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Ventilators

Novel technologies head toward affordability and accessibility

To overcome the shortage of ventilators during the pandemic, easy to assemble, portable ventilators were a savior. The stakeholders are now working toward them becoming mainstream.

The unprecedented dawn of Covid-19 boosted the demand for mechanical ventilators by leaps and bounds. The intuitive measures adopted by the government and the manufacturers to curb the initial unpreparedness for the pandemic resulted in the inflow of mechanical ventilators at the expedited rate.

The requirement for ventilation facilities during the Covid-19 outbreak quickly improved day-to-day operational capabilities. Medical associations around the world joined forces with different organizations to train respiratory therapists on operating ventilators during Covid-19. This has further stimulated the market players to increase their production capacities to meet the augmented demand. Many manufacturers were flooded with orders during the pandemic.

With the development of the Covid-19 vaccine in 2021, coupled with effective therapeutic options to treat mild to moderate symptoms of the infection, growth stabilized. In addition, an expected decrease in the infection rate of coronavirus due to high awareness amongst the population and adherence to physical distancing measures is slowing the spread.

FDA temporarily waived its enforcement and inspection requirements, which is helpful for cross-industry manufacturers to fabricate much-needed components for ventilators and other critical care equipment. Supportive and timely regulatory policies by the government are anticipated to provide a growth platform for this market in the coming financial year, thereby affecting the growth rate over the next 8 years.

A rise in the incidence of chronic obstructive pulmonary disease, rapid growth in the elderly population, and technological innovation are major factors likely to drive the market in coming years. The evolution of patient-friendly, cost-effective, and portable devices can further encourage their usage.

The Indian ventilators market in 2021 is estimated at 42550 units, valued at ₹2938 crore. This is a 7.7-percent increase by quantity over 2020, albeit an 11-percent decline by value.

The imported segment that had lost market share in 2020, with the allocation of ₹2000 crore in the PM-Cares Fund and the supply chain constraint, since their parent companies catered to their respective domestic demand before they made the product available for exports to India, regained share.

Indian ventilators market

Major vendors* – 2021

Tier I

Tier II

Others

Imported
Draeger, GE, Hamilton, Mindray, and Maquet Schiller, Philips, Allied Medical, Vyaire, Aeon Medical, Air Liquide, IMT-Carefusion, and Covidien BPL, MEK ICS, and Hoffrichter GmbH
Transport and portable

Philips

Aeon Medical

Hamilton, Draeger, and GE

*Vendors are placed in different tiers on the basis of their sales contribution to the overall revenues of the Indian ventilators market.
ADI Media Research

The transport and portable segments are dominated by Philips and Aeon Medical that commanded a combined share of 61 percent by volume in 2021. The portable machines accounted for a 30-percent share in this segment.

The indigenous machines are primarily supplied by Skanray.

The refurbished machines are no longer the preferred models. Not only are the new machines available at the prices earlier offered for the refurbished machines, the government has been discouraging machines that have been in use for more than ten years, and has become more stringent on warranty offered for machines by the manufacturers. There is a small market, with demand largely emanating from small hospitals in Tier-III cities. A couple of large refurbished players have diversified to providing services to the existing installed machines. Also, the government is encouraging the players to set up manufacturing facilities under the Make in India initiative.

As in 2020, when the NGOs emerged as a new segment of buyers, with Indian companies buying ventilators as part of their corporate social responsibility (CSR) initiative, April–June 2021 saw donations of 6500 machines from overseas.

Donations received by Indian hospitals
April-June 2021

Country Qty (units)
Australia 1056
Ireland 730
Germany 620
Netherlands 449
Japan 300
UK 250
UAE 157
Switzerland 150
Spain 141
Estonia 120
Russia 75
Kuwait 60
Luxemborg 58
Denmark 53
Oman 36
France 30
Egypt 20
Italy 20
Others 2175
Total 6500

2021 saw depressed sales. The government, a large buyer in 2020, not only did not invite fresh tenders but also did not place orders for the tenders that had been opened and L1 (lowest bidder) identified. Also, the Health Ministry issued a mandate that the states’ demand for ventilators be met by the piles stocked at the Center. Private buying is also down at a trickle with the large corporate buyers purchasing 10–15 machines over the year.

