Research on Healtheare Innovations in In Before, During and Beyond COVID-19 Dr. Kanchan Mukherjee Professor Centre for Health Policy, Planning and Management School of Health Systems Studies TISS, Mumbai ‘Webpage: https://www.tiss. edw/view/9/employee/kanchan-mukherjee/ Abstract The healthcare sector is one of the fastest growing sectors globally as well as in India, with innovations being one of the key drivers of this growth, especially during this novel corona virus disease (COVID-19) pandemic. Given its importance for the present and future, healthcare innovations have emerged as an important area of research and practice. The Indian innovation ecosystem is a vibrant space and India has emerged as the world’s third largest startup economy. However, there has been no systematic collation and understanding of the literature on healthcare innovations in the Indian context. This study aims to fill this gap and helps understand the existing scope and nature of research on healthcare innovations in India to identify research gaps for future studies. A scoping review of published peer reviewed literature from the Scopus data base was performed on healtheare innovations in India in the last 26 years (1996-2021). The selected studies were analysed using a multidimensional criteria and an iterative inductive approach, followed by a narrative synthesis to present the findings using a multiparadigmatic framework. The review found that the concept of healthcare innovation was not uniform across these studies. Theory building studies and studies on healthcare innov: n ecosystem and policies have been limited. The studies identified changes in design, services, produets, technology, organization, system interaction and conceptual elements as innovations. Healthcare innovations are important in public health, clinical practice, pharmaceuticals, medical devices and Indigenous System of Medicine (ISM), but are affected by the international and national policies affecting the ecosystem. The need for inclusive and convergent innovation as a driver for equity and increasingthe translational rate of healthcare technologies also emerges from the analysis. The review identified research ‘gaps and proposed key areas for future research across different domains of healthcare innovation. Key words: Scoping review, Health technology, Patent, Transdisciplinary, Ecosystems, Policy, Healthcare systems, Entrepreneurship, COVID-19, Innovation.Introduction Health, which is a state of physical, mental and social wellbeing (WHO); is one of the areas where the rate of progress of science and technology in the last century has been most remarkable. The healtheare system involved in providing healthcare is a complex system interacting with individuals and communities at multiple levels for improving health (WHO, 2000). The novel corona virus disease (COVID-19) pandemic has exposed the vulnerabilities of healthcare system globally. In this context, innovation and entrepreneurship in the healthcare sector is helping address these challenges and supplementing the efforts of governments and bridging the gap between actual and potential performance of healthcare systems. ‘The global healthcare industry is one of the fastest growing sectors in the world (Stasha, 2021) including India (Deloitte, 2021) and one of the key drivers of this growth is innovations. The Government of India (Gol) think tank, National Institute of Transforming India (NIT), along with other ministries and departments are involved in facilitating innovation through favourable innovation policies and entrepreneurship programmes. This has leveraged India’s position in the ranking of startup ecosystems, development of information, and increase in knowledge and technology-based enterprises (Global Entrepreneurship Monitor 2017-18: India Report). Investments in health tech startups increased by 45% and the biotechnology industry comprises more than 2700 biotech startups and estimated to reach 10,000 by 2024 (IBEF, 2021). Innovators in healthcare sector have identified ways to deliver effective healthcare at significantly lower cost, while improving access and increasing. quality (McKinsey, 2010). India has a high score in innovative entrepreneurship as per the Global Entrepreneurship Monitoring (GEM) report (2018-19), and ranks fifth in the National Entrepreneurship Context Index (NECT) (GEM 2018-19). The Gol has aggressive plans to further develop India into a global healthcare hub by leveraging its relatively lower-priced treatment options. Disruptive technologies like portable less invasive diagnostics, integrated digital platforms, artificial intelligence, internet of things (IoT) are shaping the future of healtheare in India (PWC, 2018). Despite the importance of healthcare innovation in the Indian healthcare sector, there has not been any systematic review of healthcare innovations in India. A search of the Scopus and Web of Science database did not find any systematic review or scoping studies on healthcare innovations in India. Hence, there was a need to 3systematically map the literature in the domain of healthcare innovations in the Indian context to update the current exist 1g knowledge base and ide Fy gaps for future research in this area, In this context, this study aims to answer the following research questions 1. What is the existing scope, nature and findings from research on healthcare innovations in India? 2. What are the research gaps, which provide avenues for future research? Methodology Since the aim of this study was to do a scoping review on healthcare innovations in India, the search criteria was broad based. The selection criteria included empirical work related to healthcare innovation emergence, adoption and diffusion within India’s innovation ecosystem. Since healthcare innovation is a transdisciplinary phenomenon, with research and application across multiple disciplines like economics, sociology, psychology, entrepreneurship, engineering, computer science, medicine, nursing, business, management, communication science, and information technology (IT); the multidisciplinary Scopus data base with its interrelated interface ‘was selected for searching the literature. The search used the following key words and Boolean operators: (Healthcare AND Innovation AND India). The carliest record available in the Scopus data base was 1996 and hence, 1996 formed the starting time period for this review. The search revealed 243 documents (including conference proceedings), whose abstracts were then each individually screened and assessed if they met the selection criteria, Snow balll referencing and citation tracking of these documents was done and additional studies fulfilling the selection criteria were also included. This allowed for inclusion of articles not included in these data bases. Through the above process 125 documents were finally selected for this review. An iterative inductive approach was used to analyse the studies and a review of methodology used in these studies was also performed, The selected studies were analysed using the following criteria (modified from Linsisalmi et al., 2006): 1. Source of research question (theory, real-world problems, and questions derived from existing studies) 2. Methodology (action research, case study, cross-sectional, ethnography, experiment, grounded theory, intervention, pre-posttest, and longitudinal). 