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
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
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
