Refining Care

Advancements in the healthcare industry are constantly increasing to provide extra benefit and advanced services for the patients. Accordingly, the number of growing diseases and increasing awareness about health has boosted the demand for critical care devices.

The critical care devices market in emerging nations is expected to reach USD 2.61 billion by 2021 from USD 1.78 billion in 2016, growing at a CAGR of 8 percent between 2016 and 2021. On the basis of products, the critical care devices market is divided into three segments, patient monitors, ventilators, and infusion pumps. The patient monitors segment is expected to grow at the highest CAGR in the next five years, owing to the increasing patient population base and the high adoption of advanced patient-monitoring devices by large corporate hospitals and clinics in the emerging nations.

The patient monitors segment holds the largest share of the critical care devices market in emerging nations. The increased private sector investments and expansions, premium cost of devices, high replacement rates, and development of multiparameter monitors are key factors contributing to the growth of this market segment. Moreover, development of patient monitors with wireless and sensor technology and rising adoption of home-use and remote patient-monitoring devices are other factors contributing to the growth of the patient monitors market in emerging nations.

The ventilators market segment is further categorized on the basis of products into adult ventilators and neonatal/infant ventilators. Increasing geriatric population, rising number of ICU patients in India, growing use of homecare ventilation devices, and increasing prevalence of respiratory devices are key factors driving the market for adult ventilators in the emerging nations. Increasing incidence of pre-term births in emerging nations is a key factor driving the adoption of neonatal ventilators in these regions. However, shortage of ICU beds and high adoption of refurbished products are shrinking the revenue growth of this market.

The infusion pumps market, on the other hand, is driven by factors such as rising geriatric and obese population resulting in the growing prevalence of chronic diseases in India, increasing number of hospital beds, and introduction of smart infusion pumps which are propelling the growth of the infusion pumps market in emerging nations. However, high cost of infusion pumps and rising adoption of refurbished infusion pumps are the key factors restraining the growth of this market.

In 2016, the critical care devices market is estimated to be dominated by Asia. Rising demand for remote patient monitoring, high adoption rate of technologically advanced critical care devices, and increasing patient population base are contributing to the large share of the Asian critical care devices market.

The Indian market is expected to grow at the highest CAGR from 2016 to 2021. Factors such as growing government support, increasing private sector investment, growing incidence and prevalence of respiratory and chronic diseases, and developing healthcare infrastructure are propelling the growth of the Indian critical care devices market.

Geographic expansion is the primary growth strategy adopted by major players to increase their presence in the Indian critical care devices market. Moreover, strategies such as new product launches and product enhancements; partnerships, agreements, and collaborations; and acquisitions were also adopted by a significant number of market players to strengthen their product portfolios and increase their visibility in the critical care devices market.

Noninvasive Ventilation

With increased prevalence of chronic respiratory diseases such as COPD and asthma, the use of non-invasive ventilation (NIV) has increased significantly in the subacute and home care ventilator markets. Furthermore, NIV has now proved highly beneficial in the critical care segment.

Major trends prevailing in the industry are clear preference for Opt flow over full face mask therapy, gaining popularity of full face mask, and competitive bidding system for CPAP supply.

In many hospitals NIV is now considered as a standard of care, with invasive ventilation only being used if a patient is not compliant. NIV offers many advantages to the patient: they are able to speak and swallow, there is a decreased risk of infection in comparison to tracheotomy ventilation, and there is a reduced requirement for sedation and as a result there is increased probability that the patient will be discharged from the hospital sooner. In developed markets there is an increased focus to reduce the burden of high-cost intensive care unit (ICU) departments on healthcare expenditure, with patients being moved out of the hospital sooner. A patient who is ventilated through a noninvasive device is able to move out of the ICU and into the home more quickly.

In the last decade, the potential indications for NIV in critically ill patients have grown considerably, and the performance of this mode of support has greatly improved. In children developing acute respiratory distress syndrome (ARDS), NIV can be considered as a first line of treatment in milder disease. Despite the lack of clear guidelines, this mode of support definitely has its place in the treatment of a wide range of pathologies in children, including pneumonia, upper airway obstruction, post-extubation respiratory failure, acute chest syndrome, and asthma.