3. Method (qualitative, quantitative or mixed methods). 4, Level of analysis of the innovation in question (individual, group, organization), 45, Innovation process (generation, adoption, or diffusion of innovations). 6. Type of innovation (product, process, role, structure, organizational practice, service, technology). 7. Innovation conceptualization 8. Thematic areas (public health, clinical, pharmaceuticals, medical devices, innovation ecosystems and policies). 9. Key messages, In addition, areas of convergence and gaps were identified and a narrative synthesis approach was used to summarize findings from these studies. The multiparadigmatic framework developed by Greenhalgh et a. (2004) has been used to identify the research gaps. Results and Discussion Analysing the year wise trend in literature for the 243 documents (Figure 1), it emerges that the maximum number of documents (36) were published in 2020, followed by 2021 (34 documents). Hence, the last two years saw a steep rise in publications in this area of study accounting for over a quarter (29%) of all publications in the last 26 years. This is probably a result of the focus on healthcare innovations and an increase in research in this area due to the COVID-19 pandemic. A large majority (59%) were research articles followed by reviews (14%) and conference papers (13%). The subject area was dominated by medicine (27%), followed by business management and accounting (13%) and social sciences (119Figure 1. Trend analysis of documents (1996-2021). 40 35 30 25 » ‘0 ee || I i 1= 1996 m 1997 1998 m 2004 m 2005 m 2006 m 2007 m 2008 w2009 m2010 "2011 192012 82013 2014 = 2015 = 2016 #2017 #2018 #2019 2020 2021 For the documents emerging from India (171), the analysis showed that almost one-third (32.2%) of all publications related to healthcare innovations from India occurred in the last two years, Research articles (60%) dominated followed by conference papers and review articles (around 15% each). Analysing these documents subject wise, it was found that the top three categories were medicine (30%), business management and accounting (11%) and computer science and social sciences (9% each), The majority of published studies were case studies documenting a healthcare ‘innovation’ addressing a real world problem. However, the concept of healthcare innovation is not uniform across these studies. The concept included something ‘new’ and captured a wide spectrum of products, processes, services, business models ranging from the micro to the macro. This included technological products e.g. nanomedicine (Bhatia, 2018), biotechnology (Tikas, 2019, Natesh, 2009), digital technologies (Chakraborty et al., 2021, Chawla, 2021, Verma, 2021, Pradhan et al., 2021, Pradhan and John, 2021, Seethalakshmi, 2020, Ruohonen et al, 2017, Richardson et al, 2017); diagnostics (Mukherjee, 2021, Sharma et al., 2021, Manian, 2008); tele-health (Biradar and Sukumar, 2021, Mishra, 2009, Bhaskaranarayan, 2009, Bedi, 2009, Sood et al., 2007, Kannoju, 2011); smart healthcare devices (Papa et al., 2020, Rao etal., 2018, Mony, 2018, Hafeez-Baig and Gururajan, 201 |; loT (Budida and Mangrulkar, 2018); 3D printing (Karandikar et al., 2020), regenerative medicine (Tiwari et al, 2017); indigenous systems of medicine (Sen, 2020, Patwardhan, 2014, Ramaswamy, 2018); educational process (Rajeswaran, 2021, Chaturvedi 6etal,, 2011, Lindquist et al., 2020); organizational or management practice (Coumare et al., 2021, Velamuri, 2015, Mahajan, 2020, Nanath, 2011, Malik et al., 2017, Burns, 2012, Katragadda, 2007); health insurance (Kuruvilla and Lui, 2007); public private partnerships (PPP) (Engel and van Lente, 2014); business model (Goyal et al. 2014, Scholl, 2013); medical tourism (Medhekar et al., 2014) hospital designing (Rebecchi et al., 2018); diffusion of innovation in hospitals (Menon and Jafer, 2021); an existing community-based approach being implemented in a new context (Wickremasinghe, 2018, Dwivedi, 2015); grass root innov: mn (Tiwari and Sorathia, 2014); the capacity of local stakeholders to play an active role in innovative knowledge creation in order to enhance local health practices (ethnomedicine concept) (Torri and Laplante, 2009) and communities of practice in global innovation hub (Malik et al., 2021). The term ‘disruptive innovation’ was used in the context of family medicine/primary care in India (Biswas et al., 2009) and was defined as ‘right intentions at the right time that is driven by grassroots - may shift equilibrium of system that is more adaptable to the needs of the majority’ (Marmot, 2007). Healthcare innovation was also studied from the perspective of service innovation. Service innovation was referred to as a set of practices that create value through improvements or new service proposals, service processes and model of service deliveries (Kindstrém et al., 2013) to meet customer needs and satisfaction. This includes innovations such as major or radical innovation, new services for the currently served market, © offerings to affect emotions extension of services, service improvements and changing the appearance of se and attitude of customers (Christofi et al., 2014). The role of politics in innovation in the biopharmaceutical sector ‘was discussed in a comparative case study between India and South Africa (Papaioannou et al. 2018). In the following sections, the analytical framework described in the methodology has been used to categorise and discuss the studies and their findings. 1.1 Theory based and theory contributing studies, ied in this review (Table 1).‘Table 1. Theory-based or contributing studies to healthcare innovation in India ‘Serial Title of study (Author/s) Theory No. 1 ‘Analysis of digital technologies as antecedent to care service | Technology Acceptance Model transparency and orchestration (Chakraborty et al., 2021). | (TAM), Cybernetic control theory and Temporal displacement of care theory 2 E-health and wellbeing monitoring using smart healthcare | TAM devices: An empirical investigation (Papa et al., 2020) 3 Impact of information technology reliance and innovativeness | TAM on rural healthcare services: Study of Dindigul District in ‘Tamilnadu, India (Bhagya Lakshmi and Rajaram, 2012) 4 Converging resources and co-producing for innovation: | Resource oriented and co- evidence from healthcare services (Sehgal and Gupta, 2020) | production integrated theory 5 Cause-related marketing and service innovation in emerging | Resource based and dynamic country healtheare: Role of service flexibility and service | capability theory climate (Kumar et al, 2020) 6 Bridging the service divide through digitally enabled service | Service centric value creation innovations: Evidence from Indian healtheare service providers (Srivastava and Shainesh, 2015). 