Shareholder Update - A view from the front
Updated: Jul 12
As some of you may already know, we are committed to attracting exceptional talent to come and work with us and recently appointed Michael Smith to a new position as Technical Lead. With his extensive experience and background at some of the UK’s leading manufacturers, Michael’s role is to lead the overall technical design and development of Occuity’s pioneering medical devices. Working across the mechanical design, electronics and software teams, Michael has also proactively provided guidance and oversight to the other Engineering teams.
To provide an update for our Shareholders and an insight into our work over the past two months since our last update, we spoke to Michael about his role, the projects he is focused on and how he leads technical development.
"Who wouldn’t enjoy working on developing class-leading products that are at the forefront of technology?"
Since you joined Occuity just a few short weeks ago, what have you been working on?
When I joined Occuity, it quickly became clear I was working with a smart, talented, and committed team. Of course, when you join any new company, there is a learning curve, but thanks to the subject matter experts already at Occuity, this has been pretty smooth.
The first project I started to get to grips with was the PM1 project. The focus for us is to continue to work with our accredited body, Kiwa Dare, to get PM1 through CE marking, and thus allow sales in Europe. Kiwa Dare has completed the Quality Management System review and has now started the MDR Technical File review. We’re working to ensure that as an when questions arise, we will be able to quickly provide any necessary information. Excitingly, it was also decided that the paperwork for FDA 510k submission could be prepared in parallel for launch in the USA.
Within my first few weeks of joining the team, I had the opportunity to join the senior leadership team for a key Strategy Day during which individual projects, direction, and overall business strategy were discussed and prioritised. This was a perfect opportunity for me to understand the business and it provided me with a clear direction which in turn, helped me ensure the team were focused on the correct objectives to maximise our time and resources. My key takeaway was to prioritise the AX1. The market feedback we have been getting has been quite amazing and the demand for the device is clearly huge, which makes prioritising the development of the AX1 critical. A really positive part of this is that as the AX1 utilises a similar form factor to the PM1, it is enabling us to accelerate the development of the device.
Of course, Occuity is also developing technology platforms to provide a safe, convenient, and quick way to screen for several chronic diseases. Our SD1 project – which aims to detect disease markers in the eye such as AGEs (Advanced Glycation End-products) which build up in the eye over time – is also progressing, with a number of the team focussed on this longer-term project.
How do you prioritise/maintain focus of the PM1 and AX1 projects?
At Occuity we use the latest tool methodologies and frameworks such as Agile Methodology in Project Management.
I am experienced in a variety of frameworks including Agile, in which I am a Certified Agile Scrum Master, I am a PRINCE Practitioner (a project management methodology) and I am also trained in Six Sigma which is a set of tools and methodologies used to improve processes by minimising variation, reducing defects & errors and improving efficiency. I use my wealth of experience to use whatever toolset is necessary to manage projects.
At Occuity, broadly, we use Agile methodology. This project management approach prioritises cross-functional collaboration and continuous improvement. It divides projects into smaller phases called ‘sprints’ & ‘work packages’ which guide teams through cycles of planning, execution, and evaluation. Regular project reviews are held to evaluate achievements and progress.
I also hold regular Resource planning meetings where project leads provide updates for the current cycles (sprints) and discuss resource requirements for the next sprint. We discuss blockers to project execution which is critical in enabling me to identify impediments and reallocate resources following guidance from the senior leadership team. By working in this way, I can retain visibility and control over projects, and have the opportunity to reallocate tasks to maintain focus and execution.
Occuity’s focus is to be the first to bring innovative products to the market. Time to market for our devices is therefore key and anything we can do to enhance this adds value to the business.
What challenges have you faced and how do you overcome these challenges?
Occuity’s projects are pushing technological boundaries. We’re developing new and innovative solutions that are novel, and groundbreaking, and will result in products that are ‘bleeding edge’. With this, of course, comes challenges, which are generally exciting to tackle. For example, we want all our products to be handheld. Therefore, from a design and development perspective, we need to always consider the size and weight and how these are affected by the decisions we make. The devices must also be intuitive and simple for clinicians and technicians to use, which again requires us to carefully consider things such as the user interface and all these need to enhance and not compromise the critical accuracy and precision.
We overcome these challenges by recruiting the best talent and brightest minds in fields ranging from optical engineering, electronics, software, and industrial & mechanical design. I strongly recommend teamwork and brainstorming to allow us to rapidly test and iterate solutions. The willingness to try things and learn from our mistakes is a valuable trait: it allows us to examine what worked or what didn't even more so than if we were successful first time. It also fosters critical and analytical thinking skills and allows us to innovate, redirect and try alternate methods. The more we do this, the stronger our project processes and people get!
Occuity recently announced that it had been awarded ISO 13485 for the manufacture of medical devices. How does this affect the work of your team?
Occuity’s focus is to be the first to bring innovative products to the market. Time to market for our devices is therefore key and anything we can do to enhance this adds value to the business. We were delighted to have been able to successfully demonstrate our ability to manufacture our products in-house and have this ratified by achieving ISO 13485 for the manufacture of medical devices. We did this for multitude of reasons. Primarily, it will allow us to better utilise the knowledge and skillset of the teams, which in turn will enable us to scale faster for production ramp-up and ultimately reduce costs.
Through this process, the team have gained significant knowledge about the specific manufacturing of our products and has identified numerous improvements which ultimately reduce time and costs. Significantly, these learnings don’t just benefit the PM1 as they can be applied to the AX1 as well since it shares the same platform.
Looking forwards, what do the next 6 – 12 months look like?
I’ve loved my first few months here at Occuity and am equally as excited about the months ahead. Who wouldn’t enjoy working on developing class-leading, bleeding-edge products that are at the forefront of technology? We’re looking forward to getting the PM1 to market and are working hard with regulators to complete our CE approval. We anticipate sales of PM1 to be an enabler for growth. Our fast-paced execution of the AX1 project continues and our target is to generate prototypes to demonstrate the technology and have a TRL level 5 device available in Q3 2023. TRL5 equates to a working prototype prepared for its intended environment – so this is the stage that will excite the market even more as it will literally be the world’s first, handheld, non-contact device that can measure axial length in seconds. So, within a few months, we’re going to have taken a massive step towards our goal of changing the way myopia management is delivered.