The global mechanical ventilators market size was valued at USD 5.79 billion in 2021, and is expected to expand at a compound annual growth rate (CAGR) of 4.8 percent from 2022 to 2030. Critical care ventilators dominated the market with a share of over 35 percent in 2021 due to the high adoption and installation rate in hospitals. Critical care ventilators are majorly used in hospital intensive care units. A positive impact on revenue growth is expected, with an increase in the number of hospitals and healthcare facilities. The growing prevalence of target indications is expected to boost hospital admission rates as affected patients might need frequent ventilation. Transport and portable mechanical ventilators are expected to witness the fastest growth during 2022–2030 with their efficiency in a variety of applications in different care delivery settings.

Some key drivers are, the application of transport and portable ventilators ranges from home care to ambulatory centers, growth in the market for point-of-care treatment and an increase in the cases of medical emergencies are vital factors behind the segment growth. Hospitals are encouraging the usage of portable ventilators to provide convenient and faster care to patients from an ambulance to the hospital bed. Portable ventilators prompt the patients to adopt home care, hence increasing its popularity.

The non-invasive ventilation mode emerged as the largest segment and accounted for over 55-percent share in 2021. The usage of non-invasive mechanical ventilation in a wide range of applications and its ability to offer precise and higher concentrations of oxygen are key factors contributing to the segment growth. The non-invasive ventilation can be delivered using advanced intensive care ventilators that can offer various respiratory support modes.

Extensive R&D investments in the healthcare sector and growing per capita income further boost the overall market growth. Consistent increase in the number of patients suffering from respiratory diseases is the main factor for the growth of the CPAP devices market. In the non-invasive ventilation mode segment, the CPAP accounted for over 35-percent share of the overall revenue. These devices are used in emergency settings and hospitals as an oxygen source for patients suffering from respiratory issues. CPAP devices can also support oxygen provision among patients undergoing heart treatment.

The market is moving toward saturation as various manufacturers have sped up their production capacities to meet the existing demand, and there will be ample availability of ventilators post Covid-19 situation. However, as the prevalence of chronic diseases is expected to be on the rise, the demand for critical care units like ventilators will be always there in the coming years. Moreover, with technological advancements, the demand for low-cost and advanced-feature ventilators is anticipated to increase over the next few years.

Some of the major players in the global mechanical ventilators market include names like Medtronic, ResMed, Philips, Mindray, Becton, Dickinson and Company, Drägerwerk, Teleflex Incorporated, Hamilton Medical, Allied Healthcare Products Inc., Hill-Rom, HEYER Medical, and GE Healthcare.

One of the most often overlooked supply lines in the world is not for fuel, electricity, or food. It is for the healthcare industry. Medical device manufacturing is critical to a modern society where medical care is expected. As the current world continues to experience the ripples of the Covid-19 pandemic, medical device manufacturing is more critical than ever before.

Yet today, nearly two years into the Covid-19 pandemic, supply lines are faltering. Most manufacturing and supply lines operate on a thin margin, whether making raw materials, ordering them, shipping them, or using them. They order just what they need, never more.

So when a manufacturer for sterile tubing, medical gauze, wheelchair padding, or a specific electronic chip for an imaging system falters, the entire supply line grinds to a halt. Add to this the trouble with logistics and long-haul truckers quitting in droves – you have a recipe for disaster.

Medical device manufacturers face substantial challenges today and will continue to do so for months, if not years, to come.

Still, several companies also reported not being able to meet all of the demand for products because of shortages of critical supplies or hospital staffing.

Recently, ResMed has cited supply chain challenges throughout the year as shortages of chips in particular have been a concern since 2020. Competing with makers of electric vehicles and consumer electronics, ResMed has taken to pitching manufacturers on its high margins and long-term contracts as well as the importance of the chips in helping people with breathing. One temporary solution for ResMed is to redesign its devices so that they do not use semiconductors. This was done with the company’s AirSense 10 device, by removing the 3G or 4G chip, and instead letting providers upload the data from an SD card to their patient management system manually, as was done with the device’s original manufacturing design. Resmed also is working on retrieving more parts suppliers, finding new suppliers, and validating new parts. However, this process can be time consuming.

