Our Expertise

Product Design for Regulated Industries

surgical team performing surgery
What we do in:

Product Design for Regulated Industries

If you market products to the healthcare, aerospace, oil & gas and other highly regulated industries, you know how tough and demanding creating those products can be. You have no room for error, and the customer and regulatory requirements are extreme and unforgiving. We have the know-how to develop these types of mission critical products to meet safety, regulatory, usability, functional, and manufacturing requirements. When you serve these markets, you know that product failure can lead to loss of the brand equity you’ve worked hard to build, injury and worse. You need a development partner that understands this and has the process and skill you need to succeed.

We begin your project with a strategy phase to define project success criteria that are aligned with your business goals. We conduct ethnographic and secondary research with you to define your stakeholder needs and project direction. We develop and test concepts with stakeholders then refine them until we find the optimal concept direction. We maintain direct contact with your supply chain and manufacturing teams to ensure the design meets your production and quality needs. Experienced engineers, designers and support staff design your product and create a documentation package your supply chain can use to manufacture the product.

We ensure design intent and stakeholder needs are maintained as your product transitions from concept, to feasibility, production to make sure it generates maximum revenue and profit.

Depending on your needs, the M3 team support your production runs as your virtual engineering team, or simply be on-call to help you deal with issues during production ramp up.

  • Risk Analysis
  • Ethnographic Research
  • Journey and Workflow Mapping
  • Human Factors & Usability Assessments
  • Concept Development & Prototyping
  • Engineering Analysis
  • Development Testing
  • Formative and Usability Studies
  • Certification Testing Support
  • Detailed Parts and Assemblies
  • Production Level Drawings
  • Tolerance Analysis and GD&T
  • Design Transfer Documentation
  • Production Ramp-up Support

Our
Process

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M3 Designer conducting a strategy workshop

Strategy

Define the toughest design challenges, identify opportunities, and establish product success criteria to manage development risk.

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designer sketching concepts

Concept

Develop innovative concepts that optimize usability and functionality, while still meeting business objectives.
Explore those concepts, evaluate them against success criteria, and validate with key stakeholders.

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handheld surgical device

Development

Translate the concept into a production solution, working closely with our client’s supply chain partners. Ensure that design intent and success criteria are maintained throughout manufacturing bring-up.

engineer performing contextual research
deltav prototype to production
testing a prototype robotic controller
Operators using the flexedge
concept sketches for stryker bonemill
electronics testing
M3 engineers performing process control field research
cad thermal model
technician using an emerson trex communicator
Stryker bone mill with core 2 console
M3 Engineer testing bone mill prototype
surgical team using stryker bone mill

When the repercussions of your design decisions are a matter of life or death, you should work with a design and engineering firm with a proven track record of successfully innovating under such conditions.

The award winning Mill is a testament to the partnership between M3 Design and Stryker. Great people working together deliver great results!

Mickey Noonan VP of Global Product Excellence at Stryker Instruments

Stryker Bone Mill

View the Case Study

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How can M3 Design accelerate your product development and experience designs?

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