by Jan-Philipp Beck*
We are living in extraordinary times. COVID-19 has highlighted the fragility of healthcare systems across Europe, just as immense pressure has been brought to bear on them. But the pandemic has also shown us how the momentum of human invention can be supercharged and accelerated to meet an overwhelming human need. This is innovation at increased speed, navigating a complex infrastructure that continues to struggle with the pace of change brought by ever-emerging technologies.
Towards the end of 2019, before this global pandemic struck, EIT Health convened a number of national health experts, thought-leaders, innovators and decision-makers to discuss the need for change within Europe’s digital health innovation pathway. The innovation pathway is the route a product or service takes from the beginning to the end of its lifecycle, including clinical need and idea, development, market entry, reimbursement and adoption.
The EIT Health Think Tank holds annual Roundtables across Europe, bringing multi-disciplinary healthcare leaders together to explore the most pressing topics impacting healthcare innovation today. Following the Roundtables, a consolidated summary of the insights and recommendations made within these meetings is published. The 2019 Roundtables, titled ‘Optimising Innovation Pathways: Future Proofing for Success’, gathered valuable insights across seven European countries on how the innovation pathway needs to adapt. Today’s healthcare innovations no longer fit into the more traditional categories of medicines, vaccines or medical devices, and the established regulatory and reimbursement processes are rarely fit for purpose. Now, involved stakeholders are facing a much bigger task, as technological advancements have opened the door to diverse and numerous innovation ‘types’, such as artificial intelligence and digital diagnostic support tools. digital healthcare pathway must evolve to meet the changing and growing needs of patients, citizens and healthcare systems across Europe.
Historically, the innovation pathway in healthcare is envisaged as a linear process, and innovators have tended to view the steps towards the launch of a product or service onto the market as consecutive. The challenge in such a mindset lies in the reality that steps cannot be approached in silos and are instead intrinsically interdependent. Identifying true clinical and patient need, for example, is not something to be considered only at the beginning but then never revisited. Not only do needs change over time, but so do the contexts in which they are defined. Likewise, development in digital health will be a continuous process as software is updated. We need to reframe the innovation pathway in health to become more cyclic and reiterative.
It is well understood that the digital health industry is so fast-moving that it can often outpace the speed at which pathway processes can adapt to accommodate them. It is difficult to have clearly defined regulatory processes for technology that is new or not yet known to us. We are slowly seeing newer technologies being addressed in regulatory guidance, such as the revised medical device regulation which will launch next year and accommodate technology types previously missing (such as artificial intelligence). To continue with our example, however, artificial intelligence is no longer a novel advancement and has been in use for many years. And so we must ask whether pathway processes need to be reimagined to become more agile and flexible to ensure the correct balance of efficacy and safety while also rapidly taking advantage of all that technology can offer.
Beyond regulation, there are also challenges associated with reimbursement and adoption for digital health. Firstly, the process for reimbursement is heavily fragmented across Europe – there is no central standardised European route for innovators to gain widespread reimbursement, and they must instead navigate complex funding processes at national, local or even hospital level. Secondly, traditional measures of cost effectiveness are markedly different when comparing digital health with more traditional health technology such as medicines. Many innovators are developing solutions that will assist in the management of disease, or aim to prevent them, and so routine cost effectiveness analyses cannot be easily calculated using current methods. Often, a technology is embedded in an existing diagnostic or treatment pathway, so a straightforward ‘cost replacement’ is not achieved, but rather an upfront investment that will pay dividends in the longer term. As such, innovators find there is often not the same motivation in adopting such technologies, with healthcare providers focussing more heavily on direct treatment of diseases.
The rapid rise in adoption of telemedicine during this pandemic demonstrates that speed of adoption can be achieved when the motivation and collective effort of all relevant actors is there. These technologies have a vital role to play in healthcare delivery even outside of times of crisis. They provide flexibility and continuity of care for patients who cannot make it to clinics (such as those living in remote or rural locations, disabled and elderly patients who struggle to travel, or patients juggling busy work and childcare schedules). While it is encouraging to see the current surge in adoption of telemedicine, it is somewhat disappointing to acknowledge that its value is not widely recognised under normal circumstances.
The roundtable discussions also revealed considerable differences between countries over data integration and accessibility, highlighting the need for better standardisation of data regulation, governance and utilisation by industry across Europe. As expected, the challenge of data interoperability remains a specific and ongoing challenge.
So, where can change happen?
There are elements of the innovation pathway where change could lead to the acceleration of promising solutions reaching the market:
-Facilitating a continuous two-way exchange between innovators and users (patients, citizens, clinicians) can help to ensure that solutions are developed according to real time need
-Agile regulatory processes to allow for the rapid emergence of new technologies, and the iterative process of digital health
-Aligning HTA requirements and standardising at the European (centralised) level, mitigating variance between individual member state practices and methodologies
-Modernising our view of value and cost effectiveness in the wake of digital health to identify how evidence can be continuously generated and submitted to support with reimbursement and adoption
-Developing EU-wide data regulation standards
Addressing such elements requires an entirely collaborative approach – it must involve diverse stakeholders from across disciplines and across geographies. We must move away from siloed working. Evolving the pathway to facilitate the acceleration of promising healthcare solutions to market can provide significant benefit; technology can help our healthcare services become more efficient, connected, and informed. It can also help us to be more preventative in our approach to caring for patients and citizens, which can bring improvements in quality of life and reap financial rewards for healthcare services. As we address the sustainability challenges many healthcare services across Europe face, we must grasp the opportunity to adopt new ways of working.
So, yes, the current pathway is facing multiple calls for improvement. However, ultimately these changes can only help citizens lead longer, healthier lives through equal access to innovative products and services.
*CEO of EIT Health
**first published in: www.euractiv.com
By: N. Peter Kramer
