Journal article looks at FDA draft guidance feedback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 The article looks at the FDA draft guidance “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug Device Combination Product Submitted in an ANDA”, which was published in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 […]

    MDU-tested ‘flu test kit goes on sale in Europe

    15th May 2018

    We received some excellent news last week when one of our clients reported that their ‘flu test kit has received a CE marking and is being sold in Europe. The test kit has also been cleared by the FDA. We carried out the usability validation testing on the kit in July 2017 in London, to […]

    FDA new draft guidance: Metered dose and Dry powder inhalers – Quality Considerations

    9th May 2018

    The FDA have produced a new draft guidance on Metered Dose Inhalers (MDI) and Dry Powder Inhaler (DPI) products, published on the 18th April. See https://bit.ly/2IrNNCl for a copy. Comments and suggestions regarding the draft guidance should be submitted to the FDA by 18th June 2018. If desired electronic comments can be made to https://bit.ly/2KMczvi. It is […]

    Usability Testing of Apps and Interfaces, 5 key principles

    3rd May 2018

    The mHealth global market is currently estimated to be worth $27B and is expected to reach over $111B by the year 2025! Therefore, the number of medical apps and smart-connect devices being released to market will increase vastly over the coming years as healthcare gradually transitions toward a more precision-based model. Personalised medicine will become […]

    CIEHF annual conference 2018

    23rd April 2018

    It’s Day 2 of the Chartered Institute of Ergonomics and Human Factors (CIEHF) annual conference tomorrow and Natalie and I will be attending from MDU. Natalie is leading a discussion tomorrow at 2pm about what works and doesn’t work in practice entitled “Are current risk assessment methods within industry adequately tailored to human factors requirements?” […]

    GDPR is coming !

    16th April 2018

    I am sure everyone is aware that new GDPR regulations come into force on May 25th this year and at MDU this has increased our focus on the importance of security in respect of our study participant’s data.  It is our policy to ensure that personal data entrusted to us by participants is collected, stored […]

    DDF Conference, Berlin March 2018

    26th March 2018

    I gave a talk to Drug Delivery and Formulation (DDF) conference in Berlin last week. I showed some of our own research into the preferences of users of auto-injectors. The room was full, even though I was the final talk of the day. The Devices stream was new for DDF this year and it proved […]