7 Doing well to do good: Business model innovation for social | Social Business Model healtheare (Velamuri et al., 2015) 8 In-vitro diagnostics (IVDs) innovations for resource-poor | Theory of challenge settings: The Indian experience (Singh and Abrol, 2017)9 ‘Characterizing innovations in maternal and newborn health | Theory of Change based on a common theory of change: lessons from developing and applying a characterization framework in Nigeria, Ethiopia and India. (Makowiecka et al., 2019) 10 Need for flexibility and innovation in healthcare management | Theory of flexible health systems Systems (Wadhwa et al., 2007) i “I's About the Idea Hitting the Bull's Eye™: How Aid Principles of aid effectiveness Effectiveness Can Catalyze the Scale-up of Health Innovations. (Wickremasinghe et al., 2018) The theoretical relationships between digital technologies adaptation with care service transparency and orchestration were validated empirically and path linkages analysed through a Structural Equation Modelling (SEM) study analyzing digital technologies in 100 private hospitals in India through questionnaire survey (Chakraborty et al, 2021). The study used the Technology Acceptance Model (TAM), eybernetic control theory, and temporal displacement of care theories to conceptualize the variables. The results of the study highlight the fact that the adoption of digitized technology platforms can achieve care service-orchestration among private hospitals. The study on E-health and wellbeing monitoring (Papa, 2020) was based on TAM and focused on adoption of smart wearable healthcare devices innovation through a structural equation modelling (SEM) methodology using primary data. The study found that user comfort was a significant factor in adoption of this innovation, but generalizability was low due to the small sample size of the study. Another larger sample size study used TAM and SEM to analyze the influence of IT applications and innovativeness on acceptance of rural healthcare services in a district in Tamil Nadu (Bhagya Lakshmi and Rajaram, 2012). The results confirmed literature findings that health information, perceived usefulness and innovativeness of health personnel positively influence ease of use perception for adoption of IT in healthcare services. Sehgal (2019) in their cross-sectional study used SEM methodology to understand the generation of incremental and radical service innovations based on resource-oriented and co-produetion integrated theory and found that internal resources drive a more positive 9and significant impact, which is stronger for incremental innovation (rather than radical innovation) in healthcare. Resource utilization in conjunction with co-production activities has greater potential to bring innovation that is likely to succeed and stay inimitable. Resource-based view along with dynamic capability perspective was applied toa cross-sectional sequential exploratory mixed method case study (Kumar et al., 2019) on healthcare market in India to assess the effect of cause-related marketing (CRM) to service innovation. Using SEM and in-depth interviews, the study provided an integrated framework that included CRM, service flexibility, service climate and service innovation. Service flexibility emerged as a mediating mechanism between CRM capability and service innovation. Information and communication technologies (ICTs) can be leveraged to bridge the service divide to enhance the capabilities of service-disadvantaged segments of society. Through an inductive process, a case study identified four key enablers for successfully implementing these ICT-enabled service innovations: obsessive customer empathy, belief in the transformational power of ICT, continuous recursive learning, and efficient network orchestration (Srivastava and Shainesh, 2015). The theoretical contributions from this study are largely associated with unearthing and understanding how three interactional resources (knowledge, technology and institutions) were orchestrated for service-centric value creation in different combinative patterns as resource exploitation, resource combination, and value reinforcement. The analysis also reveals the three distinct stages of service innovation evolution (idea and launch, infancy and early growth, and late growth and expansion), with a distinct shift in the dominant resource for each stage. The theoretical construct of sustainable social business model was used to describe the case studies of three hospitals making social change (Velamuri et al., 2015). Singh and Abrol (2017), in their cross-sectional study based on secondary data review (quantitative and qualitative) analysed the policies and institutional arrangements for facilitating innovation ecosystem in resource poor settings using the case of in-vitro diagnostics. The research question was built from the theory of challenge based innovation system-building approach, which enables the pursuit of non-market social calculations in policy development. Areas for future research identified included emerging institutional voids, and identifying/formation of socially responsible systems of innovation. The theory of change was applied to describe characterizations of innovations in maternal and newborn health in Nigeria, Ethiopia and India (Makowiecka et al., 2019) for examining the effectiveness of a combined range of actors in an innovation. Characterization (a process of 10describing innovations using a framework of predefined questions) could help policymakers, evaluators and other stakeholders understand the work of diverse actors implementing innovations with a common aim. The theory of flexible health systems was used in a perspective paper (Wadhwa et al., 2007), wherein the best practices from the domain of technological systems were proposed for adoption in health systems innovations to make it more customer friendly. The use of the principles of aid effectiveness was qualitatively analysed at multiple levels for diffusion of innova ns and scalability of extemally funded maternal and neonatal Health innovations (Wickremasinghe, 2018). The analysis revealed that actions by donors, implementers and recipient governments to promote the scale-up of innovations strongly reflected many of the aid effectiveness principles embraced by well-known international agreements, including the Paris declaration of Aid Effectiveness. This study provides recommendations for scaling externally funded health innovations by putting aid effectiveness principles in practice. In the next section, the review findings from empirical case studies and perspective papers have been categorized across different thematic areas: public health, clinical practice, pharmaceuticals and medical devices and innovation ecosystems and policies. 