Thought Leader | MedTech Europe: Innovative SMEs

Europe’s SME-powered MedTech sector is brimming with ideas that could benefit from a new JTI initiative writes Serge Bernasconi.

Innovative enterprise week is an ideal time to reflect on what SMEs do for Europe and what Europe can do for SMEs.

At this week’s event in Riga, we will discuss the value that nimble, idea-fuelled companies can play in delivering the economic growth Europe needs.

The MedTech sector is, in many ways, a model European industry.

Around 95 per cent of Europe’s 25,000 MedTech companies are SMEs while the industry invests heavily in R&D, fi les more patents than any other industry, provides over 575,000 jobs across Europe and delivers a positive trade balance of €15bn.


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Our companies deliver value in every sense of the word.

They develop smart new technologies that help us live longer, healthier, independent lives – a pre-requisite for socially and economically active EU citizens.

Yet, while MedTech product development and technological enhancement can be swift compared, for example, to the pharmaceutical sector, the steps on the road to adoption in European member states are often challenging.

After CE marking, many countries require additional data to be able to obtain reimbursement and bring the product to market.

One current option in helping to finance this phase is for SMEs to seek a special investment from hospitals.

Or they may seek access to what limited regional or national innovation funding is available.

For a small company – typically led by its founder and staffed by a small team – navigating this process can be time consuming, complex and unpredictable, requiring specific knowledge and expertise not necessarily available in these companies.

Systems are not consistent throughout Europe, nor is it certain to lead to inclusion in healthcare payment systems.

With increased local requirements, things are not getting any easier.

For example, Germany – where many medical technologies first meet the market – looks set to introduce new legislation that will make it more time consuming to secure reimbursement for highly innovative products, which in turn delays access for patients.

What can be done? One option is to embrace the successful joint technology initiative (JTI) model that Europe has pioneered to solve large structural problems.

Just as the innovative medicines initiative (IMI) helps support the early stages of drug development in the pharmaceutical industry, a JTI could help MedTech SMEs to demonstrate their value in meeting member states’ needs.

A public-private partnership – with support from the EU, health ministries, finance ministries and economic and industry ministries – of itself would demonstrate our shared commitment.

The idea fits neatly with European commission president Jean- Claude Juncker’s pro-growth investment plan.

It could provide the finance, expertise and other supports that SMEs and member states need.

The alternative is that smaller players no longer aim to access Europe as a preferred market – or they sell their innovations to larger companies.

A JTI for MedTech SMEs would be a sound investment.

We would be supporting the conversion of innovation into value.

It would be a vote of confidence in innovative SMEs, in jobs and a support for our health, productivity and the economy.

It would be a vote of confidence in Europe.

 

Read the most recent articles written by Serge Bernasconi - New IVDR and MDR regulations need investment to succeed

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