Maryanne Mariyaselvam, clinical research fellow at the University of Cambridge, discuss entrepreneurship in the NHS.

The national landscape – medical device innovation in the UK 

The UK has a proud heritage of inventors and innovation, having the second highest number of Nobel Laureates and twice the number per capita than the leader, the USA. However, developing, implementing and spreading innovation involves embracing success, building businesses and having customers embrace improvements and change. Innovations commonly move to more entrepreneurial environments, such as the USA. However, innovation is now a priority in our NHS, aiming to emulate US culture, in embracing pioneering entrepreneurial spirit and celebrating success. 

The clinical entrepreneur 

In recognition of this, the NHS has recently launched ‘The Clinician Entrepreneur’, a radical new programme for trainee doctors to educate and develop entrepreneurial skills alongside clinical practice, and if successful similar opportunities may be extended to other staff in time. 

Innovation, Health and Wealth 

The publication of ‘Innovation, Health and Wealth’ in 2012 emphasised the acceleration of adoption and diffusion in the NHS, with an aspiration to “put innovation at the heart of everything it does”. Crucially the recognition of the benefits to the UK economy and to the NHS of “creating wealth” has been embraced centrally. 

The NHS Innovation Accelerator (NIA) Programme 

UCLPartners and the Health Foundation co-host the NIA in collaboration with Academic Health Science Networks (AHSNs) across the country and in partnership with NHS England. Seventeen inspiring innovators have been rigorously selected to be given a helping hand to implement their proven innovations across the NHS. They aim to uncover the barriers that still exist for our patients to access the treatments they deserve. 

Accelerated Access Review 

The Accelerated Access Review is a unique opportunity to learn from the grassroots of the NHS to remove historical disincentives, impediments and barriers to innovation, and improve adoption and spread in the NHS. Organised by the minister for life sciences, George Freeman MP, the Review aims to speed up access to innovative drugs, devices and diagnostics and improve access to available and affordable cutting-edge medical products for patients, clinicians and NHS organisations. This also involves improving processes to provide a simpler and better development pathway thereby stimulating investment, jobs and economic growth to support the NHS and the broader UK economy. All this needs to be achieved with cost-effectiveness and affordability. 

Freeing the entrepreneurial spirit in the NHS 

Innovation alone is not enough. Companies may focus on a technology instead of a customer’s problems. In terms of medical devices, it is crucial that patients and frontline workers (those who experience problems) are integral to developing the solutions. Therefore, clinicians need to have entrepreneurial skills. There is clearly support from the higher NHS, and it is for local NHS institutions now to encourage staff entrepreneurship, releasing them to flourish free from constraints or unduly complex barriers. Institutions should celebrate success in innovation, and inventors should be freed to champion their innovation unimpeded and choose its direction. 

Locally, we have been involved with an innovative research and development programme at the Queen Elizabeth Hospital King’s Lynn NHS FT (QEHKL). 

It is recognised that innovation requires managed risk and individual incentivisation. Being risk averse kills innovation rapidly, and ‘over-management’ snuffs out innovation in its infancy. Innovators need freedom to take managed risk for the benefit of their patients and for future patients. We recognised that local interpretation of the National Intellectual Policy Framework may impede an innovator or a team’s ability to drive innovation. Essentially we aimed to move the default position of power and ownership into the hands of the innovator and to ensure that the emphasis was on the trust to provide additional material support in return for a negotiated share. 

In recent years, we have been lucky to have a supportive and forward-thinking NHS Innovation Hub, Health Enterprise East and the AHSN. NHS England and the chief medical officer have directly supported two of our innovations: the PneuX Pneumonia Prevention System and the non-injectable arterial connector (described below) through the NIA programme, to support adoption and spread. 

Management teams at the trust have been – in the main – supportive of our innovation team, and have enjoyed the reputational enhancement it has provided. Our mission statement is “to facilitate the likelihood of adoption of an innovation to give most widespread benefit to patients” rather than “to provide the greatest share of any future profits to a trust”. This has been realised in time to be a ‘win:win:win’ for our trust, the innovation team and most importantly for patients. 

