Developing a medical device from idea to certified product is a multi-stage process. Time and nerves are saved when the inventor teams up with professionals in product development and marketing. Heart2Save founder Helena Jäntti used Clinipower professionals’ help to refine her product idea and stated: “You really don’t have to do everything alone!”
Author: Minna Torppa
From idea to lifesaver with medical devices
Amazement and joy. This is how emergency physician Helena Jäntti describes her feelings in the process of seeing her inventions turn into medical devices. The Kuopio-based Heart2Save company, founded by Helena Jäntti in 2015, will launch the world’s first ECG jewelry in May 2021, of which Jäntti is particularly proud. It complements the existing AiVoni product family, designed to save lives.
The product family designed for monitoring cardiac arrhythmias includes a measuring device used by the customer, which, together with a mobile application, generates ready-to-use ECG data. This enables reliable identification of arrhythmias. In the treatment of arrhythmia patients, the application with its analysis services provides doctors with the ability to obtain information about the patient’s heart function both during visits and through remote monitoring.
In product development, quality management system creation, and sales preparations, Helena Jäntti has relied on the experience of Clinipower’s staff.
Developing a medical device for market entry is a multi-stage process, and navigating its complexities can seem like an insurmountable challenge for many inventors. The right partners must be found for funding, as well as for the design and manufacturing of the physical product. Additionally, an entity must be identified to scientifically validate the device’s safety and functionality in practical healthcare settings. Only then can the product be audited, certified, and marketed.
“The products would definitely have remained unfinished if I had had to push my ideas forward alone,” says CEO Jäntti. Throughout the entire product development process, she has been working full-time as a deputy chief physician at Kuopio University Hospital, with the company’s development taking place in the evenings and on weekends. It has been a busy time, as her family has also demanded its share of attention.
In product development, Jäntti says she received help from colleagues who are experienced medical experts. To verify the functionality of the devices, collaboration was carried out with Kuopio University Hospital and the University of Eastern Finland. Suunto Oy has been an important partner, providing a suitable sensor for the devices. Saurum Oy, on the other hand, was responsible for the design of the jewelry entering the market.
Heart2Save’s ECG necklace
Clinipower involved in the implementation: resulting in CE-certified devices
In product development, quality management system creation, and sales preparations, Helena Jäntti has relied on the experience of Clinipower’s staff.
“I have never been left alone with my problems. As a doctor, it has been sensible for me to focus on my own area of expertise and rely on specialists in other fields for other matters.”
According to Helena Jäntti, Clinipower’s strength lies not only in its robust expertise but also in its staff’s readiness to roll up their sleeves and practically handle the necessary tasks. The efficient CE-certification of Heart2Save’s products to Class IIa has been based on Hannele Toroi’s deep expertise. For a small entrepreneur, having an experienced expert like her involved from the early stages of product development can be considered a small-scale lottery win.
According to Helena Jäntti, Clinipower’s strength lies not only in its robust expertise but also in its staff’s readiness to roll up their sleeves and practically handle the necessary tasks.
For a starting entrepreneur, it is crucial to be able to purchase the expertise and advisory support of skilled professionals as needed. When an entrepreneur progresses through the entire product development cycle alongside a competent expert, their own expertise also grows. This way, the knowledge becomes a valuable asset for the company.
Guided by Clinipower’s experts, it is safe to develop a business.
When Helena Jäntti is reminded of an article published in Lääkärilehti in 2015, where she called for help to advance her first invention, an everyman’s device for measuring cardiac arrhythmias—while absolutely insisting on not starting her own company—she bursts into hearty laughter.
“After reading the article, Maija Laukkanen called me. Things started moving in the right direction, first with Pekka Kola’s assistance and then gradually with the efforts of Clinipower’s expanding team. Most recently, Outi Kaasinen has joined to advance the company’s business development and sales.”
The years-long collaboration with Clinipower has brought Helena a sense of security. It has meant a lot to her that she has been able to openly express her lack of knowledge about the production phases of a medical device.
https://vimeo.com/658855275Heart2Save introductory video
According to Helena Jäntti, the most challenging aspect of the entire product development process has been securing funding. The Heart2Save company was established through crowdfunding from doctors. The support from many colleagues and other investors has not only warmed her heart but also made Helena feel the weight of her responsibility. She has described the expertise of Clinipower’s staff as reassuring.
“I can say that the company has been a reliable companion for me. Or, better put, a trusted godmother who has gently guided me forward with her knowledge.”