Though Philips is well into the repair-and-replace program for the millions of respiratory devices affected by last summer’s wide-ranging Class I recall, and is already plotting its recovery from the resulting financial setbacks, the company still has quite a way to go before completely digging itself out of that particular hole.

In addition to the expanded recall, Philips also cut its estimate for adjusted earnings before interest, tax, and amortization (EBITA) by almost 40 percent in the fourth quarter of 2021 to about 650 million euros (USD 739 million), as it continued to scramble for memory chips and other parts.

In Philips’ 2021 financial wrap-up, CEO Frans van Houten noted that the Dutch conglomerate is expecting to get back on track with its pre-recall plans for widespread growth by the end of this year – but not before weathering a few more storms along the way. “Based on good customer demand and our growing order book, we expect to resume our growth and margin expansion trajectory in the course of 2022. In the short term, however, we continue to see significant volatility and headwinds related to Covid-19 and supply chain challenges, despite our ongoing mitigation efforts,” van Houten said.

Other MedTech companies also called out challenges in filling orders due to supply chain issues.

Technology trends
Pradeesh CB
National Product Manager – Critical Care & Anaesthesia,
BPL Medical Technologies Pvt. Ltd.

The primary objective of mechanical ventilation was originally concentrated on restoring the patient’s breath. With time, this concept extended as other variables determining gas exchange were understood. Today, mechanical ventilators have become more sophisticated, and have expanded their application right from the intensive care unit (ICU) to the respiratory medicine ward, and even in patients’ homes for long-term treatments. This is as a result of combining the advances in the understanding of respiratory physiology, pathophysiology, and clinical management of patients, together with technological progress in mechanical, electronic, and biomedical engineering.

The evolution of ventilation technology is still swift, with innovative devices and an increased number of ventilation modes and strategies being introduced that allows to improve the patient outcomes, patient–ventilator interactions, and enhance the overall patient care. An advancement in engineering is still playing a relevant role in the development, not only in improving the technical performance of the ventilators but also in contri­buting to a better understanding of respiratory physiology and pathophysiology, and of how different ventilation strategies interact with the respiratory system.

Ventilators today come with various diagnostic features, such as weaning protocol (NIF, P0.1, RSBI, SAT, SBT), EtCO2 measure­ment, SpO2 measurement, PEEP finder mechanism, trans-pulmonary pressure measurement, intra-abdominal pressure measure­ment, endotracheal CUFF pressure management, electrical impedance, and more, along with therapeutic features, such as hybrid modes, closed-loop ventilation modes, high-flow oxygen therapy (HFOT), recruitment maneuver mechanism, volatile anesthesia in ICU ventilation in addition to high frequency oscillatory ventilation in neonate and pediatric patient categories.

Ventilators are no more just a therapy machine, but are getting intelligent with inbuilt diagnostic features. The rationale of intelligent ventilators is to improve patient management by analyzing and integrating information coming from large number of sources, and guaranteeing continuous adjustment of the ventilation even if the expert personnel are not constantly available.

Artificial intelligence techniques are able to handle large number of variables and they can be trained on large existing data sets. All these tools have been and are currently applied to implement both open-loop (decision support) systems and closed-loop systems. Closed-loop systems have the major advantage of allowing a continuous adaptation of ventilation to the patient without requiring the intervention of clinicians.

Addressing the problems in medical device manufacturing. Every manufacturer is different, but the challenges they face echo across the entire industry. As such, dramatic changes are necessary to adapt to the mid-pandemic and post-pandemic world.

Technology. Manufacturers would do well to invest in technology upgrades. These upgrades should enhance their ability to trace and handle adverse events and customer service problems and more accurately predict demands and buffer for surges.

Suppliers. The pandemic has made it clear that reliance upon one or two suppliers for critical materials is no longer viable. So whether it is a raw material, a manufactured part, or even a single logistics company, redundancy will become the name of the game to avoid these problems in the future. But, unfortunately, redundancy is not possible in some cases without other companies building new facilities, so there will be some delay before this can happen.

Hiring. Many medical device manufacturers discover that hiring new people – and the right people – helps adjust, adapt, and improve their core businesses to become more resilient to problems. In addition, hiring the right new employees helps verify compliance, bring systems up to modern standards, boost overall productivity, and breed more innovation.

Over the years, the ventilators market has evolved significantly due to technological advancements, such as developing advanced portable ventilators and improvements in the sensor technologies used in ventilators.

