Commercialise

As innovators build more complex products and grow their businesses, it becomes impossible to separate regulation from commercial activity. Meeting the challenge of regulatory compliance can make or break business models, value propositions and scale up plans, yet few digital health companies say their regulatory and commercial strategies are aligned.

The threat of regulation

Regulation takes on new significance in the evolving digital health landscape – complex products targeting acute healthcare needs are subject to a matrix of product, data, marketing and advertising requirements. As such, digital health leaders recognise that regulation has the potential to undermine business models and value propositions.

of innovators see new and changing regulation as a serious threat with the potential to impact their business model and value proposition.

The threat of regulation

Regulation takes on new significance in the evolving digital health landscape – complex products targeting acute healthcare needs are subject to a matrix of product, data, marketing and advertising requirements. As such, digital health leaders recognise that regulation has the potential to undermine business models and value propositions.

of innovators see new and changing regulation as a serious threat with the potential to impact their business model and value proposition.

It is clear that we have passed the stage of counting steps and calories, and products are growing in ambition, complexity and sophistication. This is in part driven by the digitisation of healthcare – a shift in management processes and availability of patient data is opening up opportunities to address more acute health needs. In the US and Israel, for example, fully digitised patient data ecosystems are enabling innovators to build out product functionality and develop new solutions.

Alison Dennis, Partner

It is clear that we have passed the stage of counting steps and calories, and products are growing in ambition, complexity and sophistication. This is in part driven by the digitisation of healthcare – a shift in management processes and availability of patient data is opening up opportunities to address more acute health needs. In the US and Israel, for example, fully digitised patient data ecosystems are enabling innovators to build out product functionality and develop new solutions.

Alison Dennis, Partner

Blindsided by complexity

Innovators have found themselves blindsided by the extent of regulatory divergence globally, changing international policy and frustrated by a lack of guidance from regulators in new growth areas such as artificial intelligence (AI). As a result, regulation has been able to block growth plans.

Drivers of regulatory complexity

Differing regulation across jurisdictions

Changing and new international policy

Lack of guidance and transparency from regulators

Lack of robust controls in the company

Top areas in which regulation has derailed growth plans

International expansion

Developing new product functionality

Product improvement

International expansion

Developing new product functionality

Product improvement

Regulation is a fact of life. We embrace regulation to position our industry as a credible adjunct to medical treatment.

Megan Coder, Digital Therapeutics Alliance

Read about how the digital therapeutics industry is creating certainty for innovators in an emerging industry

Regulation is a fact of life. We embrace regulation to position our industry as a credible adjunct to medical treatment.

Megan Coder, Digital Therapeutics Alliance

Read about how the digital therapeutics industry is creating certainty for innovators in an emerging industry

Out of alignment

As digital health businesses mature and solutions become more complex, regulation cannot be an afterthought. Yet some innovators prioritise speed to market over regulatory preparedness and few leaders say their regulatory and commercial strategies are aligned.

of digital health businesses' commercial and regulatory strategies are aligned

prefer to deal with the consequences of regulation as it happens.

Reader poll

Are your commercial and regulatory strategies aligned?

Reader poll

Are your commercial and regulatory strategies aligned?

It is impossible to disassociate the regulatory and commercial activity of the business. One is informed by and contingent on the other. As digital health products become more complex and highly regulated, leaders must build regulatory considerations into their timelines. A strategy that gets the product to market at any regulatory cost risks reputation, growth and relationships with customers, investors and suppliers.

Alison Dennis, Partner

It is impossible to disassociate the regulatory and commercial activity of the business. One is informed by and contingent on the other. As digital health products become more complex and highly regulated, leaders must build regulatory considerations into their timelines. A strategy that gets the product to market at any regulatory cost risks reputation, growth and relationships with customers, investors and suppliers.

Alison Dennis, Partner

Read more from Alison Dennis about how to leverage regulation for competitive advantage

Read more from Alison Dennis about how to leverage regulation for competitive advantage

Areas of exposure

This is a high risk approach, which has already forced digital health companies to take urgent action for fear of losing investment.

Key areas of legal exposure requiring remediation

Marketing and advertising

Suppliers

Regulatory approval

Data compliance

Data is increasingly important to the value and performance of digital health products. As a general rule, the more complex the product and the more data that is collected, the more developed the privacy compliance framework needs to be. As companies build sophisticated AI systems for diagnosis, prevention and clinical settings, data aspects also go beyond privacy and cybersecurity to include questions of product efficacy.

Victoria Hordern, Partner

Read more about the three data compliance risks digital health leaders need to know

Get in touch to discuss how we can help you

digitalhealth@taylorwessing.com