Co-creating digital health applications and digital therapeutics (DTx)

Why it matters to obtain patient insights along the digital health app and DTx development journey See more

Why it matters to obtain patient insights along the digital health app and DTx development journey

Digital Health Applications, especially Digital Therapeutics (DTx), are perceived as an opportunity to innovate and create new business – particularly for the life sciences industry.

Within this context, there is a strong trend of moving more and more towards evidence-based digital solutions and away from the numerous lifestyle or wellness applications. Looking at this picture, one can observe that Life Sciences firms are willing to go much further than “beyond the pill” and into clinically proven digital solutions and applications. Yet, it seems that many application developers and providers (including life sciences firms) do not always fully understand how health apps fit into patients’ lives and how they can obtain clinical and real-world outcomes to prove the case.

How can this be achieved and how can app developers and providers ensure that the patient voice is included throughout an app’s development and commercial journey?

In contrast to the many wellness and life-style apps, Digital Therapeutics (DTx), are software-based products for the prevention, management and treatment of health conditions. A feature of DTx is that they require both clinical evidence and evidence from real-world outcomes. As such, they need to be reviewed and approved by regulatory bodies for safety, risk and efficacy.

 

The German fast track process for digital health apps

Germany was one of the first countries that passed a legislative framework for this review process- the so-called fast-track process. All digital health applications that have successfully completed the process can be prescribed and reimbursed within the country’s public healthcare system (these apps are often referred to as DiGa’s – Digital Health Applications).

However, in order to obtain DiGa approval, app developers or providers have to create evidence data beyond the Medical Device Regulation (MDR) certification. The needed evidence is usually generated in trials and observational studies (designed as randomized controlled trials) which involve the collection of real-world patient data.

The following gives an overview of the German fast-track / DiGa process. 

Click the arrows to view the steps

1 Medical Product Certification

  • Health App needs to be certified as a medical product class I or IIa
  • Regulatory basis: European Medical Device Regulation (MDR)

2 Application for Listing

  • To be submitted to BFARM (Federal Agency for Drugs and Medical Products)
  • Agency decides within 3 months
  • Basic requirements: security, quality, functionality
  • Additional requirement: positive effect on quality of care

3 Official Listing

  • In case of missing proof of effects on quality of care: provisional listing for 12 months
  • Missing evidence must be generated within 12 months
  • All listed Apps are reimbursable and can be prescribed by doctors

4 Price Negotiations

  • Negotiations take place directly between app developers and the roof organization of the public health insurers (GKV)

5 Reimbursement

  • During the first 12 months: based on app developers’ price
  • Afterward: agreed price between GKV and publishers applicable for all public insurers

Challenges for app developers

  • High documentation needs to obtain MDR Class I or IIa
  • The necessity to create evidence data on quality, as well as data on security and safety (e.g. retrospective studies)
  • Small number of official notified bodies to do MDR certification

Challenges for established players

  • Very few Apps listed in the beginning
  • High competition for listed Apps

Key Learnings for digital health app developers & providers

As of August 2022, the total number of health apps submitted to the fast track process amounts to 147. Out of these, 33 apps have been approved and listed as DiGa’s. 93 apps have been withdrawn or received a negative decision.

The most prominent reasons for withdrawal or a negative decision are poor study design, real-world patient data collection which is not in accordance with the criteria for evidence-based medicine, or simply the fact that no significant advantages or positive care effects could be demonstrated.

This clearly points to the importance of fully integrating patient insights into the app development right from the start to properly understand the impact of new digital health apps on the lives of patients as well as caregivers.

“Developers & providers should ensure to collect patient insights to get a better understanding of their preferences, daily lives and social contexts”

This will help them to identify the factors that influence patient behavior and enable them to develop apps that are able to show positive outcomes. Patient data collected prospectively would even more strengthen patient engagement and hence paint a very comprehensive picture for app development and sub-sequent regulatory approval.

This is especially true for rare diseases or conditions where there is little known about the outcome. In these cases, patients are often the sole real-world longitudinal source of information on disease progression, impacts on the physical and mental conditions or efficacy of treatment pathways.

