Imports Continue to Reign Supreme

The Indian ventilators market in 2018 is estimated at 9250 units, valued at Rs 487 crore. The imported equipment continues to dominate the segment with a 79 percent share by value, and a 64 percent share by units

Automation, ease-of-use, and enhanced safety features are reshaping ventilator technology as respiratory departments fight alarm fatigue and healthcare-associated infections like ventilator-associated pneumonia. Technology is evolving, protocols are becoming more stringent, and technicians are becoming more educated on how to utilize and care for the equipment. Engineering is still playing a relevant role in this process, 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.

The changing technology, market dynamics, and disease patterns have all contributed to the metamorphosis of ventilators. The stringent regulatory and statutory compliance requirements have also catalyzed the innovation trend of ventilators. Medical devices market drivers, such as deep miniaturization, enhanced portability, low power requirements, and enhanced clinical workflow have made significant advancements in modern ventilator designs. Since the needs of the emerging markets are different from that of developed markets, different strategies and system-engineering paradigms need to be applied.

The challenge for future research in the area of ventilator technology is to generate controlled clinical studies to support its application. With the impact of financial constraints on healthcare, research will also need to examine the economic issues related to the application of newer modes of mechanical ventilation. Integrating the vital signs monitoring with ventilation in conjunction with other assessment parameters may prove to be useful tools to measure the impact of interventions, such as suctioning, positioning, muscle reconditioning, weaning techniques, and comfort measures on mechanically ventilated patients.

Indian market
The Indian ventilators market in 2018 is estimated at 9250 units, valued at Rs 487 crore. The imported equipment continues to dominate the segment with a 79 percent share by value, and a 63.8 percent share by units. The imported segment saw an 18 percent increase over 2017 and the indigenous segment by about 15 percent. The transport and ambulatory segment, in spite of the directive that every ambulance must be equipped with a ventilator saw a marginal increase in 2018. The refurbished segment defies global trends and continues to have relevance in the Indian market. The vendors maintain that as long as they are able to guarantee availability of spare parts, service within 24 hours, and maintain goodwill with their customers, including large hospitals, this segment shall thrive. The popular brands are Maquet, Draeger, GE, Carefusion, and Belavista, the latter two now under the Vyaire umbrella. The compressor models are more popular as the reliability of a turbine-based refurbished model is in question.

Maquet continues to dominate the segment with its top-of-the-line models. Draeger is a close second, having had major success with its Savina series in the bids invited by the government hospitals in 2018, one of the large orders being 150 units by state of Gujarat. It continues to do well in 2019.

GE, Schiller, and Hamilton remain aggressive with a market share in the vicinity of 5 percent each, by value. Hamilton seems to have been shortlisted for a tender invited by the government for 1186 units; orders are expected to be placed in 2019. Mindray has a pan-India presence and is making steady progress. Its exclusive tie up with Narayana Hridyulaya for about 65 systems annually is encouraging. Vyiare, having completed its merger with Carefusion and Acutronic, is expected to have an aggressive presence in 2019.

Global market
The global mechanical ventilators market is poised to reach USD 7.13 billion by 2026 from USD 859.9 million in 2018, registering a CAGR of 6.6 percent, estimates ResearchAndMarkets. Growing geriatric population and technological innovations in respiratory care devices are the major factors driving the market. Moreover, increasing incidence of chronic obstructive pulmonary disease (COPD) and respiratory emergencies is contributing to market expansion. On the other hand, budgetary constraints faced by ventilator manufacturers and healthcare may impede this growth.

However, innovations in the field of positive airway pressure (PAP) devices and improvement in battery life of transport and portable devices are projected to have a positive impact on the mechanical ventilators’ market growth. According to the estimates by the WHO, currently, approximately 90 percent of COPD deaths occur in low- and middle-income countries. Therefore, rise in prevalence of such diseases along with the introduction and availability of portable, cost-effective, and easy-to-use products for the treatment of respiratory conditions is expected to drive the market in the years to come.

Key trends

• Critical care ventilators are expected to account for over 39 percent of the overall market share by 2026 owing to the technological advancements, such as spontaneous breathing trial (SBT) and AutoTrak.
• Transport and portable-products segment is expected to record the highest CAGR of 7.24 percent in the period 2019–2026. These devices are widely used in hospitals as they provide faster and continuous care to patients even prior to their arrival in the hospital premises.
• North America is the dominant regional market, in terms of revenue, owing to growing geriatric population, which is leading to a corresponding rise in the incidences of respiratory disorders
• Asia-Pacific and Latin America are expected to witness lucrative growth over the forecast period due to the presence of untapped opportunities, rising expenditure levels, and favorable government initiatives

Some of the key companies in the market include Dräger Medical, GE Healthcare, Koninklijke Philips N.V., Teleflex, ResMed, Vyaire Medical, and Smiths Medical. These companies focus on product development to improve their global presence and ensure sustainability.

