A Medical Device Inspired by a Real-Life Need

When Monika Filep’s daughter was undergoing treatment for leukaemia, she saw first-hand the challenges faced by children living with a Central Venous Catheter (CVC). Her experience sparked an idea for a product that could make everyday life safer and easier. That idea became Protect-it®, a medical device designed to let children be children, even during treatment.

A few years ago, starting a medical device company was the last thing on Monika Filep’s mind. She had spent much of her career working in skincare and treatment equipment, gaining experience in sales, training and hands-on treatments. She had held sales management roles in Sweden and abroad, building lasting customer relationships and developing new business opportunities, before eventually setting up her own business. But when her daughter was diagnosed with leukaemia, her priorities and plans for the future changed.

During her daughter’s treatment, Monika became acutely aware of the difficulties a CVC could create in everyday life.

“We faced real challenges when it came to freedom of movement and feeling safe. After speaking to other families in similar situations, we began to realise there had to be a better way. That was how Protect-it® began,” she explains.

Helping Children Move and Play with Confidence

Monika is one of the founders of Zupercare Nordic and has spent the past few years building the company and developing Protect-it®. The lightweight vest holds CVC tubing close to the body, giving children more freedom to move, play and enjoy everyday activities with greater confidence.

“What makes it unique is that it was developed to meet a genuine need. It offers a medical device solution in an area where standardised alternatives are often lacking,” says Monika.

Finding the Right Support and Expertise

Bringing a medical device to market takes more than a good idea. From meeting regulatory requirements to selecting suitable materials and understanding the needs of healthcare providers, Monika has had to navigate a range of challenges. She has received support from several organisations along the way, including Leap for Life.

“I’ve received support from Leap for Life, HighFive and Almi. Hearing from families in similar situations, as well as receiving valuable feedback and guidance from healthcare professionals and regulatory experts, has also been an important part of developing the product,” Monika says.

One of her biggest challenges has been navigating medical device regulations while building the business.

“I’ve learnt how important it is to persevere and to bring in the right expertise at the right time,” she reflects.

What Comes Next?

Zupercare Nordic is now working to introduce Protect-it® into healthcare settings and build partnerships with paediatric clinics across Sweden. Region Halland has already purchased several versions of the vest and is currently evaluating them.

“The next step is to scale up production and continue developing our product portfolio.”

What began as a response to a challenge in Monika’s own family has grown into a business with the potential to make a difference to many more children and their families.