The medtech industry is seeing an increase in new technology focused on addressing some of its most complex problems across the product lifecycle. However, these solutions often bring up age-old challenges, including creating more data silos and disconnected systems.

So far in 2024, we’re seeing more medtech companies strategically prioritize the fundamentals of product development and commercialization to clear a path for sustained innovation. From digging into digital therapeutics to building stronger data foundations, following are some trends currently shaping software in medtech.

1. Digital therapeutics is progressing; leading device makers will enter the space

When Pear Therapeutics became the first company to receive payer funding for its mobile application to treat substance use disorder, the industry appeared to be preparing for digital therapeutics to go mainstream. A lot changed over the past two-plus years—losses have cast a shadow on the digital health market, with some organizations filing for bankruptcy and others jumping toward direct-to-consumer (DTC).

Despite the setbacks, digital therapeutics continue to gain traction—especially for more prominent companies with the resources to apply knowledge from early innovators in the space. In the years ahead, we expect to see leading companies testing out new commercial strategies for digital therapeutics, including going DTC or designing companion apps for established therapies.

Top 20 biopharma companies like Pfizer, AstraZeneca, Boehringer Ingelheim, and Roche joined the Digital Therapeutics Alliance already, and more will likely soon join the FDA’s Digital Health Advisory Committee.

2. Regulatory teams will shift the mindset to agile project delivery

The speed at which global regulations change is driving widespread initiatives, including the shift to data submissions and a broad directive for regulatory teams to accomplish more with less. More regulatory operations and affairs teams are adopting an agile “DevOps” mindset to address these challenges. The signs of a significant culture change and a growing emphasis on driving continuous improvement are already noticeable across the industry.

While regulatory teams work on speeding approvals for more product areas and regions, they also evaluate how to drive greater efficiency across internal operations. More often, data sent to regulatory agencies is being used to identify trends, find solutions to key problems, and improve business performance.

Continuous publishing will receive increased attention as more medtechs adopt end-to-end regulatory platforms for time savings and greater efficiency. Another area of focus will be using advanced tools to improve manufacturing change control, a process traditionally handled via manual processes that often cause delays in the availability of critical devices and diagnostics.

3. Holistic clinical data management will help medtechs execute complex studies efficiently

With clinical research complexity increasing sharply in the years ahead, the industry will realize new operating models for patients, sites, and trial sponsors. The shift will move the industry from historic disconnected systems toward an era of platforms. This advancement to a platform structure can harmonize all clinical research stakeholders to increase visibility and speed.

In earlier days, the industry addressed problems by investing significant resources to find a solution. When that didn’t work, point solutions became the norm, which unfortunately lowered productivity. The companies tackling complex trials will need data-driven connectivity so patients can actively and effectively participate and data can be reviewed, analyzed, and actioned in real time. To make this a reality, all relevant data must be managed on the same platform.

Data will be shared across research participants in a controlled and appropriate manner. Each data point will initiate the subsequent step in clinical trial execution automatically, a welcomed change from traditional data silos clinical teams used to work through. This system interoperability will drive innovation by delivering the agility needed to work with diverse, distributed, and exponentially growing data sources.

4. Streamlined, end-to-end data flow to reduce burden on clinical research sites

As clinical research sites supporting medtech trials continue to consolidate and reduce staff, companies will start to compete for the best-performing sites and investigators. To win, organizations will build stronger relationships with sites and simplify their technology stacks to reduce site burden.

Over the last four years, technology designed to give patients more options to participate in trials has exploded. While an improvement for those patients, adopting patient-focused digital tools has created more apps for trial sites to learn and manage. This also increased the emphasis on where studies are conducted, instead of how trial data and information are collected and/or shared.

The industry is increasing investment in building stronger relationships with trial sites, developing new engagement strategies, simplifying site-facing technology, and streamlining how data flows end-to-end. These changes will drive more efficient study execution and management while making the relationship with sites less transactional.

5. Connecting data across clinical and medical for advanced analytics will deliver differentiation

For years, commercial teams have leveraged advanced analytics to measure commercial impact but clinical and medical analytics are still in their early days. This is quickly changing as a growing competitive market and external pressures—like the Inflation Reduction Act—drive the need for speed and agility across product development.

Medtech clinical and medical teams will begin to use advanced analytics to support site selection, drive patient enrollment, and detect gaps in standards of care. The change will have a more significant impact on how companies go to market than commercial.

To succeed, companies will now need to define their products’ markets while identifying the patients impacted and healthcare providers associated. These insights can also help companies move faster than the competition. Clean and connected data with a common architecture across customers, patients, key opinion leaders, and operations will be fundamental in making this real.

As we enter the second half of 2024, the medtech industry is poised for more transformations. Merging advanced systems, personalized medicine, and analytics will redefine patient care, delivering a more custom, effective, and responsive experience than before.

As more medtech organizations embrace these advancements, the industry will quickly be at the forefront of innovation. The improvements will help address ever-changing processes and regulations and improve outcomes. The key to staying ahead lies in understanding these trends and being an active participant in the industry’s evolution. 

Article Source: MPO