Biten Kathrani, Director R&D, Asia Pacific, Middle East & Africa, Boston Scientific speaks on driving innovation in the medical devices industry of India
Medical devices are integral to a patient-centric care continuum, from screening to diagnosis to treatment and monitoring. In India, the medical devices industry is classified into four groups: consumables (syringes, for example); implants (stents, pacemakers); instruments and appliances (surgical equipment); and diagnostics (imaging, IVD). The device industry is growing fast in India, despite the rising burden of non-communicable diseases and rising spending capabilities amongst the affluent and growing middle income population. Innovation is seen as a key growth driver to cater to the growing patient population.
What does it take to innovate?
At Boston Scientific, we have a three-step innovation process based on the well-known Biodesign approach of ‘Identify, Invent, Implement,’ conceptualised by faculty at Stanford University.
Identify: The starting point of medical device innovation is to determine the unmet needs in the clinical environment. “Voice of Customer” input is key to needs-driven innovation and defining an early value proposition. This requires dedicated innovation teams to interact with stakeholders, immerse in the clinical environment and identify the clinical and non-clinical needs. Prioritised needs are then passed on to the Invent phase.
Invent: The next step is to invent the value proposition by developing innovative concepts with a focus on the four As (awareness, access, adoption and affordability) so that we are creating a device that truly has real-world applications, rather than just creating for the sake of innovating.
Implement: We consider the physician as our partner in the innovation journey. Multiple concepts generated in the invent phase must be prototyped and tested in a simulated lab environment in partnership with physicians, in order to gain critical feedback, improvise on the go and optimise the solution. It is important to iterate at this stage to resolve gaps in the solution.
The final concept, coupled with a business case, is transitioned to a new product development (NPD) process, driven by our quality system. The NPD process focuses on ‘design to manufacture’, performance, safety and efficacy of the final product.
Principles of frugal innovation are key to success in emerging markets. Frugal innovation does not mean ‘cheap’; instead, it means ‘more for less for more’ or better clinical outcomes with less use of resources such as time, funding or materials to impact more patients who can benefit from the innovation.
The best way to encourage innovation in an organisation is to create an atmosphere that is conducive for good ideas to take root and eventually yield results. Organisations need to invest in talent, infrastructure, collaborations with stakeholders and partnerships with academia, and support all of this with the right culture and long term commitment.
Commit to quality: An innovative idea will remain just that, without the appropriate rigour in the development cycle. Invest in building a robust quality system and drive the NPD process to deliver on performance, safety and quality attributes of the product. A stage – gated development cycle with appropriate design reviews allows capturing compounding and/ or conflicting deliverables early in the design cycle and provides room to innovate and solve the problems. This needs investment in state-of-the-art laboratory infrastructure to translate an idea from laboratory experiments to clinical experience. R&D is often a time- and resource-consuming process that requires long-term commitment, but is an indispensable aspect of improving healthcare in the long run.
Intellectual property and innovation incentives: Developed markets invest in generating and protecting intellectual property (IP) to gain competitive advantage. As R&D centres in India and emerging markets develop innovative solutions, it is important that companies invest in IP awareness and protect their innovations through patents. To encourage R&D engineers and scientist to be IP savvy, companies need to develop and deploy incentives for them.
Learn and adopt from diverse industries: Ultrasonography, now indispensable to healthcare, was originally developed to help scientists study flaws in metals and in oceanography. Such adaptation of technology helps cut down the cost involved in primary research. Likewise, the use of 3D technologies like 3D printing and 3D visualisation are now being adopted for anatomical visualisation and simulation that will help further innovation and new solutions.
Foster collaboration: One of the ways medical device companies can encourage innovation is by holding internship programmes where budding graduate students from pharmacology and business schools get a chance to interact with the best-of-the-best. This helps to create a competitive yet engaging environment where young talent with their own unique way of looking at a situation can develop new and entrepreneurial medical technologies.
Democratise the innovation process: Many organisations and research institutes can get into a trap of innovating within their own four walls. Innovation can come from anywhere and anyone. Innovation is not just about products but is required across the entire value chain including business models innovation. It is important to encourage all employees, no matter what their level of seniority or role, to ‘think outside the box.’ It is equally important to collaborate with innovators in the ecosystem – academia, research institutions, start-ups and independent innovators.
Frugal innovation comes naturally to Indians. Indian innovators have delivered multiple value innovations such as the world’s most inexpensive heart valves, a non-electric victrectomy device, Jaipur foot, intraocular lens, value ECG machine and stents. Several global device companies have setup R&D centres in India to cater to emerging markets and global product development.
The healthcare scenario in India is ripe for innovation, and we should capitalise on the opportunities. India offers robust capabilities across several R&D institutions; a high calibre STEM (Science, Technology, Engineering and Mathematics) talent pool; leadership position in information technology; the government’s ‘Make in India’ and ‘Innovate in India’ initiatives; and the inherently cost-conscious Indian mentality are drivers for innovative thinking.
The Indian healthcare industry has grown to $3 billon with a CAGR of ~10% and is expected to exceed $280 billion by 2025. Needs-based innovation coupled with cost effective solutions that blend R&D investments with leveraging current capabilities are among the nation’s priorities to help deliver the innovative solutions that will help this sector grow.
At Boston Scientific, we recognise the potential India has for the global medical devices industry. We have created a state-of-the-art, integrated R&D facility to drive development of new medical devices for the region, as well as an Institute for Advancing Science physician training centre in Gurgaon, India. At this facility, we intend to focus on cutting-edge medical device innovation to address unmet needs in emerging and global markets.
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Stanford Byers Center for Biodesign http://.biodesign. Stanford.com