Medical Device Regulatory strategy for startups

The runway is short, the cash burn is high. We get it.

Startups developing digital health technology today are experiencing a once in a lifetime opportunity at true disruption. The benefits of emerging technology have allowed a wide array of unmet clinical needs to be addressed in new ways, and the medical field has never been more ready to adopt new tools.

The challenges for medical technology startups.

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.

The BML Health solution.

A more strategic approach to product development, clinical validation and regulatory affairs is possible to better suit the specific needs of startup companies in this emerging field.

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Our offering for digital health startups.

Our regulatory strategy offering is customized for startups. It is lean, efficient and designed as an iterative approach to compliance based on local or international regulatory strategy best suited to their needs.

Key features of the service offering include intermediate regulatory milestones and support for design for compliance, both of which provide a level of regulatory risk management of critical value to investors and other stakeholders.

Services for digital health startups:

Regulatory strategy and execution for market authorization in the US, Canada, Europe and all over the world, to support the business case and go-to-market strategy
Medical device product development support, support for compliance to international safety standards and certifications
Clinical validation support, well-matched to the regulatory and commercial strategies
Access to our extensive network of medical device technology professionals and clinical key opinion leaders (KOLs)
Workflow and project management
Customized service offering and pricing, directly aimed at startup pains and gains

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Our way of working.

We believe regulatory burden must be incurred only in as much as is required to serve the business case. It is critical to understand the factors involved and to act on them accordingly through true collaboration, to create an efficient and cost-effective regulatory strategy. This is a rare and valuable mindset in an industry that has been historically slow, expensive, and risk averse.

We have worked closely with dozens of medtech startups, helping them successfully navigate complex regulatory environments and ensuring that their digital health solutions have the best chance of reaching the ultimate goal: improving patient outcomes.

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