From medical devices to industrial equipment, we help founders, clinicians, and engineers navigate the full journey — prototyping, manufacturing, regulatory approval, and everything in between.
We work across the full product lifecycle — from napkin sketches to shipped units. No stage is too early, no challenge too complex.
Technical feasibility analysis, regulatory pathway assessment, and concept refinement to de-risk your idea before major investment.
Mechanical, electrical, and firmware engineering. We build functional prototypes that prove your concept and attract funding.
DFM analysis, tooling oversight, and production process development to ensure your design scales efficiently and cost-effectively.
Regulatory planning, technical file preparation, and submission management for TGA, FDA, CE Mark, and other global markets.
ISO 13485 quality management system setup, DHF/DMR documentation, and audit readiness for medical device manufacturers.
Contract manufacturer selection, supply chain setup, and production launch support to get your product to market reliably.
A clinician came to us with a novel diagnostic concept. We took it from early prototype through to a completed TGA registration — on time and on budget.
"We handle the regulatory complexity so our clients can focus on their patients and their business."
We break complex projects into clear, manageable phases. You'll always know where we are and what's next.
We dig into your concept, constraints, and goals. We identify regulatory touchpoints and technical risks early.
We deliver a detailed project plan with timelines, milestones, regulatory pathway, and budget estimates.
Design, build, test, iterate. We run lean with frequent check-ins and design reviews.
Design verification, regulatory submission, and audit preparation. We manage the process end-to-end.
ProtoPhysics was founded on a simple premise: the best products come from engineers who understand both the technical and regulatory landscape — and know how to navigate both.
We work with founders building their first hardware product, clinicians with a clinical need, and established companies looking for a reliable development partner. Our focus is physical products where quality, compliance, and manufacturing matter.
Longer-form thoughts on AI, product development, and the future of hardware — written by our team.
ProtoPhysics is built by a team that ships. Here are two live products born from the same engineering-first mindset.
Whether you're at the concept stage or ready to scale, we'd like to hear about your project.
[email protected]Send us an email and we'll schedule a 30-minute call to discuss your project, no commitments required.
After our call, we can deliver a detailed project scope and estimate within 5 business days.
All enquiries and projects are covered by strict NDA. Your intellectual property stays yours.