Neosense Technologies: Navigating Clinical Trials

Clinical trials are an essential step in evaluating the safety and efficacy of medical devices before they reach the market. However, devices designed for rare conditions or specialised procedures often face difficulty in recruiting a sufficient number of eligible patients for these trials.

In neonatal care, and especially for extremely preterm babies, advanced intensive care is vital and these infants frequently require additional oxygen supply and ventilation support. Nevertheless, maintaining optimal oxygen levels poses challenges, as deviations can result in severe complications.

Neosense Technologies AB is a Swedish medical startup based in Stockholm and specialises in intensive care units with continuous oxygen monitoring systems. Their innovative sensor technology offers real-time monitoring of arterial oxygen tension directly from the central blood circulation, which has garnered endorsements from experts in neonatology.

CEO Kenneth Danehorn provides insight into finding locations and participants for their clinical trials conducted for their class-III medical device:

Compared to class I or II devices, I can say class III seems much more challenging to gather clinical evidence and pre-market clinical evaluation (including a clinical investigation), and we expect the audit by notified bodies to be equally as difficult. However post product approval, sales and marketing is unlikely to be any different when following up on post market surveillance activities.

It is widely accepted early stage medical device companies must navigate a variety of complex challenges within clinical trials:

For a multi-centre trial like the one we are conducting, long lead times and slow progress are common. Keeping track of all consumables and equipment that are delivered and installed at each hospital and keeping track of the need for more consumables also presents a significant challenge.

When talking about potential strategies for commercialisation after clinical-trial completion Kenneth says:

We plan for distributors taking care of sales and service in their geographic region, with support from our team who will engage in marketing at congresses and other common channels. Neosense also plan to run clinical studies at hospitals to improve our burden of proof for clinical benefits.

Kenneth also gives his thoughts about digital transformation in relation to commercialisation saying:

The key benefits would be in digital trainings for the distributors and customers, online meetings with clinical advisors, tracking sales of equipment and consumables, and also running our post-market surveillance activities in a system connected to each clinic/hospital. However having products directly connected to a cloud presents more problems than advantages at this stage.

Kenneth offers this advice to other Medtech companies who are approaching this critical development stage:

Clinical trials always take longer than expected so plan for a multi-centre-trial rather than a single-center-trial. But my key learning so far would be it is often easier to analyse problems that are caused by a deviation in usability, compared to those related to a flaw in the product.

Key Takeaway:

Navigating clinical trials for high-risk medical devices demands strategic planning, extra consideration on patient recruitment, and logistics management are key. Digital transformation can deliver benefits, but it requires a careful balance, so prioritise evidence gathering for successful commercialisation.

Huge thanks to Neosense, and Kenneth Danehorn for sharing and facilitating the conversation.

Now, we turn to you: Who else in the life science sector is approaching clinical trials and has unique insights to share?

Let's continue the dialogue. ?? #LifeScience #MedTech #Clinicaltrials #Marketaccess