Vendor update
In April 2019, Dräger received FDA 510(k) clearance for Savina 300 SW 5.0, the latest in its line of Savina ventilators. The system offers advanced features such as automatic tube compensation (ATC) to aid clinicians in their daily workflow, and improve patient comfort by reducing artificial airway resistance.

In September 2018, Royal Philips unveiled its newest connected solution, Trilogy Evo, portable life-support ventilator platform designed to stay with patients to provide consistent therapy and monitoring as they change care environments and when their condition changes. Also, in November 2018, the company has received CE mark approval for its V60 Plus ventilator. This comprehensive solution expands on Philips’ noninvasive ventilation (NIV) gold-standard platform, integrating both NIV and high-flow therapy (HFT) in a single device.

In August 2018, ResMed released key upgrades to its Astral life support ventilators, including optional AutoEPAP (automatic expiratory positive airway pressure) in iVAPS for US patients. AutoEPAP is now available in the United States, and is already in use in other markets. It is an option in Astral’s iVAPS (intelligent volume-assured pressure support) mode that automatically adapts to a patient’s changing pressure needs as their respiratory disease progresses.

In June 2018, Vyaire Medical Inc. signed an agreement to acquire the ventilator business and the imtmedical brand name. A second business unit that includes test lungs will remain with the Switzerland-based IMT Analytics. The company will continue to operate from their current location in Buchs, Switzerland, which also applies to imtmedical ag under Vyaire in the coming years.

In April 2018, Acutronic Group, a group of non-affiliated companies active in neonatal ventilation, has been acquired by Vyaire Medical Inc. The group’s portfolio includes the fabian ventilator platform, the monsoon jet ventilator, the florian monitor and complimentary airway management devices and software solutions.

Technology trends
The need to introduce cost-effective, high-frequency ventilators has become essential as more patients are in need of comfortable critical care, and invasive respiratory assistance is not being favored anymore. The computer-based technology has equipped clinicians with CPAP systems and heated, humidified, high-flow nasal cannula (HFNC), which provides gentle ventilation to the patients. Modern-day mechanical ventilators enhance work process of clinicians and boost equipment productivity to help drive prior medication in respiratory distress. Clinicians can quickly alter treatments around continually changing patient conditions without exchanging devices.

There is an increasing preference for early noninvasive ventilation (NIV), coupled with high-flow oxygen therapy (HFOT), which reduces the days spent in the hospitals on invasive ventilation without affecting intensive care unit (ICU) length of stay. HFNC has seeped into the household environment. In hospitals, it has become a highly preferred method for including NIV in mechanical ventilators. Warmed, humidified gases do not lead to drying of the mucosa standard oxygen therapy. This may lead to higher compliance with HFNC and perhaps an improvement in patient’s oxygenation and work of breathing. Aside from being the cost-effective, implementable technique, it allows the clinicians to prevent situations which often prove to be time-consuming and life-threatening and reduce patient mortality rate, particularly in hypoxemic patients, and neonatal and pediatric conditions. Intended for early mediation in respiratory stress, this empowers clinicians to additionally upgrade results with less obtrusive respiratory stress treatments, thus enabling clinicians to further enhance patient outcomes with less invasive respiratory care therapies while improving clinician’s workflow and maximizing equipment investments to enhance the patient–ventilator interactions and patient care.

Advancement in mechanical ventilators goes for providing improved services, settling on better choices, and improving patient’s comfort alongside blending of pathophysiology, medicine, and engineering to enhancing the quality of medical care in respiratory distresses. However, it remains to be seen how the rising cost of intensive care and several patients in need of portable ventilators will roll out with rapidly advancing ventilator technology.

ICU data integration is the main challenge in developing effective tools for data analysis. Comprehensive intensive care would not be complete without including physiologic, hemodynamic, and demographic variables to develop a CDSS to foresee the in-hospital mortality. Training the clinicians to the point of expertise must
be the priority in the development of data-driven analytic models to drive the ventilator market toward growth.

The complexity of mechanical ventilation and of ventilators causes more than one headache to healthcare professionals. In the face of this conundrum, automation of ventilation settings could yield a solution. Closed-loop systems have been classified into simple, physiological signal-based and explicit computerized protocols or ECP. ECP systems use multiple inputs to control one or several ventilator outputs. Some examples of automation of mechanical ventilation are adaptive support ventilation (ASV; which titrates ventilator output on a breath-to-breath basis providing a preset level of minute ventilation while minimising work of breathing); intellivent ASV (an extension of ASV, including automated selection of FiO2 and PEEP); and SmartCarePS (control of pressure support level based on the patient’s respiratory characteristics). Other examples available on the market (although not totally automated) are proportional assisted ventilation plus (PAV+) and NAVA.

