MedTech – Applying The Power Of Innovation

The MedTech industry is well placed to build on and expand innovative developments and create new opportunities to deliver solutions that diagnose needs and inform care decisions, improve care delivery, and enable more comprehensive care management.

Healthcare is one of the fastest growing sectors in India and the Indian government has aggressive plans to develop India further into a global healthcare hub, leveraging its relatively lower priced treatment options. It presents a great opportunity for the growth of the entire health industry – medical devices, healthcare providers, and pharmaceutical manufacturers.

Latest advancements in technology like artificial intelligence (AI), Internet of Things (IoT), and blockchain can enable the healthcare industry to adopt disruptive technology-led service and business models, scale up for access and affordability, and take the winning leap to make India a global healthcare hub.

Technology adoption in healthcare is at a nascent stage in India. One of the first steps toward this transformation will be to use technology as the lever to break the silos and for tight coupling of data with providers and caregivers, and to encourage and enable an ecosystem of free data flow and interchange. Other steps will include adoption of IoT-enabled wearables to monitor health, AI-enabled predictive analytics to predict diseases, mobile and IoT-enabled technologies to shift from hospital-based care to technology-enabled home care, telemedicine and advanced imaging-enabled technologies to address availability of specialist doctors in remote and rural areas, and drone-enabled technologies to improve medicine availability. Sharing of health data will bring in privacy concerns, which need to be addressed through greater focus and investments in cyber security.

In addition, one needs to fund specialized domain research in medical fields like robotics-led remote surgeries, basic medicine and provisions to incentivize the participating resources for their time and effort to foster a culture of research and excellence.

Indian market
The Indian MedTech market will continue to record robust growth despite a hardened stance on pricing for essential devices. Currently valued at Rs. 27,735 crore, the market is expected to grow to Rs. 39,260 crore in 2021, predicts BMI research. Market growth will moderate over the next 6 years, reflecting an increasingly competitive operating environment and expanding market share for lower cost domestically produced products in some sectors.

The market will benefit from sustained economic growth and strong healthcare drivers. It will continue to reduce its dependence on imports, as local manufacturing expands under the Make in India initiative. The expanding private sector will remain the main growth driver.

Diagnostic imaging weakness will continue to hinder import growth, but growth rates in US dollar terms will improve due to a stabilization of the rupee against the US dollar. In the 12 months to January 2017, imports grew by 7.7 percent in local currency terms and by 3.5 percent in US dollar terms, taking the running annual total to Rs. 18,130 crore.

Despite an improved performance in Q3FY17, headwinds to exports persist with a more protectionist trade stance in the United States of America and a weaker external demand outlook in key markets. In the 12 months to September 2017, exports grew by 1.6 percent in local currency terms and by 3.2 percent in US dollar terms to Rs. 7500 crore.

Proposals by the national regulator to introduce price caps on distributor and retail margins will alleviate pricing pressures for medical devices. This will help to negate industry concerns over the prospect of hardline pricing controls on a broad range of devices similar to those introduced for cardiac stents and artificial knee joints, which risk undermining investor confidence, impeding innovation. and provoking retaliation by India’s major trading partners.

Global market
The global MedTech industry is poised for steady growth, with global annual sales forecast to rise by over 5 percent a year and reach nearly USD 800 billion by 2030. These projections reflect increasing demand for innovative new devices (like wearables) and services (like health data), as lifestyle diseases become more prevalent, and economic development unlocks the huge potential in emerging markets – particularly China and India.

Despite these apparently attractive prospects, a shadow hangs over the sector in the form of a relentless downward pressure on pricing. Governments around the world are desperately trying to reduce the cost of healthcare – especially in the most expensive part of the system: hospitals. They want to pay less for medical devices and see proof of greater value in terms of better patient outcomes.

Responsibility for many purchasing decisions has already moved from clinical to economic buyers. Short-term respites like the 2-year US excise tax moratorium on medical devices notwithstanding, pricing appears to be going in one direction only – down. Further uncertainty lies ahead, with the new European Medical Device Regulation in 2020 and regulations in China that are designed to spark local innovation.

These developments present a quandary for medical device companies that have historically concentrated on manufacturing and research and development (R&D), but are now seeing healthcare budget restrictions and new reimbursement regimes continue to snip away at margins. On top of this, new players – some from entirely different industries – are disrupting the sector by harnessing data to take ownership of customers, patients, and consumers. In this volatile new marketplace, today’s device players are in serious risk of being stuck in the middle of the value chain, as mere commodity producers.

Traditional ways of operating the business need to be challenged, and novel approaches need to be tried. A deeper understanding of the end user and their emerging needs to be developed and different scenarios of how your business might look like in 2030 need to be created. By attempting to disrupt themselves, medical device companies can stay a step ahead of emerging competitors and not wait for the how to win playbook to be rewritten. It is entirely possible (and probable) that in the future, a multi-thousand-dollar machine will be displaced by a portable device that costs less than USD 100.

