Project: Developing of standardised method for detection of stress and pain at patients in Intensive Care Units (ICU)

Pain is difficult to manage on anesthetized patients because of variation in genotype and individual variances between patients. Today there are no objective ways to record pain and monitor the effect of the treatment. In the US it is mandatory to record and treat pain. Through 40 studies and examination of 3000 patients Med-Storm has developed equipment, the Pain Detector, to record and treat pain. So far we have developed indexes for anaesthesia, postoperative care and pre-term infants. The Pain Detector of today has a measurement unit that can be connected to a PC or existing patient monitor screens. So far only Philips has opened up for us to connect to their monitor. Today our Pain Detector is well adapted to meet the needs from the scientists within pedriatrics and anaesthesia. The system is already ordered or delivered to about 100 opinion leaders who have taken or will take the method and our equipment into use in their research work within pain and stress. In order to introduce the Pain Detector monitor for clinical use, e.g. intensive care units, there is a requirement to industrialize the general Pain Detector with a new standardized index and with a design appropriate for clinical use, e.g. the Intensive Care Units. Med-Storm has decided to do this product development in cooperation with Karolinska Hospital, Solna,a world leading hospital within pain management at Intensive Care patients and Hotswap, Stockholm, with experience in development of medical devices. The design for the clinical use, among others the intensive care units, will be a small monitor where measurement unit is included. This monitor will be well suited to monitor pain in patients during anesthesia, postoperative care and for pre-term infants in pain during daily clinical use._x000D__x000D_A commercial objective of the Eurostar application is to develop the equipment to fulfill the clinical demand (Easy to Use Diagnostic tool to diagnostic/record pain) for hospitals to use our equipment as a basis for monitoring patients during general anesthesia during surgery and post operative and during Intensive Care Unit /ICU stay as well as for pre-term infants. Marketwise there is a huge demand by the world`s approx. 13 million hospital beds which may adapt our system._x000D__x000D_Hotswap AB is the Technical P in product development._x000D__x000D_The sub-contractor Orbit One AB will be used to build 3-5 prototypes. The clinical field tests will be carried out by the Medical P Karolinska University Hospital. The Hospital has already prepared a scientific protocol which include 5 sub-methods and procedures. All together 110 patients will be involved in the clinical trials managed by Karolinska Hospital._x000D__x000D_ Med-Storm will primarily work as project coordinator for product and market development in Europe,North America and Australia.. An introduction to opinion leading scientists is already launched to approximately 100 hospitals sites world wide. Our aim is now to develop the market for the hospitals with a more easy-to- use and compact equipment. The CO technical feature for "Pain Detector" to be developed is a new pain index based on our measuring method._x000D__x000D_The patent development in order COtain a strong IP position is subcontracted to Onsagers as, Norway's leading IP-advisor within medical devices. Productification will be based on clinical trails and own experience with support from Hotswap's multiple discipline team. Development and manufacturing _x000D_procedures need to meet regulatory standard in order to allow market introduction in particular in the US. Hotswap, and independent FDA advisors in Sweden and the US will assist Med-Storm and Hotswap in this work._x000D_Karolinska Hospital will after the clinical trials, publish the results in well recognised journals as part of the marketing process._x000D_The market development is an on-going process where Med-Storm is in close contact with distributors, other companies within patient monitoring and specialist at hospitals for delivering analgetics. _x000D__x000D__x000D_If the planning for project start in May 2008, the project will finish in December 2009._x000D_

Acronym Pain Detector (Reference Number: 4260)
Duration 01/06/2008 - 31/12/2009
Project Topic Med-Storm’s unique Pain Detector is the only medical device available for recording and quantify pain during pain management. The clinical and technical development of the Pain Detector will address the demand for the mandatory pain recording and treatment in the US.
Project Results
(after finalisation)
We have managed to develop a new tool which will meet the clinical demand in the hospital market. We have also met the research objectives: to document that the method is working post operatively and during intensive care.
Network Eurostars
Call Eurostars Cut-Off 1

Project partner

Number Name Role Country
3 Karolinska University Hospital Solna, Dept. of Anesthesiology & Intensive Care Medicine Partner Sweden
3 Med-Storm Innovation as Coordinator Norway
3 Hotswap Stockholm AB Partner Sweden