Fre 3 dec / År 39 / Nr 4 2021

Fast and predictable market access with Kickfile and Devicia

In a fast-paced, competitive environment where the requirements for medical devices are changing rapidly, the need for a reliable and flexible partner is evident. Kickfile and Devicia are dedicated to the development, testing, and market launch of medical devices. The companies are in fact among the very few with direct access to the experts who write new standards in the medical device industry.

The pharmaceutical industry has many well-established Contract Research Organisations, CROs, and there is a long tradition to engage their services. However, when it comes to the medical device industry, there are only a few suppliers able or willing to offer comprehensive CRO-services specifically intended for medical devices. Devicia breaks the trend and has been doing it since 2012.
“The needs of pharmaceutical developers are in many aspects different to the needs of medical device developers. That is why we are focused exclusively on medical devices where we offer support through all phases, from idea to market. As nominated experts working globally with standardisation, our place at the table provides our clients with an inside perspective to the changing regulations”, says Sofia Nordgren, CEO at Kickfile.

For empowerment of patients
Devicia was founded by EY Entrepreneur of the Year nominee Elisabeth Liljensten to meet a gap in the market, but even more importantly to meet the needs of developers of medical technology and devices. Most importantly, Devicia plays a crucial part in the empowerment of patients, as more and better medical devices can be introduced thanks to the company’s wide range of services. Sofia Nordgren explains:
“At Devicia, we employ experts in clinical studies, regulatory affairs, quality assurance and medical writing to take customers’ projects all the way from idea to market. However, it is one thing to make it to the market, and yet another to remain on the market. We help our clients develop strategies and direct their efforts to where they are best needed, which is absolutely crucial in most cases where resources are limited”.

Licensing tools for MedTech projects
The services provided by Devicia are consultancy-based. It is an excellent way for innovators, research teams and medical device manufacturers to obtain expert advice on tap, fast and reliable. Clients range from start-ups to large corporations.
For the small- to medium-sized enterprises, where resources are scarce, the ability to hire consultants may be limited. To meet their challenges, Kickfile (a sister company to Devicia) was established, where customers are able to licence or buy the support systems needed to take their medical device project further in their own time and using their own staff.
“Through Kickfile we offer complete systems for e.g. clinical evaluations and clinical investigations. All tools can be licenced or purchased for the customer to perform the tasks correctly in-house or with a mix of in-house and consultant resources. By using Kickfile they get instant access to up-to-date systems that has been audited and used operationally in both EU and US”, declares Sofia Nordgren.
After spending the last years developing its products, Kickfile has this year shifted focus to commercialisation. “Even though 2020 can be seen as our first year from a business point of view, we already have customers in both EU and US who either licence, or buy the entire system of quality management documents. We have got off to a flying start this year and are ramping up resources to meet our customer’s needs ”, says Sofia Nordgren.
When medical device standards change, as they often do, both Devicia and Kickfile are indispensable partners for forward-thinking companies developing the medical devices of the future.