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 Usability / Human Factors Engineering provider specializing in healthcare products. They focus on ensuring safety, effectiveness, and user-friendliness for diverse populations.
**Expertise & scope**
* Human Factors Engineering (HFE) throughout the product development process.
* Usability testing for medical devices, including those designed for children and sterile packaging.
* User Needs Identification, Requirements Definition, and Concept Development.
* Analytical Methods including Usability Testing and Use-Related Risk Analysis.
* Iterative IFU (Instructions for Use) testing and validation.
* Addressing challenges in usability testing with specific user groups, such as children and patients with conditions like Rheumatoid Arthritis.
* Expertise in combination products, pre-filled syringes, and injection devices.
**Reputation / proof points**
* Locations: Operates usability labs and has multiple locations.
* Expert presentations at industry conferences like the HFES Health Care Symposium.
Design Science is a Usability / Human Factors Engineering provider specializing in healthcare products. They focus on ensuring safety, effectiveness, and user-friendliness for diverse populations.
**Expertise & scope**
* Human Factors Engineering (HFE) throughout the product development process.
* Usability testing for medical devices, including those designed for children and sterile packaging.
* User Needs Identification, Requirements Definition, and Concept Development.
* Analytical Methods including Usability Testing and Use-Related Risk Analysis.
* Iterative IFU (Instructions for Use) testing and validation.
* Addressing challenges in usability testing with specific user groups, such as children and patients with conditions like Rheumatoid Arthritis.
* Expertise in combination products, pre-filled syringes, and injection devices.
**Reputation / proof points**
* Locations: Operates usability labs and has multiple locations.
* Expert presentations at industry conferences like the HFES Health Care Symposium.
Additional information
Design Science emphasizes the critical role of usability and human factors in healthcare technology. They highlight the importance of designing intuitive and easy-to-use devices, particularly for vulnerable populations like children. Their approach involves comprehensive usability testing to ensure devices are not only functional but also safe, effective, and comfortable for the intended users. They also address the complexities of regulatory requirements and sample size considerations for validation studies, offering insights into optimizing study designs. Engagement typically involves understanding user needs, defining requirements, and applying analytical methods throughout the product lifecycle.
Key Highlights
-
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.”
-
Focuses on improving healthcare outcomes through intuitive and easy-to-use medical device design.
Source
“Our mission is simple: to create medical devices that are as safe, effective, and as user-friendly as possible through comprehensive usability testing.”
-
Conducts usability validation for sterile packaging.
Source
“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.”
-
Applies Human Factors Engineering (HFE) throughout the product development process, including case studies on 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
Buyer Snapshot
Best for
- Medical device manufacturers seeking to enhance product safety and usability.
- Companies developing combination products or drug delivery devices.
- Organizations needing to meet regulatory requirements for human factors and usability.
How engagement typically works
- Collaborative, focusing on integrating HFE into the product development lifecycle.
- Data-driven, utilizing rigorous testing and analysis to inform design decisions.
Typical deliverables
- Usability testing reports
- Human factors engineering documentation
- Instructions for Use (IFU) validation
- Risk analysis reports
Good to know
- Best when early integration of human factors expertise is desired.
- Best when specific user populations (e.g., children, elderly, patients with chronic conditions) are involved.
HQ:
Philadelphia, US
Languages:
English
Timezones:
EST
Claim 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
User Types Supported:
Lay user, Professional healthcare
Use Environments Supported:
Home healthcare, Professional healthcare, Both
Standards Supported:
FDA Human Factors Guidance
Has Participant Recruitment:
Yes
Participant Recruitment Details:
The FDA has requested that manufacturers sub-divide user groups based on other characteristics, such as injection experience and training status, requiring 15 distinct participants for each sub-group. At Design Science, we’ve justified this approach to the FDA and successfully limited sample sizes to 30 participants rather than 60 participants in such cases.
Has Usability Lab:
Yes
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Sample Requirements:
The traditional 15 participant per user group sample size requirement is based on research conducted by Faulkner (2003) that suggested a sample size of 15 people was sufficient to find a minimum of 90% and an average of 97% of all problems with a timesheet software. However, given that 15 has been the “magic number” for usability study sample sizes for many years, it will take time to generate enough evidence to support a paradigm shift. For example, consider the variable of injection experience. For a combination product, we typically expect that patient and caregiver user groups will consist of a mix of injection experienced and injection naïve participants. If we apply the “magic number 15” across all sub-groups, our sample size would include 60 lay participants – 15 each of injection experienced and injection naïve patients and caregivers. If we think more critically about the effect of injection experience, it should impact patient and caregiver performance similarly, e.g., by causing additional use errors due to negative transfer or existing mental models. Thus, it is reasonable to use a matrixed approach in which half of the patient participants (approximately 8) and half of the caregiver participants (approximately 7) are injection experienced to reach a total of 15 injection experienced participants and likewise with the injection naïve participants. Thus, we can recruit a total of 15 injection experienced and 15 injection naïve participants across both user groups.
Minimum Project Size:
$50k+
Has Remote Testing:
No
Rush Available:
No
Nda Support:
No
Additional usability_human_factors_testing Details
Usability Study Types Offered
Formative study, Summative study, Both
Services Offered
Risk analysis, Task analysis, User interface evaluation, Instructions evaluation, Validation testing, Human Factors Engineering
Standards Supported
IEC 62366-1, IEC 62366-2, FDA Human Factors Guidance, 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
