The Indian healthcare industry faces many challenges and will perhaps continue to do so. But whatever the challenge, MedTech provides the solution, delivering life-changing innovations to patients at great value.
The Indian MedTech industry has entered a phase of moderate growth. Having increased by 15 percent for so many years, it is now expected that it â€¨may come down to a CAGR of 7-8 percent. Currently valued at Rs.22,400 crore, the market is expected to grow to Rs.23,680 crore by 2016 and to Rs.30,080 crore by 2019, estimates BMI Research. The increasing focus of government with Make in India, Digital India, National Health Mission, and other such initiatives is reflective by its intent to boost the sector capabilities and develop the manufacturing prowess of the nation to be able to serve a large section of global population. Given its inherent strength, the sector has the potential to drive economic growth in the coming decades.
With the presence of a growth-oriented market with huge potential, the Indian Medtech industry is replete with challenges, like inadequate quality standards, archaic regulatory standards, high import dependency, unfavorable duty structure for imports and exports, lack of tax incentives, meagre government funding to promote innovation, high capital cost, and approval delays. However, the government at the center has shown promise and it is likely that a new law shall be passed that will overhaul the regulatory framework applicable to medical devices.
Despite India's unique market dynamics and challenges, there are strategies that MedTech manufacturers can utilize to capture and maximize on the market share. Partnering with indigenous manufacturers, understanding local market dynamics, identifying target patient population and HCPs, strategically pricing products, conducting campaigns to increase awareness of disease conditions and treatment options available, adopting technology and climbing the maturity curve in marketing; identifying clinical needs, understanding local patients population requirements, not just selling products but also finding ways to add value to all stakeholders involved; and pushing for regulatory and tax changes are some of them. In order to maximize the full potential of Indian MedTech market, manufacturers are recommended to adopt these strategies, or at least some of them, so that it opens up the market to be the multi-billion dollar opportunity often discussed.
Worldwide Healthcare Predictions
On the global scenario, IDC's latest healthcare IT predictions report illustrates that digital transformation is beyond technology and impacts data, people, processes, and strategy. These predictions highlight the multitude of transformational innovations that will help to get much-needed efficiencies through proactive personalized care, intelligence-driven protocols, machine-to-machine learning, and scaling to deliver care outside provider settings.
Healthcare is beginning to harness and integrate previously untapped intelligence. There will soon be a tsunami of medical innovation driven by distilling intelligence from mass digitized PHI and the pressure for providers to deliver, and get paid on quality outcomes. Improving patient care and creating better quality of life is what it is all about and for IT to be such an integral part of this evolution is what makes it such an exciting, albeit stressful, time to be in the healthcare IT.
Technology is an ever-changing paradigm, but some issues simply keep rising to the top. The mobile revolution continues, and patient's involvement and engagement in their own healthcare is on the rise. It is becoming imperative to improve not only the patient's but also the caregiver's experience.
The major technology trends that will continue to directly affect the MedTech industry in 2016 and beyond could be listed as:
Anesthesia machines. Anesthesia equipment has evolved over the years from basic pneumatic devices to highly sophisticated computer systems. Both technological advancements and the increase in the number of surgical procedures requiring anesthesia have created demand in the anesthesia equipment market. The demand for anesthesia equipment and peripherals is rising as a result of the spiraling number of surgical procedures being performed. In the saturated anesthesia equipment segment, the focus is on developing high-quality, cost-effective products. In the consumables segment, the trend is currently favoring disposable over reusable equivalents. There has been a strong demand for reliable and easy-to-use products that can flexibly adjust to any upgrades.
The anesthesia system of the future will have an additional advantage that it would enable automated correction of physiological abnormalities simultaneously, pharmacokinetic-based anesthesia infusion pumps with DOA monitoring, or newer ventilators that can automatically adjust the ventilator settings by monitoring lung mechanics. These new monitoring techniques can potentially reduce the element of human error.