The use of NIV has recently evolved because of the emergence of high-flow nasal cannula (HFNC). This modality is now available from a number of manufacturers and has been widely adopted in pediatric practice. Different mechanisms have been hypothesized to account for the clinical benefits, including washout of the nasopharyngeal dead space, reduction of work of breathing, decrease in airway resistance, and improvement of pulmonary compliance. HFNC has been able to provide a mean pharyngeal pressure of 4 cmH2O when used at a flow of 2 L/kg/min, but this effect is variable. In clinical use, HFNC allows improvement of comfort and tolerance to NIV and reduction of air leak, gastric distension, and skin injuries, especially in younger children. The role of HFNC outside the PICU still needs to be investigated. It is believed that within a few years, the role of HFNC will be better defined and potentially widened.

To improve the success rate of NIV, the achievement of an adequate patient–ventilator synchrony is crucial. Although the performance of ventilators has improved in the last few years, patient–ventilator asynchrony in NIV remains a significant issue. As with invasive ventilation, tools to improve patient–ventilator synchrony during NIV have been recently investigated. Electrical activity of diaphragm monitoring and noninvasive NAVA are feasible and well-tolerated in PICU patients with patient–ventilator synchrony improvement. Monitoring esogastric pressure offers another way to improve patient–ventilator interaction during NIV.

Patient Monitors

Healthcare around the world is under increasing pressure with many healthcare providers now recognizing the urgent need for a wider system transformation. Vast sums spent dealing with patient safety issues are wasted, unnecessary, and unsustainable. Monitoring patients better to know their status at all times is one of the few proven actions that can be taken to address this crisis. The focus needs to shift to one that actively promotes good health practices, enables providers to move from reactive to proactive delivery, and move the burden of acute care from the hospital to the home.

Today we enter into a new era where, thanks to wearable or implantable sensors, patient monitoring will become possible from home. It will create as many opportunities as it raises questions: who should regulate the use of these new products and software applications; what and where is the frontier between medical and consumer products; can the patient trust the measurements; what should be monitored and in whom; who is going to receive, interpret, and protect the information; what is the impact on patient care; and who is going to pay for this?

Interoperability is the key to a range of ongoing and potential improvements in our healthcare system. Electronic health records (EHRs) is just the beginning. The goal is for doctors, nurses, patients, family members, researchers, and insurers to share useful medical data. This holistic approach could create communities of healthcare awareness to provide patient with knowledge, support, and the feeling that they are not alone.

Besides its safety advantages, connectivity opens the door to data integration. Integration of all monitored variables together with the patient’s history and laboratory tests coming from electronic medical record (EMR) system opens the doors to the development of smart systems (artificial intelligence) able to suggest a diagnosis or a treatment, and even to deliver therapy. Connectivity and data integration may allow the development of controllers able to process multiple parameters at the same time and guide or unload clinicians in more complex clinical situations.

Data integration is also the cornerstone of predictive analytics. Algorithms have been developed to predict cardiorespiratory deterioration. In this regard, predictive analytics may be useful to trigger the intervention of a rapid response team (RRT) and accelerate ICU admission (for patients in the ward or the emergency department) or to postpone ICU discharge for patients who are about to leave the unit. Although a very exciting and promising research field, one has to acknowledge that these systems will never be able to predict the unpredictable, that is, external interventions or accidents, which are often the cause for changes in hemodynamic status and patient outcome.

Infusion Pumps

Infusion pumps can have a potent impact on patients’ lives, and new technologies are leading to some exciting advances for these devices. For some patients, small pumps that provide instantaneous monitoring and medication can eliminate the need for manual injections.

Design engineers understand that disposable infusion pumps must remain simple to use and cost-effective, but infusion pump functionality is becoming more complex as the devices evolve. Perhaps the most important advancement is around safety, which involves developing lower friction piston seals, higher wear strengths, and longer life mechanisms. There is also a need for smaller pumps that are easier to wear, providing diabetic patients with fewer limitations in terms of travel and activity. Several market leaders are working on small insulin pumps that provide instantaneous monitoring and medication, which could make manual syringe needles obsolete in the next few years.