It is of course true that the German fast track process for digital health apps is only one example of how apps can move towards becoming DTXs, but already a number of other countries are looking to the German model, so that it can be expected that similar criteria for digital health apps approval will be established on a broader international basis.

Engaging with patients and collecting their insights

Health app developers & providers possess different options to collect patient insights.

Moreover, they should also use a wider range of sources well beyond patients. Friends, family, employers or care providers can even give a wider understanding of the impact an illness has on patients and the difficulties they have in dealing with their condition in daily life.

Working with patient organizations or patient representatives throughout the app development journey can be very fruitful and often leads to higher levels of trust and acceptance among patients and caregivers.

Here are some of the most prominent methodologies for engaging with patients and relatives and collecting their insights:

  • Available patient preference information and insights
  • Structured / semi-structured Interviews
  • Quantitative online surveys
  • Focus Group Discussions
  • Patient advisory boards/community advisory boards
  • Patient round tables
  • Structured co-creation processes
  • Companion studies (running concurrently to the original clinical investigation)

Developers & providers need to ensure that collected insights directly and continuously feed into the end-to-end patient experience development and design. The collection of insights has to be done on a continuous basis and include the patient’s entire disease pathway, not just a few times a day when the patient actually uses an app.

Embedding a health app or DTx offering into existing business processes

For app developers & providers such as life sciences companies, health apps or DTx’s open up a chance to innovate.

A health app or DTx offering can act as a differentiator that is able to lead to new and attractive value propositions and resulting business.

In this context, digital solutions can work as a stand-alone therapy or are combined with drugs to improve patient outcomes, deliver value to patients as well as caregivers and consequently drive business impact.

However, establishing a digital health offering is much more than just building a nice piece of technology.

 “Very often, app providers spend 90% or more of time, effort and budgets on developing an app or finding suitable app partners, whereas they should not neglect the needed business transformation and implementation roadmap”

This area touches on items such as organizational change or adjustment, business process review, or the alignment of commercial practice. In a nutshell, critically assessing the way organizations have been doing business in the past and how this will change with the arrival of digital apps or DTx’s.

A sound digital strategy has to reflect these elements to avoid frustration and disillusionment from not attaining objectives.

The following graph summarizes and visualizes the different steps for building a sustainable and commercially successful approach – providing value to both, patients as well as app providers.

Building & embedding a health app / DTx offering 

1 Search for existing insights, scope the app & project

  • Analyse the digital app landscape, existing uses cases & perform benchmarking
  • Identify available feedback & insights from patients on their disease journey
  • Sketch app features & functionalities
  • Scope the project
  • Build a business case

2 Perform reality check with patients and HCPs

  • Obtain insights from patients, relatives and/or care providers
  • Select & prepare suitable patient engagement methodologies & participants
  • Carry through & moderate engagement & evaluate participants’ input
  • Establish permanent patient “sounding boards” (co-creation)

3 Identify and select needed development partners

  • Develop a structured selection process
  • Identify suitable potential partners and initiate discussions
  • Scope partnership and commercial models

4 Construct the app or DTx offering

  • Build the app / DTx to meet the agreed requirements & patient needs
  • Use own or existing solution components
  • Integrate /link to partner applications
  • Carry out reality checks with a “patient sounding board” (co-creation)

5 Implement & integrate the offering

  • Develop / execute communication campaign
  • Assess existing business / internal processes & structures
  • Develop a transformation & implementation roadmap to secure that goals & benefits are attained
  • Moderate & monitor change programmes

Setting up a sustainable patient & stakeholder engagement framework

Organizations that are successfully working along the lines of patient & stakeholder engagement look at this area as a strategic opportunity to differentiate themselves and consequently generate business.

To accomplish this, they see and deal with patient & stakeholder engagement as a long-term activity and not as one that is just carried out when the need arises or on a selective base.

The following chart provides an example of how companies can set up a long-lasting engagement framework, also with an international scope.

Some companies have started to use patients & stakeholders as a “standing sounding board” to collect insights all along the development and commercial journey – not only for digital health applications and DTx, but also for their traditional therapeutic or diagnostic products. This is certainly going to play an increasingly important role for driving innovation in the life sciences industry in the future.

If you want to learn more about how to successfully co-create your digital health offering around patient insights, please reach out to us: info@admedicum.com

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