Tor 25 jul / År 42 / Nr 3 2024

TECHNIA paves way for innovation, creativity, and profitability

The consulting company TECHNIA has long had a focus on the Gothenburg region, but until quite recently did not have an established Life Science department here. With the recruitment of Sandra Larsson, TECHNIA is now building a strong Life Science presence in the region and looks forward to developing the business together with local and regional customers.

Sandra Larsson

TECHNIA are experts in developing product lifecycle management solutions (PLM). The aim is to create better efficiency, profitability, and quality for customers. The customer’s product portfolio can be developed into an optimal and profitable business thanks to TECHNIA’s services.

Challenge: How to efficiently expand on a Global market while remaining compliant

TECHNIA operates in many industries. What is specific to the Life Science industry is that it is highly regulated. All companies that develop products and services in the health sector, i.e., medical devices, pharmaceuticals, or combination products, must adhere to high standards and follow a strict process for how it may be developed, tested and verified. For companies to get their products authorized, they must comply with the regulatory requirements in the various countries they intend to sell in. So, establishing a systematic mode of tracking and controlling products, while maintaining traceability for each specific market, is a must.

On top of that, regulatory requirements are revised and updated continuously. During 2021 and 2022, major changes have taken place within the regulatory framework for the Life Science industry overall. Enhanced requirements as well as new requirements on safety and reliability of medical devices are enforced in combination with an increased demand for transparency and scrutiny. All developers of medical technology products need to prove both safety and effectiveness of the product. In the new EU Medical Device Regulation more emphasis is put on e.g., life-cycle approach backed up by clinical data as well as increased requirements for Post Market Surveillance.

“It is difficult for each individual company, and especially for small to medium-sized companies, to keep track of and adapt to the various global legislations. Especially as it is updated all the time. The directives and regulations differ from country to country, which adds to the complexity”, Sandra Larsson explains, and continues:

“All different directives and regulations need to be planned for and integrated into the development process right from the start. Full design control and audit readiness must be achieved at all times including a detailed documentation, which demonstrates that the standards and regulations you adhered to throughout the entire development process have been met. It is all about ensuring safety, quality, and efficiency in the product. These are challenges and business drivers many Life Science companies deal with where we provide help through our services.”

Development from the ground up

TECHNIA helps customers streamline their product development processes and manage regulatory complexity by implementing PLM best practices. Further, TECHNIA helps their customers apply the tools so that they get the maximum benefit from using them. This is especially important during the development of medical devices, pharmaceuticals and/or combination products.

Sandra has extensive experience of working with product development and regulatory affairs within the Life Science industry. She previously worked at a company that is a customer of TECHNIA, and then realised that it was precisely product lifecycle management that she wanted to work with full-time.

“I want to be involved in building strong product development from the ground up. Many companies still have an analogue process for their product development. Many do not have a seamless way to collaborate between different departments. Many have also not established processes for continuous improvement, and so on. TECHNIA can make a big difference to the entire business, within all divisions and departments, and that is something I would like to be a driving force in”, says Sandra.

TECHNIA strongly believes in collaboration to drive innovation and is committed to support the growth of the Life Science cluster in the Gothenburg region.