Our medtech specialists have been thinking about the trends, technologies, and developments set to drive healthcare innovation over the next 12 months. Here they outline key factors that will influence technical developments and R&D priorities for surgical and diagnostic devices. They also share insights on what’s in store for women’s health, data science, and front-end innovation.

1. MDR delay will result in shifting priorities

A delay of three or more years to full implementation of the Medical Devices Regulation (MDR) announced by the European Commission is a welcome relief for many medtech companies. But there will be frustration that R&D portfolios influenced or even dominated by the previous 2024 deadline could have been very different had December 2027 / December 2028 been the original dates. This development means companies need to re-plan quickly to take advantage of the new deadline and bring forward projects that would otherwise have been delayed by the MDR rush

2. The patient backlog will drive surgical innovation

As global health systems grapple with the elective surgery crisis following COVID-19, there are calls for urgent action. According to a McKinsey report, the pandemic resulted in a US backlog of more than 1 million joint and spinal surgeries and 1.1 to 1.6 million cataract procedures. More than 7 million people are reportedly waiting for surgery in the UK too.

Strategies to overcome this problem are likely to include a continued shift of surgical patients to outpatient and shorter-stay settings. This brings implications for the way surgery is prioritised and performed, as well as for pre- and post-operative patient management and communication. Therefore, uptake of innovative technologies which improve efficiency and accelerate patient journeys is likely to increase.

Digital solutions and surgical robotics will play a lead role in this evolution of perioperative and surgical care. At the recent Future Surgery conference it was clear that many surgical professionals believe these technologies offer tangible benefits for patients and healthcare providers alike. For instance, robotic assisted methods enable more surgeons to perform more procedures in a minimally invasive way. App-based communication between surgeons and patients is proving effective in boosting efficiency and reducing patient anxiety during post-operative recovery too. 

New technologies could also help address the surgical training backlog which is further exacerbating the elective surgery issue. Surgery cancellations during the pandemic made it difficult for trainees to gain necessary experience through observation and participation. This presents opportunities for the development of simulation and remote observation training solutions using virtual reality and telepresence capabilities.

3. New technologies will accelerate and improve diagnosis

As demand for COVID-19 testing wanes, providers are looking to expand their menu of DNA and RNA tests to take advantage of the larger installed base and maintain utilisation. We expect them to extend beyond respiratory infections with tests for sexually transmitted health, antimicrobial stewardship, and oncology.

At-home testing has also declined, but its rapid rise during the pandemic boosted consumer and clinician awareness of the advantages of testing close to the point of need. Various at-home diagnostic devices received regulatory approval, and we anticipate that growth will continue in two directions. Firstly, we’ll see increased at-home or at-work sample collection followed by central lab testing, improving patient convenience whilst leveraging the cost and performance advantages of the laboratory. The challenge here is enabling easy self-collection without introducing preanalytical error. Alongside this, there will be further developments in rapid at-home tests with equivalent performance to laboratory tests. At present this is technically possible, but costs are too high. We’re expecting significant cost-focused developments aimed at facilitating wider uptake.

Our whitepaper, Making at-home molecular tests affordable, actionable and sustainable draws on some of these trends.

Another area where we expect to see progress is the use of liquid biopsy tests in cancer treatment. This technique will increasingly evolve from its current use shaping cancer treatment decisions to also playing a role in diagnosis.

Liquid biopsy via the sampling and analysis of blood is quicker and less invasive for the patient than tissue biopsy. It also makes it possible to detect, or rule out, the presence of cancer earlier in the patient journey. Where cancer is present, this technique may provide clinically actionable information based on the tumour’s genetic profile, enabling effective intervention at an earlier stage. With the various FDA regulatory milestones that have been reached in recent years, development in this area is set to pick up pace.

We published a whitepaper looking at technical and regulatory developments that will improve the accessibility of advanced molecular diagnostics in precision oncology. You can download it here.

4. Women’s health will continue making advancements

Problematic gaps in women’s health data will finally begin to narrow, partly driven by use of apps to collect more specific information about women. As data science and analytics tools are applied to bigger datasets, we’ll see increased emergence of predictive healthcare surrounding individuals’ risk of developing certain conditions. These capabilities will enable further progress in personalised medicine, for women and for the wider population.

Regulatory change is also likely to shift the ways some products are positioned and marketed, with lifestyle and wellbeing products playing a growing role in the women’s health category. 

Our webinar ‘what’s next in women’s health?’ offers further insights on this topic.

5. Data science will unlock bigger opportunities

Developments in data science point to the rise of exciting new insights and capabilities that could benefit the medical space in 2023. As medtech companies look to do more with the data that their devices already collect, expert application of data science methodologies will be critical.

One data-driven innovation currently making waves is Google’s MedPaLM. Positioned as a ‘chatbot for healthcare’, a trial determined that 92.6% of its responses were on par with those generated by clinicians.

6. Front-end innovation will tackle new challenges

The coming year will see sustainability considerations becoming more prominent in front-end planning and decision making. Sustainability hasn’t been high on the innovation agenda for medtech in the past, but as the climate emergency intensifies this will change. More companies are assessing their net zero impact and setting carbon reduction goals. See our Net Zero Playbook for guidance on how R&D can drive concrete steps towards this.

Reducing the energy requirements associated with device manufacture may be one area of focus. We’re also expecting companies to re-evaluate the durable/sustainable split of devices and components to improve their environmental posture. Designers might look at ways to reduce the materials used or consider changes that would facilitate reuse and recycling. Circular options could be explored too, with instruments potentially reconditioned or refurbished. Clearly these developments will involve detailed assessment of safety, efficacy, and hygiene implications which will be particularly challenging to the medtech industry. Sustainability requires consideration from not only R&D but also manufacturing and logistics to make a significant impact, and for major leaps towards net zero to be achieved.

7. Design for Manufacture will act as an innovation accelerator

It has never been more important to execute the latter stages of development well, to hit launch targets and realise the value of medtech R&D investments sooner. This applies both to start-ups and acquisitions by large corporates. It requires careful attention to detail on design for manufacture, regulatory testing, and submissions, while ensuring the core science and user experience that underpins the innovation retains its integrity.

Alongside this, component shortages are expected to continue in 2023, making close bill of materials monitoring essential from the front-end innovation point onwards. According to Electronics Design magazine, lead times for high-performance microcontrollers (MCUs) widely used in medtech could reach 60 weeks. There’s likely to be an ongoing need for component workarounds, and in some cases it may be necessary to disable connected aspects of systems. Planning for this upfront enables a more agile, flexible approach where unavailable components are replaced with viable alternatives.

Seizing medtech innovation opportunities

The repercussions of the pandemic are still felt acutely in the healthcare sector and now the impact of inflation is exacerbating the challenges faced. Nevertheless, opportunities abound to innovate and drive improvements, and medtech has a vital role to play.

Here at Sagentia Innovation we can support this vision with our deep expertise in the development of medical devices, surgical systems, diagnostic solutions and more. We offer creative design, hard science, and regulatory insight to enable and accelerate the development of safe and effective solutions. Find out more here.