BP monitors. Hypertension is rapidly becoming a worrisome public health issue worldwide. The rising prevalence of high blood pressure in adults represents a major economic and social burden in both developed and developing countries. By 2025, the number of hypertension cases globally is projected to rise to 1.5 billion, equating to approximately 30 percent of the total adult population. About 75 percent of these patients are forecast to come from the developing countries. Major lifestyle factors aggravating the prevalence of high blood pressure include unhealthy lifestyles, lack of outdoor exercise, excessive alcohol consumption, obesity, rise in stress levels, and diets high in sodium and low in proteins and essential minerals. Other risk factors for developing hypertension include age, genetic predisposition, and preexisting health conditions like cardiovascular diseases and kidney diseases.
mHealth is the new technological breakthrough in the healthcare market, where ubiquitous mobile technology supports the growth and successful implementation of mobile technology in the healthcare industry. Prevention and early detection are the important factors for regular monitoring. Hence, mobile and portable devices would help the patient population to monitor their parameters. Devices when connected wirelessly would automatically transmit the required data of the patients to healthcare professionals. Another significant trend is disposable transducers rapidly replacing reusable transducers because of their lower costs as well as ease-of-use. New and innovative features are being integrated to lure customers, particularly in the upper-arm monitors where the size is not a key factor during designing.
The vendors are adopting various growth strategies for expanding their product portfolios and coming up with new innovative products. BP monitoring equipment manufacturers are collaborating with technology-based companies to emerge with innovative devices that would aid healthcare professionals to remotely monitor BP levels of the patient on a regular basis.
Cath labs. Angiographic imaging system vendors have developed new technologies to address emerging cath lab trends, including the need to reduce radiation dose, improve image quality, and enable advanced procedural image guidance. All three of these points have become increasingly important as more complex procedures are attempted in interventional cath labs and hybrid ORs. These procedures include transcatheter aortic valve replacement (TAVR), MitraClip repairs, left atrial appendage (LAA) occlusion, atrial and ventricular septal defect closure, and new interventions for electrophysiology (EP), and heart failure.
Newer angiography imaging systems enable advanced 3-D imaging with rotational angiography, which uses a quick spin around the patient to create a computed tomography (CT)-like 3-D image of the anatomy. This can all be done tableside in the cath lab. Some systems allow these images or CT or magnetic resonance imaging (MRI) 3-D images to be overlaid or fused with the live 2-D fluoroscopic images. This fusion technology is used with TAVR planning and navigation software to better guide device placement. Software also allows 3-D images to be integrated with EP electromapping systems to guide catheter ablation procedures without the need for live fluoro, helping reduce dose. With coming of newer technologies, the market for cath lab is set for a giant leap. The next generation of advances will improve operator performance, enable more complex procedures, change the reimbursement system, improve patient and operator safety, and expand the use of minimally invasive cardiovascular procedures into new areas that were previously only the domain of surgeons.
CT scanners. CT has evolved from a research tool to an important diagnostic investigating tool. Several improvements in technology with growing detection-efficiency and faster response have led to the current configuration of modern ultra-fast, low-dose, whole-body CT scanners. The complex detector is also getting miniaturized, improving signal quality at lower radiation level. Such developments have brought great advantages in the clinical settings in terms of image quality, dose effectiveness, imaging throughput, and also extending considerably the field of clinical application.
Even though technology will develop further, the trade-off between image quality and dose will remain, with any technical improvements likely to be mainly used to reduce patient exposures rather than increase image quality. In the near future, CT using protons to document the location, direction, and energy loss from a proton beam as it passes through the human body, could be used to produce a 3-D image of the body that assists in the diagnosis and treatment of a range of diseases. It might offer a number of benefits for patients, but perhaps the most notable could be the active focus on developing CT technologies that use low-dose radiation.
ECG equipment. ECG has been used as a basic cardiac diagnostic for a century and while the premise remains the same, testing systems are evolving to meet today's technology demands. There has been a trend over the past decade toward smaller, more compact, mobile ECG monitoring systems. These can be used either inside a hospital or clinic, or on the road with a visiting nurse, or on a cart for mobility between patient rooms. Another innovation offered by several vendors includes small box systems that connect via a USB to convert a standard PC or tablet computer into a resting ECG system.
