Medical device sector represents 9% of the overall Indian healthcare industry. Indian medical device market is the 4th largest in Asia and under top 20 in the world. It was valued at $4.2 Billion in 2014 and is growing at a CAGR of 16% over the period of five years. There are several contributing growth factors such as high volume demand, epidemiological transition, growing GDP; and government efforts such as Make-in-India, 100% FDI, medical parks and shared infrastructure facilities buoyed by modest private sector investment.

The industry is at the cusp of a major transitionary phase. The highly import dependent industry (more than 70% by value) has gained significant attention for the potential it holds to contribute to ‘Making in India’. Contrastingly, there are about 800 medical device manufacturers in India, but hardly 10% generate a turnover in excess of Rs.600 Million, creating a wide stratification in indigenous manufacturing landscape. Most indigenous manufacturers have historically focused on consumables and disposables.

The current shift reflects Indian companies moving up the value chain steadily. They are building competitiveness through indigenous innovation, absorption of acquiring synergistic and sophisticated technologies from global sources and strategic partnerships. On the other end, MNC’s are now seeking to grow beyond the high end of the market and establish presence in the low value segment. They are exploring possibilities such as setting up their own facility (3M in Pune, Becton Dickinson in Haryana), acquiring local manufacturers (Philips Medical System’s acquisition of Alpha X-Ray Technologies), developing cost efficient solutions relevant to the Indian context (GE’s low cost warmer) and even introducing products from Chinese acquisitions in India (Orthopedic devices – Stryker and Medtronic).

However, the segment still struggles with fundamental problems such as an inverted duty structure that often favors importers over manufacturers and slow regulatory reform. Public health procurement channels for innovative devices have also been underdeveloped and call for attention.

Despite the above challenges, devices represent the segment where greater change is expected in the next five to ten years. We discuss below pervasive innovation trends observed across segments of devices and glimpses from the evolving the Indian landscape.

Pervasive innovation trends across device categories
1. Drug device combinations – The convergent opportunity
Drug device combinations offer attractive growth opportunity for both drug and device companies. Device innovation is emerging as preferred lifecycle management strategy and source of competitive advantage for several drugs. There has been an unmet need for novel drug delivery mechanisms to improve medication adherence, drug absorption including less frequent dosing, extended-release formulations, easy administration and targeted delivery and device innovation has helped address some of these priorities. Self-injecting insulin pens are a pertinent example of drug companies leveraging device innovation. The recent Epipen pricing controversy in the US also highlights how proprietary devices have been used tactically for competitive advantage by drug companies even in the case of highly established drugs. At the other end, integration of drugs for various objectives has allowed device companies also to provide more clinically attractive solutions and seek growth opportunities. One of the older examples would be the case of drug eluting stents that now dominate markets globally. We have outlined below some of the popular areas of innovation for drug device combinations:

a. Vascular: drug-eluting stents, coated vascular prostheses
High incidence of cardiac ailments, coronary artery disease in particular, has paved way for minimally invasive solutions offered by drug-eluting stents. They combine the polymer and drug to achieve coronary revascularization and at the same time deliver anti-proliferative drug at the target.

b. Drug delivery: transdermal patches, inhalers, drug pumps
In India, drug pumps, insulin in particular, has seen an unprecedented demand, owing to 65 million diabetic patients. Insulin pumps have been in use for a considerable time, but the new pumps are being designed to be smarter, smaller and programmable, to detect insulin level and systemically release it. While insulin pumps are wearable, implantable pumps for direct CNS delivery are also being developed.

Simultaneously, innovations in nanotechnology has enabled targeted drug delivery reducing off-target toxicity and dosage quantity. Antibody-based delivery and similar technologies in particular will make delivery of large molecule drugs easy and convenient.

c. Orthopedic: Bone implants /cements
The new generation of bone implants are not only bio absorbable but also contain pellets of antibiotic drugs to be delivered at the site of the morbidity. Recent FDA approvals and clearer regulations have escalated the development of combination products and consecutively research has transpired beyond USA. Combination products has seen convergence of pharma and devices industries to co-develop products. This also presents an opportunity for CDMO’s in India to grow and offer novel solutions to address this unmet need.

Large pharma players have been actively involved in technology development like Sun Pharma’s Levulan Kerastick for treating actinic keratosis or Dr. Reddy’s Zembrace SymTouch pen to treat acute migraines.