1.2 Empirical studies on innovations for public health ‘The National Rural Health Mission (NRHM) of the Government of India was the subject of a case study (Dwivedi, 2015) focusing on bottom of pyramid (BoP) for improving service delivery using existing innovations in a different context. BoP, a phrase popularized by C. K. Prahalad (2005), describes an overlooked market ‘opportunity, the billions of people at or below the poverty line who may be viable consumers. This observation is promoting a shift in India’s healthcare industry as public and private players innovate and co-create to deliver healthcare to this large market (Parikh and Raghavendran, 2012). The role of private hospitals and business models in reaching BoP was the subject of a case study on three hospitals (Aravind, LG Prasad, Life springs), which utilized business models (organizational practice) for social healthcare (Velamuri et al., 2015). These case studies could also be viewed as frugal innovations as they highlighted need-based, bottom-up approach, which is adaptable and simple. The role of Non-Government Organizations (NGOs) in the diffusion and governance of innovations was highlighted in the context of emerging pluralism in India (Papaioannou et al., 2015) uMaternal and newborn health (MNH) featured as an important public health issue for innovations by both government and NGOs (Chawla et al, 2021). Innovative initiatives by NGOs on MNH were documented in studies by Vani (2009) and Paninchukunnath (2017). The issue of access and affordability of MNH is not limited to rural areas and also exists in urban areas in India especially among the urban poor and vulnerable. In case studies documenting innovative initiatives in cities to address MNH, it was found that the service delivery structure and mechanisms in the urban areas were weak and not clearly structured, resulting in lack of clarity on roles and responsibilities as compared with rural areas. While there are some successful models of implementation like the Urban Health Initiative, Sure start initi ive (slums of Maharashtra state), Life spring initiative, Chiranjeevi Yojna, Balsakha Yojna (Gujarat state), the convergence of these healthcare sector initiatives with other sectors was limited (Sharma et al, 2016). Use of digital technology for MCH monitoring featured in two case studies, one of which was on a digital labour monitoring tool (Tandon et al., 2019), while the other case study focused on the application of distributed processing and internet technology through innovative platform called mHealth-PHC for quality maternal and child health (MCH) and health surveillance (Pande et al., 2012). In a study on extemally funded MNH innovations, contextual qualitative analysis of MNH innovations across three countries (including Uttar Pradesh, India) provided a multilevel policy level analysis of factors affecting scaling- up and diffusion of this innovation (Spicer, 2016). The study found multiple factors as enablers or deterrents of scaling-up, which could be categorised at two levels-decision level and implementation level. The decision level factors included decision making process, prioritizing and funding, and development partner harmonization. Implementation level influencers included health systems capacit sociocultural contexts of beneficiary communities, and access to healthcare. Adoption to cultural context was also found to be positively associated with innovation adoption in case studies of technological innovations addressing disparities in cardiovascular diseases service outcomes (Sinha, 2017). The above findings light the role of culture and commu participation in innovation adoption and the focus on flagship or externally funded innovations in health service delivery by government and non-government entities. While technology was used in some innovations, organizational and social innovations were made for other initiatives, but none of these initiatives had a multisectoral collective action, which could have resulted in a convergent innovation 2A review of mental health innovations in India revealed the focus of innovations on quality improvement, community-based care, involvement of lay workers, and use of technology-based programs (Pandya et al., 2020). A case study of integrating mental health in primary healthcare in Sehore (Madhya Pradesh state) shared field experiences of enabling and service delivery package (Lund et al., 2016). Involvement of lay workers without a dedicated mental health staff in the healthcare system affected improvements in detection and treatment practices and reflects the human resource challenge in health systems, Digital gaming, as an innovative tool for improving mental health, was documented along with the barriers to its acceptance in India in a case study. Though promising in scope, these interventions face pragmatic challenges for implementation in developing countries like India. Although increased use of technology, internet penetration and growing digital literacy have enhanced their accessibility and feasibility, various factors like socio-cultural diversity, lack of standardization, poor infrastructural support, bandwidth issues and lack of practice can impair their use and acceptability (Banerjee et al,, 2020). An innovation for postgraduate training in psychiatry for adoption in higher education in an institution (NIMHANS) for improving service (Chaturvedi et al., 2011) was the only ease study documenting an innovation in mental health education, Global literature suggests innovations in education have been less studied (Hossain, 2017) and there were only two studies related to evaluation of innovation in medical education (Chatterjee et al., 2016; Dongre 2010) and one case study on continuing education for prehospital healthcare providers (Lindquist, 2020). The studies on mental health innovation have tried to address the mental dimension in the conceptualization of health. However, impact of these innovations is limited by infrastructural issues and human resources. Cost-efficiency of health innovation featured in two case studies on innovation. One case study was on primary oral healthcare delivery of an indigenously fabricated mobile dental health unit (Goel et al. 2014), while the other \was on a new diagnostic test (FELUDA) for the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV- 2 virus) (Mukherjee, 2021). The dental health unit study showed that the innovation resulted in cost and operational efficiency for non-complex dental interventions, but had the limitations of infection control, time and space constraints in setting it up in the field. The FELUDA case study used Health Technology Assessment (HTA) to highlight the impact of the diagnostic test on health systems sustainability, efficiency and equity. The effect on financial risk protection in health financing innovations was considered in two case studies, which used National 1BSample Survey Organization (NSSO) data for a comparative analysis of two schemes in two states, the Aarogyashree scheme (Andhra Pradesh state) and Rashtriya Swasth Bima Yojna (RSBY) (Maharashtra state). The study showed that although inpatient care expenses decreased, overall out-of-pocket (OOP) expenditure incurred had increased despite the scheme (Rao et al.,2014; Katyal, et al.2015). In addition, cashless and paperless transactions were considered as innovations in RSBY (Taneja and Taneja, 2016). The above case studies reflect the economic impact of health innovations and analyse the notion of value for money. One of the reasons for the poor impact on OOP expenditure in health financing innovations have been the non-inclusion of reimbursement of outpatient services and medicines, which contribute to a large proportion of the OOP expenditure. This also suggests that technology like cashless/paperless transactions serve very little purpose if the root cause of the problem is not addressed. A narrative review on primary healthcare in India (Biswas, 2009) emphasized reviving the family medicine concept and the role of information technology and communication