What drives us
Making Healthcare Accessible
for Everyone - Anytime, Anywhere
By designing and developing excellent mHealth products, we want to help transform healthcare and make it available to everyone, regardless of time and place, through patient-oriented solutions.
Just like any other mission, this one also comes with a few challenges. We are The mHealth Engineers – so we have solutions and know exactly what needs to be done to make the mHealth Challenge a success.
mHealth Challenge
What challenges do good mHealth products solve?
mHealth products are medical devices
For the CE certification of medical, digital software products, it is necessary that the fulfillment of the legal requirements of the MDR is documented – in addition, DiGAs require proof of efficacy.
Challenge
Therefore, one challenge in product development is to understand the regulatory framework as part of the solution. From the outset, it is important to choose a suitable concept for the medical purpose that is technically and regulatory feasible. Implementation involves setting up an efficient overall team and handling internal and external partners and resources.
See WhitePaper Mobile software as a medical device – can the development of mobile software as a medical device be outsourced?
Complexity as a cost factor
The complexity of product development in the regulated sector makes it desirable for the project vision to be precisely defined and sharpened in advance. It determines service areas and interfaces, obtaining suitable cost estimates for budgeting, the timeline for project planning and team composition.
Challenge
When you realize that a complex product development for mHealth software can sometimes require a budget of up to a million euros or more over a year or more, then it goes without saying that it makes sense to consider the purpose and feasibility of a product. The following white paper shows how you can approach these considerations for a digital healthcare product for your own company.
See WhitePaper Smart medical technology as DiGA
Limit hidden costs
Experts can also master the implementation of the normative requirements. However, even a high level of effort required to implement a complex product for approval is taken for granted by the user. The actual users of the mHealth product – usually patients and / or service providers such as doctors or HCPs – generally apply completely different standards for real added value.
Challenge
It is therefore essential for a patient-oriented mHealth product to take human-centered design into account during product development. After all, the user experience plays a significant role in determining both medical and economic success. Subsequent rounds are avoidable hidden costs. This applies to all phases, from conception to the clinical trial.
User experience (UX) plays an important role in the adherence of mobile health products, see WhitePaper User experience – success factor for mHealth products
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Success factors for mHealth products
You can find our current webinars and presentations in the How to mHealth section
