The Product

The project is a continuation of a Research To Business project funded by Tampere University and Business Finland at close to 600 000€. Several prototypes in clinical trials.

The wearable monitor is primarily intended to detect respiratory depression, that can follow from several causes, mostly opiate pain medication. The first step is detecting changes in respiratory rate and gas exchange. As respiration slows, blood oxygenation falls, which is detectable by the pulse oximeter.

If not reacted to, this leads to cardiac problems, first ST-segment depression, which the device detects, and later arrhythmias, and finally to ventricular fibrillation or asystole (lethal).

As a comprehensive diagnostic cardiac monitor, it can also be used for cardiac stress testing, to detect when increased cardiac oxygen demand cannot be met by coronary artery blood supply.

The device also monitors changes in blood circulation via Pulse Wave Transit Time, i.e. the time it takes from the Ecg peak to the pulse wave peak in the photoplethysmogram (finger, ear pulse oximeter sensor). This correlates roughly with blood pressure, and can be used to trigger a blood pressure cuff monitor. Blood loss (hypovolemia) can be detected by the respiratory variation of the plethysmogram waveform.

As a respiration / oxygenation monitor it can also be used to detect and follow sleep apnea and other respiratory problems..

The device can be used as mobile only (sports, self-monitoring, physiological capability monitor) when connected to a smartphone via Bluetooth and/or Thread radio, or when further connected to a PC, as a multiple patient alarming central station. Data can be saved and later analyzed with custom history data browser or for research purposes with standard commercial tools (Python, MATLAB, Excel…)

The Market

Primary market:

The global wearable / wireless monitoring market was USD 96Bn in 2022 with a projected CAGR of 24%. It is being driven by the increasing need for monitoring and the need for decreasing hospitalization of patients not in real need. Examples: GE Healthcare introduced Portrait Mobile (Impedance respiration, SpO2, no Ecg yet) in 2022 and Mindray has mWare solution in their portfolio. These recent examples show that the market for mobile patient monitors will be significantly increasing also in the future. However, the aforementioned devices cost approximately 10x the projected end user cost of our device.

Market size in post-operative monitoring: currently there are 310M surgeries performed annually, 50M in US, and one third receive Patient Controlled Analgesia for managing opiate pain medication (rendering the patient tied to the bed). Opiate Induced Respiratory Depression (OIRD) increased hospital stay +3 days (+7800 USD). Incidence of OIRD 0.5%. In 77% of cases OIRD led to severe injury. Episodes prevented with better monitoring 97% (Lee et. al 2015 closed claims analysis).

Secondary markets:

The advanced Ecg monitoring features are on par with the major competitor’s system, albeit being a fraction of the price.

Thus, Cardiac Care Telemetry units are important marketing targets, especially as they are accustomed to wearable telemetry monitoring.

A low-cost advanced wearable monitor is ideal for a field hospital or emergency team. It can manage up to 16 simultaneous trauma patients on one Central PC, as well as monitoring individuals on a cell phone (only short-range radio is needed here). The cell phone can be worn either by the individual patient or by the medical team. Cost is definitively an issue where devices easily get lost.

The advanced Ecg allows the device to be used for physiological evaluations and stress testing. The pulse oximeter is already tested in hypoxic / high altitude conditions and found to work well for detecting hypoxias. The low cost again enables sports and sell-monitoring use.

Home monitoring is also a promising market, as the same requirements as for general wards apply. The military has also shown interest in wearable field monitoring.

A sports version is also planned, for self-monitoring. Initially planned to be identical to the general product, but without alarm functionality and advanced central station features (these will in general be licensed separately).