Product Research, Development & Testing

Bring your medical device to market faster, more safely, and with more confidence.

Medical device product development is highly regulated and demanding—for good reason. CESI has the resources to support you at every step of the way as you advance your project from product concept to product launch. Then, CESI can help you train your customers to help ensure proper use in the marketplace to benefit patients.

From initial concept to final product validation, CESI offers the capabilities and expertise to support you through every stage of the process. We partner with you to:  

  • Test and validate the safety, usability, and efficacy of your product
  • Identify & mitigate potential risk factors relating to compliance, quality, and patient safety
  • Obtain valuable feedback from your target audiences
  • Perform studies required for regulatory approvals

Concept Evaluation

Timely, third-party evaluation of your concept offers actionable insight into how your customers will respond to your new product. This VOC perspective reduces uncertainty, uncovers opportunities, and mitigates risk, leaving room to correct course without sacrificing investment or delivery timelines.

Depending on the nature and scope of your program, we identify the relevant key opinion leaders to evaluate your concept. In our evaluations, we consider a number of factors, including:

  • Product benefits and patient need addressed
  • Training requirements
  • Ease of use and impact to workflow
  • Technology integration 
  • Existing substitutes or alternatives
  • Value Proposition for a healthcare system

Device and System Beta Testing

At CESI, we provide the facility and resources to help companies perform beta testing. Our clinicians and biomedical engineers are available to provide critical feedback on the performance and quality. Our evaluation observes all aspects of a product from instructional materials, to device interface, to system controls.

We work in tandem with our clients throughout the process, sharing real-time feedback to inform design improvements, mitigate risk, and further optimize the product.

Human Factor Studies

Understanding how end users interact with your medical device offers invaluable insight into both your product and your customers. Human factor studies spotlight potential pain points or design flaws that could undermine your product’s safety or negatively impact user satisfaction and adoption. 

We offer the following types of human factor studies:

  • Device-Clinician Interface
  • Device EMR interface
  • Device-Patient interface

Our team has the expertise to conduct all aspects of the study. Depending on your needs, we can recruit testers, design testing protocols, identify critical tasks, execute the study as outlined in the protocol, assess product efficacy, gauge ease of use, analyze risk, report our findings, and collaborate on solutions.

Real Users in an Authentic Environment

CESI’s lab space replicates a real-world setting, allowing you to ensure your product or technology is not only effective, but will be used as intended in clinical settings.

Product & Launch Support

CESI supports product development from concept to launch—and beyond. Learn about our product launch support and training services.  Learn more >

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