New frontiers for medical devices, between innovation and regulations

The medical technology industry is today the protagonist of the revolution that medicine is experiencing, also involving the evolution of the new frontiers for medical devices. In fact, a change in the patient’s needs and expectations is underway, essentially linked to the aging process of the population, but also to the critical issues associated with migration flows, the development of science in the medical field and cultural and social evolution.

All these factors are pushing towards the definition of new models of assistance and service delivery in the health sector, guided by a patient-centric vision. In 4P medicine – predictive, preventive, personalized and participatory – the patient plays an increasingly active role in the management of his own health, having all the information available to allow him to make informed decisions.

The process of developing a medical device from basic research to finished product is highly innovative and requires significant investments in R&D. According to data processed by Confindustria Medical Devices, the sector has invested 934.5 million euros in R&D, of which over 90% in the applied research and experimental development phases.

To grasp the digital frontiers of medical devices and the related revolution underway, however, it is necessary to enhance basic research and applied research also in universities and scientific centers both through appropriate funding and by activating continuous collaborations between industry and institutions. of research.

The financial resources offered by the NRP represent a unique opportunity to renew the production ecosystem and rethink the health system of our country, as explained by Massimiliano Boggetti, president of Assobiomedica, in this interview with Makinglife Pharmafuture & Health.

The technological and innovative push in the field of DM is surprising, what can we expect in the next few years?

The digital frontiers of medical devices are in continuous development, being part of a universe where wonder and science give life to innovation, the basis of 1.5 million technologies for people’s health and well-being.

The development, implementation and diffusion of new technologies, advanced, miniaturized and domestic, acquires an essential role in the new conception of medicine, contributing to the continuous and rapid transformation of the health system, its sustainability and the improvement of the health conditions of the population.

The ability to monitor patients in real time, even outside the classic hospital context, ensures high therapeutic efficacy, minimizing side effects and making personalized medicine possible. It is therefore a system capable of managing the client at three hundred and sixty degrees and is not limited to providing a product, but a complex and entirely dedicated service.

How can the innovations and technologies related to DM be harmonized, welcomed and fully exploited by infrastructures that instead travel at a much slower rate of modernization?

The resources made available for health in the National Recovery and Resilience Plan represent a unique opportunity to rethink the National Health Service, make it modern, sustainable, capable of innovating and bringing tangible benefits to patients. And the choices that the country will make in terms of technological innovations, priorities and spending methods are fundamental.

Confindustria Medical Devices has formulated proposals aimed at improving the health system’s ability to respond to the health – and, in a broader sense, welfare – needs of citizens. The two proposed strategic lines concern, on the one hand, the qualification of hospitals through technological contents that allow the availability and use of more modern diagnostic systems and therapies appropriate to clinical and socio-care needs and that facilitate integration with the territory; on the other hand, the strengthening of all assistance on the territory in its various articulations, looking, as far as possible, to extend home treatment.

An element common to both is the start of a digitization process, intended as a systemic collection, analysis, integration, management and treatment of the set of information deriving from the various processes in which the health practice is divided (for the clinical, organizational and administrative). In conclusion, the challenge that our country is facing in order to get out of the crisis requires implementing a state-of-the-art health system that is sustainable, resilient and capable of innovating.

Investments in healthcare by NextGenerationEu represent a unique opportunity to do so. The effort must be to create the infrastructures and a health management system that allows the best use of the tools that technological innovation makes available to maximize investments. We believe that our ideas and the innovation of the companies we represent can help create a new healthcare that’s tailored to people. We hope that the country will enable us to make our contribution.

Sustainability of research and of the DM market in the face of the new regulations in force. How to do?

Every innovation, also linked to the digital frontiers of medical devices in particular, arises from scientific research. This is why it is important to go back to financing basic research and applied research in universities, the CNR, the Irccs and research centers.

Enhance the technology parks and focus on projects that qualify our country at an international level such as the “Milan innovation district (Mind)”; these are actions that are capable of attracting investments also by companies. The medical devices sector invests about 6% of its turnover, or over a billion euros, in research and development and companies must be encouraged to undertake activities in our country that stimulate every investment model, from that between universities and industry, to that between research centers and industry, to that between start-ups and industry.

The propensity to innovate by companies in the sector must therefore be strengthened and enhanced through the synergies that can arise between the world of research and production. Research and development and technology transfer do not go through simple “switches” to be turned on episodically and kept off for the rest of the time. The results of R&D and technology transfer are all the more profitable the more it is a question of finalizing a relationship of “frequentation” between business and research that is systematic, continuous, characterized by mutual fertilization.

This is why it is important to create an ecosystem that stimulates the constant collaboration of companies with the research centers, universities, technology clusters and start-ups that populate our territory. Pre-marketing clinical investigations are of fundamental importance in the development of innovative medical devices because they fuel continuous innovation and stimulate discontinuous one. They therefore represent an opportunity for economic fallout for our country.

In fact, continuous innovation does not create new markets, but develops existing ones by making available solutions with a higher value than those already available on the market. While disruptive innovation introduces totally new solutions that respond to unmet health needs, thus creating new markets or expanding existing ones.

Generally speaking, these are solutions that make it possible to spread a new approach or a new technique that, ultimately and in an unexpected way, surpasses the existing market. All this creates a stimulating ground not only for the research and development of new technologies, but also from an economic and industrial point of view.

Today, with the new European regulations, clinical trials become one of the points of greatest attention, a crucial aspect through which product compliance will pass in the near future. And the cycle of product improvement through post market surveillance is another aspect on which the European legislator has placed its attention during the review of the system.

From a device life cycle point of view, post market surveillance is a central element in evaluating the performance and real effectiveness of a device during use on the patient by the healthcare professional. In addition to being, therefore, the optimal tool for monitoring and intercepting malfunctions or off-label uses of the device, post-market surveillance allows the generation of fundamental data on the performance of the device, to be used in terms of future compliance and impact assessments of a given technology on the healthcare system.

How to ensure the safety of DMs in the light of new technologies? What is expected from the revision of the NIS Directive?

With the approval by the Council of the joint general approach on 3 December, the process of the “Proposal for a directive of the European Parliament and of the Council on measures for a high common level of cybersecurity across the Union, repealing Directive continues. 2016/1148 “. This act of the Council will allow the French European Presidency, in the first half of 2022, to continue the discussion in the Trilogue (EP, Council, EU) of the proposed directive.

Once the legislation has been adopted, together with the European associations COCIR and MedTech Europe – of which Confindustria Medical Devices is a part – it will be possible to fully understand the practical implementations and the impact for the digital frontiers of medical devices. Given the centrality of digital transformation in the NRP, this topic also requires attention at the national level, as well as at the European level.

In particular, given the transversal nature of the revision of the NIS Directive, which horizontally affects the various industrial sectors, Confindustria together with Confindustria Brussels is following the work and contributing to the definition of the positioning of the European BusinessEurope association.

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