FDA safety communication – pen needles

    3rd October 2018

    The FDA recently published a safety communication about pen injectors with pen needles. The safety alert has come about following the FDA receiving reports of patients using standard pen needles without removing the inner needle cover. This has stopped the needle entering the skin with the result that patients have not been getting their medication, […]

    Mobile devices and use-related risk

    27th September 2018

    ONdrugDELIVERY just published a piece by me on wearable medical devices. In the article I argue that use-related risk assessments for mobile devices should include an assessment of ‘detectability’. Detectability is often used in risk assessments in other fields such as oil and gas, but have not routinely been used in the medical field for […]

    The Smartphone naive user (or lack thereof)

    31st August 2018

    Recently we were asked to conduct a formative usability study testing a mobile companion app. We started by recruiting smartphone and smartphone naïve users in a ratio of 1:1. After beginning recruitment we found it exceptionally difficult to find smartphone naïve users and after screening 107 people we had only found one who did not […]

    Information Fatigue Syndrome

    9th August 2018

    Patient: You, Me, Anyone. Diagnosis: Information Fatigue Syndrome. State: Distracted. Cause: What your looking at right now. You may have not realised it, but at some point in your life you have experienced information fatigue syndrome, where an overload of information can paralyse you into a state of inaction. As consumers and patients alike want […]

    Finding External Critical Design Attributes

    13th July 2018

    In January, 2017, FDA introduced a draft guidance “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry” (ucm536959), to help potential applicants who plan to develop and submit an abbreviated new drug application (ANDA). In a nutshell, the guidance provides recommendations and […]

    The importance of HF testing in design

    25th June 2018

    Yesterday The Sunday Times printed an exclusive about the use of an automatic syringe driver used in the NHS and beyond, which may have been linked to widespread deaths among elderly patients. According to the article, one model of the infusion pump was designed to deliver an hour’s medication whereas a very similar model was […]

    Journal article looks at FDA draft guidance feedback

    22nd June 2018

    A piece of work that I took part in has recently been published in the journal Therapeutic Innovation and Regulatory Science. The article looks at the FDA draft guidance “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug Device Combination Product Submitted in an ANDA”, which was published in 2017. The article, […]

    MDU mHealth independent research

    7th June 2018

    We’re excited to announce that we are currently undertaking our own independent research project. With the prominence of mHealth (mobile health) playing an ever-larger role in patient care and an increasing number of mHealth devices having companion apps, we wanted to explore in-depth a problem that affects all developers of mobile apps. User retention and […]

    GDPR and DPA 2018

    6th June 2018

    I am sure everyone is aware that new General Data Protection Regulations (GDPR) came into force on May 25th this year.  GDPR has direct effect across all EU member states and is in place to ensure organisations comply with GDPR legal obligations.  However, GDPR does not take into account individual countries requirements and as a […]

    Empathy Tools; the next step in testing usability?

    18th May 2018

    Inclusive design in recent years has become more and more popular, due mainly to an increasing aged population and a desire to create a product that is suitable for all. The British Standards Institute defined inclusive design as: “The design of mainstream products and/or services that are accessible to, and usable by, as many people […]