Charles Policard

- Served as Co-Entrepreneurial Lead in the NIH eC3i Program, conducting stakeholder interviews, refining the value proposition, and contributing technical expertise to commercialization planning for the lab’s next-generation wound imaging device. - Led development of a new smartphone-based NIR imaging device by redesigning an existing lab system; guided hardware redesign, app development, and proof-of-concept testing, while drafting the full DHF and DMR for manufacturing transfer and validation.

- Maintained and organized essential documentation for medical device development, including Design History Files (DHF), Device Master Records (DMR), and internal read-me files for active prototypes and imaging systems. - Managed chemical inventories and enforced light safety protocols in accordance with EHS and lab-specific hazard assessments, ensuring full regulatory compliance and a safe work environment. - Coordinated human subject data workflows, including anonymization, imaging session scheduling, and digital backup processes, while maintaining strict adherence to IRB guidelines. - Oversaw lab operations, including scheduling of research personnel, equipment maintenance, and calibration cycles, to ensure uninterrupted device testing and data collection.

- Designed, prototyped and validated a smartphone-integrated thermal imaging scanner; later integrated the system with a NIRS module for non-invasive wound assessment. - Contributed to algorithm development for tissue curvature correction using Monte Carlo simulations, improving the accuracy of NIRS-based imaging on irregular anatomical surfaces. - Fabricated and tested tissue phantoms and validated optical setups under controlled bench-top environments, supporting product feasibility for diabetic foot ulcer monitoring. Documented experimental protocols and device design iterations, contributing to early-stage DHF inputs. - Assisted in sensor calibration, alignment procedures, and light safety assessments during clinical simulation phases

- Developed and validated a custom test bench to simulate physiological flow conditions for an IVC catheter system, using peristaltic pumps, flow meters, and pressure transducers; supported design iteration and process optimization. - Created and maintained detailed Bills of Materials (BOMs), assembly instructions, and verification protocols as part of the Device Master Record (DMR), contributing to manufacturing readiness under Design Control. - Participated in cross-functional design reviews with R&D, Quality Assurance, and external stakeholders to ensure device requirements aligned with manufacturability, risk mitigation, and usability goals.