networks as a disruptive innovation for improving primary care in India. The importance of addressing social determinants of health as a tool for disruption was emphasized. Disease-specific innovations for improving healthcare delivery for Non- Communicable Diseases (NCDs) have been documented for diabetes (Thoumi et al., 2015), hypertension (Piot et al., 2016) and cardiovascular disease (Gupta et al., 2020; Sinha, et al. 2017). In the field of animal science, a case study (Ravikumar et al., 2016) documented the experiences of adoption of non-linear innovation involving the farming community to address the problem of ectoparasites affecting crops. Another case study using a multinomial logit model on adoption of livestock vaccination initiative (Rathod and Chander, 2016) found geographical access to vaccination site as a significant barrier for dairy farmers, which affected adoption of this innovation. However, interventions in these areas could be considered necessary and not ‘innovations’. Hence, pro-innovation bias should not marginalize other rationales and values. Addressing thes: actually points to the gaps in existing strategies and interventions, which have deviated from core sustainable strategies. Adoption of health information technology and communication networks through telemedicine and its role in improving access and quality of healthcare especially for rural areas were the subject of five papers (Mishra et 14al., 2009; Bhaskaranarayan et al., 2009; Bedi, 2009; Sood, 2007; Kannoju, 2011). While four of these papers were perspectives, Sood (2007) did a comparative case study analysis on telemedicine adoption between public and private healthcare organizations in India. Indian Space Research organization (ISRO), medical, technical and academic institutes involved in telemedicine courses, government and private telemedicine solution providers, Department of Information and Technology (DIT) and Ministry of Health and Family welfare (MoHFW) have been identified as important stakeholder: this field. The adoption of these services are different in public and private sectors and the use of telemedicine was assessed based on the American Telemedicine Association (ATA) framework (ATA, 2006), which identifies three services by which telemedicine supports healthcare: clinical medical services, health and medical education, and consumer health information. The comparative case study found that government telemedicine initiatives have promoted medical education and consumer health information, while private telemedicine initiatives have performed well in all three services. Also, telemedicine ‘was a top-down technology push initiative by the government, while it was more of a needs-pull initiative by the private sector. The cultural subsystems are an important variable affecting adoption of telemedicine and there is a need to integrate socio-technical issues in telemedicine implementation (Sood, 2007). However, there are problems related to access and use of information technology. A sequential mixed method study (Shilpa et al., 2020) on the use of mobile-based Comprehensive Public Health Management (CPHM) app found key barriers to the use of technology, which included limited technical expertise and support from the technical team, electricity cutoff in villages, no intemet connectivity in the field, traveling to primary health centre (PHC) to syne the data and enter the data in multiple registers and tablets. Although ease of monitoring continuity of care was a positive factor, the monitoring emphasis was on the paper-based records. The role of Health Management Information ‘Systems (HMIS) is critical in evidence-based decisions in healthcare, which is one of the dimensions of Universal Health Coverage (UHC). An innovative initiative of creating interoperability among multiple HMIS through the creation of a master facility list (MFL) was initiated by the Ministry of Health and Family Welfare (MoHFW) to provide a national identification number to health facilities (Mishra and Sahay, 2020). Currently, only two national public health information systems have been selected and there is a need to integrate with other HMIS holding facility data with the MFL, issue public notification of standards for MFL, do a comprehensive data 15quality audit of existing MFL facility data and establish robust governance mechanisms. The literature on digital innovation for public health in low and low-middle income countries argues that technical innovations are incomplete unless accompanied by associated institutional and social innovations (Sahay, 2018). The innovative MEL initiative is an example of a technical innovation, which is yet to be associated with institutional and social innovations. In another case study related to Health Management Information System (HMIS) in Bihar state, the findings are used to propose an integrated Health Information Architecture (HIA) that could enable healthcare providers, policymakers and program managers of public health agencies to use data for decision-making. With the increasing use of health informatics, the threat of data security is igh. In this context, a case study proposed security framework for addressing innovations like electronic health records (EHR), taking integrity, confidentiality and availability into consideration (Ganiga et al., 2020). The Indian studies on information technology adoption in healthcare reveal many structural and ecosystem factors affecting technology adoption. ‘The COVID-19 pandemic has resulted in an upsurge of tele health services as well as highlighted the need for robust HMIS for data management. However, acceptance of technology is dependent on individual behaviour, perceived use and usefulness. A seemingly simple inclusion of computerization of medical records can lead to resistance from users, which can hamper adoption and diffusion of new technology (Mukherjee and Babu, 2014), 1.3 Studies on innovations for clinical practice Many qualitative case studies documented innovations, which were useful for clinical practice or hospital settings. These innovations ranged from addressing individual patient care like innovative surgical instrument for endoscopic sinus surgery (Ahilasami et al., 2020), remote biosensor for maternal and neonatal monitoring (Mony et al., 2018; Rao et al., 2018), mobile and media technology for cleft lip speech therapy (Dhaky et al. 2011), adoption process of an innovative in house hand scrub for reducing hospital-associated infections (Sharma et al., 2015) to multidisciplinary administrative innovations including innovations for tackling COVID-19 (Mahajan et al., 2020; Rahman and Khan 2020) and supply chain management using an innovative hospital revolving fund (Chandra et al., 2013). The use of emerging technologies to revamp clinical functioning and improve patient experiences in India was the subject of a case study on Procto technologies (Chauhan and Kumar, 2013; Chauhan et al, 2015); while intemational cooperative technology platforms to address access and safety of 16haemoglobinopathies in Italy, Pakistan and India was documented in another comparative case study (Agarwal, etal. 2014), which was a collaborative exercise between Jagrit innovations, India and Cure2Children