Five steps to futureproofing Europe’s health innovation pathway in the digital age

14th November 2020

Jan-Philipp Beck, EIT Health CEO, discusses the findings from our recent Think Tank report into accelerating the adoption of new healthcare solutions to meet the needs of  today’s patients and citizens.

These are extraordinary times. COVID-19 has tested each and every one of us individually and highlighted the fragility of our healthcare systems across Europe.

However, it has also proven our resilience as an industry, showcasing our ability to work together across borders, accelerating the pace of change and meeting urgent healthcare needs.

We’ve had to keep up with the changing pace of the virus, delivering innovation in fast-forward, despite a complex infrastructure that struggles to adapt to ever-emerging technologies.

Never before has it been so clear how urgently we need to reform this journey from innovation to adoption. Called, the ‘innovation pathway’, it describes 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 uptake.

In 2019, before the global pandemic struck, our thought-leadership forum, the EIT Health Think Tank, held its annual Round Table Series on the subject, Optimising innovation pathways: future-proofing for success.

Even prior to COVID-19, it was clear that technological advances in healthcare, such as artificial intelligence (AI) and digital diagnostic support tools, had evolved beyond traditional categories of medicines, vaccines, or medical devices and the established regulatory and reimbursement processes were rarely fit for purpose. At the same time, we need the digital healthcare pathway to meet the changing and growing needs of patients, citizens, and healthcare systems across Europe.

1. Innovation should not be seen as a linear process

Historically, the innovation pathway in healthcare is regarded 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 mind-set 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 and then never revisited. Needs change over time, as do the contexts in which they are defined. We need to facilitate the continuous dialogue between innovators and users (patients, citizens, clinicians) to ensure solutions are developed according to real-time need.

Likewise, digital software updates require space for ongoing adaptation. We need to reframe the innovation pathway to recognise this need for continuous evolution.

2. Regulatory changes need to evolve more rapidly alongside technology

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 technologies that are new or not yet known to us.

We are gradually seeing newer technologies being addressed in regulatory guidance, such as the revised medical device regulation, which will launch next year and accommodate missing technology types, such as AI. However, this has been slow – AI has been in use for many years and is no longer considered a novel advancement. Pathway processes need to become more agile, balancing efficacy and safety with the need to take advantage of all that technology can offer.

3. Remodelling reimbursement in the era of preventative healthcare

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 traditional medicines. Many innovators are developing solutions that will assist in the management of disease, or aim to prevent them, and so routine cost 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 focusing more heavily on direct treatment of diseases.

We must modernise how we view 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.

4. Taking advantage of the rise in telemedicine

The rapid rise in adoption of telemedicine during this pandemic demonstrates that speed of adoption can be achieved when the motivation and collective effort exists.

Telemedicine has a vital role to play in healthcare delivery even outside of times of crisis. It provides 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).

5. Developing EU-wide data regulation standards

The Round Table 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. Therefore, we must work together to develop EU-wide data regulation standards.

Change happens when we work together

To create a sustainable healthcare future we must grasp the opportunity to adopt new ways of working. We can only do this if we work together, by involving diverse stakeholders from across disciplines and across geographies. We must move away from siloed working.

Modernising the pathway will help to accelerate the delivery of promising healthcare solutions to market, providing significant benefits. Technology can help our healthcare services become more efficient, connected, and informed. It can also help to shift our approach to healthcare, putting more emphasis on preventative care, which can help improve patient quality of life and reap financial rewards for healthcare services.

Ultimately, these changes will provide equal access to innovative products and services, helping citizens to lead longer, healthier lives.

You can read the full report here