Every politician needs a story to tell about the state of the country and how it got to be the way it is, so they can spin a narrative about their actions. On Thursday, Lord Darzi delivered a novella length account of the state of the NHS and how it ended up in “serious trouble.”

The NHS “is in serious trouble”

Lord Darzi’s headline conclusions are set out in a summary letter to health and social care secretary Wes Streeting, who commissioned his review days after the general election.

The surgeon and former minister in Gordon Brown’s government says he was “shocked” by some of the things he saw during his short inquiry, even though he has worked in the service for 30-years. “People are struggling to see their GP” and waiting lists “have ballooned.” A&E “is in an awful state.”

Cancer care and cardiovascular care are “lagging behind other countries” or going backwards. And the NHS “is not contributing to national prosperity as it could”, with 2.8 million people inactive due to long-term sickness, up nearly a million on the pre-Covid era.

Why?

The report notes that some of the reasons for the NHS’ plight are beyond its direct control. The health of the nation has “deteriorated” as poor-quality housing, low-incomes, and insecure employment have escalated, driving demand “from a society in distress.” Social care faces a crisis of its own.

However, it lists some historical causes, starting with the austerity of the Cameron/Osborne era and moving on to the Lansley reforms of 2012, which it describes as “a calamity without international precedent” that dissolved lines of management and accountability.

By the time Covid-19 arrived, the NHS was in a poor state, had to cancel far more elective procedures than comparable systems, and has struggled to recover. Playing into these problems, Lord Darzi argues that successive administrations have put resources in the wrong place.

Hospitals continue to get more funding and staff than other parts of the system, even though policy makers have talked about a ‘left shift’ into community and primary care and prevention “since at least 2006, and arguably much longer.” And there has been a serious shortfall in capital spending for facilities and technology.

In the review, Darzi estimates that if the NHS had invested at the rate of comparable countries, it would have spent an additional £37 billion; enough to eliminate backlog maintenance three times over, build Boris Johnson’s 40 new hospitals, or modernise every surgery in the country.

Technology: in the digital foothills

Or fund two more rounds of the National Programme for IT. As things stand, Lord Darzi says health services are stuck “in the foothills of digital transformation” and this is one reason for poor and falling productivity.

Hospitals do have more staff than before the pandemic, but they are unable to work effectively in aging and collapsing buildings with poor IT systems. They just end up “wasting time solving problems, such as ringing around wards desperately trying to find beds” which “crushes their enjoyment of work.”

The report argues for “a major tilt towards technology” and duly ticks off the “enormous potential of AI.” But it’s more interested in community and primary care.

It notes that community services have been slow to adopt the kind of automated route planning and activity tracking that has transformed logistics and delivery services, and that while some GPs “have made significant shifts towards a digital model for patients,” others haven’t.

Even biggish, national programmes haven’t made the impact they should. Virtual wards and remote consultations “have not radically reshaped services.” The NHS App “is not currently living up to its potential impact, given the vast scale of its registered user base.” Just a handful of areas are effectively using data to inform services.

Critical, but not dead

Lord Darzi concludes in the review that the NHS is in a “critical condition.” But he doesn’t think it is dead. Towards the end of his summary letter, he specifically addresses the right-wing commentator trope that its universal, taxpayer-funded model should be abandoned.

Every country “with the prominent exception of the United States” is striking for universal healthcare, he says. And private or social insurance are just more expensive ways of achieving that. So, the question is “not whether we can afford the NHS” but how to turn it around.

He also rejects the idea that there are too many managers or that the service has been badly managed. Certainly, he says, people have been focused on “keeping the show on the road” but in a “broken system” different decisions “would have made only a marginal difference.”

Instead, and even though Streeting didn’t ask for policy proposals, the report identifies some themes for the new ten-year plan for the NHS that is being drawn up in Whitehall. These include re-engaging staff and empowering patients, taking steps to “lock in the shift to care close to home” by “hardwiring” the financial flows that will be needed to deliver it, and encouraging multi-disciplinary working.

In the review, Lord Darzi also calls for better productivity through a “tilt towards technology” and argues this will be a good investment if it succeeds in “getting more people off waiting lists and back to work.” Crucially, he warns that “change will only be successful if the NHS can recover its capacity to deliver plans as well as make them.”

