We are your usability testing partners for medical devices.

A collective of expert consultants who will guide you through usability testing for your medical device. We will plan, develop,  execute and report on usability  test studies getting your medical device market ready and approved quickly.

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services

Why You Need Us

Regulatory Approval

Understand first. Did you know the FDA requires human factors testing for new medical device approvals?

Valuable ROI

Budget Friendly. Did you know that starting your usability testing process early will save you money in the long run?

Safer Devices

Success through safety. Did you know that one-third of medical device incidents each year involve use-error and human factors issues?

Building the Right Device

Design the device that your users need and want to use. Did you know that testing your device early and often with users means your get it right the first time and improves market adoption?

PROCESS

Our Approach

Thoughtful

As a small collective of specialists, we take the time to really understand the needs of our clients and the product challenges they face as they move closer to a market ready product.

How do we apply this principle?
  • We use a collaborative process that ensures we understand your company and needs right from the start. You book a consultation with us and we take away your challenge and provide a roadmap.
  • We’re in this together. We consider your budget, time and needs to propose solutions that will be the most valuable to your company.

Empathetic

We put human factors and patient well-being first in everything we do. As fellow entrepreneurs, we can empathize with our clients to understand their concerns when going through the testing process.

How do we apply this principle?
  • We use ethical, psychological and cognitive principles to guide us within the framework of usability testing.
  • We understand that each client is unique and we offer flexible, tailored solutions.

Experienced

Our strength lies in our  domain expertise; deep product knowledge and a suite of specialized skills pertaining to usability engineering, regulatory requirements and clinical research and usability testing.

How do we apply this principle?
  • We see the big picture; this is only one important step in your device product lifecycle.
  • We will draw upon the expertise that is most relevant for your product development needs.
who we are

About us

Michaela Shaw

Quality and Regulatory Consultant

For almost 20 years I have been passionate about partnering with new and innovative entrepreneurs and early stage organizations to bring their medical device products to market. Through my regulatory consulting firm, Shaw Quality Solutions I have focused on leading medical technology companies to obtain worldwide regulatory approval. I believe in bringing solutions that cater to my clients unique needs while working within the constraints of complex regulations.

I’m proud of the success of my clients and my contributions in bringing safe and effective medical devices to users. Important innovations such as tools that improve a surgeon’s ability to perform surgeries, mobile applications that improve diagnosis and home use devices that help people minimize serious cardiac incidents are examples of products that I have helped bring to market.

I believe it is my role as a regulatory professional to share the best practices for usability testing with my clients so that together we can bring safe products to the market that improve people’s lives.

Linnea Aasen-Johnston

Clinical Business Consultant

I have over 15 years of clinical research and clinical marketing experience in the medical device industry and I never tire of meeting a new client with a healthcare innovation that is waiting to be brought to the market. For this reason, I founded BESPOKE Business Solutions Inc. to provide clinical business consulting to healthcare technology companies, research networks and other life science organizations. My core services include clinical strategy, planning, trial execution, clinical marketing and training. I specialize in clinical trials for novel technology and innovative care pathways in the Canadian healthcare market. My approach is solutions-focused and I am passionate about excellence and improving outcomes. I achieve this  through multiple stakeholder alignment and collaboration.

I believe that companies need high value, quality options for their service providers to support them at each step of development, launch and market penetration and it is my goal to continue to provide this value through MedTest Usability Partners.

who We work with

Our Partners

You X Ventures

Design & Usability Partner
MedTest has partnered with You X Ventures for all software related medical testing. You X has a depth of experience in human centred design, usability and user-testing for Healthcare Technology Products.
CRAFT AMAZING

Customer Testimonials

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John Doe

Marketing Manager

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Steve Mark

Founder & Leader

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Sarah Smith

Operations Team