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.
Understand first. Did you know the FDA requires human factors testing for new medical device approvals?
Budget Friendly. Did you know that starting your usability testing process early will save you money in the long run?
Success through safety. Did you know that one-third of medical device incidents each year involve use-error and human factors issues?
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?
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.
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.
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.
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.
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.
