Three important regulatory challenges to consider for digital health and medical technology startups

The pace of innovation and technological advancement in the digital health industry has never been higher. Record levels of venture capital investment have fueled a wave of new medical devices, technologies and innovation that are changing the way healthcare is delivered. Medtech startups are taking on some of the greatest challenges to human health and achieving serious progress.

On what seems like a weekly basis new inventions and medical technologies are introduced that would have sounded like science fiction just years ago. We recently covered a new spine implant technology that allows individuals with severed spines to walk again. And a fully self directed surgical robot that is better at performing complex laparoscopic surgeries than human beings.

Startups developing digital health technology today are experiencing a once in a lifetime opportunity at true disruption. Sadly many of these promising medical technologies will never reach the healthcare marketplace to positively impact patient outcomes due to the myriad challenges that exist in the process of taking a medical technology from a concept or an idea to a solution that gains adoption in the healthcare ecosystem.

A key consideration for digital health startups in this process is attaining regulatory approval in their jurisdiction (Health Canada, FDA, CE Mark). Medical devices and medical technology are among the highest regulated industries and the regulatory burden is often underestimated by early stage medtech entrepreneurs more naturally focused on technology, product development, fund raising and other tasks.

Below are three important regulatory challenges medical technology startups should focus on from the earliest possible stages to enhance the possibility that their regulatory approval process will be smooth.

1. A great product and significant funding are not enough 
Even with great ideas, significant funding and high technological skills, most startups find themselves in over their heads when eventually faced with the safety and efficacy requirements of a regulated industry, often under pressure to deliver solutions under unrealistic timelines.

2. Regulatory compliance strategy begins at the ideation stage
Digital health startups tend to focus on speed, application development and an MVP. The regulatory strategy is often a lesser priority or gets postponed to a later stage. But a lack of focus on regulatory approval in the earlier stages can lead to costly product redesigns and missed deadlines, ultimately placing the enterprise at risk. Even MVPs should be compliant.

3. Medical device startups need a customized regulatory strategy
The traditional approach to medical device regulatory affairs is not well suited to address the need; it is long, expensive, and fraught with unknowns – at odds with the short runways and high cash burns of medtech startups. A customized strategy is needed.

There are many additional regulatory challenges beyond those listed above facing early stage digital health companies. This is why it is so important for them to secure the services of employees, expert firms or partners that have successfully navigated this complex process before and that understand what it takes to achieve regulatory compliance.

At BML Technology we have worked closely with dozens of medtech startups and other digital health companies helping them to successfully achieve regulatory approval for their medical technology. We understand the process in all its intricacy and what is required to achieve their ultimate goal: improving patient outcomes.

It is also critical to address the challenge with a regulatory strategy customized for startups – one that is lean, efficient and designed as an iterative approach to compliance, with intermediate regulatory milestones and support for design for compliance built in, providing a level of regulatory risk management of critical value to investors and other stakeholders.

Bottom line, medical technology startups must develop a regulatory strategy that is accorded the same degree of importance as other core strategic initiatives of the firm. Those firms that address the process early, devote resources, secure competencies and treat it with respect will be glad they did and reap the rewards, those that don’t may not be around long enough to change course.


About BML Technology

BML Technology understands digital health. At the intersection of medical technology, clinical research and patient-centric healthcare BML drives the mainstream adoption of digital technology in healthcare. Offering a full range of services to the digital health ecosystem BML manages the complex stakeholder interactions necessary to get digital health solutions to market and gain adoption.

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BML Technology

At the intersection of medical technology, clinical research and patient-centric health care, we manage the complex stakeholder interactions necessary to get digital health solutions to market and gain adoption.