Medtech prototypframtagning

PERIsign prototype for clinical study

Standbacka Medical and Together Tech's collaboration is entering a new phase

Stomach pain can be anything from the consequences of a late dinner to a life-threatening condition. For the doctor, it is extremely difficult to be able to determine how urgent the situation is using only the hands. For the patient, it is of course impossible to know, and often associated with great stress and anxiety while waiting for the right care. With PERIsign, doctors all over the world should be able to quickly make the correct diagnosis and patients should be able to feel safer.

It is Strandbacka Medical that is behind the innovation and product idea around how to be able to detect peritonitis. After looking for the right partner to further develop the concept and technology and take the product to clinical study, the choice fell on Together Tech.

- We immediately got a good relationship and saw a clear commitment. Together Tech was quick to put together a good team that inspired trust and seemed to enjoy working with each other. The fact that we can now go into a clinical study shows that we made the right choice, says Andreas Jonsson, Chief Surgeon at Halland Hospital and together with Ingrid Jonsson, founder of Strandbacka Medical.

About PERIsign

PERIsign detects the potential difference in the muscle layers of the abdominal wall. Through the software, one can objectively visualize whether the patient has an involuntary muscle defense when the abdominal wall is provoked. You can compare this to what the EKG does for a patient with chest pain. With the help of the product, the healthcare staff can be able to quickly determine whether the stomach pain is due to an acute, serious illness and therefore requires immediate care.

- We are very happy and proud to help Strandbacka Medical and that it went so well in developing a prototype for a first clinical study. We hope to demonstrate that the medical device has a clinical value, i.e. can detect peritonitis. The prototype is developed as a class IIb(2b) medical technology product with associated documentation, says Håkan Rolin, business manager for Software Development and with long experience in medical technology product development at Together Tech.

Medical technology innovation

PERIsign registers the muscle activity in the layers of the abdominal wall. Through the software, it is possible to objectively visualize whether the patient has involuntary muscle defense when the abdominal wall is provoked. This can be compared to what an EKG does for a patient with chest pain. With the help of the product, healthcare professionals should be able to quickly determine if the abdominal pain is due to an acute and serious condition, thus requiring immediate care.

Together Tech's mission is to develop the entire PERISign system

This includes the development of electronics, software, and mechanics for EMG measurement, as well as the analysis and visualization of the same. The product is a medical technology product and is being developed in accordance with standards such as ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 60601.

Open and close dialogue - a success factor

- Medical technology product development is about people's health, technical precision, and regulatory processes. Our recipe for success is based on a close and open dialogue between the customer, us as developers, and CRO, says Håkan Rolin, with agreement from Andreas Jonsson.

The commitment and willingness to find solutions that Together Tech has already shown bode well for the future. Through market research and interviews with clinicians across the country, we know that PERISign has great potential and fills a gap in the assessment of patients with abdominal pain. We look forward to the clinical study, concludes Andreas Jonsson.