R&D, and support from colleagues 

A local team with a can-do, managed risk approach has opened up an innovative but safe environment for staff and patients. But innovation is best performed with a team approach. We founded the King’s Lynn Institute of Patient Safety (www.KLIPSUK.com) to allow like-minded individuals from within and outside our trust to share in the workload and successes of our innovation projects. This has allowed the self-generation of a ring-fenced research and innovation fund under control of the innovators in order to test our innovations. 

A Selection of Innovations 

KLIPS has produced 12 patent families of innovations, spread along the innovation and implementation pathway from the prototype stage to CE and FDA approved and successfully marketed. This is the result of the hospital trust’s permissive strategy to entrepreneurship. 

Here are some of our innovations, currently available for clinical use: 

The PneuX Pneumonia Prevention System prevents ventilator-associated pneumonia (VAP). It consists of the Lotrach tracheal tube and a Tracheal Seal Monitor. This innovation has been funded and is being forwarded directly with industry. Bacterial contamination of the lungs and VAP is the most common cause of nosocomial (hospital-acquired infection) death in the ICU. This is prevented by the continuous isolation of the lungs that is not attained by standard tubes, and is highly cost-effective, according to the NHS Technology Adoption Centre. This has been chosen for the NIA programme as a proven innovation with the intent to be supported by the NHS for a fast, systematic adoption throughout our NHS. 

The Needle-free Non-Injectable Arterial Connector (NIC) prevents wrong-route drug administering. Developed within the NHS and manufactured in the UK, this winner of the AAGBI Innovation Award (2015) and the National Patient Safety Award (2012), prevents the serious error of accidental arterial injection and bacterial ingress into arterial lines. It improves accidental blood spillage and supports the EU needle-free directive. With demonstrated cost-effectiveness, the NIC has been chosen for the NIA programme as a proven innovation with the intent to be supported by the NHS for a fast, systematic adoption throughout our NHS. 

The Drug Guardian improves medication security by protecting staff and patients. This is a battery-driven device (which can be retrofitted) to be placed in a drug enclosure, providing a managed solution to drug theft and tampering. This protects patients, staff and accountable management responsible for these drugs. An AHSN study has shown that practice in NHS trusts is routinely very poor and in contravention of CQC guidance, Royal Pharmaceutical Society Guidelines (Safe and Secure Handling of Medicines, March 2012) and in some circumstances in contravention of UK law (Health and Social Care Act, 2012). Utilising operant conditioning, Drug Guardian has resulted in near-complete compliance with the above standards within days, with minimal training. Studies have demonstrated that it is highly cost-effective. 

The A.P. Advance Laryngoscope makes airway intubations safer. This was developed directly in collaboration with industry and provides a single device to satisfy the needs of standard difficult airway intubations. This is provided by a unique prism system that allows the convenience and safety of multiple blades to be used on a single device, substantially improving both safety and teaching. 

SavetheWire prevents retained foreign objects, specifically the ‘never event’ of guidewire retention. It is designed for convenient use and easy implementation with minimal additional training, which removes the possibility of accidental guidewire retention in the patient’s circulation. The operator is prevented from completing the procedure until the guidewire is removed and disposed of. 

Summary 

So, how can you help? Innovation is a long and hard process. An early adopter is an innovator’s hero. So, to do your part to support innovation in the NHS, when you see a UK innovation that has been judged to be good for patients, supported by our NHS and shown to be cost-effective, you can and should help by facilitating early implementation in your hospital. 

QEHKL, members of KLIPS including the authors and Health Enterprise East are proud to variably share in ownership of the intellectual property of these innovations.

FOR MORE INFORMATION

E: [email protected]

PneuX Pneumonia Prevention System: Vennermedical.com

A.P. Advance Laryngoscope: Vennermedical.com

NIC Needlefree Arterial Connector: Amdelmedical.com

Drug Guardian: KLIPSUK.com

Safe-T-Guidewire Box: KLIPSUK.com

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