Panorama MedTech 2026 : challenges transforming the medical device industry

An industry that remains strategic for France 

The French medical device industry remains a major player in the healthcare economy. The sector currently comprises nearly 1,518 companies, accounts for approximately 90,000 direct jobs, and generates nearly 36 billion euros in revenue, an increase of about 9 percent. France also maintains strong industrial capacity, with more than 400 production sites spread across the country.  

However, behind these positive indicators lies a more nuanced reality. The industrial landscape is gradually becoming polarized. On one side are innovative companies capable of raising capital, accelerating their growth, and consolidating their market position. On the other are small and medium-sized enterprises (SMEs) facing a continuous rise in costs and regulatory constraints that are undermining their business models.  

This pressure is reflected, in particular, in an increase in the number of liquidations and an acceleration of the consolidation trends observed in recent years. 

MDR: when compliance directly impacts innovation 

Anticipating regulatory requirements to preserve innovation 

One of the most striking findings concerns the impact of the European Medical Device Regulation (MDR). 

Originally designed to enhance patient safety and improve device evaluation, the MDR now imposes significant costs on manufacturers. According to data collected from manufacturers, 72% of companies incurred new regulatory expenses in 2025, while nearly half estimate that the increase in costs exceeds 60%.  

For many MedTech companies, this trend is leading to a reallocation of resources. Budgets and teams that were once dedicated to research and development are now being redirected to meet compliance requirements, maintain existing certifications, and produce increasingly complex technical documentation.  

In this context, the challenge is no longer simply to design an innovative system, but to ensure its regulatory viability throughout its entire life cycle. 

Why an integrated regulatory strategy Is becoming essential 

Given this growing complexity, compliance can no longer be viewed as a simple validation step at the end of a project. It must be integrated from the earliest stages of development in order to anticipate the requirements of the MDR, effectively structure the generation of evidence, and minimise the risk of delays during the certification and market authorisation phases.  

This approach also makes it possible to align regulatory, clinical, and market access issues at an earlier stage. In a constantly evolving environment, regulation thus becomes a strategic lever for securing investments, accelerating device development, and preserving the innovative capacity of medtech companies.  

Access to reimbursement is becoming the main obstacle to commercialisation 

From CE marking to market launch: a journey fraught with obstacles 

Obtaining CE marking is no longer synonymous with rapid market access. 

Industry leaders now emphasize that reimbursement procedures are one of the main obstacles to the commercialization of innovations. About 68% of startups now consider access to reimbursement to be their biggest challenge, ranking even ahead of financing or regulatory requirements. Furthermore, 67% of companies wait more than a year between obtaining CE marking and the actual launch of their solution.  

This situation has significant consequences: 

• Longer return on investment.

• Delays in patients’ access to innovations.

• Funding challenges for startups.

• Cancellation of certain product launches.

According to the data presented, nearly 45% of the stakeholders surveyed for the 2026 panorama report that they have already abandoned or postponed certain product launches due to these constraints. 

Obtaining CE marking is therefore an essential step, but it is no longer sufficient on its own to guarantee the commercial success of an innovation. 

The need to demonstrate the value of innovations 

Faced with ever-increasing reimbursement requirements, health authorities and payers now expect more than just a demonstration of technical performance. 

Manufacturers must be able to provide robust evidence regarding the device’s clinical benefit, its impact on the care pathway, its medical-economic value, and the outcomes observed in real-world settings. 

This development marks a true paradigm shift for the MedTech industry. The generation of evidence is no longer aimed solely at meeting regulatory requirements, but also at demonstrating the overall value of innovation to all stakeholders.  

Clinical investigations under pressure 

Clinical delays that threaten the competitiveness of MedTech companies 

Clinical research remains at the heart of medical device development. Yet it, too, faces growing challenges.  

Nearly one-third of the companies surveyed report facing difficulties in conducting their clinical trials. Among the main obstacles are administrative delays, contract negotiations with research sites, and organizational issues related to study initiation.  

Some manufacturers report, in particular, that the time required to finalize contracts can be as long as 134 days, whereas the theoretical timeframe set forth in the Public Health Code is 45 days. 

For manufacturers, these delays pose a major risk: 

• Discrepancies in development schedules.

• Increase in research costs.

• Delays in obtaining clinical data.

• Loss of competitiveness compared to international competitors.

Effectively managing the feasibility, study start-up, contract negotiation, and site coordination phases is therefore a strategic priority for ensuring that development timelines are met. 

The “Study Start-Up” program: a key driver for accelerating development 

Early feasibility assessments, the selection of the most suitable centers, rigorous monitoring of contract negotiations, and the rapid activation of sites are all critical steps in ensuring that development timelines are met. 

Beyond the operational aspect, effective study start-up management also helps improve the overall quality of clinical trials by fostering smoother coordination among the various stakeholders. For MedTech companies, these steps are no longer merely administrative requirements; they now represent a strategic advantage for accelerating the generation of clinical evidence and facilitating market access.  

Digital health and artificial intelligence: growth hindered by regulatory uncertainty 

Digital health is emerging as a growth driver for the MedTech industry 

Another key trend observed in the sector: the rise of digital health. 

For the first time, the e-health and Software as a Medical Device (SaMD) segment has surpassed the in vitro diagnostics segment among the business areas represented in the industry. This trend confirms the accelerating digitization of healthcare solutions and the growing integration of artificial intelligence into medical devices.  

However, this trend raises significant regulatory questions. 

Only 2% of the companies surveyed currently consider the regulatory framework to be well-suited to the challenges posed by digital technology and AI. In contrast, 67% consider it insufficiently clear, and 31% consider it too rigid.  

Manufacturers must now navigate a number of requirements: 

• MDR and medical device regulations.

• Clinical validation of algorithms.

• Health data management.

• Cybersecurity.

• New obligations related to AI.

This complexity underscores the need for a multidisciplinary approach that combines regulatory, clinical, data, and health economics expertise. 

Balancing technological innovation and regulatory requirements 

In addition to complying with the MDR, they must demonstrate the clinical performance of their algorithms, ensure the security and confidentiality of health data, meet cybersecurity requirements, and anticipate the introduction of new regulations related to artificial intelligence. 

This complexity is profoundly transforming the development strategies of digital health stakeholders. The success of a project now depends on the ability to coordinate several key areas: regulation, the generation of clinical evidence, data management, market access, and demonstrating value.  

Now more than ever, the development of digital solutions requires an integrated, multidisciplinary approach capable of supporting innovation from its conception through to its adoption by healthcare professionals and patients. 

Toward an integrated approach to the development of medical devices 

The major challenges identified by the sector have one thing in common: they can no longer be addressed in isolation. 

Today, regulatory strategies directly influence clinical needs. Clinical data drive reimbursement applications. Health economic evidence is becoming essential for demonstrating the value of innovations. Digital solutions, for their part, must simultaneously meet technological, regulatory, and clinical requirements.  

Faced with this reality, manufacturers are increasingly seeking integrated approaches capable of supporting the entire development process: 

• Regulatory affairs and quality.

• Clinical operations.

• Clinical investigations.

• HEOR and real-world evidence.

• Market access.

• Digital health and artificial intelligence.

This end-to-end approach not only helps ensure the security of projects but also accelerates the delivery of innovations to patients.