Medical Devices

  • balancing_business

    Balancing Business Needs and End-User Acceptance for a Prescription Management Enhancement

    A pharmaceutical company came to Battelle for help in redesigning the cap and mouthpiece of a nebulizer using human centric design (HCD) principals. At the same time, they were considering adding a prescription management feature to monitor the usage and dosage of the drug.

  • Male doctor pushing male patient in wheelchair.

    Communicating the Hospital Environment

    Battelle conducted contextual research in a series of smaller hospitals to better understand the process of dispensing daily medication to patients. We observed hospital environments with different procedures and equipment in place, and created a report highlighting the operational differences.

  • disclosure_policy

    Developing a Responsible Disclosure Policy

    An infusion pump manufacturer came to Battelle for help in putting together a responsible disclosure policy. While their device had not been hacked, they realized that the life-critical nature of the device gave it a very high risk profile and made it likely to come under heavy scrutiny from security researchers.

  • Human Centric Design and User Insight to Enhance Medical Device Development

    Battelle’s Human Centric Design (HCD) team visited patients in their homes, offices and clinical settings to get a deep understanding of how they manage the unique aspects of their disease.

  • device_vulnerability

    Interpreting Fuzz Testing Results for a Device Vulnerability Assessment

    Fuzz testing is commonly used as a first step in assessing the vulnerability of a device to malicious hacking or unintended effects caused by bad data. A company came to Battelle for help in designing and executing a fuzz test protocol and interpreting the results in way that made them understandable and actionable.

  • Complex Medical Information

    Presenting Complex Medical Information in an Easy-to-Understand Format

    A large pharmaceutical client came to us for evaluation of their Instructions For Use (IFU) for an injection device. They had been working with a design firm to develop the IFU, and had added a large number of images in the hopes of making the IFU easier to understand.

  • Male doctor sits on edge of patient bed.

    Reducing Patient Risk Through Design

    A large medical device manufacturer asked us to perform a human factors study on an autoinjector. We observed some inversions where users would have injected their thumbs instead of the desired injection site if the device they were using had been real.

  • Man injects self with needle.

    Saving Unnecessary Costs on an FDA Revalidation Request

    A pharmaceutical client added an exhaust sound suppressor to their autoinjector to quiet the device. The FDA thought that this fundamentally changed the device by removing an auditory signal of injection completion and wanted revalidation of the new design for usability.

  • Male and female sitting across table from each other.

    Studying Safety for Devices Under Stressful Conditions

    A client needed a comparative formative study two of different devices for administration of glucagon in rescue situations (i.e., diabetic severely hypoglycemic and going into shock).

  • usability_studies_developer

    Usability Studies Clarify Make-vs.-Buy Decision for Device Developer

    A pharmaceutical company was evaluating potential options for a combination drug and injection device for a highly viscous drug. There were custom-made and commercial-off-the-shelf (COTS) options available. They came to Battelle for help in deciding which one would be most likely to be accepted by their end users.

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