Likewise, patient–ventilator interaction still represents a challenge for most healthcare professionals. Asynchronies cause discomfort, increase dyspnoea, may induce lung injury, and prolong ventilator use. Current knowledge on asynchronies mainly comes from small physiologic or observational studies, and precise information, such as epidemiology, assessment, and management, is lacking. New technologies may help doctors in their management (predicting and preventing them), but there is still a long way to go.

Outlook
The use of artificial intelligence (AI) in healthcare is receiving increasing interest, driven by a surge in scientific research and funding. In AI, data is fed into the computers, which detect and implement the rules, and continuously assess the information to re-calibrate, if needed. AI could reduce the inter-clinician variability and offer other benefits, as search of complex relationships in the vast quantity of data, analyze variables to predict outcomes of interest, and develop additional models that could aid healthcare professionals in extracting useful information for clinical decision making.

Some of the ongoing examples of research in AI include neural networks for breathing-pattern recognition – machine learning algorithms that have the ability to learn input and output relationships from sets of data, being able to detect asynchronies and wean patients; decision tree classification, such as the Aegle project, for predicting risk of certain events using logistic-regression models that recognize patterns of data, which are then used as inputs for a machine learning-based patient-specific algorithm to evaluate the risk of a specific event or outcome; and development of smart alerts via machine-learning methods to avoid ever-growing evidence of alarm fatigue.

AI-based systems could help nowadays when microprocessors can execute actions as fast as it is needed to make a decision in real time. That means that software could be added to medical equipment in order to help in situations where the user does not have the time or knowledge to make a good decision

As an example, one could have software that would help a doctor to understand how the respiratory mechanics of a patient is, or to receive recommendations from the ventilator to set it according to the patient’s needs. Unfortunately even the fact that today industry has the technology to move forward to use AI, most of the regulatory agencies (FDA in US, Cofepris in Colombia, or ANVISA in Brazil) do not have the structure to analyze if an application would improve the current state of ventilated patients at the ICU.

Without any doubt changes are required not only in the medical devices industry and regulatory structure but also in the market. The market has tools using AI for several medical tasks, but is not prepared to accept this new technology.

Industry Speak

Industry Speak

Industry Speak

A Ventilator Cannot Stand Alone in a Digital ICU

Manju Goyal
National Business Manager – Life support,
Mindray Medical

When we think about ventilator from a buyer’s perspective, we often think of various aspects like ventilation modes, special features, running cost, and the most important aspect, i.e., safety of the patient. We think these are most influencing factors for ventilator purchase. Without any doubt these are most critical when the treating doctor is in front of a ventilator and can access ventilator settings and monitored data. But when he is not in front of the ventilator, what is most important for him is the accessibility of the ventilator’s data so that he can remain connected with his patient.

Let us try to check the relevance of this idea from a different angle; when we talk about critical care, the medical industry accepts that data accessibility from a patient’s monitor is very critical and this data needs to be monitored for at least 18 hours a day. To make this happen, a number of simple ways are available for the doctor to access the patient’s data from anywhere. It is very nice to see that many companies have addressed this need of data connection pretty well. But from a clinician’s point of view, hemodynamic parameters shown on the patient’s monitor are outcome of many other devices, which include the ventilator and volumetric pumps. So from his perspective, patient’s information being presented to him is not complete until he gets ventilator data so that he can relate hemodynamic changes with ventilator settings.

This concept is very powerful and the degree of impact depends on the ICU setup, which includes clinicians and trained staff availability in the ICU. This tool also shows its impact in war-room concept where an expert monitors peripheral hospital every minute – there ventilator data is an absolute necessity so that he can help and guide the clinician team on site very well without losing time and information. The concept of e–ICU also demands the ventilator data to be captured.

As most ventilators have limited memory, so it is painful to trace some specific case via non-electronic media; in such cases, solutions such as saving and reviewing data on patient monitor central station is the easiest and the most economical way to be chosen for a hospital.

The way IT is expanding its wings in healthcare, it looks like new-generation ventilators are ready to play their part well, and they are no more to be considered as a standalone device.

Technological Advancements and Emerging Trends in Ventilators

Moulyashree SC
Design Engineer, D&D (RMS),
Skanray Technologies Pvt. Ltd.

Ventilator is a device which is used to assist people in breathing when they are unable to do so themselves. Ventilator gas flows into the lung based on trans-respiratory pressure. There are two ways of accomplishing it.

