Medical device design & development

Design and development that plugs into your program, and grows with it.

Mycel Design augments your team or owns portions of scope outright. We bring in trusted specialists as the program needs them, so you move faster without adding headcount.

Start a conversation How we work
Core work, done by Mycel Connected specialists, one agreement

Ways to engage

Three ways to bring us in

Augment your team

Senior capacity embedded in your team, working inside your processes, tools and design controls.

Own a scope

A defined part of the program delivered end to end, from proposal to final report.

Assemble a team

Several disciplines for a program phase, sourced and coordinated by Mycel under one agreement.

How engagements run

Capabilities

The disciplines a device needs, through one point of contact

Core Done by Mycel

  • Mechanical designConcept through design transfer: CAD, mechanisms, enclosures, tolerancing, DFM/DFA and drawings.
  • Systems & design controlsRequirements, traceability, risk inputs and design history file documentation, delivered into your quality system.
  • Prototyping & testIn-house builds in engineering and composite materials, fixtures, bench testing and V&V protocols.
  • Analysis & simulationFEA and CFD run alongside the design work, to settle decisions early and support verification.
  • Technical & program leadershipScoping, proposals, schedules, change control and development process improvement.

Connected Through specialists

  • Human factors & usabilityUse-related risk analysis, formative and summative studies, IEC 62366 files.
  • Industrial design & UXForm, ergonomics, colour-material-finish and user interface design.
  • Electrical & electronicsCircuit and PCB design, power, sensing and electrical test.
  • Firmware & embedded softwareEmbedded control, with a software lifecycle to IEC 62304.
  • Quality & regulatoryQMS support, submission strategy, and 510(k) and De Novo preparation.

See services in detail

In-house analysis

Test the decision before you build the part

Most small design firms send analysis out, or skip it. Mycel runs structural, thermal and flow analysis in-house, next to the design work, so questions get answered while the CAD is still cheap to change.

Analysis guides design decisions and verification planning, and it can stand in for a test that can’t be run directly. When a model supports a regulatory submission, we build its credibility under ASME V&V 40, validating against targeted sub-system tests, with rigour in proportion to the model’s risk.

Questions we answer before the first prototype

FEA

Will this snap fit still hold after repeated assembly?

CFD

What pressure drop and shear does the fluid see through this path?

Thermal

How hot does the enclosure run at full duty cycle?

Drop

Where does this housing crack when it hits the floor?

Device experience

Medical device development since 2014

Nearly 12 years of development inside ISO 13485-certified quality systems, across the device types below.

Surgical

  • Stereotactic surgery
  • Surgical robotics
  • Laser surgery
  • Steam ablation

Drug delivery

  • Injectable
  • Inhalable
  • Ingestible
  • Aerosol delivery

Diagnostics & imaging

  • Breath diagnostics
  • Gastrointestinal diagnostics
  • Laser imaging
  • Ultrasound and RF imaging

Implants & equipment

  • Implantables
  • Sterilization equipment

More on our experience

  • Insured: E&O, CGL, cyber
  • MSA and mutual NDA ready
  • Time & materials or fixed price
  • Remote across Canada and the US

Need more hands on a program, or an owner for a scope?

Tell us where the program is and what’s in the way. You’ll hear back from Nathan directly.

Start a conversation

Or email hello at myceldesign dot com