Reaction: ministers face tough choices

The media latched on to the dismal aspects of the report, with the BBC running stories from patients about their experiences and papers appealing for examples of poor care. Staff bodies and think-tanks found its conclusions realistic – but were significantly more interested in what comes next.

Sarah Woolnough, chief executive of the King’s Fund, described the report as “authoritative and sobering” and said ministers now face “tough trade-offs between tackling immediate NHS pressures and prioritising reform of the root causes of the crisis.”

This theme was picked up by Matthew Taylor from the NHS Confederation, who also argued that ministers will need to “work on two fronts”: first, “to help the NHS avoid a winter crisis”, and second, “to prepare for the long-term through the planned ten-year strategy.”

Neither, he argued, could be done without more money and “emergency funding will be needed in the Autumn Budget” to head off a financial crisis that is threatening to reduce services and staff just when they should be ramping up for winter.

The Nuffield Trust also argued that “the health service is staring down the barrel of a significant shortfall in funding in this current year” and that chancellor Rachel Reeves will need “a clear plan to tackle this” – while working out a longer-term funding settlement.

Do politicians want to make them?

It’s not at all clear that the government sees things this way. For the moment, at least, Reeves is holding to the line that there won’t be more money in October. Indeed, the NHS is being asked to make cuts to fill its share of the £22 billon “black hole” that the Treasury has uncovered in this year’s finances.

Meanwhile, Reeves’ boss, prime minister Keir Starmer, is suggesting that there won’t be much coming at the end of the comprehensive spending review, either. In a speech to the King’s Fund, he played up the “unforgivable” state of the NHS outlined in the Darzi review and put the blame firmly on the Conservatives (“as everybody in the country knows, the last government broke the NHS”).

But when it came to looking forward, he said the government would not “raise taxes on working people” so the NHS will just have to “reform or die.” As if the NHS has been refusing to change, instead of being landed with impossible reforms and no money to fund them. As Lord Darzi had just explained.

Streeting picked a similar approach, attacking the Conservatives in the Commons, and then picking a fight with the British Medical Association, which he accused of “sabre rattling over pay” and being “locked into a way of life and a way of practising medicine [that is] very hard to move to a different place” (The Guardian).

Read into Darzi review what you will

The problem with stories is that people can use them in different ways; to inspire action, to defend inaction, to identify new villains. And it’s far from clear that former Labour peer Lord Darzi and today’s Labour politicians are on the same page when it comes to how to read his report.

Lord Darzi clearly believes the NHS has “strong vital signs” and can be restored to health with the right treatment. But in public at least, Sir Keir, Reeves and Streeting are keener on the “it’s broken” and ‘the Tories broke it” bits of his report than on the policy and funding implications, at least as they apply to them.

As a trust chief executive told the Health Service Journal recently: “Mr Streeting made it clear that he will ‘still be blaming the Tories if we have a bad winter’ but ‘thereafter it’s our fault’.

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Setting the Stage for EPR Vendor-NHS Trust Success

Richard Baylor, COO at St. Vincent’s Consulting and former Cerner (now Oracle) executive, and Paul Charnley, Luminary advisor and former NHS CIO of the Year share their insights on building strong EPR vendor-trust relationships. Beginning with the crucial topics of early engagement, strategic alignment, and moving beyond contractual agreements to develop lasting partnerships.

Early engagement, strategic alignment

From a vendor’s perspective, Richard emphasises that the foundation of a successful relationship lies in early engagement and meticulous procurement processes. He likens the procurement phase to ‘dating’, where compatibility and shared values are established before formalising commitments akin to a ‘marriage’ through contractual agreements.

Richard underscores the importance of ensuring that client stakeholders are fully involved in these initial stages. Often, trusts engage consultancies to manage business case and procurement activities, which can lead to key stakeholders not being fully involved until later stages. Including these stakeholders early on ensures that their needs and perspectives are integrated from the outset.

According to Richard, strategic alignment on high-order objectives, such as innovation, is pivotal. Aligning the EPR supplier’s innovation goals with the NHS trust’s digital leadership aspirations fosters synergy and mutual growth. Clear and consistent communication from the outset ensures alignment and prevents misunderstandings.

From the NHS trust perspective, Paul highlights the importance of defining success criteria early to integrate EPR systems seamlessly into healthcare delivery. For trusts, success extends beyond technical functionalities; it encompasses selecting a partner who understands and supports broader organisational goals.

