Test

Product safety and performance testing is a critical step. Select testing strategies that take into consideration the unique characteristics of the technology but do not discard fundamental elements, such as your project schedule and budget.  The goal of testing is to ensure that the product meets safety and performance goals. By considering testing early in the product lifecycle, you will ensure a smoother path to market.

Your testing phase may also include product verification and validation to ensure that the product is designed correctly and meets the intended use and needs of the user. Significant financial resources are often required for testing, underscoring the need for careful planning.

Considerations

  • Develop and carry out a design verification and validation plan that allows you to verify your design inputs as you define them and ensure that your device meets user needs and intended use. Consider how an end user should be involved in the plan and how the device should be tested in simulated or actual use.
  • Perform user testing with your target users. This may involve several iterative cycles and can focus on specific components within your technology, such as application installation and user interaction. Alternatively, your user testing may focus on full technology functionality. Issues and user experience discoveries that arise in testing can be fed back to mediate design or coding problems.
  • Talk with third-party testing providers to better understand standards-based testing that your device may undergo.
  • General areas of testing often include usability, biocompatibility, sterility, packaging, and user safety.

Resources

FDA: Digital Health

The U.S. FDA provides information on laws and guidance documents impacting digital health innovations.

Tech Lab Testing and Utilities

The Office of the National Coordinator for Health Information Technology’s Tech Lab Testing and Utilities supports a collaborative work environment for digital health developers and providers to test tools and health information technology functionality.

Canadian Surgical Technologies and Advanced Robotics

The Canadian Surgical Technologies and Advanced Robotics support all stages of medical device knowledge translation by enabling meaningful collaboration of researchers and clinicians.

Clinical Trials Ontario

Clinical Trials Ontario is a nonprofit organization—established with Ontario governmental support—dedicated to strengthening, promoting, and capitalizing on Ontario’s competitive advantages for conducting high-quality clinical trials.

MaRS Excellence in Clinical Innovation Technology Evaluation

The MaRS Excellence in Clinical Innovation Technology Evaluation program connects health technology innovators with experienced researchers to get the right evidence and data they need to show the value of their product. The program also facilitates discussions with relevant health system stakeholders to determine what it takes to get their technology adopted successfully.

National Science Foundation

The National Science Foundation is a U.S.-based organization that provides comprehensive training, education, and testing services to assist medical device companies.

National Research Council Canada

The National Research Council is Canada’s largest federal research and development organization, which supports industrial innovation, the advancement of knowledge and technology development, and the fulfillment of government mandates.

Small Company Innovation Program

The Small Company Innovation Program matches small-to-medium Michigan-based technology companies with experts at Michigan’s 15 public universities and awards grant funds for research, development, and testing projects.