Prepare preparation for innovative health technologies

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Senior social scientist Michael Morrison explains why disruptive technologies require institutional and systemic preparation to truly reap the benefits of healthcare innovation

Some innovations are incremental. They provide a minor improvement over what happened before; a higher resolution of a photo taken by a cell phone camera, or a tire that has increased grip for wet driving conditions. Other innovations are more radical and disruptive. Biomodification technologies; editing genes with tools such as CRISPR / cas9, 3D printing of living cells (“ bioprinting ”) and cell reprogramming to create “ induced pluripotent stem cells ” (iPSC) capable of becoming any cell type in the body – eyes, liver, heart and so on, clearly fall into the latter category. (1)

These technologies are at different stages of development as drugs for the treatment of human diseases. The degree of development of a technology is most often understood and measured in terms of “technological readiness levels” or TRL. TRLs were originally designed by NASA to measure the degree of development of components or systems of the Space Shuttle. (2) They operate on a scale consisting of nine levels, where level one “observed and reported fundamentals” roughly equates to basic research and level nine “actual system proven in flight through successful mission operations. Is a fully functional product or service. TRLs have proven to be a useful tool for monitoring technological development and are now widely used by many companies and state agencies in various countries and technology sectors.

Breakthrough innovation

However, this is not the only way to design or assess readiness. Although widely misused, the concept of “disruptive innovation” was popularized by American 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 incumbent and established suppliers. Examples include mobile phones disrupting the landline (“landline”) market and personal computers disrupting the dominance of the mainframe market on a large scale. Importantly, according to Christensen, disruption is not just a property of technology, it involves a new way of doing things; new business models and potentially new supply chains, new manufacturing methods or facilities, different sales and marketing techniques, and new knowledge and skills among those needed to use the established product or service.

This has implications for innovation in the health sector. Healthcare is often seen as resistant to disruptive innovation. There are good reasons for this; human health and well-being depend on the reliable and systematic application of evidence-based quality standards, both in medical practice and in medicines (medicines and medical devices). When disruptive new medical technologies emerge, they require, as Christensen illustrated, new ways of doing things. Therefore, to adopt radically different technologies like cell and gene therapy or bioprinting, health systems must adapt how they work in order to make the new technology viable. The extent to which a health system, and in particular its clinical sites, has the capacity to cope with these new ways of doing things can be understood as the degree of “institutional readiness” (IR). (2)

Institutional preparation

IR was originally developed as a framework to assess the degree to which a clinical site must 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 ultra-low temperature freezers, and appropriate systems in place to monitor outcomes and costs. Institutional readiness has since been adopted for specific areas, such as institutional readiness of hospital pharmacies for new cancer therapies (4) for COVID-19 vaccines (5) and for digital technologies in healthcare.

In addition, the literature on “technological transitions” highlights a third dimension of readiness, beyond TRLs and IRs, although the two overlap. Any technology sector is “an interdependent and co-evolving mix of technologies, supply chains, infrastructure, markets, regulations, user practices and cultural meanings”. (6) These elements constitute a “socio-technical system”. The introduction of a new non-incremental innovation often requires modifying one or more elements at this systemic level. For biomodification therapies, strengthening readiness at the system level involves:

  • Establish appropriate regulatory channels.
  • Ensure that reimbursement models are in place to deal with the anticipated high costs of the first products.
  • Ensuring that there are enough people with the right skills at all stages of the translation journey, from biomedical scientists, engineers and materials scientists to the qualified people who can sign each batch of product. (7)
  • Build a specialized infrastructure of supply chains and manufacturing facilities.

In line with the move towards patient-centered medicine, it is recognized that charities and patient organizations also have a role to play in developing the way clinical services are structured and delivered, for example by providing feedback on the impact on the quality of life of the different options. and helping to develop patient reported outcome measures (PROMs) to evaluate treatments. It makes sense to consider systemic readiness at the nation-state level, as different countries typically have distinct regulatory and legal systems, different degrees of investment in the academic science base, and health and commerce sectors. differently constituted.

To date, technological readiness has received by far the greatest attention. Despite this, all three aspects of preparedness are important to deliver new, functional, sustainable and accessible health technologies and to ensure that investment in innovation ultimately benefits patients. Moreover, these three measures do not involve a discrete division of labor, with companies dealing with TRL, hospitals building IR, and national governments supporting systemic preparedness. Instead, it is essential to ensure that technology design, clinical practices and priorities, as well as national policies and initiatives develop in harmony. Ultimately, disruption of the socio-technical health system is likely to produce only costly failures, unless the change of one element is accompanied by a harmonious adaptation, of the kind that facilitates preparation, of the other relevant elements. . This is important for successful innovation in biomodification technologies, but it is also a useful lesson for other emerging health technologies.

The research behind this exhibit has been supported by Economic and Social Research Council grant number ES / P002943 / 1 and Leverhulme Trust grant number RPG-2017-330.

The references

(1) Michael Morrison (2020) Targeted political support for emerging biomedical innovations. Open access government

(2) Andrew Webster and John Gardner (2019) Aligning Technology and Institutional Readiness: Adopting Innovation. Technology analysis and strategic management, 31 (10); 1229-1241, DOI: 10.1080 / 09537325.2019.1601694

(3) Clayton Christensen (1997) The innovator’s dilemma: When new technologies bankrupt large companies. Harvard Business Review Press; Boston, MA.

(4) Anne Black (Editor-in-Chief) (2020) Institutional Pharmacy Preparation for Marketed CAR-T Therapy: Checklists for Pharmacy Services v4. NHS Specialist Pharmacy Service.

(5) Ian Allen (2020) Institutional Readiness to Manage Pfizer-BioNTech COVID-19 Vaccine in Trusts. NHS Specialist Pharmacy Service.

(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 and social sciences 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.

Note: this is a commercial profile

© 2019. This work is licensed CC BY 4.0 license.

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