While the traditional 12-lead ECG system will remain the mainstay in cardiac diagnostics in the clinical or hospital setting, the future of cardiac assessment may shift to patients triaging themselves before requiring analysis by these more complex systems. There is a trend in the Holter monitoring and consumer markets toward inexpensive wearable or smartphone-based ECG monitors. Unlike traditional Holter and cardiac event recorders, the new generations of devices are inexpensive or even disposable, and are much easier to use - with the elimination of electrode wires, devices are simply stuck on the patient's chest. Some new devices interface with cell phones to eliminate the need for an external base station hardwired in the patient's home.
MRI equipment. A new way of using MRI scanners to look for evidence of multiple sclerosis (MS) in the brain has been successfully tested by researchers at the University of Nottingham and Nottingham University Hospitals NHS Trust. Research team at Nottingham has found a way to use clinical MRI to distinguish between MS lesions and other brain white spots, which are found in MS. They have used a clinical MRI scanner of the type all neuroscience centers have to carry out a special type of scan called a T2-weighted imaging process, which is able to reveal lesions in the brain's white matter that are centered on a vein, a known indicator of MS. A total of 40 patients were recruited from the neurology outpatient department of Nottingham University Hospitals NHS Trust. Within the test cohort, all patients with MS had central veins in more than 45 percent of brain lesions, while the rest had central veins visible in less than â€¨45 percent of lesions. Then, by applying the same diagnostic rules to the second cohort, all the remaining patients were correctly categorized into MS or non-MS, by the blinded observer, taking less than two minutes per scan.
The next decade will witness further sophistication of these techniques and with data available from larger studies, it is expected that imaging will continue to provide new and unique insights in neurology and neurosurgery, which should hopefully contribute to better management of patients with diseases of the central nervous system.
Oxygen concentrators. The most recent offerings in oxygen delivery products are continuing the industry's emphasis on smaller, lighter, and more reliable technology. Some devices even offer features that have never been seen before, such as the market's first fully integrated stationary and portable oxygen concentrator (POC) system. Together, manufacturers are providing patients with more options and more freedom to integrate oxygen therapy into their lives, a fact that improves compliance, outcomes, and quality of life.
Future oxygen technologies will continue to be focused on clinically sound therapy but may incorporate much more software and intelligence in the design. In a future clinical world of evidence-based care, compliance, and outcomes, data will continue to gain importance. Concurrently, as providers face higher operational costs and lower payments, the technology will need to be more intelligent to eliminate unnecessary and costly non-value-added activities.
Patient monitoring equipment. The digital technology revolution in healthcare has changed the way the hospitals connect and communicate. Convergence of new measurement technologies, patient demographics, and managed care cost initiatives is driving patient monitoring away from caregiver facilities and into patients' homes. Remote monitoring equipment has come in the forefront of wearable devices and sensors, and advances in data integration and interoperability have revolutionized patient monitors.
The way forward is a truly connected system that provides information from wherever a patient may be to a clinician, wherever the clinician may be. It would consist of a standalone device portion that continuously monitors all five vital signs - blood pressure, blood oxygen saturation, skin temperature, respiration, and heart-pulse rate - using a thumb-and-chest sensor. The measurements would be displayed on a device resembling a big watch that is worn on the wrist. Via the next-generation Wi-Fi wireless technology, the vital signs data would be transmitted across a hospital network to a workstation or a tablet.
Ultrasound equipment. Innovative advances in high-resolution ultrasound now enable detailed anatomical characterization and accurate differentiation of benign diseases from malignant ones. Ultrasound has become the core component of thyroid nodule guidelines, but it is important that the key technological aspects of the modality are understood. The large evidence base for ultrasound elastography indicates that the assessment of nodule stiffness can improve the imaging evaluation of thyroid lesions and potentially avoid unnecessary FNAC/surgery for benign nodules, particularly if integrated with ultrasound classification. The potential for 3-D and CEUS in thyroid nodule ultrasound has not yet been realized, but the emergence of these novel approaches is an illustration of the huge strides that have been made in the underlying ultrasound technology. Elastography shows promise for improving clinical outcomes in numerous applications. The technology has seen strong investment over the last 18 months as suppliers strived to develop a reproducible methodology. Whilst advances have been made, the technology still requires further refining for widespread use. Nevertheless, elastography has been shown to improve clinical outcomes in obstetrics and gynecology, breast imaging, and imaging of the liver.