foundation, Italy. The ease study of Aravind Eye Hospital exemplified the role of lean management process innovation to improve access, quality and affordability of eye care (Sharma and Kakoti, 2012), Although clinical or surgical innovations involve medicines or devices, their defining characteristics are the special combination of clinical-surgical skills and abilities they entail. While incremental innovations can happen in daily practice, major surgical procedures (radical innovations) are developed in specialised academic centres and are not patented. The motivation could be academic prestige, thrill of being first, etc., and costs of research and development are generally lower than medicines or devices. No formal regulatory approval is required for its diffusion and its evaluation is left to the medical profession in the spirit of clinical autonomy. Sometimes, the presence of a surgical team capable of performing an experimental operation helps an institution portray itself as a modem facility using breakthrough technology to provide high-quality care which helps hospitals attract physicians and patients, and provides them a competitive advantage in their local and regional markets. 1.4 Studies on patents, pharmaceuticals and medical devices ‘The impact of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement on innovation, access to medicines and the tension between patent as an incentive for innovation and right to medicines and health in the Indian socio-cultural context has been the topic of discourse in some of the perspective papers on the pharmaceutical sector in India (Jafar and Sajna, 2018; Pai, 2015; Renganathan et al., 2016). The creation of innovations in a knowledge-intensive sector like the pharmaceutical industry is essentially a dynamic process and the capability of firms to renew or reconfigure technological capabilities is based on their ability to develop new competencies by acquiring knowledge and integrating it with existing knowledge (Kale, 2005). There is no empirical evidence to suggest that patent rights have led to increased innovation in developed countries (Correa, 2015) and widening the Intellectual Property Rights (IPR) regime to developing countries has in fact adversely affected local innovation (Jafar and Sajna, 2018; Correa, 2009). Several local pharmaceutical companies have merged with Multinational National Corporations (MNCs) post~TRIPS implementation, which has shifted the innovation focus in pharmaceutical sector in India to diseases of the developed world (Safar and 7Sajna, 2018). Nevertheless, pharmaceuticals have been included as a strategic sector in the ‘Make in India” campaign, which opens possibilities for new innovations. In an opinion article, a strategy is proposed for need- based innovation of new affordable pharmaceuticals using organ printing technology (Kamalasanan, 2016). Biotechnology products are the fastest growing segment among pharmaceutical industry and the advent of biopharmaceuticals and biosimilars will require changes to existing innovation policies (Desai, 2016). Although India is one of the largest manufacturers and exporters of generic medicines (which is much cheaper than branded medicines), the use and prescription of branded medicines is very high and contributes to the high Out of Pocket (00P) medicit 1 expenditure in India. To address this issue, the Jan Aushadhi Scheme (IAS) was implemented as a policy innovation to make generic medicines more accessible (Mukherjee, 2017). However, although the scheme has been in place for over a decade (with name changes), the adoption of the scheme by healthcare providers and acceptability of generic medicines by patients remains low (Thawani, 2017). However, the case study of the Chemical, Industrial and Pharmaceutical Laboratories (CIPLA) showed how innovation in manufacturing and marketing helped an Indian pharmaceutical company change the discourse on use of generic drugs for HIV/AIDS and made these HIV generic medicines available for the global south at affordable prices (Jafar and Sajna, 2018). Three documents focused on the role of innovations in ISM (Patwardhan and Mutalik, 2014; Sen and Chakraborty, 201 ; Ramaswamy, 2018) and the importance of integrating traditional knowledge with modem science and the creation of a new model for integrative medicine. However, innovation in ISM has been less studied. In the pharmaceutical sector, four types of policies (policy set) appear to have stimulated and supported innovation processes globally: policies that strengthen the requisite knowledge base, stimulate capacity building, create space for startups to emerge and small and medium-sized enterprises to grow and policies that provide incentives for innovation (Mytelka, 2006). However, pharmaceutical innovation system remains underdeveloped in the Indian context (Abrol et al., 2019). In pharmaceutical innovation, a strong interdependence exists between pre-marketing approval, patent, payment/reimbursement and post-marketing policies. In the case of life-threatening disease, the tension between pre-marketing approval and early product availability becomes critical. Pharmaceutical innovation is also affected by international trade agreements, for e.g. TRIPS and national policy environment. 18While pharmaceutical companies advocate for patent rights citing research and development costs, it has also been reported that information manipulation exists (Das, 2012) and the costs portrayed as research and development could also include marketing costs. Moreover, what constitutes true innovation is questionable as ‘cases of ‘evergreening’ (minor change) are exposed. The Novartis case in India is a notable example which exposed the nuances between true innovation and evergreeing (Ehrlich and Fenster, 2013; Nomani et al, 2020). While the Indian Supreme Court decision favoured generic production of a costly anti-cancer medication within the context of an international policy, India’s own national policy to increase the use of generic medicines has to date been unable to break the dominance of branded medicines in the market. This is reflected in studies on the JAS schemes in India (Thawani, 2017; Mukherjee, 2017). The poor uptake of the JAS scheme for generic medicine is best understood through the lens of political economy and actor network theory, which affects both supply and demand. On the supply side, there is the power play resulting from the nexus between pharmaceutical ‘companies and medical professionals, who inspite of being mandated to write generic name of medicines, write brand names and contribute to the supplier-induced demand of costly branded medicines. On the demand side, people’s own perception (conditioned over many years) that branded are better quality than generic medicines and the technology (branded medicine) itself becomes an actor as part of the actor network theory influencing the patient's choice and demand In the context of innovation in medical devices, there are very few studies because the Indian medical device market is dominated by imports (Chaturvedi et al. 2015) which makes the products costly. Hence, there is a need for local innovation to increase accessibility and affordability of medical devices. The ‘Make in India’ and ‘Start