The Indian neonatal equipment industry is on the brink of a major change, with the Make in India regime to promote manufacturing of medical devices in the country and the establishment of newborn care units to improve the status of neonatal care in the country.

Increasing pressures to leverage new technologies to make care safer, more efficient, and cost-effective have pushed the boundaries of neonatal care, opening the doors of neonatal intensive care units (NICUs) to an era of smarter, safer, and wireless technologies. Advances in sensing and monitoring technologies in NICUs have enabled easier and faster measurement of a wider range of physiologic parameters. Current patient monitors in the NICU have channels to incorporate the ECG recordings, respiratory rate and airflow, oxygen saturation over time, invasive arterial blood pressure, and temperature. The value-based healthcare model has led to the development of well-equipped NICU centers along with increasing number of approvals for these devices from the FDA. Modern neonatal ventilators are getting smarter, with wider range of support options and monitoring, in parallel with improvements in noninvasive respiratory support. Advances in conventional CT, MRI, and ultrasound imaging of neonates have gained traction in the past one year, opening up new insights into brain injury and disease. The U.S. FDA clearance of the first MRIdevice specifically for neonatal brain and head imaging in NICUs is anticipated to take fetal imaging and diagnosis to the next level.

In the past few years, neonatal care in India has become a priority due to the concerns over the infant mortality rates. Advanced NICUs have been established in teaching and nonteaching hospitals in large cities, whereas smaller cities and towns have witnessed a dramatic growth in the number of nurseries for newborns in small private hospitals and nursing homes. In the public sector, the delivery points at sub centers, primary health centers, community health centers, and district hospitals have been equipped with resuscitation equipment, including Made in India self-inflating bags, warmers, and suction units. Under National Health Mission, more than 700 state-of-the-art special newborn care unit (SNCUs) have been established across the country to provide 247 comprehensive care to the newborns by dedicated trained staff. With these initiatives to promote neonatal care in the country, the future of neonatal equipment innovation, production, and scale-up is brighter than ever.

The Indian neonatal equipment industry is on the brink of a major change, with the Make in India regime to promote manufacturing of medical devices in the country and the establishment of newborn care units to improve the status of neonatal care in the country. The Made-in-India resuscitation bags, phototherapy units, weighing scales, and radiant warmers have taken a firm hold in the Indian neonatal equipment industry. India is almost entirely self-reliant in terms of phototherapy units and infant warmers, but still depends on the international market vendors for CPAP equipment, ventilators, and incubators. Breakthrough innovations in the technology and affordable neonatal care equipment will go a long way in making India a hub of affordable healthcare technologies.

With the goals of attaining Single Digit Neonatal Mortality Rate by 2030, Ministry of Health and Family Welfare released operational guidelines for planning and implementation of family participatory care (FPC) for improving newborn health, in July 2017. The guidelines provide details of infrastructure, training, role of health care providers, and steps in the operationalization of FPC in the newborn care unit.

Facility-based newborn care (FBNC) is being scaled up for care of small or sick newborns by establishing SNCUs at district hospitals and medical colleges and newborn special units (NBSUs) at the level of first referral units (FRUs) to provide round the clock services for sick newborns.

UNICEF India played a key role in partnership with the state governments in the early operationalization and expansion of these services in the country. UNICEF India, in 2016, focused on institutional capacity building to improve coverage/quality of skilled attendance at birth, strengthening facility-based newborn care at SNCUs, linking facility-based and community care, and strengthening real-time monitoring systems for newborns. SNCUs scale-up in high-priority districts continued, and the number of functioning SNCUs increased from 63 percent to 73 percent (77/107) since 2015, according to the UNICEF India Annual Report 2016.

In 2016, SNCU development accelerated in Bihar, Uttar Pradesh, Chhattisgarh, Jharkhand, and North East, where earlier progress had slowed. The SNCU real time monitoring system developed by UNICEF was scaled up in 11 more states, covering 541 SNCUs across 28 states, in 2016 from 440 SNCUs in 17 states, in 2015. With these initiatives gaining momentum, the status of neonatal care in India is anticipated to improve over the next few years.

Global Market Dynamics

The global fetal and neonatal care equipment market was valued at USD 6.7 billion in 2016 and is projected to grow at a CAGR of 7.6 percent over the next few years, states Grand View Research. The neonatal care equipment industry is undergoing changes in regards to regulatory protocols, preventive care, reimbursement models, healthcare digitization, patient interests, physician preferences, and executive priorities. Stakeholders need to be aware of the challenges posed by the industry and anticipate new ways to find business models and capitalize on the market transformation.

