Employee health checks are common procedures, but who knew that a health check can be conducted for medical device companies or product development projects as well. The aim of Clinipower’s Health check -service is to recognize critical development areas, blockers, and strengths of a business or a product in terms of requirements of the field, and provide transparent information to support decision making.
Author: Minna Torppa, Translation: Kristiina Mäki
Health check -service investigates significant themes of the health tech field
Maija Laukkanen, CEO of Clinipower, developed the Health check -service soon after founding the company in 2015. The service originated from a practical customer need once a customer company requested help in ensuring operating conditions of their partner.
Health check has developed into a flexible service: it can be customized to meet the needs of each customer. Health check can be conducted for a large international or national company, that aims to broaden their business to medical device manufacturing, as well as for a startup, which funding is for example in Tempo-phase. Furthermore, Health check can be carried out for a product concept even though there would be no company around it yet.
Health check can be conducted both for a large company and a startup, as well as a product concept even though there would be no company around it yet.
Health check typically takes from three to five days. During this time, the subject is investigated from multiple perspectives. Along with systematical progression, various significant questions emerge:
- Is the product done according to EU standards and are the standards interpreted correctly?
- Does the organization fulfill requirements of regulation?
- How are aspects related to data privacy and product safety considered?
- Which aspects should the company consider when choosing partners?
- Which regions does the product marketing target and how active will the marketing be?
- How much financial resources and competent personnel does it require to place the product on market?
Some questions can be answered already during the Health check. Answers to some questions need to be searched for a longer time.
“Sometimes the Health check can result in a situation where the company decides to give up their plans to manufacture a medical device, and will stick to a less regulated business. Despite the outcome, it is important that the company does its decision deliberately and commits to the goals of the path they will take“, Maija Laukkanen emphasizes.
Health check -service is a starting point to health tech field
Many customer relationships of Clinipower have initiated from the Health check. “It has been a foundation for projects. A starting point”, Maija Laukkanen summarizes.
She has met various companies over the years. There have been companies that are very aware of the regulations concerning medical device manufacturing as well as companies that are quite unaware of them. Especially software companies have invested in increasing the awareness in the recent years.
Especially software companies have invested in increasing awareness of the regulations concerning medical device manufacturing in the recent years.
“An interesting topic is also the criteria based on which medical device development projects are granted innovation funding. In some health tech projects, that are operated with help of public funding, there are only such operators among the developers that don’t have readiness to work as medical device manufacturers. However, when building an innovation ecosystem, it can be estimated for what kind of roles companies have readiness, in terms of a product development project. The easiest way is to check whether a company has an ISO 13485 -quality management system or plans to build one. If there is no such system nor a plan for building it, challenges can be expected if the aim is to produce devices or systems to health care”, Maija Laukkanen points out.
Eudamed increases transparency to business
The need for Health checks has increased recently. This might result from registration of medical device products and manufacturers to Eudamed-database that is going on in the whole Europe. The database is meant to serve various actors, such as authorities, procurement organizations, and citizens. When everything is ready, all the companies operating in the EU and their products can be seen with just few clicks.