up India’ policy initiatives are aimed at fostering innovation through an enabling ecosystem for medical devices (Sahu and Panja, 2017). Currently, both pharmaceuticals and medical devices in India are under the purview of the Drugs and Cosmeties Act and the approving authority is the Drug Controller General of India. As compared to the pharmaceutical industry, the medical device industry is younger, more heterogeneous and with a shorter product life. A high level of incremental innovation exists for medical devices and the effectiveness of the device is often dependent on the skills of the practitioner using or implanting the device. State regulation, social control, improvements in critical inputs of pharmaceuticals, diagnostics, medical devices, 19traditional healthcare are issues in innovation policy (Abrol, 2016). Governance innovations were reflected in two case studies. In a cross-sectional action research study (Ray and Mukherjee, 2007) based on secondary literature review, a framework was developed for better implementation of e-governance in Indian healthcare sector. In the other case study, role of innovative institutional structures in integrated (health and nutrition) governance in Chhattisgarh was discussed using a mixed methods study. The innovation outcomes described included ‘community participation, improved service delivery, accountability and human resource rationalization (Kalita and Mondol, 2012). The role of open innovation and governance modes in organization design at the base of pyramid was discussed in an in-depth case study of a PPP model (George et al., 2015). Frugal innovation in vaccine biotechnology was explained through the case study on Shantha Biotechnics (Chakma et al..2011), while the managerial innovations of Life Spring Hospitals was considered as a case of social innovation in Indian healthcare (Scholl, 2013; Nanath, 2011). While the Novartis case study represents one dimension of the private sector, it is not the only one. The case study on Shantha Biotechnics provides an example of the positive role of private sector in global health and access to medicines. The company was able to produce hepatitis B vaccine and price it at less than USD 1/dose by focusing on cost-efficiencies targeting the poor, partnering with non-traditional sources and focusing on innovation and quality. Aravind eye hospital, Life Spring hospitals, Narayana Hrudalaya case studies show how private hospitals have been involved in lean management and frugal innovations for providing good quality affordable healthcare. The above case studies highlight the role of internal and external drivers of healthcare innovation in India, While many innovations have been internally driven by organizations and industry notwithstanding a challenging ecosystem, there are examples of innovative policies not succeeding due to resistance from industry and professional groups. Hence, understanding innovation policies and ecosystem. is critical for understanding the creation, adoption or diffusion of healthcare innovations, which is discussed in the next section, 1.5 Studies on Healthcare Innovation Ecosystem and Policies Innovation ecosystems can be considered as breeding grounds for cross fertilization of ideas across multiple sectors and disciplines (Frew, 2007). Involving society and societal orientation are very important in innovation lifecycle and for developing sustainable innovation ecosystems (van Drooge and Spaapen, 2017). The innovation. 20translation ecosystem (transformation of knowledge through successive fields of researches from a basic science discovery to an effective public health impact) is a complex process and may have unidirectional (NIH, 2007) or 4 multidirectional approach encouraging multidisciplinary collaboration (Woolf, 2008) and involve research and non-research activities (Drolet and Lorenzi, 2011). Components of a translational ecosystem include medical research and development (R and D science and technology institutes), translational units [Science and Technology Entrepreneur Parks (STEP), Technology Business Incubator (TBI), Special Economic Zones (SEZ), etc.], funding entities, regulatory bodies and technology transfer entities (Dixit et al., 2018). However, studies on Indian ecosystem were limited. A qualitative case study on Centre for Cellular and Molecular Platforms (C- CAMP) has documented the experiences and challenges of such an innovation ecosystem in biotechnology (Tikas et al., 2019). The review finds that India currently has 22 funding entities, 10 regulatory bodies, 23 technology transfer entities and each innovation has a different route to translation and there is a need to bring all stakeholders together at a common platform for smooth linkages to create indigenous affordable innovative solutions. Based on the discussion above, it emerges that the India has a complex innovation ecosystem with innovations having to negotiate multiple regulatory and policy frameworks. This would result in a slow approach to adoption and diffusion/dissemination of healthcare technologies and create innovation gaps (Nomani, 2020). In spite of this, India is recognized globally as a hub for innovations and the COVID-19 pandemic provided an opportunity for healthcare innovations (Mukherjee, 2021). Since, surveillance and control strategies for COVID-I9 are heavily dependent on quick and reliable testing, medical device sector (which are mainly import dependent in India) emerged as a hotspot for innovation and many new rapid diagnostic tests were developed for SARS-CoV- 2 screening. However, Health Technology Assessment (HTA) was done on only one of these, FNCAS9 Editor- Limited Uniform Detection Assay (FELUDA) which showed its cost effectiveness as well as positive impact on the Indian healthcare system and the importance of HTA in health innovation ecosystem (Mukherjee, 2021). Study limitations Although the study used a broad selection criterion, the review was limited to published literature in English language in the Scopus data bases and their references, and hence would have missed studies which did not fulfil the sele n criteria, Healthcare innovations are also reported on grey literature like reports, social media, news 21ete, However, these were not included in this study, since the focus of this research was on published scholarly peer reviewed studies, Conclusions Healthcare innovation is a complex phenomenon involving multi-level, multi-dimensional and multi-disciplinary web of interactions. A sustainable healthcare innovation would require behavioural change in the health systems and the actors (including end users or patients) (Plamping, 2009; McNichol, 2012). A holistic systems approach to innovation is the key to generate, adapt, diffuse and sustain healthcare innovations. Innovation is embedded in both policy and institutional contexts, and different innovation outcomes emerge as a result of the interactions between those with a techno-centric focus, and the traditional habits and practices of the actors towards innovation. The term ‘technology’ is ubiquitous and includes artifacts, activities, knowledge and modes of organization. The interaction between society and technology leads to the construct of the socio-technical system. This