Paul also points out the necessity of having the supplier’s delivery and service personnel involved early in the process, rather than only interacting with the sales team. This approach prevents the scenario where the client and the supplier’s long-term project team only meet at the ‘ceremony’ of contract signature, akin to an arranged marriage.

Early meetings between the client and supplier delivery/service personnel fosters mutual understanding and trust from the beginning. Strategic alignment, as Paul highlights, is achieved through shared definitions of success and mutual understanding, facilitating trust-based partnerships that enhance patient care.

Beyond contractual agreements

Both perspectives converge on the significance of fostering partnerships that transcend mere contractual obligations. Richard stresses the need for sustained engagement and organisational connectivity within NHS trusts to prevent relationships from becoming transient.

He highlights the importance of differentiating between personal, professional, and organisational relationships. While personal relationships between key individuals can be crucial, long-term success depends on nurturing all three types of relationships. Relying too heavily on a few personalities can create challenges if key team members depart.

Therefore, aligning corporate values during procurement ensures long-term compatibility and minimises potential conflicts. Richard emphasises the significance of proactive efforts and sustained involvement across all levels of the organisation, aiming to foster enduring connections that bolster mutual trust and collaboration, even amidst staff changes.

Paul highlights the value of building authentic relationships grounded in open communication and mutual support. He identifies shared values like integrity and patient-centred care as fundamental to establishing trust and fostering collaboration.

Transparency and alignment on strategic objectives from the outset are crucial for nurturing resilient partnerships that can adapt and flourish in dynamic healthcare environments. Additionally, Paul advocates for EPR vendors to invest in supporting NHS trusts beyond contractual obligations, citing long-term benefits derived from such proactive engagement.

Key Takeaways:

• Involve key client stakeholders early in the procurement process to ensure their needs are integrated from the start.

• Align the vendor’s innovation goals with the NHS trust’s broader objectives, especially around digital leadership, to promote mutual growth.

• Establish clear and consistent communication from the outset to ensure alignment and prevent misunderstandings.

• Include the vendor’s delivery and service teams early, not just the sales team, to build mutual understanding and trust before the contract is signed.

• Define success criteria early, focusing on both technical and broader organisational goals to ensure seamless integration of EPR systems into healthcare delivery.

Cultivate personal, professional, and organisational relationships to ensure long-term success, reducing reliance on key individuals who may leave.

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This scenario and similar examples are unfortunately playing out across the NHS on massive scale. Patients missing crucial information about their appointments and clinicians in a rush to organise on-the-day resolutions whilst juggling other important tasks. It is an untenable situation for both, and tends to be caused by the NHS’ dated and manual approach to admin.

Recent news headlines often feature details of ground-breaking progress in digital technology, particularly generative AI. And with the growing pressures of staff burnout, patient backlogs and growing clinician vacancies, trusts and their workforce are crying out for this type of digital support with appointment booking and patient communications.

Now is an opportune time to make these changes – Lord Darzi’s Review of the NHS, which is intended to give “an honest appraisal of the current state of the health service”, will hopefully give the new Labour government the impetus to take a data-driven, digital-enabled approach to healthcare policy. They just need to know where to prioritise.

Clinicians dominated by admin

A recent survey from the RCNi showed  that 42% of nurses spend at least half their working week (20 hours) on non-clinical admin tasks – a mammoth amount of time to spend on duties that could be automated or easily completed by someone with less specialised training. The same survey, which was supported by SPS, also found most nurses (64%) work at least six hours of overtime every week.

A direct impact of this workload is that clinicians’ face-to-face time with patients is limited. However, there are less visible, indirect effects too. Just like the nurse that rushed to book me an x-ray before my fracture clinic appointment, much of the day is spent manually correcting flaws in the admin process. That nurse may have to manually book ten more x-rays or turn more people away that haven’t completed diagnostics. The time spent doing this, which is wholly avoidable, reduces the number of patients they can see or extends their day by hours. The clinical role that nurses are trained to do is unfortunately diluted by admin.

And the same applies to other clinicians, who are in desperate need of admin support that can be eased by technology. For example, The Guardian reported how staff are “babysitting” patients and working 16-hour shifts. NHS England also logged an absence rate of 5.6% last year – equivalent to losing nearly 75,000 staff to illness (including burnout).