Fusion ultrasound systems are also gaining interest. The use of ultrasound in conjunction with MRI and CT images improves diagnostic outcomes. Furthermore, growing interest in minimally invasive procedures has resulted in strong growth in the interventional ultrasound market. Advances in new software and connectivity to advanced visualization tools have streamlined fusion technology for radiologists, further driving adoption. This technology is projected to be one of the most important advances in premium ultrasound equipment over the next five years. Despite the high cost of premium ultrasound systems, the advanced features in these systems are important not only for some traditional applications such as obstetrics and gynecology, and cardiology, but perhaps also for the newer applications of breast imaging, interventional cardiology, and internal medicine.
Ventilators. Traditional invasive products are making way for more portable ventilators and non-invasive products, a trend that is exhibiting tremendous growth prospects supported by improving convenience to patients and reduced healthcare costs. The steep growth in information technology has led the industry to rapidly develop new software, user interfaces, and algorithms that are implemented in the machines by different vendors. This translates into a new generation of high-performing ventilators, often offering several vendor-specific features.
Future ventilators are expected to be miniaturized into a single chip, which can also be used for ECG and EEG monitoring, offering enhanced portability to enable transport from one healthcare facility to another. Low-power design using smaller batteries, longer backup time, and wireless connectivity to enable remote monitoring from a distant site coupled with leveraged technical expertise, and minimized onsite repair visits could be the focus in coming years. Emphasis on developing devices, incorporating distinctive and proprietary algorithms for new modes of ventilation with adaptive facilities for each patient based on variants and combinations of the classical pressure and volume control modes, could be in limelight in the years ahead.
X-ray equipment. Over the last decade, the field of medical imaging has evolved from analog technology toward the digital age. This shift in medical imaging has seen the emergence of flat panel detector (FPD) technology in everything from cardiology systems to portable X-ray equipment. Digital solutions have already begun to revolutionize medical imaging by offering improved image quality, faster processing time, and dose-reduction advantages over their analog predecessors.
The information age is changing how patients seek out care. Patients are better informed about their options, such as the degree of technology available and the quality of care a provider can offer. As this trend continues and patients are more willing to choose their providers, hospitals will face the added challenge of competing for patients. This is a critical issue as volume is a key factor for the success of any service line. Furthermore, when referring physicians are aware that state-of-the-art digital technology is available at a certain facility, it breeds confidence in sending patients to that location, knowing that their imaging study takes less time, requires less dose, and can be associated with higher image quality.
New and Ongoing Challenges
Adapting to the above trends is by itself a crucial challenge for MedTech manufacturers. In addition to these, however, some concerns will remain.
Quite naturally, product quality is a primary concern among medical device developers. Avoiding recalls is of primary importance, and the use of adequate processes to ensure product safety, reliability, and security is stipulated by standards and regulations imposed by various governments and international regulatory bodies. To make matters even more difficult, these regulations are being constantly updated.
Changing legislation remains to be one of the main causes of concern for medical devices developers. Evolving regulations on the security, privacy, reliability, and safety of medical devices can have a significant impact on the internal processes, as well as the profitability of development companies. Upcoming changes to Europe's medical devices regulatory process are expected to take effect in 2017, leaving developers with the challenge of preparing for these adjustments well in advance.
While opening up new areas of innovation, the Internet of Things (IoT) also brings technical challenges for MedTech manufacturers. Collecting, securely managing, and simply making sense of the vast amounts of data that sensors in IoT-enabled devices gather is going to be a difficult task. Due to the sensitivity of the information, special care will have to be taken to securely transmit and store data in the cloud, and to avoid breaches.
Overall, 2016 certainly looks interesting for MedTech companies. Adapting to a rapidly changing market landscape, and overcoming emerging challenges to keep pace with and take advantage of rapid development will require a great deal of flexibility, and innovative business management solutions and tools.