For us, DiGA development goes hand in hand with a promise. Every DiGA development takes place under consideration of the attributes agile, flexible, trustworthy, honest and in partnership. No matter whether in the DiGA conception, the DiGA development up to the successful DiGA admission into the DiGA listing of the BfArM. [bornholdt lee] is your DiGA partner in your DiGA project.
Product Owner, IT Expert, eHealth Specialist & Managing Director at Bornholdt Lee GmbH
Over 20 years of IT project experience and conception of numerous digital health applications
DiGA expert informs!
What is a DiGA?
DiGA is the abbreviation for digital health application. A DiGA is basically a digital medical device that has some special features.
A DiGA must follow certain guidelines set by the German Federal Institute for Drugs and Medicine (BfArM). If all guidelines are followed in the DiGA development and the DiGA is included in the DiGA directory, the DiGA can be prescribed by physicians:inside. DiGA are also often called "app on prescription".
DiGA Development Process
The DiGA development process is a complex process that must be thought through from A-Z. Due to the guidelines of the German Federal Institute for Drugs and Medicine (BfArM), there is no room for maneuver in DiGA development. [bornholdt lee] has already accompanied and implemented a DiGA project from the idea to the inclusion in the DiGA directory. According to our expertise, the DiGA development process can be divided into 6 phases.
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The 6 stages of DiGA development
Phase 1
DiGA Analysis Phase
Our user-centric approach focuses on the fact that we will look at you, the stakeholders as well as the end customers*. Only in this way can we understand the problems and causes more concretely, analyze them and identify opportunities and possibilities.
Phase 2
DiGA solution finding phase
After the analysis follows the creative solution finding. Together we discuss requirements and possibilities and in the end so an innovative digital health application that will solve wishes and problems of end customers!
Phase 3
DiGA prototype development
To reduce risk or to convince potential investors, for example, we conduct a proof of concept or develop an interactive prototype to present the product idea even without final implementation.
Phase 4
DiGA implementation
Using the basic principles of agile software development, we develop the functionalities in iterative steps, which have previously been (finely) conceived with the help of wireframes and designs, among other things, and are finally tested by our quality sizing.
Phase 5
DiGA-Go-Live
Once the product has reached market maturity, it is released! We are happy to look after the product in day-to-day operation and provide support. Based on feedback, we carry out continuous further developments and optimizations.
Phase 6
DiGA listing
After publication, inclusion in the DiGA directory can be applied for. We are happy to provide support with the help of our technical expertise. The required technical documentation is, of course, already prepared during implementation.
Digital Health
Medical device, app on prescription (DiGA) or other digital health applications in the digital health space? Or simply support in the DiGA Fast Track process to be included in the DiGA directory? Let's talk together to find out which solution is optimal for you to embark on the digital transformation and not only increase patient compliance but also improve quality of life through improved therapy support.
What sets [bornholdt lee] apart in DiGA development
We know the challenges involved in launching a medical product or founding a company: Preparation of a business plan, clarification of financing, review and implementation of required regulations and requirements of various ordinances and legal bases, certifications and audits, compliance with data protection guidelines and IT security, ... all of which are not foreign topics for us!
We have already successfully supported numerous digital health start-ups and assisted them in the successful introduction of medical devices into the DiGA directory. Therefore, we can not only support with expertise and experience at every step to DiGA, but also actively contribute with know-how to the success! And if we can't, we have a network of (legal) experts and consultants to fall back on.
Whether at our headquarters in Hamburg or digitally throughout Germany. [bornholdt lee] is your DIGA partner!
AGILE AND FLEXIBLE
We are not a large corporation and can respond specifically to the needs of our customers: In DiGA development we act agile, flexible, transparent and price-conscious!
TRUSTWORTHY AND HONEST
Open and direct communication is important to us: we talk about difficult situations as well as solutions. We know the limits of IT, but also the opportunities in innovations.
IN PARTNERSHIP
We are partners for our customers and feel responsible for our customers and our customers' products from the idea to the operation.
DiGA FAQ
In our DiGA FAQ we answer common questions about DiGA, DiGA development and many other exciting eHealth topics.
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How is DiGA defined?
DiGA is the abbreviation for digital health application. Basically, a digital health application is a digital medical device. Digital health apps are digital medical devices certified by the Federal Institute for Medicine and Drugs that can be prescribed. Often, digital health apps are also referred to as "app on prescription."
What is the difference between DiGA and medical device?
Every DiGA is a digital medical device, but not every digital medical device is a DiGA or a digital health application. While a DiGA must go through the certification process of the Federal Institute for Drugs and Medical Devices (BfArM) and is a DiGA after successful inclusion in the DiGA directory, different standards apply to digital medical devices. You can read more about this here: Read more
Why should you develop a DiGA?
A DiGA is more than just a digital medical device. The possibility of positioning a DiGA as a prescription app after successful DiGA development and certification brings great opportunities. Throughout Germany, your app can be prescribed by doctors and billed via health insurance companies. This brings great opportunities not only for patients, but also for you as DiGA publisher. We would be happy to support you in developing DiGA.
How long does a DiGA development take?
The duration of a DiGA development can vary greatly. In the context of the duration of DiGA development, the certification process of the BfArM is very important here and must be taken into account. The DiGA development goes through several process steps and can vary massively depending on the complexity of the project or the DiGA development. For a more accurate estimate of the duration of a DiGA development, request your DiGA idea here for free. Click here for a free DiGA consultation.
How much does a DiGA development cost?
A DiGA development is a highly complex development process. [bornholdt lee] is an expert in the field of DiGA development, having already successfully certified a DiGA. The cost of DiGA development up to the BfArM verified DiGA varies depending on the idea, vision and scope. For a cost calculation now make a non-binding free consultation appointment!
DiGA development references and more
PINK! Coach App (DiGA)
The PINK! Coach App accompanies patients after diagnosis and therapy as a support service in aftercare. Patients are motivated to adopt a more sustainable lifestyle, can obtain information, exchange information in the community, or organize documents for the upcoming doctor's visit (follow-up examinations).
Phileo is a digital assistant for stress prevention in the workplace supported by a scientifically based approach. With the help of the app, users can learn to deal with situational stress at work and to balance work and private life in order to promote well-being and mental health.
We are happy to support you in problem solving, idea generation, implementation of digital health applications and/or the application for DiGA certification.
Bornholdt Lee GmbH specializes in the design and development of digital sustainable solutions, smart products and innovative platforms that simplify and improve lives and thereby enhance quality of life.
The focus of digital solutions are mobile apps (iOS / Android; native and hybrid), web and backend services, web applications as well as voice control, augmented reality and IoT products.
Product Owner, IT Expert, eHealth Specialist, Mentor in the eHealth Network Hamburg & Managing Director at Bornholdt Lee GmbH
Over 20 years of IT project experience and conception of numerous digital health applications.
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