Punit Bhatia

Responsibilities: • Lead clinical development for low-field MRI and robotic-assisted systems, supporting 0→1 product lifecycle from early feasibility through clinical deployment. • Act as the primary clinical interface to urologists and KOLs, translating procedure-level observations into validated clinical requirements, risk mitigations, and design inputs. • Define and validate clinical performance metrics using bench, phantom, and simulated-use models; execute EVT, DVT, and PVT to ensure seamless hardware–software integration across imaging coils. • Support regulatory and quality compliance by maintaining traceability (user needs → design inputs → risk controls → verification) in accordance with FDA 21 CFR 820, ISO 13485, and ISO 14971. • Manage tech debt backlog, ensuring tickets are clearly described, estimated, and prioritized, leading to on-time SW feature delivery. • Support GTM initiatives, communication, and customer outreach as a cybersecurity expert for clinical data management and interoperability. • Partner with executive stakeholders to align clinical priorities with product strategy, tracking OKRs and KPIs across multiple product lifecycles. Key Achievements: • Accelerated time to clinical readiness by ~20% through cross-functional execution between 6+ teams (R&D, quality, clinical, manufacturing) and coordination with OEMs, and vendors. • Contributed $4M in B2B deals through product demonstrations and strategic collaboration with sales and clinical teams to tailor solutions to customer needs. • Led VOC-informed UI/UX improvements for clinical webapps, enhancing workflow efficiency by ~40% and improving adoption and usability. • Strengthened cybersecurity posture by implementing secure authentication and robust PII/data handling policies compliant with HIPAA, FDA, and SOC standards. • Partnered with service and clinical teams to analyze parametric and QC data, driving process improvements that reduced downstream service costs by ~$30K/month.

Responsibilities: • Conducted market and user journey research to refine product positioning for Concha’s OTC hearing aids and Soundscope app, improving customer onboarding experience and product fit. • Worked with external partners to integrate healthcare payment systems, aligning app functionality with payer expectations (FSA/HSA), and informed discussions around reimbursement pathways for OTC medical devices. • Performed thorough proofreading and quality checks of over 50 regulatory documents and submissions for 510(k) clearance. • Gathered, prioritized, and communicated sales and customer feedback to inform product development and drive feature enhancements. • Contributed to the creation of strategic marketing plans, including market opportunity analysis, customer segmentation, product positioning, messaging, and pricing strategy. Key Achievement: • Identified 2 new market segments in the hearing loss space through pre-launch partnerships initiatives with retailers, health systems, benefits providers, and audiologists.

• Conducted stakeholder interviews to identify current challenges and user needs to confirm Eysz’s value proposition for a SaMD to detect pediatric absence epilepsy. • Authored design and test-method V&V plans and protocols for Eysz's absence seizure detection SaMD. • Defined product requirements, created prototypes for new software features, and led user training sessions.

• Led 30+ complex IT projects for a biopharma client as part of a merger and acquisition (M&A) project transfer, focusing on process optimization, data analysis, and cross-functional coordination for the seamless transition of software platforms and development processes. • Analyzed large unstructured datasets to identify key operational metrics, delivering insights that enhanced process efficiency by 20% and supported strategic decision-making. • Collaborated with portfolio and IT leads across 3 global locations to identify project requirements, risks, and assumptions. Executed comprehensive change management strategies and communication plans, guaranteeing project success and on-time delivery for all phases of the Software Development Life Cycle (SDLC). • Resolved 95%+ of ServiceNow tickets within SLA timeframes, improving system efficiency and user satisfaction.

A professional degree blending the engineering, clinical, and entrepreneurial aspects of translating medical innovation into clinical reality, involving regulatory, reimbursement and business strategy.