A webinar hosted by the Biomedical Engineering Study Program (KK) of STEI ITB on August 21, 2021, featured three innovative medical device products that have been researched for years. These devices are NIVA, Respinos, and Diagnostic & ELISA.

The webinar was held to commemorate the 76th Indonesian Independence Day and to share information on medical device innovations currently being and already being developed at ITB for Indonesia.

"The Indonesian people are capable of providing innovations that benefit the nation and state. Health technology is already and will always be needed, requiring further development, especially with the COVID-19 pandemic," said Prof. Tutun Juhana in his remarks.

NIVA (Non Invasive Vascular Analyzer)

The shape of the NIVA tool

This device has been researched and developed by Biomedika ITB since 2013 in collaboration with industrial partner PT. Selaras Citra Nusantara Perkasa (SCNP) Tbk.

NIVA is an early detection tool for blood vessel flexibility. This tool was created because cardiovascular disease, especially heart disease and stroke, is the number one cause of death in Indonesia and often has no symptoms. The hope is that this tool will enable early detection and faster treatment.

Other benefits of NIVA include measuring vascular function and risk, based on photoplethysmography (PPG) and blood pressure sensors, an integrated solution for measuring blood vessel health, early detection of potential cardiovascular disease, and increasing knowledge in innovation and production of medical devices domestically.

The production preparation phase has begun, starting with obtaining a business registration number for the electromedical and electrotherapy industry and obtaining a medical device production certificate. PT SCNP Tbk has also prepared production infrastructure in accordance with Ministry of Health regulations. ISO 13485 certification is currently underway.

NIVA is planned to be commercialized in the second quarter of 2022 at a competitive price that will be affordable for community health centers, clinics, hospitals, and others.

Respinos

The shape of Respinos, a continuous isoman monitoring tool

Respinos is a tool resulting from collaboration between ITB Electronics, Airlangga University, Padjadjaran University and PT. Xirka

This tool was created due to the high COVID-19 pandemic in Indonesia and the limited facilities and workforce. Furthermore, self-isolation and patients with mild symptoms require monitoring.

Respinos is a continuous self-isolation monitoring device that can be controlled remotely by doctors because it is integrated with an application that can be accessed using a smartphone.

The device can measure breath rate, inspiratory time, inspiratory pause, expiratory time, oxygen volume in one time, inspiration and expiration ratio, heart rate (BPM), and body temperature.

There are two main modes: respiration monitoring mode, which continuously transmits SpO2, respiratory rate, and temperature data, and spirometer mode, which functions as a spirometer with instructions via an app. It connects to a smartphone, Wi-Fi, and Bluetooth. All parameters can be monitored by a doctor on the website.

Diagnostik & ELISA (Enzyme-Linked Immunosorbent Assay)

Pemaparan mengenai Kit Diagnostik Hepatitis B Berbasis ELISA

Research on this device is a collaboration between Biomedica STEI ITB, SITH-ITB, and PT. Elda Sarana Informatika. This device is used to detect Hepatitis B.

ELISA itself is the result of research conducted by SITH-ITB which then created another tool resulting from the development of ELISA.

The advantages of ELISA are its high levels of specificity and sensitivity, namely 96.7% for diagnostic specificity and 95.0% diagnostic sensitivity, respectively. It can be used for early detection, is effective for large sample sizes, and in the future can be developed for other infections and diseases such as HIV, Dengue, Covid-19, doping, and drugs.

Then, a device called the ELISA Reader was created, a device that can read the reaction between a reagent (a Hepatitis B diagnostic kit) and a patient sample. This device was developed by ITB's Biomedical Engineering Department and PT. Elda Sarana Informatika.

The ELISA Reader has received ISO 13485 certification and D4T Electrical Testing with category A. The trademark registration is under the name ELISA Reader THEIA type L450. Distribution and production permits have been registered since July 2021 but have not yet been issued and are still in process.

Commercialization plans are currently underway, with trial production and quality control (QC) on six units. The marketing channel will be an e-catalog, targeting educational institutions, health laboratories, and hospitals.

With the innovation of various types of medical devices, the quality of Indonesian health can be improved and the need for imported equipment from abroad can be reduced.