What We Do Advisory Services Product Development

Product Development

Your MedTech Champion for Accelerating Innovation from Concept to Commercialization

Medical device development breaks down when engineering, quality, and regulatory operate in isolation. Prototypes fail electrical testing. Designs miss essential FDA design control requirements. Software architectures reveal cybersecurity gaps too late in the process.

Avania closes these gaps by integrating regulatory intelligence into engineering from day one. Our Global Design Lab unites hardware engineering, firmware development, mechanical design, and IEC pre-testing with regulatory strategy that anticipates FDA and EU MDR expectations before they become costly risks. Whether you’re developing an early proof-of-concept or preparing design verification for a 510(k), we connect engineering execution with regulatory readiness to accelerate your path to market.

Key Differentiators:

Engineering and regulatory integration supported by 100+ commercialized products
Regulatory-first design philosophy embedding FDA and EU MDR requirements into critical engineering decisions
In-house hardware, firmware, and PCB development with IEC 60601 pre-compliance testing
End-to-end support from feasibility prototyping through verification, validation, and submission
Expertise in connected devices, wearables, interventional technologies, and SaMD/AI
Full usability and human-factors engineering (UX/HF) capabilities

The MedTech Product Development Challenge

Progressing from concept to a cleared or approved device requires more than engineering skill. It requires understanding FDA expectations for your design history file before building. It requires clarity on IEC standards before finalizing electrical and mechanical design. It requires designing for manufacturability, safety, usability, and cybersecurity at the same time.

Most development firms build what you ask for, while regulatory consultants advise on what FDA expects. The gap between them leads to redesigns, failed testing, and submission delays.

Avania removes that gap. Our Global Design Lab builds prototypes shaped by regulatory strategy. When we design a PCB, we consider IEC 60601 electrical safety from the start. When we develop firmware, documentation aligns with IEC 62304. When we build your design history file, it reflects the device as engineered. Regulatory and engineering tell one story because they were built together.

MedTech Focus

Our heritage is medical devices. We work daily with IEC 60601, IEC 62304, IEC 62366, ISO 14971, and 21 CFR 820.30. When we design a prototype, we’re already thinking ahead to verification testing. When we develop firmware, documentation aligns with what FDA will expect. When risks arise during design reviews, we distinguish critical issues from manageable tradeoffs.

Why Avania: The Trusted Champion for MedTech Product Development

Our Experts

The Minds Behind Your Success

Our product development team brings deep engineering, regulatory, and clinical experience across every phase of the device lifecycle. These leaders have taken complex technologies from concept to commercialization in some of MedTech’s most demanding categories.

VP Product Development and Engineering

Matt Asselin, MSc

Engineering leader with experience taking cardiovascular, neurology, women’s health, and respiratory devices from concept through commercialization.
Former Philips engineering leadership.
Now leading Avania’s Toronto Global Design Lab.

VP Regulatory Compliance and Engineering

Acacia Parks, PhD, MBA, RAC

Expert in digital health, cybersecurity, and SaMD programs.
Former CSO for multiple successful digital-health companies.
Bridges regulatory, clinical, and engineering strategy.

Director of Quality Services

Catriona Boyd, RAC, CMDA

Specializes in QMS implementation
Specializes in DHF development
Specializes in software/cybersecurity quality systems aligned with FDA and EU MDR

Consultant, Cybersecurity Specialist

Nicholas Butt

Leads cybersecurity integration for connected devices and software-based technologies.
Strong record of FDA-accepted cybersecurity documentation and PCCPs.
Experienced in SaMD/AI, PCCP, Cybersecurity Documentation, DHF generation

Comprehensive Product Development Services for MedTech

Prototyping & Design Iteration

Proof-of-concept through engineering prototypes using production-equivalent materials. Rapid prototyping via 3D printing, CNC machining, and PCB fabrication. Design for Manufacturing guidance ensuring scalable, cost-aligned production readiness.

Hardware, Firmware & Mechanical Design

Multi-layer PCB design with EMI/EMC considerations and sensor integration. Embedded firmware for MCUs and RTOS environments. Full mechanical design and 3D CAD. All engineering work incorporates IEC 60601 requirements and full 21 CFR 820.30 traceability.

Human Factors & Usability

User needs analysis, use environment characterization, and formative usability studies. Summative validation per IEC 62366. Use-related risk analysis integrated with ISO 14971.

Verification & Validation

Design verification: performance testing, electrical safety, biocompatibility, environmental testing, and software verification per IEC 62304.

Design validation: simulated-use testing, clinical validation studies, and real-world performance assessment. Includes V&V master plans, protocols, and global site coordination.

IEC Testing & Pre-Compliance

Test plans aligned with IEC 60601-1, IEC 60601-1-2, and device-specific standards. Pre-compliance testing to detect issues before certified lab submission. Standards gap analysis and full coordination with accredited labs. (Pre-testing only; we are not a certified IEC laboratory.)

Design History File & Design Controls

Complete DHF development aligned with FDA and EU MDR expectations. Design inputs tied to user needs and regulatory requirements. Full traceability across outputs, verification, validation, and risk management.

Software & Digital Health

Software lifecycle management per IEC 62304. SaMD regulatory strategy. Mobile and cloud architecture, interoperability (FHIR/HL7), cybersecurity documentation per FDA guidance, and PDURS strategy. For large-scale builds, we partner with internal or external engineering teams while providing regulatory leadership and system architecture oversight.

Global Reach

Integrated FDA, EU MDR, TGA, PMDA, and Health Canada requirements built into development from concept phase. One development program designed for efficient global submissions.

Doctor using calculator and work on laptop computer

Client Success & Impact:

Proof of Our Partnership

“Avania provided electrical system design, firmware development, and complete development management to transform our concept into a market-ready device. Their work delivered exceptional technical and regulatory results — Paraglide launched as the first automated repositioning system, sold out its initial run, and is now improving care across Canada.”
Matthew MacKenzie, President
MacKenzie Healthcare Technologies

“What differentiates Avania is their depth — understanding the physiology, engineering, and clinical need. They refined our indications, built our testing strategy, and advocated effectively with both Health Canada and FDA.”
Joe Fisher, Chief Scientist
Thornhill Medical

“Avania delivered the clarity and expertise we needed at a pivotal moment. Their biocompatibility strategy led to clearance, and their fractional quality support helped us achieve ISO 13485 and MDSAP certifications.”
Karen Brunet, Founder & CEO
Cntrl+

our approach

Avania’s Integrated Approach to Product Development

Strategic Partnership:

We embed within your R&D, regulatory, and quality functions — participating in design reviews, resolving technical issues, and providing direct, actionable guidance. When there’s a problem, we tell you early and clearly.

Two colleagues reviewing financial data and charts

Purpose-Built Expertise:

Our team includes biomedical engineers, former FDA reviewers, clinical researchers, and manufacturing specialists. We balance regulatory rigor with usability, manufacturability, and cost to produce solutions that work in practice.

two surgeons analyzing a patient’s medical scans during surgery

Flexible Engagement:

Turn-key ownership of entire development phases. Targeted support filling internal gaps. Advisory retainers for ongoing strategy. Project-based deliverables. Avania can scale up or down as your program evolves.

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Operational Excellence:

ISO 13485:2016-certified quality systems. FDA 21 CFR 820-aligned design controls. EU MDR and IVDR documentation standards. When inspectors review your documentation, our work withstands scrutiny.

Ready to Move Your Device From Concept to

Validation?

Advance your product development program with a partner built for MedTech. Avania integrates engineering execution, regulatory intelligence, and global requirements to keep your path to market moving with confidence.

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