Founded in 2005 and built around a device to help women with stress incontinence, Invent Medic grown its focus to encompass female health in general, aiming to build a pipeline of medical technology designed and developed with women’s health and quality of life in mind.
Invent Medic’s core product, TVS, is a vaginal device designed by Jan Clarén and Lars-Olof Henriksson in development for the non-surgical alleviation of stress incontinence. Both Clarén, now the company’s technical advisor, and Henriksson, have years of experience in the field of medical devices and incontinence treatment. Stress urinary incontinence is the unintentional passing of urine during activities that increase pressure inside the abdomen and push down on the bladder such as coughing, lifting or running. This is a is a common problem for many women, and can lead to curtailment of work and social activities, as well as sports and exercise. The company initiated a multicentre clinical study for TVS in the fourth quarter of 2016 running through to the fourth quarter 2017, with CE marking expected during 2017 or in the beginning of 2018.
Bringing innovation to women’s health
While Invent Medic is currently focused on the development of TVS, its aim is to seek out and bring a pipeline of medical devices and accessories to women’s health in areas where women are being underserved.
“We are open to discussion and welcome people to come to us with their ideas on medical devices for improving women’s health, whether it’s just a concept or a part-developed project,” said CEO Karin Bryder. “Building on the experience that we have gained through developing TVS, as well as being ISO 13485 certified, we can manage the whole process from an idea to approval and the market.”
Dealing with change
There are significant changes on their way to the European Union’s regulatory framework for medical devices. This includes more stringent clinical evidence, adding unique device identification, and intensified market surveillance, amongst other requirements.
“The TVS development has kept this new directive in mind from the beginning, and we are also working to comply with US regulations to smooth the path to a global market,” said Bryder.
Keeping it lean
Invent Medic is currently running as a virtual company, and will outsource to specialists as required for each step of development.
“We are small and lean, with a strong core, including experts in quality management, in devices laws and directives, and in product development and marketing for devices. Our strength is our team and their knowledge and experience. We plan to grow organically,” said Bryder, who joined the company in 2015.