title: Case studies of innovative medical device companies from India: barriers and enablers to development.
abstract: BACKGROUND
  Over 75% of the medical devices used in India are imported. Often, they are costly and maladapted to low-resource settings. We have prepared case studies of six firms in Bangalore that could contribute to solving this problem. They have developed (or are developing) innovative health care products and therefore are pioneers in the Indian health care sector, better known for its reverse engineering skills. We have sought to understand what enablers and barriers they encountered.
  
  
  METHODS
  Information for the case studies was collected through semi-structured interviews. Initially, over 40 stakeholders of the diagnostics sector in India were interviewed to understand the sector. However the focus here is on the six featured companies. Further information was obtained from company material and other published resources.
  
  
  RESULTS
  In all cases, product innovation has been enabled by close interaction with local medical practitioners, links to global science and technology and global regulatory requirements. The major challenges were the lack of guidance on product specifications from the national regulatory agency, paucity of institutionalized health care payers and lack of transparency and formalized Health Technology Assessment in coverage decision-making. The absence of national evidence-based guidelines and of compulsory continuous education for medical practitioners were key obstacles in accessing the poorly regulated and fragmented private market.
  
  
  CONCLUSIONS
  Innovative Indian companies would benefit from a strengthened capacity and interdisciplinary work culture of the national device regulatory body, institutionalized health care payers and medical councils and associations. Continuous medical education and national medical guidelines for medical practitioners would facilitate market access for innovative products.
authors.affiliation: Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase I, Bangalore, India.
authors.forename: Szymon
authors.initials: S
authors.lastname: Jarosławski
authors.forename: Gayatri
authors.initials: G
authors.lastname: Saberwal
mesh_terms: D001709:Biotechnology / Q000458:organization & administration*; D057191:Capacity Building; D002202:Capital Financing; D003132:Commerce; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence / Q000592:standards; D019719:Diagnostic Equipment / Q000191:economics / Q000592:standards; D019981:Health Care Sector; D006801:Humans; D007194:India; D007221:Industry; D007407:Interviews as Topic; D009935:Organizational Affiliation; D019982:Organizational Case Studies; D011357:Product Line Management; D018581:Technology Transfer