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
Formative Testing
Gather data necessary to ensure the best possible outcomes in upcoming validation testing.
HOW WE ITERATE
Connected medical system
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.
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
Bold Insight resumes in-person research, considered Essential business for healthcare-related research
Bold Insight conducts research that informs the development of safe and effective products, including medical devices. The portion of the research that is related to the commercialization of medical...
Webisode: Possible impact if in-person human factors research is not considered essential
As an industry, we’ve done a lot thinking about the impact of COVID-19 on research that informs the development and commercialization of safe and effective medical devices. In this webisode, Bold...
Human factors research in the times of COVID
How to continue to support development of safe and effective medical devices Many thought pieces are being pushed out around what remote research methods are available to replace research that would...
Bold Insight resumes in-person research, considered Essential business for healthcare-related research
Bold Insight conducts research that informs the development of safe and effective products, including medical devices. The portion of the research that is related to the commercialization of medical devices is therefore considered Essential Business as defined in Illinois Executive Order 2020-32...
Webisode: Possible impact if in-person human factors research is not considered essential
As an industry, we’ve done a lot thinking about the impact of COVID-19 on research that informs the development and commercialization of safe and effective medical devices. In this webisode, Bold Insight’s Managing Partner Korey Johnson describes why at least some of this research must be...
Human factors research in the times of COVID
How to continue to support development of safe and effective medical devices Many thought pieces are being pushed out around what remote research methods are available to replace research that would have otherwise been conducted in person if not for COVID. We’ve published some ourselves (Three...
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.
- Controlled processes
- Vendor management
- Rigorous auditing
- Information security standards
