Hemodynamic Stimulation Device
Development and Productization of Patented Biomedical Therapy
As an consultant to Vasoactiv Biomedical, I led the engineering design, development, and productization of a patented hemodynamic stimulation device for the ambulatory treatment of sepsis and septic shock. Through close collaboration with the startup founders, industrial designers, regulatory compliance engineers, and medical experts, I helped to develop a high-performance, safe, and user-friendly device that meets regulatory standards. The device has been granted FDA 510(k) clearance as a Class II medical device.
Mechanical
Engineering
Consultant
Role
Industry
Biomedical
Biotech
Medical Device
Tools
SolidWorks
Figma
Excel
Duration
~1 year
Mechanical Design
Medical Device Design
UX/UI Design
Skills
Design Process
1. RESEARCH |
Reviewed relevant FDA, ISO, and UL codes to ensure compliance with regulatory standards.
Conducted competitor analysis to assess the strengths and limitations of similar products.
Performed on-site studies with nurses and medical professionals in clinical environments to evaluate spatial, environmental, and usability constraints.
Researched anthropometric data to determine optimal product dimensions for both user and operator ergonomics.
2. DEFINE |
Developed comprehensive product design specifications, incorporating functional and performance requirements while aligning with clinical needs and regulatory guidelines.
Collaborated with quality and compliance engineers to draft a testing plan for FDA, ISO, CE and UL certification.
3. DESIGN |
Solidworks, Figma
Partnered with industrial designers to create a design that is highly functional, intuitive, and visually appealing, embodying a sleek, sterile, and advanced biotech aesthetic.
Worked with graphic and UX designers to develop a clear, user-friendly interface featuring instructional diagrams for electrode placement and intuitive controls for adjusting electrical current amplitude, pulse width, and frequency.
4. PROTOTYPE |
Built full-scale mockups using MDF and foam core to evaluate form, scale, and ergonomics.
5. TEST & ANALYZE |
Conducted on-site evaluations with nurses and medical technicians to assess usability, portability, and integration within medical spaces and bedside environments.
6. REFINE & ITERATE |
Refined multiple design iterations to enhance usability, functionality, and regulatory compliance.
Optimized the design for manufacturability and cost efficiency.
Successfully achieved FDA 501k certification for Class II medical device.