India’s strong pharma industry offers ripe collaboration opportunities for device companies to co-create value and seek growth opportunities. 3D Printing – Rapid Prototyping, Lean Manufacturing and Customized Products 3D printing has seen unfettered growth and acceptance across several industries like automobiles, aircraft and gaming. It has begun to make its mark on the medical device industry as the next generation additive manufacturing process, navigating through evolving regulatory policies. 3D printing technology has evolved substantially and can work with materials ranging from wood to plastics to polymers to metals. It has found application and is expanding possibilities across product development and commercial manufacturing:

a. Product development – As a Rapid prototyping method, it is being employed by researchers and manufacturers to speed up the development cycle, engage in cost effective design iterations and ultimately shorten the time to market. It has lowered barriers to entry as it is relatively easier to begin prototyping efforts with a desktop 3D printer as compared to traditional CNC machining approach with heavy equipment. This is very pertinent in the Indian context where shared infrastructure and technical expertise for design, prototyping and validation is still hard to find for ventures and academic institutions.

b. Medical models for surgical and educational use – 3D printing is being increasingly used globally and in India for creating medical models and educational replicas in a rapid and cost effective manner. This paves the way for more experiential educational experience and very importantly, improving surgical outcomes by providing surgeons a critical tool for to plan and prepare more effectively. Companies in India today are able to supply such medical models at an affordable price range of Rs.5,000 to Rs.20,000 thereby creating the possibility of widespread adoption. Mumbai-based company, Anatomiz 3D, helps surgeons customize solutions and plan treatments. In a recent example, Anatomiz, helped print the 3D model of tongue and tumor using thigh muscle for an oral cancer patient to remove the tumor and recreate the tongue. Similarly, Bangalore based DF3D focuses on supporting cranial maxillofacial orthopedic surgeons and can ship a model to any surgeon in India from their Bangalore location in two days.

c. Customized implants and other devices - 3D printing is the ideal solution for personalized prosthetics, bionics and orthotics for low volume custom production. 3D printing expands possibilities for clinical intervention in areas such as orthopedics and trauma. While this area of application is relatively nascent on the adoption curve, we anticipate progressively increasing acceptance and high innovation quotient from the clinical community over the next five to eight years. Examples of innovators in India include Ratna Nidhi Charitable Trust, a Google grant winner of $350,000, designs and manufactures 3D printed Jaipur Foot. They are currently conducting a pilot study and aim at serving 200 amputees in the near future. Orthopedic implants are the next dimension of innovation. Medanta: The Medicity successfully performed a surgery on the failing spine of a woman and inserted for the first time a 3D printed titanium implant.

d. Tissue engineering and other applications - An additional nonlinear innovation has been in the field of tissue engineering. Pandorum Technologies, makes 3D-engineered human tissues that can be used for testing. The manufactured tissue mimics actual human tissue,allowing researchers to avoid testing on animals and humans. This will propel avenues for transplantable 3D organs addressing the acute shortage of human organs available for surgical transplantation.

3D printing has the potential for being cost effective- low lifecycle cost, low tooling cost; efficient- reduced material wastage, accelerated lead time and customizable- design flexibility.

To truly realize the potential in device development and prototyping, India needs to urgently bridge the void with shared resource facilities that can be equipped with common infrastructure for design, rapid prototyping and validation. Given the advent of 3D printing, such common facilities are becoming more capital efficient and easier to operate. To open commercial application avenues especially in more regulated device categories such as hip and knee implants, the global regulatory landscape needs to evolve. Overall, the potential clinical impact of medical applications of 3D printing are exciting and it is crucial that India maintains the innovation momentum to pursue locally relevant solutions.

3. Biomaterials
Biomaterials have been constantly evolving from metals to polymers to ceramic to newer bio-absorbable variants and combinations involving collagen and stem cells to become more bioinert, bioactive and biodegradable. They are finding application in wound healing, orthobiologics, cardiac implants, dental implants and targeted drug delivery.

In cardiovascular space, the third generation of stents gaining popularity and adoption is bio-absorbable stents which prevents stent thrombosis, avoids alteration in vessel geometry and fracture, and additional cost of replacing/removing stents through a second surgery. The most popular product available on the market today is Abbott Vascular’s AbsorbTM. Recently Meril launched its indigenously made bioresorbable cardiac scaffold (BVS), a naturally dissolving cardiac stent made out of biodegradable material and used for clearing blockages in arteries of the heart.

Biomaterials have found myriad of applications in orthopedics through orthobiologics. Orthobiologics are made from substances found naturally within the body and uses biomaterials and cell-based therapies to speed up the recovery process. They can include Bone Graft Substitutes (Autografts, Allografts, Bone Morphogenic Proteins (BMPs), Demineralized Bone Matrix (DBM)), Viscosupplements (hyaluronic acid – HA), Bone Growth Stimulators, Platelet Rich Plasma (PRP), and Bone Marrow Concentrate, Stem Cells and others. Chronic and rapid wound healing and dermatological treatment/ enhancement applications have been at the forefront pushing innovation and advancement in biomaterials.