Embracing automation

Digital technology is capable of making a huge impact on clinicians’ admin workloads, for example by helping with notetaking using digital dictation, and makes for a logical next step. Forbes also recently highlighted how healthcare vendors have gone one step further to integrate ambient listening tools using generative AI. Rather than taking manual notes or even dictating them yourself, these tools allow clinicians to be fully present with their patients while transcribing key details – even potentially sharing them with the patient after their consultation.

Digital automation could also be introduced directly into the clinician admin process, logically coordinating appointments (such as booking diagnostics before consultations) and communicating directly with a patient. The letter templates currently used by the NHS are not flexible enough to communicate a patient journey that can sometimes involve multiple appointments across multiple specialities or even multiple hospital sites; resulting in the ad-hoc manual overhead we see today. More than 33% of patients in hospitals are treated by more than one department.

This may seem like an ambitious upgrade, but the new government has committed to a modernised, patient-centric health service in its manifesto, including a renewal of the NHS app. While the Chancellor has warned that public spending may be limited, research has shown that placing the current admin workload on nurses costs an estimated £13 billion. Releasing this workload to admin specialists or automation could generate billions of pounds in savings for the NHS every year, with the added benefit of improving the patient experience and letting clinical staff focus on their day jobs.

Change from the ground up

The NHS has attempted to introduce digital technologies before without mass adoption and full-scale success. Investments have tended to focus on high-cost solutions that, when bolted onto the NHS’ rigid processes, have resulted in more work than they have alleviated. Overcoming the admin challenges facing clinicians requires a bolder approach than the optimisation that has been attempted in the past.

For the government to achieve the change its aiming for across the NHS – and action the feedback that doctors and nurses have given since Covid – a true reengineering is required. What I call ‘Optimisation 2.0’, that goes beyond simply purchasing new software. Instead, it focuses on redesigning tired admin processes around the new possibilities that digital technology and AI offer.

Building a health service that enables clinicians to focus on care and gives patients more agency cannot be left as an empty electoral promise. Lord Darzi’s review is a vital step – discovery is the first step to the path to change – but it must be reflected in policy and implemented sooner rather than later. Tens of thousands of clinicians are counting on it.

By Ryan Reed, Head of Public Sector and Digital Transformation Expert, SPS

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However, cyberattacks are not the only threat to patient data. A range of diverse risks also exist on systems, applications and hardware that store sensitive information, and each of these vulnerabilities must be addressed to protect the healthcare sector from future attacks.

These attacks emphasise the need for healthcare providers to holistically evaluate their patient data management systems and ensure they are safeguarded against all threats.

Evaluate existing IT infrastructure

All businesses face cybersecurity challenges. For the healthcare sector, the magnitude of connected networks and devices exposes organisations to external risks, with many hospitals and clinics maintaining patient data in outdated operations systems. In fact, Prof Ciaran Martin, the founding CEO of the UK’s National Cyber Security Centre (NCSC) recently warned that “In parts of the NHS estate, it’s quite clear that some of the IT is out of date.”

This is important as once software passes its end-of-life and is no longer updated, it stops receiving updates, increasing the likelihood of the information housed within it can be easily accessed by cybercriminals.

This was proven in 2019 when software technologies company Check Point tested the cybersecurity of a Philipps HDI 4000 ultrasound machine and was able to gain access to the machine’s entire database of patient images. The vulnerability was caused by the machine using Windows 2000, which was passed its end of life and so no longer received updates and is prone to attacks.

To mitigate this threat and limit exposure within healthcare organisations, their systems must be regularly evaluated for weaknesses. This can mean separating outdated systems from networks storing patient data to ensure they are not used as a back door by cybercriminals.

Identify the best cloud solution for hospital workloads

NHS Guidelines advise health and social care providers to use cloud computing services to house data, with all data needing to be hosted within the UK borders to ensure data sovereignty. As a result, many public institutions leverage public cloud systems – a multi-tenant environment, with different customers using the same pool of IT infrastructure – to store sensitive data.

However, in June, Microsoft admitted there was no guarantee of sovereignty for UK policing data stored on its hyperscale public cloud infrastructure, raising questions over the level of oversight and control the police could ensure with its data. Organisations that use this platform are at risk of their data being transferred internationally, opening routes for foreign governments to access British citizen’s data.

As a result of this and other damaging cyber incidents, many people are concerned with how the NHS stores patient data, with 87% of the public in favour of keeping their personal healthcare data stored in the UK.