Fetal monitors are anticipated to witness fastest growth rate in the coming years, owing to their utility in determining the baby's heart rate during pregnancy and labor. Fetal monitoring devices are essential as they allow continuous monitoring of the baby's heart rate and contractions and assist in labor too. Monitoring devices segment held the largest share in the year 2016, owing to factors such as constant technological advancements in neonatal monitors including improvements in connectivity and ease-of-use in home settings. On the other hand, respiratory devices are expected to exhibit fastest growth rate owing to increasing demand for respiratory care in neonatal in order to reduce the length of hospital stay and risk of long-term disability.

Asia-Pacific market is anticipated to register the fastest growth development in the forecast period. Increasing number of government initiatives in developing countries such as India have established strong demand for pediatric health equipment.

Vendor Updates

In July 2017, Phoenix Medical Systems partnered with Windmill Health, to present NeoBreathe, one of the world's first foot-operated newborn resuscitation systems.

In May 2017, Masimo announced FDA 510(k) clearance of O3 regional oximetry for pediatric patients.

In March 2017, GE Healthcare acquired Monica Healthcare for its advanced fetal monitors, to expand the company's digital maternal–infant care offerings.

In November 2016, Hamilton Medical released the Hamilton-C1 neo versatile neonatal ventilator that combines invasive and noninvasive modes, with the additional options of nCPAP and high flow oxygen therapy. Drger introduced the new IncuWarmer Babyleo TN500, offering optimal thermoregulation in open care, closed care, and transition.

In January 2016, Maquet Medical Systems launched a dedicated neonatal intensive care solution, SERVO-n sensitive and responsive in conventional modes of ventilation and compensates for variable leakage.

Research Updates

The technological advancements in the neonatal care equipment have paved a way for the introduction of modern neonatal ventilators, advanced fetal imaging, and contact-free monitoring. At present, monitoring technology in the NICU requires multiple wired sensors to track each baby's vital signs. The large number of wires in and around the incubator might be reduced by introducing wireless systems. Ongoing researches in the industry focus on implementing wearable, wireless devices in the NICUs facilitating a safer environment for the neonates.

Neonatal imaging using an MR-compatible incubator. A research team led by Catherine Limperopoulous, at the Children's Research Institute, Children's National Health System, Washington DC developed an MR-compatible incubator with an integrated head coil designed for neonates and small babies to provide comfortable transportation of the baby from the NICU to the MR scanner.

Neonatal brain imaging system. In a research project funded by European Research Council, a team of researchers at the Centre for the Developing Brain, Perinatal Imaging and Health, Kings College, United Kingdom, designed a neonatal brain imaging system (NBIS) consisting of a dedicated 32-channel receive array coil and a positioning device that allows placement of the infant's head deep into the coil for maximum signal-to-noise ratio (SNR).The system makes it possible to push the technical boundaries of MRI in the neonatal brain to attain high-resolution anatomical, which was not previously achievable in neonatal imaging. The positioning system allows to exploit the SNR, gain capability and demonstrates substantial benefits for imaging neonates in natural sleep by minimizing handling and reducing the startling effect associated with the start of scan sequences. When combined with retrospective motion correction to eliminate scan repeats, it has been possible to achieve near-perfect success rates with artifact-free images. The system is now being applied to a much wider range of neonatal brain imaging studies.

Epidermal electronics. Researchers at Northwestern University, Illinois, US, led by John Rogers, have developed incredibly thin, stretchable electronic patches for monitoring a wide variety of vital signs and bodily movements. These patches, still under human trials, are reported to have a strong potential to make human healthcare and rehabilitation much more efficient and effective. The patches are created by putting tiny semiconductor chips on a stretchable substrate embedded with wavy patterns of metal filaments, which make it possible to carry electrical signals. The device uses tiny antennae to transmit information wirelessly, and can be a game changer in changing the NICUs in future to a wireless unit.

Outlook

The increasing demands for high-end, technology-integrated, home-based infant care and neonatal solutions mirror the healthcare industry's shift toward value-based care. There is a need for affordable technologies that can conveniently reach and cater to customers in the low-income settings and assist in disease monitoring through diagnostic applications on mobile phones.

The face of NICUs has been evolving significantly with advancements in technology gripping the neonatal care equipment industry. Strengthening of delivery points for providing comprehensive and quality reproductive, maternal, newborn, child and adolescent health (RMNCH+A) services, ensuring essential newborn care at all delivery points, and establishment of SNCUs and NBSUs are giving a boost to the neonatal care status in India. With the Make in India initiatives to boost the manufacturing of medical devices in the country, the Indian neonatal equipment industry is anticipated to flourish in the years to come

 Atul Jabde

Industry Speak

Advances in Noninvasive Ventilation

Ventilatory support for premature infants with respiratory distress has undergone significant change over the past 10 years. The latest trend in the field of neonatal intensive care is the use of nasal ventilation, which minimizes or avoids the practice of endotracheal intubation.