Technological advances in microprocessor-controlled ventilation, integrated with the complexity of new ventilator modes, have provided multidisciplinary teams in healthcare organizations with various opportunities to improve the care of critically ill patients on ventilators. Advanced ventilators are also primed for any type of exigencies and have numerous checks and balances in place. Patient-specific parameters, such as air pressure, air volume, and flow speed, and general parameters, such as air leakage, mechanical failure, power failure, battery backups, oxygen tanks, and remote control, are all equipped with sensors and monitors.

New portable life-support ventilators are lighter and smaller, providing invasive, noninvasive, and mouthpiece ventilation. The advanced ventilation technology combines responsive leak and circuit compensation and precision flow trigger controls to enable comfortable breathing and accurate therapy. In recent times, manufacturers have been developing wirelessly connected portable ventilators to have a meaningful impact on patient outcomes. By connecting to a cloud-based patient management application, the current Bluetooth-enabled devices turn medical-grade data into actionable information, delivering it directly to the mobile devices or desktops of care providers multiple times per day. This solution enables care teams to monitor patients remotely and proactively, allowing for fast and informed clinical decisions, including early intervention, which can help avoid unnecessary readmissions and lower the cost of care.

Recently, various low-cost, easy-to-assemble, portable ventilators were proposed to fight the ongoing and future pandemics. These mechanical ventilators are made from components that are generally readily available worldwide. Such components are already associated with day-to-day gadgets or items, and which do not require specialized manufacturing processes.

But many experts are against the usage of these mechanical ventilators in real-life situations, owing to poor reliability and inability of these designs to meet certain clinical requirements. Each design has its own merits and demerits.

Jeevan Lite. Indian Institute of Technology-Hyderabad (IIT-H) researchers developed a Smart IoT-based ICU ventilator, Jeevan Lite. Unlike the regular ventilators, the Jeevan Lite ventilator is portable, cost-effective, IoT-enabled, and is powered by Lithium-ion batteries. It can be operated in SIMV (synchronised intermittent mandatory ventilation) and CMV (continuous mandatory ventilation), adoption and hybrid modes of ventilation for five long hours. It can be controlled with a smartphone mobile application. While the regulator, which is being used commercially now in hospitals, costs ₹15 lakh, the Jeevan Lite is being sold at ₹4 lakh.

Dr Pankaj Garg
Senior Consultant Neonatologist,
Sir Ganga Ram Hospital

“A neonatologist today is looking at two very different situations in NICU – one the preterm neonate born in the hospital requires very little ventilator support and mostly gets on CPAP or heated humidified high-flow nasal cannula (nasal high flow) very early, and the other neonate is a term neonate born outside the hospital and is referred late and requires high-frequency oscillator or inhaled nitric oxide. We in India lack small-size surfactant delivery tubes with side port to deliver surfactant (less than size 2.5), small laryngeal mask airway (size 00), and nasal CPAP and HHFNC interfaces at reasonable cost. We are also in need of powerful standalone high-frequency oscillator and inhaled nitric oxide delivery system at affordable cost for the management of neonates with persistent pulmonary hypertension of neonates and in cardiac patients.”

SVASTA, PRANA, and VaU. The Indian Space Research Organization (Isro) has developed three types of ventilators and has come forward to transfer the technology to industry for clinical usage. SVASTA (space ventilator-aided system for trauma assistance) operates on compressed air without any electricity. It can work in different modes via varying mechanical settings alone. PRANA (programmable respiratory assistance for the needy aid) is an automated AMBU bag compressing system, which can operate in both pressure and volume-controlled modes, with precise control over I/E ratio, tidal volume, PIP, among others. VaU (ventilation assist unit) is a pneumatic state-of-the-art ventilator, equivalent to commercially available ventilators that can operate in dual mode – use air/oxygen from the hospital or use air from ambient. SVASTA is very easy to operate and has minimum electricity dependence (making it viable to use in power failure scenario) but suffers from poor control over ventilation parameters. PRANA can be easily assembled and requires only easily available, low-cost parts but require manual check-ups and replacement of AMBU resuscitator on a timely basis. VaU is the most efficient system with utmost control over ventilation parameters, but many sensors and feedback systems make it costly. The device is not yet clinically approved and validated.

