What’s on the cards for medtech innovation in 2025?

Although major trends in medtech don’t vary much year to year, some exciting sub-trends are emerging within them. Wider factors – including strategic investment and the shifting regulatory landscape – will also impact innovation in the medtech space.

Here, medtech experts at Sagentia Innovation discuss five dominant themes for 2025 and beyond.

1. Strategic investment will drive new R&D models for medtech

According to JP Morgan’s Q3 2024 Medtech Licensing and Venture Report, venture investments were up by around $1billion year on year. The same quarter saw a significant jump in private equity deals across the sector.

Innovation is often a top priority following strategic investment, especially for private equity companies taking a ‘buy and build’ approach. In fact, private capital investment is frequently associated with subsequent growth of intellectual property (IP) assets. Recent analysis performed by the EU’s IP Office indicates that a 100% increase in private investment correlates with a 10% rise in trademark and patent filings.

So, ripple effects of 2024’s investor activity will likely include an uptick in commercial innovation aligned with prevailing healthcare trends as investors seek to maximise returns. R&D may be handled differently in these scenarios. For instance, it’s common to see non-core aspects of development outsourced to third party R&D consultancies earlier in the product development process. We’ve certainly been having more conversations along these lines and expect collaborative innovation to be a key theme for the year ahead.

2. Large electromechanical systems are moving back up the agenda

Recent years have seen a high level of focus on smaller medical devices and wearables. This has largely been driven by the trends for decentralisation and personalisation. However, it’s also corresponded with a period where healthcare providers have been reluctant to spend on big-ticket hardware.

We are seeing the pendulum start to swing with renewed appetite for complex electromechanical systems that add value to patient communities. Large medtech companies’ design teams are familiar with these systems and established regulatory pathways are geared towards their assessment. So, there’s a good chance that new concepts could enjoy rapid progress, not only if they are substantially equivalent to a predicate device, but also if the commercial opportunity and clinical need drives the rapid investment in a de novo device.

3. Diagnostics and image analysis will benefit from AI models

Facilitating earlier diagnosis of disease along with personalised treatment is an enduring medtech trend, and we expect to see more examples of AI being harnessed to accelerate progress in this space.

Genomic medicine will continue to grow and be used earlier in the cancer treatment pathway. AI models are an important tool to enable more patterns and mutations to be linked to disease as the amount of sequencing data grows. 

Moving beyond genomics, multi-omics is maturing. One area commanding a lot of attention is the largescale study of proteins – proteomics – to unlock valuable disease and biomarker insights. Applying AI to the analysis of proteomic data enables patterns to be identified more quickly and efficiently than with human researchers alone.

In a similar vein, we anticipate increased use of AI in image-based pathology to improve the accuracy, speed, and efficiency of image analysis. This is driven by a shortage of pathologists and holds great potential for early detection of abnormal cells and image-based classification of tumours, supporting pathologist decision-making and reducing cognitive load.

4. Regulatory developments could expedite time to market in the US

It’s often the case that new regulations and governmental initiatives spur investment in R&D. This was seen a few years ago in medtech when the US Executive Order on Advancing American Kidney Health led to increased activity focused on ‘hospital at home’ treatments. 

The new rule from the Food and Drug Administration (FDA) amending the current Quality System regulation requirements for medical devices could have a similar impact across the wider medtech sector. Coming into effect in February 2026, it will harmonise and modernise requirements, aiming to “provide timelier introduction of safe, effective, high-quality devices for patients”.

When President Trump takes office in January 2025, further evolution of policies and regulatory obligations can be expected. In his September 2024 speech at the Economic Club of New York Trump suggested that ten old regulations will be eliminated for every new regulation introduced. It remains to be seen whether this will hold true, but the statement sends a clear message about his intentions.

Trump’s plans to increase import tariffs may also impact the sector, but there is a high level of uncertainty on this matter at present. Imports account for around 30 percent of the US medical device market, so tariff hikes may create a gap that can be filled by domestic manufacture. However, medtech companies importing components from overseas will also be exposed to the new tariffs.    

5. The sustainability mindset will extend into new areas

Last year, we predicted that sustainability would begin to impact R&D at a practical level in 2024. This proved to be the case, as evidenced in developments such as Ambu’s launch of the world’s first single-use endoscope made from bioplastic. Trade association MedTech Europe has also upped its focus on sustainability, issuing ten recommendations for a patient-centric EU Green Deal.  

Through 2025, more widespread use of materials with good sustainability credentials is to be expected. This will be most evident across endoscopy and other categories associated with high use of consumables, such as diagnostics. Medtech companies are also beginning to consider the bigger picture on sustainability. For instance, many are looking at how actions taken before, during, and after procedures can be optimised to reduce waste and enhance energy efficiency. Increased awareness of these factors will filter through to R&D design rules linked to sustainability.  

Accelerating medtech innovation

As these themes continue to evolve, Sagentia Innovation can support your R&D journey, delivering value to investors, healthcare providers, and patients alike. We bring deep expertise in medical devices, surgical systems, diagnostic solutions, women’s health innovation and more. Our strengths in creative design, hard science, and regulatory insight enable and accelerate the development of safe and effective solutions. Find out more here.