Oxygen therapy administered through nasal cannulas or masks has always been thwe first approach to alleviate hypoxemia in patients. In conventional oxygen therapy, the flow used is generally low, due to the fact that high flow rates without an appropriate humidity level may cause discomfort.

In this scenario, high-flow nasal cannula (HFNC) allows oxygen administration of up to 60 L per minute with a high humidity level; solving the issues raised in the past. Reasons for increased popularity of HFNC are that it is simple and easy to setup, causes minimal nasal trauma, and is well-tolerated by patients due to high humidity. Many research papers show various merits of HFNC, which includes reduction in the dead space, work of breathing, and CO2 in upper airways. Using high-humidity level HFNC allows toleration of the administered flows and prevents the impairment of the cleaning and defense mechanisms of the airways.

How Technology Makes Life Easier?

The new non-invasive ventilation (NIV) algorithm, in the ventilator enables detection of gas leakages, which helps the management of the main respiratory parameters such as pressure and flow. These measurements are now possible even in an open system. NIV minimizes both the risk of respiratory failure after extubation and the frequency of reintubation. In the newer method of triggering using the external respiration sensor, patient abdominal movements are converted to a stable, responsive (<30 ms) trigger signal. This synchronized non invasive ventilation (S-NIPPV) increases effectiveness and reduces reintubation rates.

It has been observed that numerous manual FiO2 adjustments by the nursing staff have been necessary to treat preterm infants with frequent SpO2 fluctuations in NIV modes. To avoid or treat hypoxemia and hyperoxia, nurses need to make a manual intervention (or FiO2 adjustment) nearly every 10 minutes. An automated FiO2 controller (according to patient's SpO2) is able to drastically reduce the amount of possible interventions. This definitely reduces the stress level and workload of nurses and therapists, giving them more time to focus on other important treatment of these critical patients. The combination of an external respiration sensor (for S-NIPPV) and a closed loop FiO2 controller can help avoid CO2 retention, improve tidal volume and oxygenation, reduce bradycardia and the duration of desaturations. This technique has the potential to reduce the overall oxygen consumption of the patient and improve oxygenation in a much more natural way.

Atul Jabde
General Manager–Ventilator Sales,
Schiller

M.Rakshith Shetty

Industry Speak

Tele NICU Connect

India contributes to about 30 percent infant mortality of the world and the maximum number of deaths happens within two to four weeks of baby born. The available numbers of pediatricians are less for treating sickest neonates and also trained nursing staffs are minimal for treating critical care babies. The biggest problem is non-availability of vital health information to pediatrician where ever they are and on time (online). Manual data capturing errors in NICU may result in wrong diagnosis and treatment. Our solution aims at providing real-time remote monitoring connected through critical care medical devices and video solution. The technology helps in monitoring key vital health parameters remotely and assesses the trending of the crisis over period of time. This helps in providing right medical intervention at the correct time.

Tele NICU Connect is a concept of connecting remote NICU to Specialist Centers through real-time monitoring system and video link. Key equipment in the NICUs like baby warmers, incubators, patient monitors and ventilators are connected through indigenously developed hub and Internet. Bed side crucial supporting devices streams the key vital health parameters or information through servers or cloud infrastructures to the remote centers to view the data live. HL7 Export system is designed to convert the vital information to HL7 format for the integration into EMR / HIS system. Customized alert mechanism and historical trendings are tracked in order to provide an alarm and relevant information to neonatologists viewing from remote place/command center. Neonates with critical conditions like sepsis, hypothermia, and hypoxia are monitored remotely and timely interventions are made to save lives of neonates, hence reducing infant mortality.

The infant incubators and warmers in the NICU play the role of bed and provide conducive environments for critical babies and vital health parameters are measured. These devices are operated under isolated environment and monitoring the health of the babies will require staff nurse or neonatologists to visit the bed. Tele NICU Connect would virtually bring these devices and babies to the place where the specialist neonatologist is and can monitor the babies remotely. This will have a significant impact, when these warmers are located in the remote area maternity hospitals and require immediate attention for babies by neonatologists.

Healthcare analytics and artificial intelligence is the future of healthcare IT. With critical care data aggregated and saved for future use, this will be vital information for the healthcare analytics. Prediction algorithms will power the decision making for avoiding mortality or crisis. Marking the vital data variations due to critical illness and presenting it as a case study will be the key for research development and training upcoming neonatologists. Tele NICU will help in connecting the critical care facilities and echo systems by providing the required information at the right time. The rural maternity hospitals with NICUs, remote referral hospitals without specialized neonatologists will be greatly benefited with this technology upgrade.

M. Rakshith Shetty
CEO,
Fanem Medical Devices India Pvt. Ltd.

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