Trends that will influence the direction of the MedTech markets
Exponential advances in technology have made MedTech ripe for innovation. Whilst the industry still lags behind other industries, in the past few years there has been an increase in device innovations aimed at tackling some of the most intractable healthcare challenges. Some innovations likely to transform healthcare in the near future are listed. Inevitably, some of these predictions will happen sooner than we think, while others may never happen.

X-ray equipment. The radiation-shielding screen not only provides protection from harmful radiation, it also provides a workspace for radiographers to carry out their work efficiently and with complete confidence that they are protected. The screen today is modern, durable, up-to date with hospital infection control, and of course, aesthetically pleasing, for not only staff, but patients too. The next-generation screen now introduces a modular system that can be installed anywhere and with less installation down time. Due to the new structure with steel workings within the screen, the aluminum trim has been removed so the top of the screen is completely lead X-ray glass, leaving a futuristic look.

Ultrasound equipment. Ergonomics and mobility are being addressed by vendors to differentiate systems and grow user volumes. New-generation ultrasound systems stand out in terms of design. Most are noiseless to permit sonographers to minimize distraction and focus on the exam, with settings customized and organized depending on clinical preferences. Some have slanted bodies to prevent users hitting their knees or feet on the machine, with keyboards that can be raised or lowered depending on user height, probes that are shaped to match the human palm, and rotatable LCD monitors for sharing the display with colleagues. Other innovations include the possibility of use in both sitting and standing positions, with memory features to accommodate different users. Some recent ultrasound machines have tablet-sized touchscreen-based interfaces, which significantly reduces the reach and steps in order to start and complete an exam. This enables faster workflow. Touchscreens allow users to tap in order to start functions, pinch and drag to zoom in and out, and swipe to expand the image.

MRI equipment. In recent years, some of the advances in MRI technology have been on the software side. These advancements enable faster contrast scans, simplified cardiac imaging workflows, and even the ability to perform MR scans. The software also delivers multiple, adjustable contrast images, and quantitative data from a single 5-6 minute scan. The software reduces the need for several scans using different protocols, helping to reduce scan times and increases patient throughput. Another important innovation is development of propeller imaging. Now many vendors have a propeller type of method. The method is based on constructing parts of images at a time, and running the scan so quickly that the second time one runs it they acquire another part of the exam, and the third time another part of the exam. So it looks like one is acquiring a single picture – a full picture at one moment in time. And it reduces the amount of time exposure for each part of the image.

ECG equipment. Early detection of heart diseases and timely treatment can prevent them. Manually, there are several chances of misses or misdiagnosis. With the help of artificial technology researchers have for the first time found that AI has the ability to diagnose heart attacks. In cardiology, AI has been successfully applied to problems in the diagnosis and the treatment of several diseases like ischemic heart disease, early repolarization syndrome, atrial flutter/fibrillation (AF), bundle branch block diseases etc. The technology still will not replace a skilled physician who understands the fine points of the art of medicine and the ECG reading; however, AI will reduce the burden of ECG diagnosis that has increased tremendously.

Endoscopy equipment. Lately, the focus seems to be less on enhancing image quality and more so on efficiency and cleanliness. In response to current incidents involving cross-contamination with conventional endoscopy, there has been development and testing of single use video endoscopes as well as a disposable sheath prototype for both a gastroscope and colonoscope. This endoscope allows complete isolation of the scope itself encapsulated with a disposable sheath system. The disposable sheath system includes a sheath cover and cuff, which incorporates all working channels for suction, irrigation, and tool passage. This allows the contaminated part of the procedure, the disposable sheath, to be discarded after patient use reducing the risk of endoscopic bioburden cross-contamination and infections. As for the single use endoscope, upon completion of the procedure the entire scope is discarded.

Defibrillators. Transvenous pacemakers and ICDs are effective treatment modalities for cardiac bradyarrhythmias and tachyarrhythmias. However, these systems are associated with device-related complications, mostly related to the transvenous leads, which result in morbidity and mortality. Transvenous pace and shock leads have shown high failure rates during long-term clinical follow-up. Device infections (sometimes involving the pocket but more so when systemic) are associated with a high risk of mortality. To reduce complications related to transvenous leads, both the leadless pacemaker and the subcutaneous implantable cardioverter-defibrillators (S-ICDs) were introduced and have shown clinical efficacy and safety. To date, these systems are only available for patients either requiring single-chamber right ventricular pacing or shock-only defibrillation therapy. Combined use of both devices could bring the benefits of leadless therapy to a larger patient population by providing both bradycardia pacing and defibrillation therapy.

Ventilators. Alarm fatigue continues to be a major healthcare concern, and is ranked as a health technology hazard. Mechanical ventilators are often one of the major sources of an alarm and several manufacturers have developed technology to reduce the incidence of nonactionable alarms. Ease of use within the context of alarm management is a key to patient safety. While ventilators have default alarm settings, the ability to customize those settings is important. Modern devices have an intuitive and simple touch, turn, and confirm interface to allow the user to change parameters. Users can customize settings to suit the needs of the individual patient.

