Patient Groups Struggle with Digital health Skill Gap

Which digital health skills gaps are biggest for patient groups?

A recent Australian report highlighted that one of the biggest barriers to digital health was lack of skills. No surprises there. What is interesting is that the survey of 114 digital health start-ups said that the key gaps were not for technical or clinical roles, but in attracting people with the right business and regulatory skills.

If this is reflected across the world, there are some implications for patient groups, including:

  • One, how can you be sure that a technical partner, for example an app developer, also has the business skills to help promote uptake, usage and sustainability of an app?
  • Two, how can you include someone on the development team to ensure that the complexity of regulation risk is well-handled?
  • And three, how can you manage overall risk to the patient group from digital health projects?
Where are the real skills gaps?

A recent `State of Healthtech’ report from Victoria, Australia drew on a survey with 114 health and wellbeing digital startup companies.

Although the report highlights that health is a globally regulated industry, the survey revealed that:

  • 35% of startups do not understand how to navigate the domestic regulatory environment
  • A further 45% do not understand how to navigate international regulatory environments.

The report pinpointed the key skill gaps in digital health:

“Startups are able to access the essential clinical skills and health and medical

research expertise they need to be internationally competitive. However, startups report an immediate need for Regulatory & Legal, Sales & Business Development and Business & Management expertise, which is considered difficult to recruit for.” – State of HealthTech, Victoria

What can you find out about a development partner?

The scale of regulatory or business expertise needed will depend on the nature of the intended digital project. However, with the definitions of `medical devices’ toughening up in both the US and EU, and increasing awareness of privacy risks and data security, the demand for specialist regulatory input is likely to continue to intensify.

Through the years working on, it is clear that publicly available information on digital health developers is extremely variable. At worst, it barely exists, whereas the best developers can demonstrate their track record in key areas, for example:

  • Patient-centric design
  • Regulatory compliance and governance
  • Business stability and sustainability
  • Technical delivery
  • Uptake and usage of digital interventions, sometimes including outcomes.

Pragmatically, though, there is still a lot of power in word of mouth recommendations from other patient groups. The developer relationship with a patient group is very different from them working with pharma, clinicians or investors, and some experience of this can be vital. 

How can you manage risk?

Not every patient group wants to work with pharma on a digital project. However, there are some advantages because of the size, scale and experience of pharma teams. Examples can be found below:

  • Firstly, pharmaceutical companies are highly conservative and risk-averse in dealing with regulatory issues. Their specialist teams should do the heavy lifting on navigating regulatory complexity.
  • Secondly, they work with digital agencies all the time. They have the budget for developers with strong track records, and the procurement and project management skills to help ensure delivery, marketing and implementation.
  • And lastly, they will protect the project from liability risks, minimising the risk both for the partner patient group and the pharma company itself.

In reality, pharma companies also struggle to recruit and retain healthcare regulatory expertise. They have the budget to snap up all the specialists, which makes it harder for developers and patient groups to get access to regulatory skills. 

While many of us are still largely lost in the fog of regulation around digital health, regulatory risk will remain a key barrier to full participation from patient groups.


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