In the beginning was normality. Or so we all thought. Now normality has changed. It adapted, it progressed, it enveloped us all and we have all had to adapt to a new normal. One that challenges our perceptions of personal and family safety, and for employers, the safety of our employees and their families, their friends and their connections.
Until March this year, life progressed as it had done at THAY Medical since its inception nearly six years ago. We were growing at over 20% revenue year on year, we had expanded into Sweden and were planning more to realise more of our vision and our company goals. Then, restrictions started, and the face of human factors engineering changed. In fact, two teams from THAY Medical were performing human factors studies when COVID-19 affected the ability to travel and perform these safely. One team were left with difficulties to return from the USA, but luckily all ended well.
So, THAY Medical had to react, to adapt and change. Immediately, the team pro-actively reviewed health and safety processes, risk assessed how we did our work, listened to the industry and found a way forwards. We adopted for the first time, remote testing. We changed our primary meeting room at our headquarters to enable remote testing and performed our first remote Summative human factors study on a home-use medical device successfully. Post-study we held a ‘lessons-learned’ meeting and found minor improvements could be made, which were implemented quickly for the subsequent study. We converted a room adjacent to our warehouse to be a decontamination room so that manufactured products from our clients could be received, decontaminated, cleaned, stored ready for transport to study participants – to ensure the risk of transfer of COVID-19 was minimised. Post-study, items could be again decontaminated and stored. The safety of the study participant our top-most concern.
Additionally, we looked at our ISO 13485 certified Quality Management System and determined changes were required in how we worked, what we documented and recorded, and how we ensured compliance. We changed some processes to meet a requirement to focus on safety for all involved, including our own staff. We improved our document control process as an example, improved the efficiency of our Study Protocols and Reports, what data we collected and how we analysed study data. The restrictions were an opportunity to look inside THAY Medical and challenge how we operated. Our Quality Manager focused on driving these operational enhancements with the team. THAY Medical is a better more efficient organisation now we believe.
During the restrictions, some regulations were amended or updated, and as such we had to adopt them. One of our primary regulations IEC/ISO 62366-1 was amended and so we had to implement the amendments fast. We continued to send Study Protocols to the US FDA (through our customers) and ensure they met the current human factors team thinking and product-specific guidance. With the travel restrictions, THAY Medical had to place on hold all US-based Formative and Summative studies – but now we have the ability to perform these again in the USA for our customers so that regulatory submissions are less-delayed.
We continue to adapt right now – we are building our new in-house innovated and COVID-19 safe ‘face-to-face’ test facilities in the next few weeks at our headquarters. We have built a capability in the UK to perform studies whilst we are currently restricted from hospitals and clinics and other clinical venues. We will be able to offer the full human factors engineering service for nearly all types of medical device and healthcare product. We will be resuming ‘face-to-face’ studies in the next month in cities such as London (UK), Birmingham (UK), Cambridge (UK), Manchester (UK) and Stockholm (Sweden). Through our partner organisations more cities are available in the USA, Germany, Holland, Spain, Australia and Lithuania. We aim to be a one-stop human factors engineering service provider for all global compliances and to ensure that the most-usable and safe medical devices and healthcare products come into the market for us all to use.
Our team has remained working throughout the past six months and will continue to do so. We thank our loyal customers for this. We thank you, our readers, for your continued support. We are here to provide essential human factors and usability engineering services for our global customers. We will continue to do this, with your support and in times of uncertainty. We will look back in years to come at 2020 with a safer perspective and note it as a reactionary time of change which we adapted to, and THAY Medical will be proud to be part of this change in this sector.
Managing Director, Consultant