According to the American Diabetes Association, in addition to eliminating injections, insulin pumps deliver more accurate dosing. This can improve A1C levels (blood sugar levels), decrease large blood-glucose swings, reduce low blood-glucose episodes, more efficiently deliver boluses, and allow diabetics to exercise without first having to eat large amounts of carbohydrates.

Newer pumps do not require tubing. The insulin-delivery device is placed directly on the skin, and adjustments are made through a small device that works within a six-foot range of the insulin delivery device. Patients can carry the device in a pocket or purse when traveling and keep it nearby when at home or work.

One of the most exciting pump technology advances is the ability to use pumps in tandem with glucose-sensing technology (known as an artificial pancreas) that administers insulin based on actual glucose levels as determined by the glucose sensor. Insulin delivery is halted once a pre-programmed glucose level threshold is met.

The most urgent engineering need at the moment is improving the piston seal used in insulin pumps. Specifically, these pumps need seals that have a long life and provide a strong seal with a very low friction rate. A certain amount of friction is necessary but if it becomes too much, malfunctions can occur.

Preventing occlusions in the line delivering medication is another critical consideration. To ensure strong alignment and to keep the device centered and concentric, most insulin pumps use either a dual seal such as an O-ring or multiple-lobe seals. Since insulin pumps tend to be small and intricate with many moving parts, this is especially important.

The material compound to be used in the seal is the first of three important decisions. There are thousands of potential polymeric compounds to consider, including silicone, PTFE (polytetrafluoroethylene), and EPDM (ethylene propylene diene monomer). Zeroing in on the best compound is a matter of considering its ability to be sterilized, availability, leachability, extractability, along with applicable regulatory requirements. Infusion pump manufacturers will want to work with a supplier that has the ability to completely understand how the seal must function within the device, the manufacturing requirements, and the regulatory environment.

In some cases, it may be advantageous to add a coating to the seal to reduce friction, increase the life of the seal, and/or add antimicrobial properties. However, the coating should be tested rigorously to make sure it will not have a negative impact as part of the solution. It is important to look at the release properties, temperature performance, abrasion resistance, and product integrity.

The third consideration in improving insulin pumps is the geometry of the seal, which determines its degree of force, the coefficient of friction, and hydrodynamic qualities. It is critical that the seal remains in line with the required gradient (measurement) of dosage. Equally important is to consider how the needle will be voided after use and whether or not one or several lay downs on the bore of the syringe will be needed (this is determined by the motor’s mechanical force to move the plunger).

With more patients adopting wearable devices, there is a much higher demand for small pumps that are less visible under clothing. These slim devices are even moving toward being controlled through gadgets the patient already carries, such as a smartphone, smart watch, or fitness tracker (e.g., Fitbit).

The result is a trend away from round reservoirs toward the oval or rectangular reservoirs used in slimmer devices. These new reservoir shapes create an unequal distribution of forces that seals must compensate for. Combined with a need for compatibility with the body as well as the medicine being delivered, the challenge level is high for seal manufacturers. Essentially, each pump requires a custom-designed seal that precisely fits the needs of the design, taking into consideration strength, reservoir geometry, and material compatibility.

The trend toward home-based healthcare will hasten the pace of innovation, shining light on the need to manufacture defect-free infusion pumps. Infusion pumps are expected to be used more extensively for chronic disease treatment, clinical nutrition, cancer treatments, and anesthesia.

Manufacturers will be looking to partner with suppliers familiar with new, more effective compounds and the latest engineering techniques to help them develop these much-needed devices and bring them to market as quickly as possible.

Way Forward

In India, each year about five million patients are admitted to the ICU wards. Giving additional skill sets to the intensivists with proper training has been the biggest obstacle in this over-populated country. In line with that growing need, the critical care market in India still remains an evolving department. Quality and healthcare costs are becoming day-to-day issues. The future will see an increasing use of protocols, virtual consultations, and regionalized care for more complex and common diseases such as trauma and acute lung injury. Intensivists will be skeptical due to difficulties in demonstrating benefits of any new drug, ventilator, monitor, or laboratory test, when added to basic, life-saving treatments. Computers will have an increasing presence in critical care, now eased by a user group that is increasingly adept at using them. However, ICUs will still rely on human resource, making the myth of a fully- automated ICU bed unlikely.