To safeguard patient data and ensure they are compliant with the sovereignty guidelines, IT leaders need to investigate their current cloud solutions and check the risks affecting patient data. Easing concerns by introducing a suitable sovereign cloud designed to meet legal, regulatory and operational requirements will enable NHS trusts to embrace the cloud while ensuring patient data is kept in the UK.

Create secure physical locations for health data

Sensitive patient information is also vulnerable to inefficient data management, particularly when data centres that are located on-premises run essential systems required to keep hospitals and clinics running. In July 2022, overheating and power outages in two data centres at Guy’s Hospital and St Thomas’ Hospital occurred when ageing technological infrastructure failed to cope with record temperatures and overheated, subsequently causing weeks of disruption to clinical services and patient data. This IT failure was attributed to a combination of factors, including  insufficient cooling systems, outdated technological infrastructure, and fragmented management of the data centre’s various components. To mitigate physical security issues, hospitals and clinics should review their current data storage plan and adopt a secure private sovereign cloud service managed by infrastructure experts to reduce the reliance on outdated and insecure data centres.

Setting the healthcare sector up for success

Attacks on NHS data like the 111 service attack on Advanced’s health systems and the Synnovis data breach set hospitals and clinics back months and highlight vulnerabilities within the healthcare sector to external threats. Yet, cyber threats are not the sole risk to patient data. It is also necessary to make sure this data can be viewed by medical practitioners to ensure the availability and resiliency of this data.

To ensure data is readily available and resilient, IT and security leaders need to follow this blueprint to enhance their security and protect patient data against all forms of disruption.

By Rick Martire, General Manager for Sovereign Services at Rackspace Technology

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Telemedicine has received widespread acceptance and adoption over the past few years, primarily as a result of the Covid-19 pandemic. In 2021, more than a quarter of medical specialists used telemedicine for at least half of their patient visits. What’s more, only 15 percent of primary care physicians think telemedicine might not be appropriate for their particular patients.

As a result, medical records and patient meetings have increasingly moved into the cloud, putting those electronic health records (EHRs) at a higher risk of unauthorized access by malicious actors. The increase in HIPAA violations and cybersecurity incidents in the healthcare industry since then shows that companies still have more work ahead to better protect EHRs.

What’s more, ransomware attacks in healthcare nearly doubled from 2022 to 2023, underscoring the growing threat. This threat continues into 2024, with major incidents like the Change Healthcare attack, which continues to cause disruptions and could wind up costing a total of $2.3 billion, and the Ascension attack, which impacted care at over 140 hospitals, further demonstrating the vulnerability of the industry.

On July 11, a bipartisan group of U.S. senators introduced a new healthcare cybersecurity bill to address the growing risks. However, legal experts say that the bill doesn’t offer anything new compared to other initiatives that have previously been proposed or are in progress. Without clear next steps on how to turn around the string of breaches, it will be up to individual chief information security officers (CISOs) and organizations to protect health data and ensure compliance.

Handling HIPAA compliance the wrong way

Let’s go over some of the top HIPAA compliance mistakes that companies make and how to avoid them.

As basic as it may sound, failing to use encryption and multi-factor authentication (MFA) represents a significant vulnerability in HIPAA compliance. Encryption ensures that even if unauthorized individuals access sensitive data, they cannot read it without the decryption key. Meanwhile, MFA adds an extra layer of security by requiring users to provide two or more verification factors to gain access to patient information. Without these critical safeguards, organizations leave themselves exposed to data breaches, risking severe legal and financial repercussions.

Many organizations also fail to rigorously manage third-party vendors, such as billing partners and healthcare software vendors, that may have access to protected health information (PHI). Third-party vendors must adhere to the same HIPAA requirements as the primary organization, and any lapses in their security practices can lead to data breaches. Look for third parties that advertise compliance with HIPAA, SOC 2, or HITRUST. SOC 2 and HITRUST are even more strict than HIPAA when it comes to data protection and cybersecurity.

The next mistake I see companies make is assuming one-and-done compliance audits are enough or conducting audits inconsistently. Compliance is an ongoing process that requires regular audits and consistent enforcement of policies and procedures. Lax enforcement can lead to non-compliance creep, leaving the organization vulnerable to data breaches.

Next, as healthcare increasingly integrates new technologies such as AI and machine learning, some organizations fail to address the associated compliance risks. AI systems require vast amounts of data, raising concerns about how the AI companies are processing, storing, or sharing that data. Without proper safeguards and clear guidelines on AI use, organizations risk violating HIPAA regulations, as AI systems could inadvertently expose sensitive information.

