Overcoming Adoption Challenges in Healthcare for Societal Benefit

BIN@Sheffield2017 Meeting Report

The Business Innovation Network (or BIN) is holding its annual meeting in Sheffield this week. This is an unusual event in that it seeks to stimulate economic growth and wider societal benefits by harnessing the specific-but-often-disparate strengths of a city and region, in particular the academic base. I had the privilege of attending a morning dedicated to medical, dental and social challenges, and chaired the session on overcoming barriers to adoption in healthcare. My experienced speakers - who kindly  also formed a panel for a lengthy Q&A session - were Keith Jackson (CEO of 8-Q and former MD of JRI Ltd.), Jason Brannan (Communications Director for Y&H Medilink), and Fernando Monteiro (Professor of Biomedical Engineering, University of Porto).  While some of the more obvious issues were raised and discussed, there were also some points that were less predictable and therefore worth capturing on this blog.  Those that struck me included:

• Regulations are essential for patient protection and a cornerstone of responsible innovation. While the new medical devices regulations were undoubtedly going to stress our industry (with a heightened risk of losing businesses that manufacture excellent products), there were also some benefits beyond increased patient safety. Firstly, innovation would need to make a demonstrable difference before it could be placed on the market. Secondly, the new regulations also presented new business opportunities. My previous two blog posts deal with the new regulations and responsible innovation.

• One good example of an emerging business opportunity is the translation of in silico modelling for use as a real tool for validating medical devices or drugs as a part of a comprehensive pre-clinical screening and testing programme. Tremendous academic progress has been demonstrated by groups such as Insigneo in Sheffield, but the attractiveness to industry of this work will be increased by the inclusion of modelling in the new medical devices directives (and parallel developments at the FDA).  The development of sound, validated modelling tools will therefore assist both the development of healthcare technologies and their passage to the market.

• The final point made by the panel was that it was possible that some contemporary healthcare solutions were potentially over-engineered (and therefore costly). New approaches were needed to determine which solutions were “good enough” in terms of delivering a satisfactory and cost-effective result without compromising quality of life. The innovation community is already complex, but there is a case for bringing together even more multi-skilled teams to tackle challenges that have reached new levels of complexity.

Wider changes and the huge scale of the healthcare challenge suggests that societies will need to find new ways of covering the costs (and risks) of translating from the laboratory to the clinic.  Multi-disciplinary partnerships with private and public sector entities will be increasingly attractive as a means of sharing risks and costs, with some degree of government engagement and involvement. These could be all the more successful if city and regional councils can work together to strengthen the environment or “place” where innovation is developed and tested.  We will perhaps see the rise of new not-for-profit entities to act as umbrella organisations that address the more complex healthcare challenges. City regions that best understand and support these changes will benefit from the high value jobs and economic growth that the healthcare industry will deliver.

The UCL Special Inquiry into Regenerative Medicine Research

University College London (UCL) has published the findings of a Special Inquiry into Regenerative Medicine Research, a lengthy document that seeks to understand the role of one of the UKs foremost research institutions in the rise and subsequent fall of Paolo Macchiarini. By way of brief background, Macchiarini was considered to be a leading researcher and pioneering surgeon in the field of regenerative medicine for tracheal and airway "tissue engineering" until a series of troubling revelations - associated with several tragic deaths - culminated in his public exposure in 2016.  Many aspects of the story, especially the role and personality of Macchiarini himself, have been covered by the media (including social media), and it is clearly a complex scenario. Macchiarini could not though have achieved his notoriety alone, indeed he became an internationally respected figure in the wider tissue engineering community, and the UCL report provides a substantial insight into how senior academics and hospital clinicians became associated with him personally and professionally.  The report is especially compelling as it has been written by some of the UK's leading academics and clinicians with an international reputation for excellence and probity including in the broad field of tissue engineering and regenerative medicine (TERM), and who have had access to at least some key documents and people. This makes it a more reliable document than some previous media reports, as well as essential reading for all researchers in the TERM field (as well as bioethicists, lawyers, and clinicians more generally). Inevitably though while resolving a number of issues, it also raises questions where more information is needed, and perhaps some of these unanswered questions could only be resolved in a legally empowered inquiry. Before considering these though, it is important to bear in mind the following:

• TERM is a broad field that is largely concerned with the development of therapies that promote the successful healing of human tissues in situations where this would not otherwise occur naturally.  While more research is needed, it is a field that offers potential solutions where current clinical interventions are either limited or do not exist.  Many thousands of scientists, engineers and clinicians are engaged in sound and responsible research all over the world (including at UCL), and in parallel other experts including regulators and industries are working equally hard to reduce risks while bringing benefits to patients.  The Macchiarini story is not a reason to curtail this activity, but it is essential that it informs practice, especially proper governance in responsible translation to the clinic.
• The clinical cases covered by this inquiry involved sometimes subtly different interventions, and this diversity is greater when considering all of the surgical procedures where Macchiarini was involved outside of the UK. When patients die, this is always a tragedy for them and the families left behind. Even if interventions were classed as palliative, this does not negate questions related to the governance of an experimental medical procedure and informed consent (questions that lay largely outside of the scope of this inquiry, but questions that should arguably be now addressed using a robust instrument).

While UCL's report on the special inquiry is both detailed and insightful, it also recognises the scale and complexity of investigating experimental clinical interventions involving more than one organisation (and therefore the limits to this type of investigation). The subject of the inquiry was the primarily the role of UCL staff in forming a relationship with Paulo Macchiarini (including the award of an honorary chair), and the role of the institution in a series of operations that sought to apply experimental TERM-like technologies in human tracheal/large airway surgery. In places the inquiry also considered interactions between academic and clinical staff, and aspects of local compliance with legal, regulatory and governance requirements.  In my experience of working in a mixed clinical-basic science environment, senior staff understand very clearly which organisation they work for (it is printed on their payslip), and also to whom they are responsible to when working (which could be an NHS Trust), irrespective of the honorary contracts they hold. In simple terms, if a clinician is treating a patient, they are responsible to the relevant NHS Trust irrespective of which organisation is printed on their personal payslip. Likewise it is the NHS organisation governance that applies when treating patients, irrespective whether the intervention is established or experimental.

Outside of the remit of this report lie a number of as yet unanswered questions. For example is the current legal, regulatory and ethical framework fit for purpose, and if "yes" then were established legal/governance processes and procedures accidentally or deliberately bypassed in some clinical cases covered by this inquiry (and indeed others around the world)? While my experiences suggest that our existing legal and regulatory framework is both robust and fit for purpose, this is a question that can only be addressed fully by a wider pool of experts (including in law, ethics and regulatory affairs). It is also a question that is arguably more pertinent to the hospitals concerned rather than their associated universities, and it seems therefore likely that this UCL report is only a first step towards gaining a better understanding of these events in the UK and beyond.