Relavent. In a new paper published in Frontiers in Medical Technology, the researchers behind the Relavent ventilator (previously known as Jamvent), have demonstrated that the design achieves all of the performance requirements set out in ISO 80601, the international standard for critical care ventilators. The team also showed that the system performs equally well with a home-use oxygen concentrator as with pressurized gas supplies like those found in hospitals. The paper also sets out the designs of the prototype and details the rigorous testing required for regulatory approval. They hope that following funding and approval as a medical device, the ventilators can be used in low- and middle-income countries (LMICs) and newly emerging economies (NEEs), which suffer from an historical long-term shortage of ventilators.

The next step toward approval as a medical device will be development from the advanced prototype stage to a mass-producing medical device, which must be carried out under special regulatory conditions. To do this, they have launched a start-up, known as Phaedrus World Medical Limited alongside two experienced med-tech entrepreneurs. They are currently seeking investment to turn their designs into useable ventilators. This work was funded by Royal Academy of Engineering and Imperial College Covid-19 Response Fund.

Non-invasive bilevel pressure ventilator. Developed by a group of scientists from Spain, they presented a non-invasive, low-cost, easy-to-build portable ventilator using a high-pressure blower to push air to assist patient breathing. Along with providing control over basic ventilation parameters, such as I/E ratio, breathing rate, they also tested their prototype on 12 patients against a commercially available ventilator. They observed better patient therapy, using the proposed prototype. The low cost of this device makes it feasible to be easily assembled and used in low/middle-income countries. But this design does not provide any control to operate their device in pressure or volume-controlled modes. Moreover, it uses a high-pressure blower to push air, resulting in air heating after continuous use.

Low-cost mechanical ventilator. Another team of scientists from Spain and Brazil also developed a low-cost portable ventilator, using rack and pinion arrangement to compress AMBU resuscitators, assisting patients’ breathing. They provided precise control over the I/E ratio, oxygen delivery percentage, and volume delivered per breath. Along with this, they offered a complete description of electronics used in the device to replicate system designs for easy deployment. But this design is also unable to operate in volume-controlled mode. Also, the PEEP valve is connected far away from patient exhalation, leading to the accumulation of CO2 in air delivery pipe, leading to an inaccurate O2 delivery ratio.

Eric Noronha
General Manager,
TBS India – Bangalore

“There have been several recent developments in the field of prolonged weaning – ventilator strategies, use of protocols, early mobilization and physiotherapy, and specialized weaning units. There are few published data on discharge home rates, need of home mechanical ventilation, or long-term survival of these patients. Whether artificial nutritional support improves the outcome for these chronic critically ill patients is unclear and controversial how these data are reported on the optimal time of initiation of parenteral versus enteral nutrition. There is no consensus on time of tracheostomy or decannulation. Though several individualized, non-comparative, and non-validated decannulation protocols exist, universally accepted protocols as well as randomized controlled trials on this critical issue are lacking. End-of-life decisions should result from appropriate communication among professionals, patients and surrogates, and national legislations should give clear indications. The present medical training of clinicians and locations like traditional intensive care units do not appear enough to face the dramatic problems posed by these patients. The solutions cannot be reserved to professionals but must involve also families and all other stakeholders. Large multicentric, multinational studies on several aspects of management are needed.”

These systems are being developed in many stages. Some gaps may exist at each stage of development, including research, testing, and mass manufacturing by manufacturers. For better outcomes, common problems such as placing an exhaust valve near the patient to prevent CO2 accumulation in the air pipe, proper sterilization of air ducts after use, better control over ventilation parameters, and operation in pressure- and volume-controlled modes should be integrated into future portable ventilator designs. Furthermore, these systems must be put to test in real-world scenarios, such as hospitals, where they must run continuously for days without monitoring under high load conditions.

Complete bench-testing of these ventilators is required to provide deeper insight into the gaps in the performance of these low-cost-portable systems. Rather than the urge to make quick money, every system should follow the rules established by numerous health groups. Government agencies can also act at this point to guarantee that the automated mechanical resuscitator systems are developed using correct instruments and technique. Engineers, doctors, scientists, and even policymakers must work together to improve the design and execution of these low-cost portable mechanical ventilators in order to effectively combat current and future pandemics.

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