A negative-pressure ventilator generates a negative pressure at the body surface that is transmitted to the pleural space and then to alveoli. As a result, a pressure gradient develops between the airway opening and the alveoli, and air flows into the lungs, eg, Iron Lung. With positive-pressure ventilators, gas flows into the lung because the ventilator establishes a pressure gradient generating a positive pressure at the airway opening. The volume delivered depends on the pressure difference between the alveolus and the pleural space based on lung and chest wall compliance.

Modes of mechanical ventilation have shown a steady evolution over the last four decades. They have increased in complexity as engineers attempt to add technical capabilities that better serve clinical goals. The modes are combinations of volume-controlled, pressure-controlled and pressure-support breaths, mandatory/assisted breaths, and invasive and non- invasive supports.

Currently, the work on lung-protective tools and open-lung ventilation strategy to prevent alveolar collapse and maintain optimal recruitment are gaining high importance. Manufacturers are coming out with proprietary modes that target on work of breathing, amplify the patient’s ventilatory effort, thus giving freedom to adopt his own breathing pattern, which helps in quick weaning from the ventilator. Ventilator graphics constitute a valuable tool and provide thorough understanding of the associated problems, patterns, and possible corrections to provide high-quality care.

Future ventilators will have smart algorithms that will project the trend and estimated weaning time, based on patient history. More intelligence will be built into the alarm-management system, which not only ensures safety but is also capable of warning about potential hazard. Remote monitoring of critical parameters will help to ease the work of doctors as well as service personnel. Technological advancements will reduce the footprint of ventilators while enhancing the features with advanced blowers and smart batteries that can really work for long hours, independent of pneumatic and electrical source.

Aerosol drug delivery system

Kamal Kishore
Business Manager,
Aerogen India Ltd.

By definition aerosol is a suspension of fine particles of solid or liquid droplets either in air or in some other gas. Common types of aerosols found naturally around us are dust, fume, smoke, and fog. Aerosols can be natural or anthropogenic.

In the healthcare segment, drug aerosols are used very frequently to treat lung diseases. It is becoming standard of care for delivering antibiotics, nanotherapeutics, broncho-dialators, insulin, pain management, and even cancer therapy.

With increasing environmental pollution, especially in big cities, the incidence of chronic respiratory disease are on the rise. Recent studies point out that more than 90 percent deaths due to chronic obstructive pulmonary disease (COPD) happen in low- and middle-income countries. Amongst the non-communicable diseases, COPD is the second-biggest cause of death. In India as well we have seen rapid increase of COPD in the last few years. COPD needs to be treated as per the evidence-based protocol, and also managing comorbidities to minimize mortality rate.

The demand for nebulizers has increased manifold because of rapid increase in COPD and other chronic respiratory disorders. The nebulizer segment is expected to increase at the rate of 25.8 percent CAGR in 2015–2023, to reach an estimated market size of USD 68 million by 2023.

Common nebulized delivery devices are low-volume nebulizers, metered-dose inhalers, and dry-powder inhalers. However, being non-directional, these have low particle-deposition efficiencies in nasal or lung regions. Thus there is a requirement for high-performing aerosol drug-delivery system to provide targeted treatment to pre-determined sites in the respiratory system.

The working methodology of traditional small-volume pneumatic nebulizers and pressurized metered-dose inhalers is based on old technology with great limitations.

Vibration mesh technology (VMT)/vibronic-based drug-delivery system (DDS), has emerged as a high-performance drug-delivery system to specific sites, providing an optimal combination of particle characteristics, inhalation waveform, particle release position, and drug-aerosol dosage

Aerogen is the sole producer of VMT/DDS, which can be used for all recommended drugs, with wide application range. The technology also avoids any type of drug decomposition due to heat while aerosolization, and hence does not reduce the medicinal property of the drug while in use. Also such DDS does not affect tidal-volume delivery while being used with mechanical ventilator – hence even suitable for pediatric and neonatal use. This ensures smaller dose of drug and no drug wastage, especially while using on neonatal patients. There is flexibility for use in different connecting sites like Y-piece, dry side of humidifier, inspiratory limb of ventilatory Ckt, with NIV mask, HFNC, with ultra for spontaneous breathing patient, and more. It can deliver six times more medication with specific ultra-combination and four times more medication in non-invasive ventilation, thereby improving the patient response to treatment very fast.

There are a few key facts about vibrating mesh drug-delivery system:

• Reduction in the hospital admission rate by 32 percent.
• 85 percent patients achieve symptom control with one 2.5 mg Salbutamol dose.
• 75 percent lower drug use while nebulization.
• 30 percent higher discharge rate from hospital.