Author: Furio Gramatica
To make Europe more competitive and improve its delivery of health care and technologies, the players in this field must apply an innovative, value-based approach to their activities. My team and I believe this requires the creation of a medical ecosystem that encourages collaboration of all stakeholders throughout the health care cycle – particularly during the innovation procurement process.
This is reflected in the work of EURIPHI (European Wide Innovative Procurement of Health Innovation) and NOBEL (Mobilising the European Nanobiomedical Ecosystem) – two EU Horizon 2020 projects in which we participate. Recognizing that value-based innovation procurement is pivotal to both projects, we joined up to exchange ideas and knowledge, identify the main obstacles to innovative health care delivery in the context of procurement, and realize practical solutions that will allow us to make significant progress.
Below I highlight the most pressing challenge to overcome as well as some viable ways to address this.
SMEs: understanding value
From my team’s perspective as a health care provider responsible for integrating innovations into the daily routine of our processes, we often see the impact of a technology that has not been well considered, and thus cannot be used within the organization.
The understanding of “value” (the outcomes that matter and the cost of care taken from multiple perspectives resulting in the most economically advantageous offering) is at the heart of this challenge. This requires a rethink of the awarding process in innovation procurement.
Small- and medium-sized enterprises (SMEs) are major owners of technological innovation and know-how, but we have found that they have little experience of actual clinical and organizational applicability. Indeed, we regularly receive proposed solutions from SMEs which have clever technologies, but in most cases, they are unaware of the impact their technology would have in real settings.
This means that even if there might be some improvement the technology can offer, the “value”, including the impact on the cost of care and organization, is completely unknown to them. Therefore, the failure of most new medical technologies to enter the medical market is not related to their technical features, stability, or reproducible performances. Rather, it is related to the impact on workflow in real settings, often not optimized and resulting in a solution of limited value being offered.
However, with a limited ability to interact with key actors in health care, SMEs are unable to access the knowledge and tools that would allow them to appreciate the specific unmet needs of an organization. This is where “smart health care providers” can work together with SMEs to help them exploit their knowledge into real solutions and scale them up.
In our opinion, the Innovation Loop (iLoop) created by Fondazione Don Gnocchi and refined within the NOBEL project, is a promising approach that can foster a higher-value health care solution. This seven-step process is a tool that smart health care providers can use to support SMEs in fine-tuning the ‘last mile’ of their product development, so that they can transform them into viable technologies.
Having guided many companies through iLoop, we see our role as a type of translator or mediator between SMEs and clinicians, whose work relies on quite different sets of technical language and terminology, not to mention viewpoints. Along the way, we work together to seek improvements and refinements, ensuring the technology can be integrated and scaled up.
This additional cycle of technological evolution can take one to two years, but we believe it is well worth the time and effort. It consists of the following steps:
- Scouting of CE-marked medical technologies
- Collaborative procurement agreement with vendors
- Integration of different systems to collect data
- Development of data analysis tools
- Outcome- and cost-focused controlled trials (Innovation trials)
- Workflow optimization
- Sustainability and reimbursement models
The iLoop process, and most notably innovation trials (Step 5), are an opportunity for companies to measure the impact of their technology on the health care organization, its usability and acceptance, and its sustainability in a real-world setting. This will in turn influence innovation procurement with innovation trials as part of value-based collaborative procurement agreements (Step 2), where EURIPHI partners provide the necessary supportive tools for implementation.
Innovation trials, where both outcomes and usage data generated by a technology solution are measured at the same time, represent the most important step of iLoop. They are a combination of clinical trials and assessments of the impact on the organizational costs in a daily practice. Both are key criteria of a multi-criteria-based decision on the “value”.
To date, these types of trials are still relatively unknown, and they are quite costly for SMEs albeit possibly less costly than classical trials. Because they would benefit all parties involved, we believe innovation trials should be framed around a public-private partnership between companies and health care providers on one side, and funding by public authorities (at European level and/or national and regional level) on the other side.
As a catalyst for value-based innovation procurement which promises to improve outcomes for patients while optimizing health system efficiency, conducting innovation trials is a win-win process of economic value to all the participants. Thus, a health care policy that sets up a public-private co-funding arrangement for this activity makes the most sense to us.
It is also possible to apply iLoop to pre-commercial procurement/public procurement of innovative solutions (PCP/PPI), a main focus of the EURIPHI project. PCP/PPI is a relatively new instrument that can facilitate the introduction of innovative solutions, applying a value-based approach.
In PCP, public procurers buy R&D from several competing suppliers in parallel to compare alternative solution approaches and identify the best value for money solutions that the market can deliver to address their needs. PPI is more focused on integration of innovation, which makes it superimposable with the iLoop scouting, testing, and integration phases.
The EURIPHI project is exploring PCP/PPI as a potential way for encouraging cross-border collaboration among multiple institutions. It is more than a buying proposition; it is a basis for building good partnerships that work on the value-based introduction of technologies into the health care system. In this way, we avoid the risk of introducing innovation for the sake of innovation that is not necessarily responding to health care needs.
In implementing PCP/PPI within the context of iLoop, we believe that EURIPHI is filling a gap that otherwise would not have been possible. Value-based PCP/PPI is a concrete way to make collaborative procurement agreements a reality where SMEs become partners to innovate the delivery of care provided and create a resilient, sustainable health system.
Again, we envision this as a co-development process that is financed under public-private value-based partnerships. There are some limitations to the current instruments, but we feel that these can be overcome. This is why EURIPHI and NOBEL partners have joined forces.
Working together, we are hopeful that we can make positive strides towards realizing innovative health care delivery in Europe.
Furio Gramatica, physicist by training, is Director of Development & Innovation at Don Gnocchi Foundation, an Italian chain of healthcare and research centres specialized in post-acute medicine. In this role, he is responsible for the integration and translation of innovative solutions – from research and industry – into clinical practice and for developing alliances with relevant stakeholders in Europe. In the same organisation, he also managed medical technology research team and founded the Laboratory for Nanomedicine and Clinical Biophotonics. Formerly, he spent several years at CERN, Geneva, and in high-technology companies, with R&D and innovation management roles.
Dr. Gramatica collaborates with companies and institutions in the field of medical technology and, for twenty years, has been collaborating as expert with the European Commission. He has an intense policy making activity, at European level, in healthcare technology products and services innovation and serving.
His current main research interests are co-operation models among the stakeholders of the health technologies ecosystem (healthcare providers, SMEs, large industry, procurers, regulatory and reimbursement agencies, …) and the development of viable, real-world-data based metrics for an effective use of Value-Based Healthcare.
About the NOBEL Project
NOBEL is a collaborative project funded by the European Commission under the grant agreement #766492 of the Horizon 2020 research and innovation programme. From precision engineering to smart connected HealthTech, and from academic research to the clinic, NOBEL is creating an European HealthTech ecosystem, for the convergence of nanomedicine with photonics, robotics, biomaterials, smart systems, Digital Health and Textile. NOBEL has three main missions (i) ECOSYSTEM: building a unique meeting place for all stakeholders from academia to industry, SMEs, clinicians and policy makers (ii) STRATEGY: shaping a common vision for the future of HealthTech in Europe, the Continuum of Care, integrating the separate roadmaps of individual technologies, and showing how concretely these medical technologies may improve the whole journey of patients, for a more, preventive, predictive, personalized and sustainable medicine. (iii) SUPPORT TO INNOVATION: accelerating transfer to market of the most useful disruptive medical innovation, through to the HealthTech TAB (Translation Advisory Board) – www.healthtechtab.eu – a premium mentoring service offering free-of-charge tailored support to selected innovations by our team of world-class industry experts.