Clinipower team has strengthened as Raimo Asikainen joined us as a Senior Quality Engineer in the beginning of the year 2022. His versatile experience with medical devices spans from developing innovations and writing manuals to information security, sales, and quality management.
Raimo Asikainen tells that he will start his work at Clinipower by registering products of a customer company to the new Eudamed-database. What follows after this first project is yet to be defined, as Asikainen has a very versatile background and skills.
“I once wrote my master’s thesis about innovation management in creative work. I made the thesis for a design office that focuses on mechanical and industrial design as well as service design. I investigated what the barriers of an individual and organization are for innovation, what aspects hinder innovation, and how the barriers can be removed.”
Asikainen chats that he “slipped” into the medical device field already in the 90’s when he started as an x-ray equipment mechanic and visited hospitals around Finland. Working with medical devices was interesting from the beginning – and felt also ethical.
“Working in a field that aims at helping people motivates me. I came to Clinipower from Philips, where we worked for example with cancer care related software.” As the lead quality engineer of two project development projects, Asikainen supervised that both internal guidance and requirements of export countries were followed.
Before this he worked at Benemen with an ISO 27001 based information security management system project, and at Finn-Id Oy with developing logistics processes of equipment maintenance in hospitals. This company also developed solutions with which measurements could be wirelessly transferred from bedside to a patient information system.
“I got familiar with the regulation as we created a quality management system according to the ISO 13485 -standard.” Asikainen is interested in working with quality management systems in the future, too. As the role of regulation strengthens and becomes more and more precise, the workload of regulatory specialists and quality managers increases.
“Working in a field that aims at helping people motivates me.”
“Regulation is a good thing although the requirements can sometimes seem a bit peculiar. In the end, regulation benefits both device manufacturers and patients. Regulation of artificial intelligence needs to be specified even more. For medical device industry newcomers, there should simply be services that help them get to development work with a low threshold.”
At the turn of the millennium, Raimo Asikainen worked seven years at Philips as technical editor of documentation. With this specialty he will now strengthen the service offering of Clinipower.
Asikainen gained practical work experience from international business outside the medical device field during a post in Shanghai in 2007-2009. His responsibility was to establish a new technical wholesale company to this metropolis, which included tasks from creating a logistics center to hiring employees. He was also responsible for sales to existing customers and new customer acquisition.
Text: Minna Torppa, Translation: Kristiina Mäki