Crafting DiGA
in Germany
Newsletter
Let's connect and receive our newsletter.
Future healthcare will be preventive, personalised and data driven.
DiGa Factory accelerates the transition into a digital healthcare system by building DiGA (digital health applications) in Germany. DiGA Factory’s hands-on faculty supports founders, investors, corporates and healthcare professionals to co-create DiGA.
Joint expertise covers the full spectrum of the DiGA development chain – from early ideation to successful scientific proof of sustainable benefits for patients, healthcare professionals, payer and society at large.
DiGa Factory is the one-stop-shop for crafting DiGA in Germany.
Who we are
Team
Guido Axmann
Managing Director, DiGA Factory
Monika Rimmele
Managing Director, DiGA Factory
Who we are
Faculty Members
Guido Axmann
Co-Founder and CEO at xircle.ai - Business Angel in (Digital) Health
Dr. Holger Friedrich
Founder and Managing Partner of Pathways Public Health
Alexandra Jelen
Managing Partner and Co-Founder of HEPICC GmbH
Gregor Jelen
Managing Partner and Co-Founder of HEPICC GmbH
Dr. Ole Dammann
CEO of KFGN
Rieke Schulz
Founder and managing partner of Pathways Public Health
Dr. Benedikt Zacher
Chief Investment Officer of Vindex - Business Angel in (Digital) Health
What we offer
Our services
Step 01
Ideation & Reality Check
Review and sparring of existing ideas and the underlying business case. Market research and development of feasible and applicable concepts for innovative digital health and digital care apps (DiGA + DiPA) for the German healthcare market. Further proposal of venues for existing ideas and further developing concepts for an official DiGA application regarding market access and reimbursement.
LEARN MORE
Step 02
Funding & Resources
Assessment of the financing requirements as well as financing purposes of Your digital health app and identification of the most suitable investor: Matchmaking with venture capitalists, family offices or alternative funding sources, e.g. grants.
LEARN MORE
Step 03
Medical Device Registration / CE-Marking
Advice for and active support for the approval of your digital health application as CE-marked medical device: definition of intended purpose and medical claims, determination of risk class as well as support for the development of the technical file and of a quality management system.
LEARN MORE
Step 04
Market Access
Support during the whole application process and price negotiations for your DiGA, including Consultation meetings with the BfArM, drafting applications, informal and formal engagement of stakeholders to gain market access and the best possible reimbursement.
LEARN MORE
Step 05
Sales (Prescription)
Engaging with your customers from pre-launch to launch to product maturity of your DiGA: Assessment of your HCP and patient journey, creating a stakeholder mapping, selection of strategic medical partners (pre- and post launch), advisory boards, public medical relations and commercial support to accelerate and expand market traction.
LEARN MORE
Step 06
Reimbursement (Evidence & Pricing)
Developing an evidence roadmap and collecting appropriate medical data for regulatory approvals and reimbursement purposes of your DiGA: Definition of therapeutic benefit and target patient group, development of study design and design of digital test systems as well as trial conduction and medical evaluation of study data to validate patients benefits.
LEARN MORE
Pathways Public Health is a strategy and process consultancy specialized in the German healthcare system. It offers both the development of new care and treatment concepts and the implementation of new examination and treatment methods in standard care. Pathways initiates and supports all relevant decision-making processes to gain market access and reimbursement of medical services.
Healthcare Products Innovation and Commercialization Consulting. HEPICC supports healthcare start-ups and companies in the areas of digital health, business strategy, product design & development, CE marking, market access, marketing & sales.
kfgn is a group of six sites across Germany conducting clinical trials for the pharmaceutical industry. Established in 1995 kfgn calls on more than 25 years of experience in clinical research. Kfgn is part of the Pratia S.A. network with sites in Poland, Ukraine, Czech Republic, Bulgaria, Spain and Germany.
Vindex GmbH is an innovative young startup which develops novel digital services & technologies for personalized prevention. Vindex actively develops an interface that combines new digital health technologies and clinical diagnostics. The goal is to enable everyone to be aware of their individual health status anytime.
Xircles provides access to comprehensive medical knowledge that makes treatments faster and safer. Anywhere, anytime.
Get in touch.
© 2023 DiGA Factory. All Rights reserved.