Bioactive nanoglass fibers, dermal fillers, collagen scaffolds, polylactic acid variants are some of the areas of research.

Similarly, biomaterials are finding application in dissolvable sutures, adhesives, lubricants, concentrated antibiotic delivery at the site of morbidity, dental implants, arterial prostheses, ophthalmic lenses, semipermeable membranes for dialysis, heart valves, among several others. Material innovation is also creating and redefining new possibilities in device innovation. The most appropriate example would be MiraCradle highlighted at the end of this section. It is an innovation in Phase Change Materials (PCM) at the heart of the development of a novel CE marked neonatal cooler by Pluss, a VC funded Indian venture to address the glaring unmet need for neonatal cooling devices across India and other low and middle income countries.

Leading Indian academic institutions have been engaged in this area of research and have made notable contributions:

National Chemistry Lab in Pune has developed several successful technologies like- polyethylene implants for reconstructive surgery of maxillofacial bones, which is commercialized by BioPore Surgicals, Development of novel resorbable silk-based bone graft implants, bone fixation screws and membrane based oxygen-enriched air generation system, which are licensed to start-up companies, Novel expandable biliary stent being developed in collaboration with a biotech start-up company.

There is potential for India to further increase the momentum of innovation engagement to encourage more India specific as well as globally relevant solutions that are backed by sophistication in material science innovation.

4. IoT – Breaking down silos and promising connected care
Technology providers, technology users, information aggregators, information analysts and patients have in the past worked in silos. However, IoT is creating possibilities for a more integrated and responsive platform for the industry to work together and sharpen their efficiencies. IoT is defined as- “The Internet of Things (IoT) is a network of physical devices and other items, embedded with electronics, software, sensors, and network connectivity, which enables these objects to collect and exchange data”. In addition to cost containment, IoT also allows to keep up with constant innovation and shorter product lifecycles, gather real time data for augmented intelligence, and create end-to-end communication from wearable/ implantable/ ingestible diagnostic tools to treatment decisions to ICU monitoring to post-discharge care. While, IoT has given a blueprint to create value, we are still in nascent stages of effort to capture such value. Big Data companies are championing the phenomenon by nurturing intrapreneurs and incubating several startups. One such example is Oxyent.

Oxyent offers latest Cloud Computing, Big Data & mobility enterprise solutions. They have recently designed iNICU device that captures data from various monitors of NICU. It allows doctors to tweak parameters of measurable outcomes or change alarm thresholds. This additionally permits remote monitoring and dataset collection for analysis. It is being backed and mentored by IBM under the ‘Smartcamp’ effort.

Several innovative companies in India and other countries have integrated connectivity building blocks in their devices and are positioned competitively to succeed in the emerging ecosystem with greater IoT penetration. Other notable examples that have emerged are Spectral Insights, Forus Health, Cardiac Design Labs, Closeconnexions among others. Globally, medical device industry leaders have spelt out the objective to transition into more service oriented businesses; and connecting devices with greater central control paves the way for that. Indian IT companies are already deeply engaged in this transition as one of the largest segments of service providers to global medical device companies.

While there is immense global potential for Indian device companies also to leverage the emerging opportunity, it would be optimal to first begin with implementing solutions in the Indian healthcare setting. India will have to work on creating a stronger backend to realize the full potential. Better data security measures, infrastructure to support IoT, reach of ‘internet’ to rural areas, education and training in designing and use of technology will have to be undertaken before unleashing the strengths of IoT. Furthermore, the new generation of devices being innovated and manufactured will have to incorporate sensors and microprocessors for future integration with IoT networks.

5. Miniaturization and portability of devices
Driven by need for portability, extension of applications, less invasiveness, enhanced performance & safety, cost optimization, lighter yet more power; medical devices are trending toward miniaturization. This has benefited public health, private health and patients likewise. It has facilitated rendering of better medical services in remote, previously inaccessible areas. Within hospitals, it has improved the device utilization, floor utilization and patient throughput. For patients, it offers possibility of home healthcare. Miniaturization is being witnessed in implantable, imaging and diagnostic devices as well as treatment equipment.

