Market access as a service for medtech devices

How to support medtech clients in accelerating their go-to-market process and reduce costs, while fulfilling the strict quality of CE mark requirements?

Background

Certifications and quality seals (such as the well-known CE mark in Europe) help providers of apps and medical wearables to win the trust of users and partners. In addition, certification is legally required for certain kinds of medical products. It is therefore essential for a new commercial product to be recognized by quality standards.

Challenge

A short time to market is critical to every business, and it is especially important in the field of medical applications and wearables, where new innovations are constantly emerging.

The strict regulations and quality requirements lead to long product development cycles, which need to be supported by considerable investment before a certified product is available. The certification process can be complex and time consuming—many companies struggle to complete the process and some even go out of business while waiting for certification to be granted.

The question was: How can we accelerate the process to go to market and reduce costs while fulfilling the strict quality requirements?

Solution

Decomplix was founded in 2016 as a joint venture, with Creaholic being one of the founding parties. Because Creaholic has many projects in the medical field, Decomplix is both the product of long experience and a perfect fit for future development—we now have a trusted partner who might help our clients to accelerate innovation by getting their products certified fast.

With an expert platform, Decomplix takes care of CE certification and guarantees Common Quality Seals for medical devices and app providers. It’s a trusted platform for providers as well as users and health care professionals.

The Decomplix business model makes customers (in this case medical device developers) into “partners”, which helps build and maintain a trustworthy relationship. We helped with the process for setting up the company, and supporting it with its internal business strategy know-how.