socio-technical system is shaped by social interests (current and historic), the operations of power, and the context in which the technology is developed. In this context, the role of HTA, which provides evidence on economic value, population health value and health systems value, in the innovation ecosystem remains less explored. In the Indian context, systematic review or scoping studies were very limited. There were only two Indian studies, which were database searches, but limited in scope, in the areas of nanotechnology and mental health, The review on nanotechnology was a replication-extension study, which mapped the nanomedicine innovation landscape in India (Bhatia et al., 2018) and the study on mental health was a review of mental health innovations in India (Pandya, 2020). There were only eleven theory-based or contributing studies in the Indian context, identified in this review. A large proportion of healthcare innovation studies conducted in India were cross-sectional case studies (there were no longitudinal case studies), which provided useful information but were limited in generalizability. These empirical studies mainly focused on a real world problem or described a particular innovation, and were mainly qualitative in nature. There were four quantitative studies using Structural Equation Modeling (SEM) methodology, and only two studies using mixed methods. A grounded research methodology was applied to only one study describing the frugal innovation in vaccine (biotechnology) generation, adoption and scaling (diffusion). Policy perspective or analysis was very limited and the majority of 22studies did not apply a multi-level dimension of analysis. Hence, there is a need for more studies applying a systems approach to frame the research question and using a multi-level integrated dimension of analysis in the Indian context. A limitation in methodology, which emerged from this review was the source of data for these studies, ie. the academic electronic databases. While these data bases capture high quality academic publications in various research disciplines, many healthcare innovations do not get published in scientific literature, but are reported in media (social media, news, business and government reports, webportals etc.). Hence, future researchers may consider a broader based exploratory search method to include grey literature (along with academic sources), along with targeted searches of dedicated websites and subsequent snowball sampling of the most relevant websites to get a comprehensive picture of the healthcare innovation space. Healtheare innovation in the Indian context involves technological and organizational renewal within an environment featuring diversity of stakeholders. It involves changes in design, services, products, production process (technology element), new/altered organizing or administering (organization element), new/improved ‘ways of interacting with other organizations/knowledge bases (system interaction element), and new world views, rationalities, visions, strategies (conceptual element). Healtheare innovations could be systemic or frugal in nature aimed to improve service delivery and could be union/federal government-led (e.g., National Health Mission) or state government initiatives (e.g., state-funded Public Private Partnership models). In addition to healthcare service delivery for public health, the review finds that innovations are important in clinical practice, pharmaceuticals, medical devices and ISM, but are affected by the international and national policies affecting the ecosystem. Health innov: ms in India span the entire spectrum of prevention, diagnosis, treatment, rehabilitation as well as organization of health care. COVID-19 has resulted in crisis-specifie innovations but many of these innovations can be useful in the long run for the health systems. The role of inclusive innovation as a driver for equity and increasing the translational rate of healthcare technologies also emerges from the above discussion. Actors and stakeholders involved in healthcare innovation include the government, private sector, academic institutes, international institutes (involved in collaborative programmes), civil society organizations and patient groups. Although, collaboration has been identified as a factor facilitating innovation in general, the 23review of pharmaceutical innovations in India shows that collaborations (reflected through mergers) has actually curtailed innovation and shified the focus to diseases of the developed world. The FELUDA case study highlights the importance of HTA to provide evidence on value of healtheare technology from the systems perspective to policymakers for evidence informed decision making. In order to identify research gaps and areas of future research, the framework provided by Greenhalgh (2004) has been modified and used in this study. This framework attempts to integrate work from various paradigms and disciplines into a single conceptual model to cover key areas in healthcare innovation life cycle. Using this modified framework, the research gaps emerging from this review is shown in Table 2. Table 2. Research gaps in healthcare innovation Healtheare Research Gap innovation domains/stages Emergence What constitutes a healtheare innovation? How do these innovations arise and in what circumstances? Adopters and | Which factors tend to produce adoptable innovations? Adoption Why are some innovations rejected after adoption? ‘What roles do societal structures play in individual decisions on innovation adoption? How do various internal and external factors contribute to foster innovation adoption? Diffusion ‘What is the nature of interpersonal influence and leadership on diffusion of innovations? ‘What is the role of Supplicr-Induced Demand (SID) in the spread of healthcare innovations? Policy and How can the impact of innovation be assessed and anticipated? Ecosystem ‘What is the link between innovation (science) and decision making process (policy)? ‘What criteria guide the policy choice of innovations for diffusion/scaling? Can HTA be used to guide scaling-up of cost-effective innovations for sustainable healthcare systems? How do innovative startups respond to regulatory constraints and changes? To what extent are existing healthcare innovations addressing the UHC dimensions? What is the extent of alignment of innovation policies with the UHC goals? How are new technologies shaping the healtheare ecosystem? Are innovations addressing equity or creating inequity? 24What constitutes a well-functioning ecosystem for innovative startups and how can such ecosystems be nurtured by policy? The study concludes that although a rich body of literature has been developed on healthcare innovation in the Indian context, the approach has been fragmented. Healthcare innovation transcends multiple disciplines but an interdisciplinary approach to the issue is lacking. Different authors have conceptualized healthcare innovation differently and focused on their own areas of expertise in their research. While this is has helped a domain specific development of understanding of healthcare innovation, it only represents part of the picture. 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