Design Science
★★★★★
4.8
/ 5
•
18 reviews
Design Science specializes in human factors and usability testing for healthcare products, ensuring safety, effectiveness, and user-friendliness for diverse populations.
Design Science is a leading provider of human factors and usability testing services, dedicated to enhancing the user-centered design of healthcare products. They specialize in guiding clients through every stage of product development, from initial user needs identification and requirements definition to validation and regulatory submission. Their expertise is particularly crucial for medical devices, where usability directly impacts patient safety and treatment efficacy. Design Science employs rigorous research methodologies, including field research, contextual inquiry, and analytical methods, to uncover valuable insights. They focus on understanding user needs, optimizing product design, and ensuring products are intuitive and easy to use, especially for vulnerable populations like children or individuals with chronic conditions. The company's services extend to validating sterile packaging, conducting risk analysis, and providing iterative IFU testing. They are adept at navigating complex regulatory landscapes, including FDA requirements, and have a proven track record of helping manufacturers strengthen their submissions and unlock their products' full potential. Design Science collaborates closely with clients, acting as dedicated human factors partners to achieve optimal usability and market success.
About
**Who they are**
Design Science is a specialized firm focused on human factors and usability testing, particularly for healthcare products. They aim to ensure that medical devices are safe, effective, and user-friendly across diverse user populations.
**Expertise & scope**
* Human Factors Engineering (HFE) and Usability Testing
* Usability validation of sterile packaging
* Designing and testing medical devices for specific populations, including children and individuals with conditions like Rheumatoid Arthritis
* Development of Instructions for Use (IFU) and secondary packaging
* Use-Related Risk Analysis
* User Needs Identification, Requirements Definition, and Concept Development
* Field Research & Contextual Inquiry
* Comparative Evaluation, Heuristic Analysis, and Expert Review
* Early and later stage formative studies
**Reputation / proof points**
* Experience presenting at industry conferences such as the HFES Health Care Symposium and the International Symposium on Human Factors and Ergonomics in Healthcare.
Design Science is a specialized firm focused on human factors and usability testing, particularly for healthcare products. They aim to ensure that medical devices are safe, effective, and user-friendly across diverse user populations.
**Expertise & scope**
* Human Factors Engineering (HFE) and Usability Testing
* Usability validation of sterile packaging
* Designing and testing medical devices for specific populations, including children and individuals with conditions like Rheumatoid Arthritis
* Development of Instructions for Use (IFU) and secondary packaging
* Use-Related Risk Analysis
* User Needs Identification, Requirements Definition, and Concept Development
* Field Research & Contextual Inquiry
* Comparative Evaluation, Heuristic Analysis, and Expert Review
* Early and later stage formative studies
**Reputation / proof points**
* Experience presenting at industry conferences such as the HFES Health Care Symposium and the International Symposium on Human Factors and Ergonomics in Healthcare.
Additional information
Design Science emphasizes the critical role of usability testing in enhancing healthcare outcomes. They highlight the importance of designing intuitive and easy-to-use medical devices, especially for vulnerable populations like children. Their approach involves comprehensive testing to ensure devices are not only functional but also safe, effective, and confidence-inspiring for users. They also address the complexities of regulatory requirements, such as those from the FDA, and how to navigate them through robust human factors engineering practices. Their work includes refining study designs and sample sizes to provide meaningful data for product development and regulatory submissions.
Key Highlights
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Specializes in human factors and usability testing for healthcare products.
Source
“Design Science specializes in human factors and usability testing for healthcare products, ensuring safety, effectiveness, and user-friendliness for diverse populations.”
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Focuses on designing medical devices that are safe, effective, and intuitive for children.
Source
“Our mission is simple: to create medical devices that are as safe, effective, and as user-friendly as possible through comprehensive usability testing.”
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Conducts usability validation for sterile packaging.
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“Join us to listen to one of our Senior Human Factors Engineers, David Grosse-Wentrup, while he shares his methods for the usability validation of sterile packaging.”
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Applies Human Factors Engineering (HFE) throughout the product development process, including for combination products.
Source
“Below I will dive deeper into our presentation, "Beyond Validation: Unlocking the Full Potential of Human Factors Engineering" to elaborate on one of the specific case studies we presented that highlights a real-world example of applying HFE throughout the product development process.”
Certifications & Trust Signals
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Experience presenting at industry conferences like the HFES Health Care Symposium.
Source
“HFES Health Care Symposium 2025: Pushing Boundaries and Questioning Traditions”
Buyer Snapshot
Best for
- Medical device manufacturers seeking to improve product safety and usability
- Companies developing combination products
- Organizations needing to meet regulatory human factors requirements
How engagement typically works
- Project-based consulting
- Collaborative development support
Typical deliverables
- Usability testing reports
- Human factors engineering documentation
- Risk analysis reports
- Instructions for Use (IFU) development and testing
Good to know
- Best when requiring specialized expertise in healthcare product usability and human factors.
HQ:
Philadelphia, US
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Usability / Human Factors Testing
Countries:
United States, United Kingdom, Germany, Europe
Industries:
Medical Devices
Pricing model:
Custom pricing
Usability Study Types Offered:
Formative study, Summative study
Services Offered:
Risk analysis, Instructions evaluation, Validation testing, User interface evaluation, Task analysis, Other
User Types Supported:
Lay user, Professional healthcare, Both
Use Environments Supported:
Home healthcare, Professional healthcare, Both
Standards Supported:
FDA Human Factors Guidance
Has Participant Recruitment:
Yes
Participant Recruitment Details:
Recruitment strategies for testing with children are discussed, and the FDA expects usability data for children as young as 10. They also note that testing for younger children, sometimes as young as 6, can be important. They have justified approaches to the FDA to limit sample sizes.
Has Usability Lab:
Yes
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Sample Requirements:
The FDA has requested manufacturers sub-divide user groups, requiring 15 distinct participants for each sub-group, exploding sample sizes. They have justified approaches to the FDA and successfully limited sample sizes to 30 participants rather than 60 in some cases.
Additional usability_human_factors_testing Details
Usability Study Types Offered
Formative study, Validation testing
Services Offered
Risk analysis, Task analysis, User interface evaluation, Instructions evaluation, Validation testing
Standards Supported
IEC 62366-1, ISO 14971
User Types Supported
Lay user, Professional healthcare
Use Environments Supported
Home healthcare, Professional healthcare
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Minimum Project Size
Custom
Pricing Model
Custom
