Product Development

At Innovate Medtech, we specialise in transforming concepts into reality. From initial ideas to tangible outcomes, we provide detailed renders, innovative designs, and functional prototypes to bring your Medtech vision to life.

Get in touch

01 — Discover, Conceptualise & Protect

Ideation + IP strategy to frame the problem, align on users, and shape protectable value.
Clarify user needs and business goals
Light patent landscape / FTO direction (non-legal) to guide novelty
IP ownership: you own all foreground IP; we assign inventions to you
Concept exploration and sketching; define the Minimum Viable Concept (MVC) scope

Deliverables: Need statement, IP plan, concept sketches, preliminary claims themes

02 — Proof of Concept & Early Prototyping

Build and iterate toward an evidence-backed MVC.
Concept development and R&D
Initial MVC prototyping; refinement and iteration cycles
Early feasibility / preclinical studies (if applicable)

Deliverables: Early prototype(s), feasibility findings, iteration notes (design rationale), next-step plan

03 - Define & Plan (Design Controls begin)

Turn insights into a testable, executable plan
Product Requirements: URS / Design Inputs and system architecture
Risk management plan (ISO 14971) and regulatory pathway (FDA/TGA/EU)
Development plan with milestones, budget, and timeline

Deliverables: PRD (design inputs), Architecture pack, Risk Register v1, Regulatory strategy brief, Development Plan

04 — Architecture & V&V Strategy

Blueprint the system and how we’ll prove it works.
System architecture, interfaces, and traceability setup
Verification & Validation (V&V) strategy and test method development
Usability plan (ISO 62366) and initial protocols

Deliverables: Traceability Matrix v1, V&V plan, draft test protocols

05 — Design & Prototype (Iterate)

De-risk quickly with looks-like / works-like builds.
Industrial, mechanical, electronics, firmware, and software design (DfX)
EVT/DVT-style prototyping and bench testing to strengthen your IP portfolio
DHF documentation in step with design evolution

Deliverables: CAD & drawings, BOM, prototype units, DHF updates

06 — Design Freeze & Verification Readiness

Lock the design and get test-ready.
Final design outputs; DFM/DFX; supplier selection and pilot build plan
Complete traceability: Inputs ↔ Outputs ↔ Protocols
Verification protocols approved; pre-subs as needed

Deliverables: Design Freeze, approved Verification Protocols, DMR draft, manufacturing transfer plan

07 — Verification, Validation & Manufacturing Transfer

Prove it, then scale responsibly.
Verification vs. design inputs; summative usability (ISO 62366)
Validation (bench/clinical as applicable); close residual risks (ISO 14971)
Complete DMR; tech transfer to CM, IQ/OQ/PQ, pilot builds; submission support (e.g., 510(k)/TGA/CE)

Deliverables: V&V reports, DHF/DMR complete, process validation, submission package

Get started today

Partner with us to revolutionise the medtech industry and bring your ideas to life.

Let's Talk

Ready to take your ideas to impact?

Partner with us to accelerate your medtech innovations.

Product Development

Our process

Discover how we've helped clients worldwide