This leads directly to the final major mistake I see some companies make, which is not knowing or monitoring where all their data is. One major factor here is “shadow IT,” in which IT teams and other employees use software and applications that haven’t been officially approved. So if your team is, for instance, using an AI chatbot like ChatGPT to summarize notes, you may not even be aware that your patients’ data is being shared with third parties.

Some ways to combat shadow IT are to educate your employees about the risks and to ensure that you have provided HIPAA-compliant tools so they can complete their tasks without resorting to unapproved software.

The future of HIPAA compliance

While it’s possible that at some point the government could provide more helpful guidance around healthcare cybersecurity, the truth is that companies should really be acting now to prevent data theft and ensure HIPAA compliance. The priority for healthcare entities should be to know the top risks and mistakes that may result in breaches and learn how to avoid them.

By Eva Pittas of Thoropass

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Sam Shah has a very diverse portfolio: spanning clinical work, academic leadership, legal advice, and health tech advisory roles that see him travelling from the UK to the Middle East and back.

Shah has developed this diverse range of interests since he left NHS England and then NHSX, where he was director of digital development. So, he has excellent insight into the progress the NHS is making on digital – and he doesn’t think it’s great.

Lots of noise, very little action

“I do not think health tech has moved forward for the past five years,” he says. “There has been a lot of talk, a lot of initiatives, but very little activity. There have been five changes of leadership at NHS England on digital in the past five years, and a lack of transparency about what they have been doing.

“The digital maturity assessment [that was supposed to underpin the frontline digitisation programme to implement and expand electronic patient records] has never been published in full.

“NHS England says 90% of trusts have an EPR, but […] that statement is meaningless unless you have a definition, or can say how things have changed over time, or whether these tools are being used, or what difference they have made.

“The cost isn’t clear because it’s subject to constant reassignment. And even though the last Budget made another announcement on funding, there is no programme, no proper senior responsible officers, to spend it.”

In fact, he argues, Wales, Scotland and Northern Ireland have all made a lot more progress for a lot less noise by creating teams with clear digital responsibilities, allocating them a budget, and letting them run “small, useful” programmes in collaboration with their healthcare systems.

A three-point plan for progress

The UK is almost certain to go to the polls for a general election this year and it’s almost certain that Labour or some version of it will be voted in. Shah knows exactly what he would like shadow health and social care secretary Wes Streeting, who likes to talk about “reform” and apps, to do.

“He should establish a strategy, aligned with the system – which means industry partners as well as people working in healthcare,” he says. “He should pick three things to do well, and find the budget to do them, but delegate it so people don’t have to keep going back to the centre.”

And what three items would be on Shah’s wish list? “Number one would be to make it easier for clinicians to collaborate with other clinicians,” he says. “Not just referrals, or sending people from GP surgeries to hospitals, but the co-ordination of care across the system, or what we used to call ‘any to any’.”

This would not just smooth care pathways, he adds, but Amazonify healthcare. Just as people can use apps to track their parcels and modify their deliveries, they’d be able to see where they are in the healthcare system and make choices accordingly. Health is complex but decent platforms would make things a little easier.

“The second item on my wish list is to sort out the data environment,” Shah continues. “That doesn’t mean putting in one EPR, but making data fluid, so we can sort out data for our planning and our public health and our research colleagues.

“And the third thing would be to sort out the front end: whether that’s the frontend for clinicians or for patients.” Shah says this means modern, mobile technology that makes it easy to do basic tasks, like putting together a patient list, or viewing a series of appointments on a calendar.

Not lots of apps. “Clinicians are getting app fatigue from being told to download this and login to that,” he says, “and we don’t want to start giving our patients app fatigue as well. They are much more likely to want one login and one place to see everything, end to end as far as the NHS is concerned.”

Sort out today’s problems, then see what AI can do

Interestingly, Shah’s wish list doesn’t include AI, even though it seems to be compulsory for Streeting and other politicians to claim that it will solve all the NHS’ problems. “AI is interesting,” he says, “and everybody is interested in generative AI in particular, but we need to get the basics right.

“We need to solve today’s problems and then start layering in AI, when it’s mature enough, and we know which of tomorrow’s problems it’s going to help us with.”

