BioSim Design
Engineering Innovations Await You
At BioSim Design, we are dedicated to providing exceptional engineering consulting services to medical device companies. Our expertise bridges the gap between concept and reality, ensuring compliant, innovative designs to enhance your product offerings.
CAD and Technical Drawings
Services
Computational Simulation
Additive Manufacturing
Software Development
Pioneering Medical Engineering Solutions
Established in January 2025, BioSim Design specializes in CAD, Computational Simulation, Rapid Prototyping, and Software Development. Extensive experience in ensuring adherence to 21 CFR 820.30 Design Controls puts innovation on the right direction.
We cater specifically to Medical Device Companies, focusing on Life Cycle Management and Quality Assurance. Through our comprehensive consulting services, we help researchers and developers progress their projects to new heights, maximizing efficiency and innovation.
Project Examples
Custom Orthosis Designer Web Application
Completely customized orthosis designer that easily runs on any computer. Runs with an accompanied iPhone Scanner App and HIPAA compliant server, database, and log-in system.
About Me
On the software side, I build custom applications tailored to the problem — design tools, clinical workflows, data pipelines, or anything that doesn't fit an off-the-shelf product. When patient data is involved, I develop with HIPAA technical safeguards built in from day one.
I operate inside regulated environments under 21 CFR 820.30 and EU MDR — building Design History Files, running verification and validation, and producing documentation that holds up under audit.
My earlier career includes R&D engineering at Integra LifeSciences, working on Class II and Class III implantable devices. I currently serve as Senior Biomedical Engineer at Able Hands Orthotics, where I lead a patient-specific 3D-printed orthoses platform spanning iOS scanning, custom design software, and clinical fabrication.
I hold a B.S. in Biomedical Engineering from The College of New Jersey (Magna Cum Laude), with undergraduate research conducted under NASA-funded grants.
BioSim exists for the in-between work — the FEA study a small team can't staff, the regulatory package an overloaded engineer can't get to, the CAD revision needed before the next print run, or the custom software a workflow demands. If that's your problem, fill out the form below.
I'm Calvin, founder of BioSim Design. I help medical device startups and engineering teams move from concept to compliant, manufacturable product — bringing in surge capacity for the technical work that doesn't yet justify a full-time hire.
My work spans the full development cycle: CAD across SolidWorks, Rhino 3D / Grasshopper, and Fusion 360; finite element analysis in ANSYS, COMSOL, and Abaqus; and additive manufacturing for both prototyping and patient-specific end-use parts.
