In the fall of 2022, Tanja Tervonen and Wycliffe Raduma embarked on their Biodesign immersion journey at Helsinki University Hospital's (HUS) Ear, Nose and Throat unit, tasked with identifying unmet needs that could serve as the foundation for a new commercial medtech solution. Through the observation of clinical practice, they identified problem and challenges that various patient populations faced. It was during this intensive need-finding phase that they crossed paths with Saku Sinkkonen, an Otologist and ENT Specialist, and Ville Sivonen, a Clinical Researcher and Audiologist, each with over 15 years of experience in their respective fields.
Together they identified that there was a major need for scalable hearing loss screening as they found out that 1 in 4 people is projected to have hearing problems by 2050. 80% of these people will not be diagnosed, and those 20% that are, are diagnosed approximately 9 years later than they should.
This problem also generates global annual losses of ~$1 trillion worldwide and almost 50% of these costs are related to diminished Quality-of-Life (WHO 2021). Furthermore, it's not just about hearing; it's a mental health crisis in disguise as there is substantial evidence in place linking Age-Related Hearing Impairment to changes in cognitive ability and even memory disorders when untreated.
Their choice was clear, there is an increasing need to mass screen the population for hearing loss. However, healthcare systems are already burdened and not equipped to screen this growing population effectively creating unnecessary costs for society and delays in treatment paths. They proposed to solve this this problem by empowering clinicians to diagnose and refer multiple hearing loss patients in minutes, not hours. Together they created a project Otos based on the need-findings from Biodesign and the research that was carried out by Sinkkonen and Sivonen at HUS.
In the follwing interview Tanja Tervonen shared how the journey continued after the Biodesign Fellowship.
What happened immediately after the Biodesign project ended in spring 2023?
We got Research to Business (R2B) funding for our project from Business Finland. The R2B project started in June, straight after the Biodesign project had ended. So, we had a good momentum to continue with our project immediately.
Tell me more about the funding you received and what it enables for you to do?
We received Business Finland’s Research to Business funding for 18 months which enables us to build our investigational device and do a feasibility study to assess the compatibility of our concept in a clinical environment. It also allows us to do usability testing, as it is a key component of overall risk management and safety of medical devices.
Even though these studies are important in defining whether our concept can be commercialized or not, the exploration of the different commercialization paths, business models, and markets is the key in this funding. Therefore, validating the concept with potential customers to understand whether there is a product-market fit or not, is essential. Furthermore, the exploration of different markets and finding the right commercialization route for the concept through participating in different national and international conferences, fairs, pitching events etc. is allowed, and I believe even encouraged.
Tell me about your team and how it evolved from Biodesign.
We have four key persons in our team:
- Wycliffe – Commercial and Technical Lead (Aalto University)
- Tanja (me) – Team Lead (Aalto University)
- Saku – Clinical Lead (Otologist, ENT Specialist, HUS)
- Ville – Clinical Researcher (Clinical Engineer – Audiology, HUS)
This core team was already formed during the Biodesing program, as we met Saku and Ville during our Clinical immersion in August-September 2022. We decided to pursue the R2B funding together with the concept that is based on the research of Saku, Ville, and their colleagues. At the moment I and Wycliffe are working full-time, whereas Saku and Ville are participating in the project besides their clinical work. Now they are conducting our feasibility study at HUS.
With R2B funding, there have been a couple of additions to our team:
- The project’s PI Jouni Partanen (Professor of Mechanical Engineering and Advanced Production Technologies, Aalto University), is managing and supervising all project activities and is responsible for financial and administrative aspects.
- Poonam is a Master’s Student in New Media (Aalto University, School of Arts). She is conducting the Usability study for our project.
We are also working with a multidisciplinary PDP team (9 students) from Aalto University and ESADE for 8 months. They are investigating the possibilities of other technologies that could bring additional value to our project.
Besides of this, we have other ongoing student projects and a vast network of mentors and advisors from different fields, such as regulation, software, marketing and sales, lean thinking, Audiology, MedTech, etc. helping us to go forward.
Where are you now with your project and what have you learned so far?
We have our investigational device ready, and we have started our clinical and usability studies.
I feel that the learning curve during the Biodesing and R2B project has been steep. The field of MedTech and innovations was new to me when I jumped into the Biodesing project. Now, looking a year back – I can just be amazed at how much I have learned about regulatory aspects related to medical devices, agile concept formation, IPRs, commercialization of products, different funding instruments, team creation, etc. during this journey. If someone had asked me a question related to, for example, MDR, ISO 13485, QMS, vesting, ESOP, or sensorineural hearing loss, a year ago, I would have just smiled nicely and admitted that I needed to investigate it a bit. Now the situation is totally different, and I think it is one of the rewards of this project – learning new things and spending time with extremely experienced professionals who are willing to challenge and help us, to get our project forward.
But if I need to mention some challenges they would be the regulatory hurdles, as applying the right permissions can be time-consuming.
What are your next steps? / What are you looking forward to doing next?
I’m looking forward to getting our first results from the clinical studies to support our hypothesis. These studies will help us to move forward with the market validation and discussions with potential future partners/customers.
What would you say to people who are thinking about applying to the Biodesign Finland program?
Don’t hesitate to apply – this is a great opportunity to find an actual need and create ideas that truly can have a huge impact on the world.