Context: Innovation in India’s Emerging MedTech Landscape

In 2018, Priyanka, founder of Manuh Collective, joined Biodesign Innovation Labs in Bengaluru as a Public Health Research Consultant on a Government of Karnataka–funded project. The three-month engagement aimed to strengthen research and regulatory pathways for a pediatric respiratory aid, developed from a CAMTech Hackathon prototype addressing critical gaps in child respiratory care.

At the time, India bore one of the world’s highest burdens of pediatric respiratory illness—particularly pneumonia and neonatal distress—while access to affordable, compliant respiratory devices remained limited. The regulatory environment was also evolving: the Medical Devices Rules (MDR) 2017 had just taken effect, introducing new requirements for manufacturing, ISO 13485 quality systems, and CDSCO clinical validation.

Within this landscape, Priyanka’s work focused on integrating public health research, design strategy, and regulatory preparedness to help the startup progress toward certification and safe deployment.

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Strategy and Partnerships

The project strategy centred on three priorities: building regulatory maturity, securing partnerships with licensed manufacturers and hospitals, and charting a pathway for clinical validation. Given limited funding, design and user research operated in tandem to optimise costs without compromising safety.

The team collaborated closely with the Government of Karnataka and leveraged IKP EDEN, a hardware incubator under IKP Knowledge Park, which provided prototyping facilities, mentorship, and compliance support. This ecosystem partnership proved critical in translating an early-stage prototype into a manufacturable, standards-ready product.

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Implementation and Regulatory Acceleration

To reduce the typical 8–12 month regulatory lag, Priyanka established weekly consultations with CDSCO officers, often working alongside Roshan, the product lead, to interpret compliance requirements and maintain continuous communication with regulators. A comprehensive live documentation system was developed, consolidating research inputs from CDSCO meetings, user interviews, and internal design revisions.

She also conducted extensive field research with over a dozen medical professionals—including senior anaesthetists and paediatricians—from 12 hospitals across Bengaluru. Insights from this research shaped a working clinical dossier, later presented to a notable Bengaluru-based institutional hospital for ethical and procedural approval. This submission resulted in formal approval for clinical trials, supported by a team of qualified doctors and domain experts who would oversee trial design and monitoring.

Scaling toward production required ISO-certified facilities and close coordination between design, materials, and cost management. Priyanka played a bridging role between medical practitioners, the CEO, and design engineers—aligning safety expectations with financial and technical feasibility.

Cross-border engagement with paediatric specialists in India and Bangladesh, who were advancing related patents and trials, further accelerated the approval of the clinical trial by the relevant institutional committee, leading to faster validation. The effort demonstrated how strategic timing, regulatory fluency, and stakeholder collaboration can enable lean startups to achieve compliance and pilot readiness under resource constraints.

 

Summary

This case underscores the importance of integrating design thinking with regulatory and clinical processes to advance responsible innovation in emerging health systems. Set against India’s rapidly evolving regulatory landscape, it highlights how lean, adaptive methods—live documentation, concurrent workstreams, and multi-stakeholder engagement involving clinicians, domain experts, and regulators—enabled progress under constraint. The process also reaffirmed that rigorous user research, clear market segmentation, and defined customer need are as critical as licensing itself. While securing approval for clinical trials and manufacturing licenses laid the groundwork for validation, the deeper challenge—and opportunity—lay in preparing for market penetration and responsible commercialization in resource-limited contexts.

 

Organisation: Biodesign Innovation Labs
Location: Bengaluru, India
Funding: Government of Karnataka
Year: 2018

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