a. Implantables: With the increasing use of drug pumps such as insulin pumps and increasing wireless connectivity with smartphones, efforts to reduce the size of pumps are being made. For e.g. Jewel Pump designed by Debiotech, Switzerland, is a miniaturized Patch-pump with 500U insulin for up to 7 days use. Additionally, it is detachable at will, watertight for bathing and swimming, includes direct access bolus buttons and a discreet vibration & audio alarm. Pacemakers have been constantly evolving since their genesis and have reached a stage where the pacemaker has reduced to size of a vitamin capsule. Medtronic and Abbott acquired St. Jude Medical are pioneering the research. St. Jude Medical recently got FDA approval for their smallest “wireless” MRI-compatible pacemaker.

b. Diagnostics: Miniaturization of X-Ray, Ultrasound devices etc. are pushing them towards handheld technology without compromising the quality and accuracy of diagnosis. This expands the reach of devices to rural areas, disaster sites, and even in ambulances, permitting a broader portfolio of offering for PoC.

c. Treatment equipment: Miniaturization has also permeated to treatment equipment enabling therapies such as dialysis at home. Globally more advanced solutions such as ingestible pill with camera to assist during endoscopic procedures, such as that developed by Olympus, are mushrooming. India will need the impetus to explore these more advanced territories and exploit the commercial potential.

Despite the indisputable potential of miniaturized devices, there are several technological barriers like heating, integration with existing modalities, data accuracy, precision and high R&D cost, that need to be overcome. Several Indian institutions are engaged in this area of innovation. Healthcare Technology Innovation Center (HTIC) in IIT Chennai has developed a cardiac arrhythmia screening device in a miniaturized form (handheld) and Hyderabad based startup Monitra Health is now pushing the boundaries further by developing a wearable option. Portable and miniaturized solutions offer value across highest value and lowest resource settings.

While this is a focus of several Indian innovators, given the potential for clinical benefit as well as value creation, there is merit is fostering even greater momentum.

6. Robotics
Robotics is moving beyond the realm of traditional repetitive jobs like assembling to more versatile approach areas like healthcare. Robotics offers a minimally invasive solution which reduces complications, human error, ergonomic drawbacks, enabling a more controlled, controllable environment for surgical manipulation, better vision due to magnification and machine learning for greater precision, reducing chances of blood loss and tissue damage. Robotics by definition is not limited to full scale automated machines and taking over surgeries with little human assistance, but also extends to individualistic elements like robotic arms. In healthcare, most common robots in existence are human controlled, human delegated and human supervised. Robotics has branched into motion controlled and voice controlled devices and are largely used for:

a. Surgery
Surgical application is the hallmark of robotic development. Compared to any other application area, surgical segment has witnessed the highest advancement and acceptance. Robotics is being employed in treatment in therapeutic areas like urology, gynecology, thoracic, pediatric, general surgery, head and neck and bariatric surgeries. This also enables surgeries being performed from a remote location with similar and in some cases better health outcomes. Some commonly identifiable systems are: Da Vinci system with arms and human like wrist motion being used for prostate surgery and eye surgery The Sedasys system used to give anesthesia in routine endoscopy and colonoscopy procedures. Nanorobots to cross the blood-brain barrier for treatment of infection, cancer and type 1 diabetes

b. Rehabilitation
Robotics in rehabilitation is being used for dealing with disability, faster recovery from disability, providing support in the form of exoskeletons like Ekso Suit and prosthetics. Robotics can compensate for the patient's inadequate strength or motor control and can be individually calibrated to suit the patient need. Globally, rehab centers have installed robotic systems for increasing motor functions in stroke patients, for instance, as well as assisting in collecting and storing samples for diagnostics. In India, adoption is still at a very nascent stage and has been limited to bigger corporate players such as Apollo Hospitals, which offer robotic Neurorehabilitation and houses following robotic systems:
n    LOKOMAT for intensive locomotion therapy.
n    ARMEO for functional therapy of the upper extremities. ERIGO for early rehabilitation and patient mobilization

c. Hospital and pharmacy
Robotics in pharmacy has taken automatic dispensing to next level of efficiency, streamlining processes, controlling costs and improving precision. In India, Rowa Smart System, developed in Germany is being used at Aster Medicity (Kochi) to arrange inventory, check date, make records and dispense them accurately to the patient.

In the hospitals, robots are being used for disinfecting the patient rooms and operating suites. For e.g. high-intensity ultraviolet light delivered by Xenex Germ-Zapping Robot. Biggest challenges in adopting robotic alternatives in India is the steep learning curve, cost and time required for setup. Major efforts are required in terms of capacity building for widespread adoption of robotic surgery so that the application and presence is not limited to metro cities. Some of the more aggressive companies in robotics today are:                       

(Courtesy: Assocham report: Embracing Innovation, Driving Growth Across Healthcare Continuum)