Senior Researcher in Social Science Michael Morrison explains why disruptive technologies need institutional and systemic readiness to truly realise the benefits of healthcare innovation
Some innovations are incremental. They make a minor improvement on what has gone before; a higher resolution of a picture taken by a mobile phone camera, or a tyre that has increased grip for wet driving conditions. Other innovations are more radical and disruptive. Biomodifying technologies; gene editing with tools such as CRISPR/cas9, 3D printing of living cells (‘bioprinting’) and cellular reprogramming to create ‘induced pluripotent stem cells’ (iPSC) capable of becoming any type of cell in the body –eye, liver, heart and so on, clearly fall into the latter category. (1)
These technologies are in various stages of development as medicinal products for treating human diseases. The degree of development of a technology is most commonly understood and measured in terms of ‘technology readiness levels’ or TRLs. TRLs were originally devised by NASA as a way of measuring the degree of development of components or systems for the space shuttle. (2) They operate through a scale consisting of nine levels, where level one “basic principles observed and reported” roughly equates to basic research and level nine “actual system flight-proven through successful mission operations” is a fully functional product or service. TRLs have proven a useful tool for monitoring technology development and are now widely used by many firms and state agencies in a variety of countries and technology sectors.
However, this is not the only way in which readiness can be conceived or assessed. Although much misused, the concept of ‘disruptive innovation’ was popularised by the US academic and business consultant Clayton Christensen in his 1997 book ‘The innovator’s dilemma.’ (3) Christensen identified ‘disruptive’ innovations as those that provided a service or function in a new and different way from the services and products offered by established, incumbent providers. Examples include mobile phones disrupting the market for fixed (‘landline’) telephones, and personal computers disrupting the market dominance of large-scale mainframe computers. Importantly, in Christensen’s account, disruption is not simply a property of technologies, it involves a new way of doing things; new business models and potentially new supply chains, novel manufacturing methods or facilities, different sales and marketing techniques, and new knowledge and skillsets from those needed to use the established product or service.
This has implications for innovation in the healthcare sector. Healthcare is often seen as resistant to disruptive innovation. There is good reason for this; human health and wellbeing depend on the reliable and routine application of evidence-based standards of quality in both medical practice and medicinal products (drugs and medical devices). When disruptive new medical technologies come along, they require, as Christensen illustrated, new ways of doing things. Therefore, to adopt radically different technologies like cell and gene therapies or bioprinting, healthcare systems need to adapt how they operate in order to make the new technology viable. The extent to which a healthcare system, and especially its clinical sites, have capacity to cope with these new ways of doing things can be understood as the degree of “institutional readiness” (IR). (2)
IR was initially developed as a framework to assess the degree to which a clinical site needs to adapt, to successfully deliver biomodifying therapies and other interventions that depend on human cells or genetic modification for medicinal effect. For example, hospitals need appropriate staff training, access to infrastructure such as very low-temperature freezers, and appropriate systems in place to monitor outcomes and costs. Institutional readiness has since been adopted for specific domains, such as institutional readiness of hospital pharmacies for new cancer therapies, (4) for the COVID-19 vaccines (5) and for digital technologies in healthcare.
In addition, the literature on ‘technology transitions’ highlights a third dimension of readiness, beyond TRLs and IR, although overlapping with both. Any technological sector consists of “an interdependent and co-evolving mix of technologies, supply chains, infrastructures, markets, regulations, user practices and cultural meanings.” (6) These elements comprise a ‘sociotechnical system.’ Introducing a new, non-incremental innovation often requires changes to one or more elements at this systemic level. For biomodifying therapies, building system-level readiness involves:
- Establishing appropriate regulatory pathways.
- Ensuring reimbursement models are in place to cope with anticipated high costs of early products.
- Ensuring there are enough people with the right skill sets at all stages of the translational pathway from biomedical scientists, engineers, and material scientists to Qualified Persons capable of signing off on each batch of product. (7)
- Building specialist infrastructure of supply chains and manufacturing facilities.
In keeping with moves towards patient-centric medicine, there is a recognition that patient charities and organisations also have a role to play in developing the way clinical services are structured and delivered, such as providing feedback on the impact on quality of life of different options, and helping to develop suitable patient reported outcome measures (PROMs) to evaluate treatments. It makes sense to consider systemic readiness at the level of nation states, as different countries usually have distinct regulatory and legal systems, differing degrees of investment in the academic science base, and differently constituted healthcare and commercial sectors.
To date, technology readiness has received by far the greatest attention. Despite this, all three aspects of readiness are important in delivering functioning, sustainable, and accessible new health technologies and in making sure investment in innovation ultimately benefits patients. Moreover, these three measures do not imply a discrete division of labour, with firms dealing with TRLs, hospitals building IR, and national governments supporting systemic readiness. Instead, it is critical to make sure technology design, clinical practices and priorities, and national policies and initiatives are developing in alignment. Ultimately, disrupting the socio-technical system of healthcare is likely to produce only expensive failures unless change in one element is accompanied by harmonious adaptation, of the kind that facilitates readiness, in the other relevant elements. This is important for successful innovation in biomodifying technologies, but is also a useful lesson for other emerging healthcare technologies.
The research underpinning this piece was supported by the Economic and Social Research Council grant number ES/P002943/1 and the Leverhulme Trust grant number RPG-2017-330.
(2)Andrew Webster & John Gardner (2019) Aligning technology and institutional readiness: the adoption of innovation. Technology Analysis & Strategic Management, 31(10); 1229-1241, DOI: 10.1080/09537325.2019.1601694
(3)Clayton Christensen (1997) the Innovator’s dilemma: When new technologies cause great firms to fail. Harvard Business Review Press; Boston, MA.
(6)Frank W. Geels (2018) Disruption and low-carbon system transformation: progress and new challenges in socio-technical transitions research and the Multi-Level Perspective. Energy Research & Social Science 37, 224-231.
(7) Saranya P. Wyles and Andre Terzic (2019) Building the regenerative medicine workforce of the future: an educational imperative. Regenerative Medicine 14(7), 613–615.
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Biomodifying technologies at the HeLEX centre at the University of Oxford
Dr Michael Morrison discusses his work at HeLEX, aiding innovation in biomedical technologies and developing biomodifying technologies.