CT scanners. The latest configuration of the spectral CT has faster reconstruction speeds and better visualization of bone marrow pathology. These faster reconstruction speeds have been shown to enable the imaging of up to 200 CT patients per day. The scanner’s ability to estimate electron density enhances tissue characterization, while a new radiation therapy planning couch and bariatric table permit larger patients to be scanned with increased positioning controls. The new portable scanners feature directional wheels, maximizing mobility and allowing easier and quieter movement in small spaces. The latest advanced data acquisition system delivers a 50 percent increase in CNR versus other portable CT technologies. A small footprint is ideal for mobile use yet it has a 40 cm gantry opening for improved coverage of adult head and neck, and full-body pediatric scanning. The system also features an internal drive system, making portability less strenuous, while also offering smart-sensing collision avoidance software to maximize control and patient safety.

Patient monitoring equipment. With the hyper focus on healthcare costs, a connected OR can serve to cut the incredibly high cost of OR time. Better networking and integration of OR through upgrades of existing networks, or through the creation of new network platforms, can definitely provide tremendous cost savings. Whether a facility has 50 ORs or just a few, networking an OR can save lives and make the facility much more efficient. Manufacturers are constantly updating their software to ensure that the products they sell are up to date and comparable to the latest OEM equipment. Manufacturers are focusing on the development of technologically advanced monitoring system such as multimodality monitoring that is used in neuro-critical care settings. It allows clinics and hospitals to track multiple parameters of brain physiology and function (such as brain tissue oxygen tension) to determine the brain’s relative health or distress. With this new technology, professionals can quickly and efficiently identify the root cause of an illness to prevent any misdiagnosis.

Nuclear medicine equipment. Nuclear myocardial perfusion imaging (MPI) with PET and SPECT has been the gold standard for noninvasive detection of coronary ischemia and infarcts. However, the high radiation doses patients receive are making some providers think twice before referring their patients for nuclear MPI. Newer dose-lowering technologies have helped reduce radiation dose by more than 50 percent for cardiac computed tomography angiography (CTA) scans, making it much more attractive as a diagnostic imaging modality. New CT technology – including perfusion imaging with advanced visualization software and CT-fractional flow reserve (FFR) imaging – may lead to increased use of CT. When 64-slice CT scanners were first introduced a decade ago, CTA dose was 20–30 mSv, but new reconstruction software, more sensitive detectors, and other technologies have reduced this below 10 mSv. With the newest scanners and software, it is now possible to perform CTA with about 1 mSv of dose. This new dose profile has made CTA much more attractive, and nuclear imaging now finds itself in the position as the high radiation dose technology being called into question.

Cath labs. The market will see greater efforts and several new technologies to reduce radiation dose in both CT and cath lab angiography imaging systems. This includes increasing use of ultrasound and transesophageal echo (TEE) during procedures to cut or eliminate use of angiographic X-ray. There also will be increased use of 3-D navigation aids using 3-D echo, pre-procedural CT, or rotational angiography imaging to reduce procedure times. A handful of centers also will build out interventional magnetic resonance imaging (MRI) suites to eliminate radiation entirely for long procedures, such as EP ablations. There will be greater emphasis on reducing staff radiation dose and related orthopedic problems due to wearing heavy lead aprons all day. This includes adopting new technologies in the lab to better protect staff, including real-time dose monitoring systems, use of new, very light-weight aprons, and possibly robotics to remove the physician from the radiation field.

Anesthesia equipment. Recent models have added new ventilation modes and most manufacturers are trying to increase the similarities between their ventilator and anesthesia monitor interfaces. The new machine has ICU quality ventilation across all patient categories and has low flow and minimal flow anesthesia modes to improve anesthetic delivery and reduce financial impact. Anesthesia machines using the latest vent technology such as turbo vent ventilation with airway pressure release ventilation (APRV), and volume auto flow, which provides protective ventilation therapy in the OR for all patient categories are worth the initial investment.

Medical researchers, informatics specialists, and digital entrepreneurs have been exploring the use of AI in the healthcare sphere for decades, but it is only within the past couple of years that the technology has really begun to take off. Indications are that in healthcare, AI, now commonly known as machine learning (ML) is set to explode. Imagine an environment in which machines capable of cognitive computing and processing vast amounts of data can support you with unprecedented accuracy, efficiency, and patient-specificity on everything from monitoring the depth of anesthesia, determining the amount of anesthetic gas to administer, somatosensory evoked potential monitoring, classifying patients, and mitral valve analysis to coding and billing. All clinicians, including anesthesiologists and nurse anesthetists, are likely to find themselves incorporating ML tools and capabilities into their practices in the not-too-distant future.

Way forward
The future of health is more challenging and the possibilities more exciting than ever before – including the need for strategies and judgement on how best to shape healthcare. While predicting the future is by its nature challenging, one thing all the above predictions have in common is that the developments are made possible by the advances in technology and the emergence of new collaborations and partnerships. MedTech industry is well placed to build on and expand innovative developments and create new opportunities to deliver solutions that diagnose needs and inform care decisions, improve care delivery, and enable more comprehensive care management.