Criticality of human factors work
Human Factors (HF) work is essential for effective device development and regulatory approval. While HF guarantees a consistent focus on users, aligning HF with product development and meeting ever-increasing regulatory requirements is a challenge in itself. Particularly when bringing combination products to market, taking over a yet unfamiliar platform product and onboarding all necessary partners adds up and requires a considerable amount of time and effort.
Introducing Ypsomed human factors services
With Ypsomed Human Factors Services, we are committed to simplifying this journey, providing our pharmaceutical partners a single point of contact and helping make self-medication more accessible to patients at home. Extending our platform approach with integrated human factors services, we strive to minimize risks for market approval, expedite the time to market for combination products, and further streamline processes to increase agility and efficiency for our pharmaceutical partners. For this, we provide the necessary human factors expertise and incorporate insights from past projects to efficiently navigate the regulatory process.
Extending our platform approach with integrated human factors services, we strive to further streamline processes to increase agility and efficiency for our pharmaceutical partners and expedite the time to market for combination products.
Fully compliant products
Because we are already familiar with the development journey of the medical device and combination product, we will deliver a product fully compliant with international regulatory requirements for human factors.
By using Ypsomed Human Factors Services, you benefit from:
- De-risked market approval by incorporating insights from past projects.
- Streamlined and expedited go-to-market process by aligning human factors with product development.
- Reduced efforts by having access to cutting-edge human factors expertise.
Ypsomed human factors services program
We support you with our team of human factors specialists end-to-end in the product development process – from use-related risk analysis, custom instructions for use (IFU) and labelling design, to formative human factors studies, managing FDA correspondence, and human factors validation study planning and execution. For this, our pharmaceutical partners only need to provide the input of intended use and target markets of the combination product. We take care of all human factors-related activities and lead this part of the project, supported by our US-based partner Interface Analysis Associates (IAA).
1. Client selects Ypsomed platform product
2. Development of use-related risk analysis (URRA)
3. Development of custom instructions for use (IFU) and labelling
4. Formative human factors study
5. Revisions to study procedures, IFU, labelling and URRA
6. Human factors validation study protocol for FDA review
7. Human factors validation study execution
8. Client hands in documents to FDA
Strategic partnership with IAA
To secure long-term access to cutting-edge human factors capabilities and testing facilities in the US, Ypsomed has entered into a strategic partnership with Interface Analysis Associates LCC (IAA), a leading human factors consultancy in business since 1993. IAA is led by Dr. Anthony D. Andre, CPE, a renowned expert in human factors for medical devices and drug delivery combination products. IAA has an unparalleled track record of evaluating, designing, or testing more than 1000 products for over 400 clients in a variety of domains. The partnership with IAA enables Ypsomed to access specialized resources that support human factors activities in bringing the product to market and optimizing the user experience for the intended users. This includes effective FDA correspondence and human factors validation study protocol submission.
We chose IAA as our partner because they support our mission with their
- Tremendous experience & expertise in design, evaluation, and testing combination products
- Three decades of collaboration with FDA
- In-house facilities that allow usability testing to be carried out flexibly
- Perfect fit in unwavering commitment to quality and high work ethic
Interested?
Are you interested in learning more about Ypsomed Human Factors Services and how we can help you bring your combination product to market? Just leave your email in the field below and we will be in touch.
Published examples of our human factors activities
Over the past decade, we have built strong in-house expertise along the entire human factors journey, from basic research in the user perspective of drug delivery to formative human factors evaluation studies and detailed usability testing with eye-tracking. The following examples provide a brief insight into our work.
Schneider A, Kolrep H, Horn HP, Jordi C, Gierig S & Lange J (2023), “Understanding patient preferences for handheld autoinjectors versus wearable large-volume injectors”, Expert Opinion on Drug Delivery, 20:2, 273-283, DOI: 10.1080/17425247.2022.2162037
Lange J, Schneider A, Jordi C, Lau M & Disher T (2021), “Formative Study on the Wearability and Usability of a Large-Volume Patch Injector”, Medical Devices: Evidence and Research, 14:, 363-377, DOI: 10.2147/MDER.S337670
Schneider A, Richard P, Mueller P, Jordi C, Yovanoff M & Lange J (2021), “User-Centric Approach to Specifying Technical Attributes of Drug Delivery Devices: Empirical Study of Autoinjector-Cap Removal Forces”, Patient Preference and Adherence, 15:, 159-168, DOI: 10.2147/PPA.S298725
Schneider A, Mueller P, Jordi C, Richard P, Sneeringer P, Nayyar R, Yovanoff M & Lange J (2020), “Hold the device against the skin: the impact of injection duration on user’s force for handheld autoinjectors”, Expert Opinion on Drug Delivery, 17:2, 225-236, DOI: 10.1080/17425247.2020.1704730
Lohmeyer Q, Schneider A, Jordi C, Lange J & Meboldt M (2019), “Toward a new age of patient centricity? The application of eye-tracking to the development of connected self-injection systems”, Expert Opinion on Drug Delivery, 16:2, 163-175, DOI: 10.1080/17425247.2019.1563070
Schneider A, Kolrep H, Jordi C, Richard P, Horn HP & Lange J (2019), “How to prevent medication errors: a multidimensional scaling study to investigate the distinguishability between self-injection platform device variants”, Expert Opinion on Drug Delivery, 16:8, 883-894, DOI: 10.1080/17425247.2019.1637852
Lange J & Nemeth T (2018), “Formative usability evaluation of a fixed-dose pen-injector platform device”, Medical Devices: Evidence and Research, 11:105-112, DOI: 10.2147/MDER.S159733
Schneider A & Lange J (2018), “Pen devices for self-injection: contrasting measured injection force with users’ perceived ease of injection”, Expert Opinion on Drug Delivery, 15:2, 115-125, DOI: 10.1080/17425247.2018.1415884
Lange J, Richard P & Bradley N (2015), “Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population”, Medical Devices: Evidence and Research, 8, 255-264, DOI: 10.2147/MDER.S85938
Lange J, Richard P & Bradley N (2014), “Usability of devices for self-injection: results of a formative study on a new disposable pen injector”, Medical Devices: Evidence and Research, 7, 95-203, DOI: 10.2147/MDER.S63918
