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mdtalk Episode 9: How Do We Tackle The Biggest Challenges of MedTech?

By November 14, 2022No Comments
episode 9 mdtalk - how do we tackle the biggest challenges of medtech

Through the mdtalk podcast and video series, we’re on a mission to highlight the most important issues impacting clinical research, the patient experience and the future of healthcare.

Listen to the episode here or search for mdtalk wherever you get your podcasts. 

Digital transformation in healthcare is a hot topic for clinical trial organisers and sponsors – and a complex one too. 

In this episode, mdgroup’s Chief Operating Officer LaQuinta Jernigan is joined by Adam Spinks and Lyndon Johnson from 8fold Governance. Together, they delve into the challenges posed by the rapid advancement of medical technology and why compliance, good governance and patient-centricity are vitally important wherever technology is adopted.

Collectively, 8fold Governance has almost 100 years of combined experience in the UK health sector and provides end-to-end services for health technology companies including information governance, compliance, clinical safety, software development and more. 

Adam, Director of Governance and Legal Affairs, has supported the strategic and operational needs of NHS Commissioning organisations and providers across multiple sectors. He’s also helped health technology providers design, develop and implement their products across the UK health service to improve patient care and service delivery.

Lyndon Johnson, 8fold Governance’s CEO has played key tactical and strategic roles in scaling businesses in the healthcare sector and has a wealth of clinical knowledge and experience in primary, secondary, community and private health.

Episode overview

LaQuinta, Lyndon and Adam sat down to discuss the ongoing digital transformation of the healthcare industry globally, the main challenges presented by technological advancement, and why compliance and patient-centricity are so important when it comes to heath tech.  

To set the scene for their discussion:

  • The US digital health market was valued at $195 billion in 2021 and is on course for 16% annual growth between now and 2023
  • The first half of 2020 saw unprecedented investment in digital health activity, including record-level venture funding of $5.4 billion
  • The pandemic significantly accelerated tech adoption by HCPs and patients. For example, at the end of 2019, less than 200,000 people were using the NHS app in the UK. By the end of 2020, the app had almost 2 million users. 

Therefore, it’s no surprise that many tech innovators are wanting to capitalise on the digital health boom – yet many won’t have the necessary understanding of the complexity of the health market or the clinical journey.

That’s where getting the right governance and compliance is vital. 

Putting governance and compliance at the heart of MedTech

It’s important that MedTech innovators have the right processes and frameworks in place to ensure their products meet the highest standards of clinical safety and efficacy.

Lyndon describes how tech innovators in the clinical space need good governance and clinical safety “baked into” the heart of their company. No matter how fast-moving health innovations are, patient safety must always be the highest priority. 

As for all medical professionals, the Hippocratic oath “do no harm” should underpin everything MedTech innovators create. To ensure this, exceptionally high standards of compliance must be met – and it’s much easier later down the line when companies invest in getting this right from the start.

What’s more, any data leaks from health tech companies tend to be high profile, which can cause deep-rooted mistrust amongst patients and clients. When it comes to the healthcare industry, trust is a critical factor. 

Adam agrees with the need to embed governance right from the beginning: “Trying to retrofit or reverse engineer things at a later stage is much more challenging than it is to start on the right foot and have the right foundations in place. Governance and compliance aren’t just about having the right paperwork in place. It’s not a tick-box exercise. It’s about living, breathing and doing these things every day.” 

Understanding the risks and challenges of digital transformation 

Lyndon explains how, in the UK, frontline healthcare practitioners have historically been seen as the “guardians” of patient data – whereas the data provided by health technologies has the potential to empower patients to improve their own health. 

When coupled with the challenge of introducing new technologies into a system like the National Health Service, Lyndon highlights how MedTech could be perceived as highly disruptive: “I think, in terms of how the [UK health] sector may be disrupted, it’s not ‘if’ but ‘when’. And the challenges are many, but the benefit is huge in the long run.”

As well as systemic challenges, Adam also highlights the practical challenges of digital transformation. For example, a breakdown in communication between healthcare providers and health tech companies could cause confusion or hesitancy and lead to slow adoption. Adam says: “Having a common language and way of understanding how technology works, how it’s been developed safely and appropriately, making sure everyone’s comfortable with what’s going on is really important.”

LaQuinta adds that as the use of digital technologies in healthcare increases, patients will have more access to medical records and treatment paths than ever before. Inevitably, people will have concerns over how sensitive health data is stored and education is key. Sponsors, HCPs and patients must feel confident that new technology has met rigorous legal, compliance and data protection standards – and transparency around this is essential.

Digital literacy and health tech accessibility

Digital transformation has the potential to make healthcare more accessible – but we must also work to ensure certain patient populations don’t get left behind.

Adam and Lyndon share some of the accessibility solutions they’ve seen successfully implemented, including:

  • Providing access to medical records via a patient portal with the opportunity for patients to access their own data or delegate access to a family member. This also offers patients and carers a sense of ownership over who has access to their data and for what purpose.
  • Delivering a consistent user experience by presenting health technologies in a way that’s consistent with user expectations and intuition. This includes using common interfaces, features, language and menu structures to allow for easier adoption.
  • Leveraging charity or patient-led support groups to create spaces for people to learn about new technologies face-to-face.

Ultimately, digital transformation of healthcare is inevitable – as we’re seeing across all sectors. However, LaQuinta reminds us that no matter how revolutionary, technology cannot replace the need for the human touch in patient care.

Effective adoption of health technologies

Lyndon reflects on his past experience as a frontline clinician and highlights the importance of introducing new technology to time-restricted healthcare workers in the right way, demonstrating a clear patient benefit and improvement to their workflow.

Healthcare infrastructure can be a barrier to adoption too. Adam explains how in some environments a lack of smart devices means there’s no option to embrace digital technologies – no matter how keen healthcare providers are to use them.

Adam says MedTech innovators must be mindful of the limitations and constraints within a clinical environment and consider solutions to the entire problem – not just one aspect of it.

Healthcare innovations to watch

LaQuinta, Adam and Lyndon finish by discussing the MedTech innovations they’re most excited about in terms of the impact they could have on the future of healthcare.

Lyndon describes a project currently combining MRI scans with clinical data to accurately diagnose dementia and deliver a prognosis. 

He highlights how this is an excellent example of using health data to provide patients with a full picture of their health and empower them to make decisions: “The more knowledge people have, the more in control they feel. And I think that’s technology’s biggest asset going forward.”

Thank you to our guests, Lyndon Johnson and Adam Spinks.

Find out more about them and 8fold Governance at

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