Developing a digital solution for mental health care comes with a huge responsibility to put patient safety first. At Thalamos, we’ve always prioritised fulfilling this duty; delivering genuine care quality improvements by integrating Clinical Safety (providing the safest and best quality care) and Lived Experience (input from those with personal experience of being sectioned) into our product development. However, early on, we discovered that an agreed-upon model for how to approach this was non-existent.

Over time, we’ve therefore been on the journey of building our own, best-in-class model: Clinical Safety and Lived Experience by Design. With the help of Dr Lia Ali, Thalamos’ Chief Safety Officer (CSO), and Steve Gilbert OBE, a Lived Experience consultant – both of whom sit on our steering group – we’re working to build Clinical Safety and Lived Experience into the core of our product development. 

We’re sharing our lessons and reflections in a bid to open up the conversation and encourage safer practice across the sector. Recently we were able to do this by contributing to the Digital Clinical Safety (DCS) Strategy. As a result of suggestions made by Dr Iain Grant, a member of our clinical safety team, the DCS Strategy now aims to widen access to supplier safety cases in order for risk patterns and lessons to be shared. Meanwhile, we’re hoping to further promote transparency and shared learning here by discussing the importance of care quality delivery, and sharing everything we’ve learned so far from developing Clinical Safety and Lived Experience by design. 


The importance of prioritising patient outcomes

While Clinical Safety and Lived Experience are far from new concepts, interpretation varies widely. Delivery is often performative, approached simply as a ‘tick-box’ exercise to ensure compliance. But this only wastes time, as the product will likely hit problems later on when it fails to adequately cater to patient safety. Ultimately, it’s one thing to say you’re clinically-led, but what does this mean in practice?

Every single decision and action taken throughout development, however small and seemingly insignificant, has ramifications further down the line. And these impact users. While our Thalamos Assess platform is not directly used by patients, the decisions made on it will direct treatment and therefore have an effect on patient outcomes and experience. Therefore, to be truly clinically-led, we need to consciously evaluate our product to ensure that its effect on patient care is positive. 

It’s understandable that, as businesses, healthtech companies must balance cost alongside all other considerations. But highest quality care is not mutually exclusive from best value. Lower cost should never come at the expense of patient outcomes. It’s possible to deliver technology in a way that incorporates Clinical Safety and Lived Experience to guarantee care quality while remaining economically profitable. But it requires a conscious effort.


The challenges every healthtech company must face

It’s very easy to say how not to go about integrating Clinical Safety and Lived Experience, but to do it right is a whole other ball game. Understanding the challenges it poses is an essential first step. 

First of all, communication is key. Every single team member, from programmers all the way through to the company CEO, must share a common understanding of why the Clinical Safety and Lived Experience input is necessary. Then, the complexity of how they aim to interact with the product must be navigated. At Thalamos, while digitising the pathway underpinning the Mental Health Act, we are consequently changing the way parts of the system work. So, understanding how this will impact outcomes for patients, as well as practitioners, is hugely important. 

Tangible ways of addressing these within each department – from coding to UX design – are then needed to help the team control these outcomes. If everyone knows exactly how their actions may impact patient care, why it’s important to address this, and what they should be doing to mitigate the risks, then it becomes much easier to safeguard against developing a product which endangers patient safety. 

Balancing the competing views of multiple stakeholders is a further challenge. What might seem the best design feature for one practitioner, may produce a negative effect or complication for a colleague or patient elsewhere in the system. We have to acknowledge each person’s lived experience and bring the separate threads together in a way that produces optimal outcomes for everyone. 


How Thalamos have approached it so far

At Thalamos, we’re working to build Clinical Safety and Lived Experience into every single aspect of product design, from start to finish. We’ve found having a clinical governance framework within which to work absolutely essential. Providing every team member with guidance against which to check their decisions and actions helps us to confidently meet target criteria. Instead of retrofitting the technology post-development to meet care quality standards, it is consciously moulded around this from the start. 

Our framework currently revolves around the four ethical principles outlined by the MHA review, encouraging us to check that our technology is supporting them, rather than fuelling the problems that they’re trying to solve. The MHA review principles are:

  • Choice and autonomy – ensuring service users’ views and choices are respected
  • Least restriction – ensuring the MHA’s powers are used in the least restrictive way
  • Therapeutic benefit – ensuring patients are supported to get better, so they can be discharged from the MHA
  • The person as an individual – ensuring patients are viewed and treated as individuals

Additionally, we’re transforming ‘Swifter, Simpler, Safer’ from a mere slogan into a genuine, practical model against which to also evaluate our technology. For example, this could involve considering whether a design feature on a certain digital form will help speed up admission (Swifter), make it easier for clinicians to complete an assessment (Simpler), or remove bias from the system (Safer).

Meanwhile, consistently consulting our steering group and stakeholders has allowed us to navigate product development as safely as possible. For Lived Experience to have any meaningful impact you have to really listen and implement suggested actions – they may just mean the difference between failure and success. For example, our Lived Experience group advised against developing a video conferencing tool – a tool later ruled unlawful by the high court. This advice ultimately prevented us from producing something that threatened patient safeguarding. 


Looking forward

We have come to understand that progress in implementing Clinical Safety and Lived Experience by design is not linear, but exponential. The steps you take may seem small, but they form a bigger picture which ultimately safeguards the patients on whom your product will have an impact. 

Having team members who are ‘bilingual’ – who can speak to Lived Experience themselves and also understand the technical processes of design, such as coding – is ideal. But successfully implementing Lived Experience and Clinical Safety predominantly relies on ensuring open, continuous communication between every division of the team. 

We’ve learned not to focus on whether the process is inherently ‘good’ or ‘bad’, but to strive towards progress and development. Where we have got things right, we’re aiming to demonstrate it using data. Making our progress and the lessons learned public will also hold us to account and widen the conversation across the sector. 

And that’s what needs to happen next. As healthtech innovators, we have a duty to ensure clinical safety and evaluate the implications of our technology. By working together, sharing our individual practices – both ‘good’ and ‘bad’ – we can develop a clearer template for building technology that truly delivers quality care.