More Than Medical Apps

DiGA
Consulting

We are your trusted DiGA one-stop-shop: From strategy, regulatory requirements, and listing, to commercialization and beyond.

Explore Our Services Get In Touch

30+

DiGA Projects

15+

DiGA Candidates

5+

Successfully Listed DiGAs

5

DiGAs in Progress

1

Central Partner

DiGA Services

DiGA Fast-Track Guidence

Despite a comprehensive DiGA guide, Germany’s DiGA fast-track process still holds a variety of implementation complexities. We know the regulatory requirements by heart, and are actively participating in shaping the future of Germany’s DiGA regulation.

With the “DiGA Guideliness”, the German authority in charge of DiGA (BfArM), provides a solid guide around BfArM’s regulatory requirements. Just as with any regulation, the devil is in the details: Frequently, DiGA manufacturers become aware of the underlying complexity too late in the process, e.g. when working on accessibility, interoperability, data protection and security, ISO compliance and DiGA billing requirements. We make sure that our clients actually understand what it means to be compliant with DiGA regulation – as early as possible. No matter if your questions are related to product development, the preparation or execution of BfArM meetings, or the preparation and submission of your application documents.

DiGA Value Proposition Design

A DiGA can only be as good as the underlying value proposition and product strategy.

As for any digital product, for DiGAs the key to success is a coherent product offering. This can be a well-thought feature portfolio within the application, but may also include on-top service offerings. In reality, there are often dependencies to other already existing or technically related products in other markets. With the official DiGA directory getting more and more crowded, a concise USP towards healthcare professionals and patients becomes even more relevant. We support you in defining your value proposition, and provide guidance on how to avoid the common mistakes.

Economic Benefits & Pricing

For sustainable success, a deliberate and strategic DiGA pricing approach is key.

The DiGA pricing framework already regulates various aspects of DiGA reimbursement, such as price groups, maximum reimbursement amounts and threshold. However, further aspects such as the expected economic benefit for statutory health insurers or reimbursement amounts of comparable products are also part of our clients’ SHI price negotiations. Based on our experience, we advise you on how to address these issues at an early stage – so that you can gather the relevant data as part of your evidence generation strategy.

Patient Facing Commercialization

Patients play a crucial role for a DiGA’s commercial success.

Unlike traditional medical products, patients play a crucial role in DiGA sales. Following the main digital functionality, directly convertible patient awareness can be generated via digital sales channels. With an existing indication, prescriptions may even be issued without an additional HCP visit. Our experts support DiGA manufacturers in gaining an overview of effective patient-facing distribution channels and developing individualized commercialization strategies based on best practices.

HCP-Facing Commercialization

Clinics are and will remain key for patient access and sustainable prescription volumes – but addressing them is costly.

As prescribers – and in many cases also co-users – of DiGAs, healthcare professionals are and will remain a fundamental part of a successful DiGA sales strategy. After specialist offices, the sales focus of DiGA providers is now increasingly shifting towards General Practitioners. However, addressing them via a dedicated sales force is only reasonable in certain scenarios. We support you in sustainably aligning your HCP-facing commercialization strategy – either via sales partnerships or through an effective use of alternative channels.

IT Forensics

Handling health data makes data security and data protection one of the major challenges in the DiGA listing process.

Already before the most recent, very prominent data breaches, data security and protection related to DiGA was a key concern of regulators. IT Forensics is our offering to make sure that there is no accidental transfer of personal data to servers outside of Europe, putting your DiGA’s listing success at risk, sometimes because of issues as simple as using a Google Font.

DiGA Sales Force Training

DiGA sales with an own field force is the biggest challenge – and yet the key to success.

More and more DiGA providers have realized that there is no way around point-of-care marketing and sales. The best approach in many cases is the personal exchange through an own, dedicated sales force. With regards to the best sales approach (which style, which content), Pharma and MedTech are still the benchmark. Therefore, the question for DiGA manufacturers is: “What can I learn from established companies and how do I communicate professionally?” With our knowledge of (perceived) prescription barriers in medical offices, the essential prescription triggers, and effective communication strategies, we support your sales force training.

DiGA Monitoring

Gain valuable insights for the development of your DiGA by taking an external perspective.

The DiGA market is constantly evolving. In addition to new listings, deletions and transitions from provisional to permanent listings, there are, however, a number of developments with far-reaching influence on a manufacturer’s DiGA success. These include, among others, the monitoring of the competent authority BfArM and its current interpretation of requirements. Whether from an investor’s or entrepreneur’s perspective, tracking pricing decisions and the latest developments in DiGA marketing also often play an important role. As a DiGA partner from the very beginning, Digital Oxygen knows the background and puts the latest events into the client’s context.

References

DiGA Fast-Track

Advice for an existing health app.

App concept analysis for DiGA capability
Support of the development team in the fulfillment of all technical requirements
Support in the preparation and implementation of BfArM meetings
Advice on the DiGA billing process and the selection of appropriate service providers

DiGAs are no ordinary health apps – enough time should be allowed for topics such as data protection or interoperability.

DiGA Value Proposition

Design workshops for a pharmaceutical company.

Introduction on the possibilities and limitations of the DiGA Fast-Track Framework
Analysis of selected, already listed DiGAs and possible competitors in the same therapeutic field
Design-thinking workshops for the creation of customer profiles and possible value propositions for physicians and patients

DiGAs can complement existing therapeutic approaches or enable completely new forms of therapy. This is especially true for pharma.

DiGA Sales and Commercialization

For an in-preparation DiGA.

Benchmarking of the sales mix of other, comparable providers in the dimensions of patient pull and HCP push
Monitoring of DiGA market places
Social media benchmarking for supported channels and tracked content tonality
Potential assessment for sales partnerships

Following the main digital functionality of DiGAs, manufacturers in DiGA sales are quickly breaking new ground – both in exchange with practices and in patient marketing.

Spotlight
Healthcare Insights

Whitepaper: Digital Health Applications (DiGA) in Portugal

25. June 2024

The whitepaper "Digital Health Applications (DiGA) in Portugal," explores the necessity and current status of implementing a DiGA framework in Portugal, offering expert insights and strategic recommendations for enhancing healthcare through digital solutions.

Webinar | Digital Devices in Pediatrics

24. May 2024

Discover the Transformative Reimbursement Pathways in Pediatric Healthcare through Our Engaging Webinar. Learn about the key aspects, benefits, and processes for achieving reimbursement for innovative healthcare solutions.