Medical devices

We believe that institutionalizing best practices in user-centered design and human factors engineering leads to better health outcomes for all.

Applying human factors best practices to product development is much more than a validation study. Yes, we have the expertise to plan, manage, and execute your human factors validation study… but creating safer and more efficient, effective, and engaging experiences for your customers starts much earlier than that and so do we.

Medical Device Product Development

The foundation for safe and effective use begins with exploratory research and spans the entire development process.

Start the process

Exploratory Research

Understand the challenges faced by patients, caregivers, and healthcare providers.

HOW WE EXPLORE

Exploration

Connected
medical system

Exploration

Next-Gen
osteoarthritis

Documentation

Our method focuses on high risk areas and closely follows FDA regulations assessing risk through identification of use errors with guidance from HCPs.

HOW WE DOCUMENT

Risk Assessment

For surgical
equipment

Training

Human factors
course for FDA

Design

Know where you stand and get the insight you need to focus future development efforts or to document achievement of objectives.​

HOW WE DESIGN

Packaging

Clinical workflows
& package design

User interface

Expert evaluation
of mobile app

Formative Testing

Gather data necessary to ensure the best possible outcomes in upcoming validation testing.

Protocol & IRB

HOW WE ITERATE

Formative Test

Connected
medical system

Formative Test

Electronic
health record

Summative Testing

Assess if the user can safely and effectively perform critical tasks for intended use in the expected use environment.

HOW WE PARTNER

Summative Test

Pediatric kit

Exploratory Research

Understand the challenges faced by patients, caregivers, and healthcare providers.

HOW WE EXPLORE

Connected medical system

Next-gen osteoarthritis

Documentation

Our method focuses on high risk areas and closely follows FDA regulations assessing risk through identification of use errors with guidance from HCPs.

HOW WE DOCUMENT

Risk assessment for surgical equipment

Human factors course for FDA

Design

Know where you stand and get the insight you need to focus future development efforts or to document achievement of objectives.​

HOW WE DESIGN

Clinical workflows and packaging design

Expert evaluation of mobile app

Formative Testing

Gather data necessary to ensure the best possible outcomes in upcoming validation testing.

HOW WE ITERATE

Connected medical system

Electronic health record

Summative Testing

Assess if the user can safely and effectively perform critical tasks for intended use in the expected use environment.

HOW WE PARTNER

Pediatric medical injection kit validation

We partner with you to reach validation at any stage.

Our vast recruiting network stretches beyond the traditional, including clinical trial sites, to expand our participant population access.

Part of our DNA
Our experience with medical devices and related products

Injection
Devices

• Form factor considerations
• Clinical and home use
• Needle safety devices
• Connected devices
• On-device labeling

Packaging,
labeling,
& IFU

• Clinical applications
• Connected devices
• Injection devices
• Infusion pumps
• Oral therapies

Digital assets & connected devices

  • Digital therapeutics
  • Patient support applications
  • Websites & desktop software
  • Clinical decision support systems
  • Remote patient monitoring and management

Pumps, diagnostics, & more

• Infusion pumps
• Surgical devices
• Clinical diagnostics
• Robotic surgery systems
• Patient & caregiver diagnostics

Medical device insights

Physicians and specialists weigh in on telehealth improvements

Both patients and clinics have had to rapidly adopt to telehealth due to safety concerns associated with in-person visits. Last summer, we published a blog post highlighting common areas of concern that healthcare professionals (HCPs) have when using telehealth. We suspected a gap between...

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We are ISO 9001:2015 certified

We take the quality and integrity of our research seriously, and invest heavily in the development of expert human factors practitioners.

Our commitment to quality

Industry standards and best practices

We don’t just adhere to best practices, we work with other industry thought leaders to define them through our corporate memberships with AAMI and other organizations.

Internal and external training

All of our human factors practitioners go through a robust internal training program prior to their first project, benefit from our apprenticeship model, and have plentiful external training opportunities.

This globally-recognized certification represents:
  • Controlled processes
  • Vendor management
  • Rigorous auditing
  • Information security standards