Instead, he has costed his wish list – he reckons it would cost around £4.7 billion over the first three years of a five-year programme. After that, there might need to be some “top ups” – although he argues his wish list would deliver efficiency savings.

For example, a transparent and efficient referral system would reduce the need for referral administration and cut the number of GP appointments that are made by patients desperate to find out what has happened to their test or trip to outpatients.

Better data could help public health and its partners in local government to get back to addressing some of the inequalities, determinants of health, and lifestyle choices that drive demand at a fundamental level. And some nifty administrative tech could deliver significant efficiencies.

“I see in my own practice that people are in pain, so they ring a call centre for an urgent appointment but it’s made at a centre they cannot get to, at a time they can’t make, so they don’t turn up,” he says. “It really should be possible to stop that happening.”

Soundbites and spin doctors  

Still, Shah is not exactly confident any of this will happen. Having seen some politicians at close hand, he feels they’re looking for soundbites to deliver to their electorate.

“They don’t want practical or costly. And this is practical and costly,” he sighs.” Those of us who have been in the system: we can say the right thing and not worry about it being the popular thing. But most politicians aren’t in that position.”

This might be an argument for following the lead of Wales and, to some extent, Scotland, and creating an arms-length body to plan and deliver NHS IT. Or, perhaps, to re-create one, as the NHS in England has tried a similar idea before, with the NHS Information Authority, and then NHS Digital, and NHSX.

Shah feels the idea has merit – but the fate of these bodies shows there are pitfalls. “There is no doubt that NHS England has got too big and there is an argument for breaking it up again,” he says. “But you should only do it if you can find the right model, and the right leaders.

“It can’t be like NHSX, where the friend of a politician was parachuted in, and created a circus before he went off to the zoo [NHSX boss Matthew Gould eventually departed for the Zoological Society of London].

“You need a good operator, who understands the NHS, but knows how to run a major programme and handle a big budget. If you can’t find one, you shouldn’t bother.”

Finding causes for optimism

And if Streeting did come knocking, would he be tempted to go back? Shah laughs. “Only if he liked my plan and could accept a dose of reality,” he says. And only if the right team was appointed, and promised the space to build, implement and deliver products.

Still, he says, there are reasons for optimism about health tech. “I think there is a commitment to improve access to healthcare for society, and I think it is recognised that inequalities have widened and there is a need to address them” he says.

“So, there is an opportunity for digital, which is to bring data together to help clinicians to do the job, and to help planners make better public health decisions. And, of course, to be more transparent with the public. I think digital and data can get into quite an interesting space, and there is an opportunity to do it.”

Biography:

Professor Sam Shah  works in digital health across the College of Medicine and Dentistry with Ulster University and is visiting faculty at UCL and UCLan. Sam works clinically in primary care and is an NHS consultant at the Royal Wolverhampton NHS Trust. Sam was previously chief medical strategy officer for online healthcare provider Numan. He works with a number of organisations in health tech, supporting development of ecosystems. He has a particular interest in health tech regulation, public health and behaviour change.

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Highland Marketing asked some of its associates and clients what they hope the general election will mean for the NHS and digital health. They argued that whoever becomes the new health and social care secretary will need to invest in sorting out the basics of infrastructure, devices, and care records, if they want to build the foundations for the adoption of AI and innovation in the future.

Yet, at the same time, they argued a new government should be looking for ways to invest in technology that can address some of the immediate challenges facing the NHS, from managing waiting lists and improving patient flow through the system, to maintaining a focus on quality and addressing inequalities. There was also a plea for the next administration to work with the health and med tech industries; and to crack the stubborn nut of interoperability.

Jeremy Nettle, chair, Highland Marketing advisory board: The main parties have focussed on the NHS, because it is one of the top concerns for voters. They’ve shown much less interest in social care, but the health service’s problems won’t be resolved without a functioning care system to reduce demand and free up discharges.

So, whoever becomes the new secretary of state, let’s hope they remember the job is health and social care. They’re certainly going to be taking on the job at a challenging time, with junior doctors about to strike again and waiting lists growing after a period of stability.

The capacity and reform required will not be delivered without investment in technology. Organisations need better infrastructure, devices, and software systems to support the AI that politicians are hoping will be a panacea. Working with the private sector on waiting times could also create a new focus for data sharing. After all, the only person with a true 360 view of their healthcare is the patient themselves.

Jane Rendall, managing director, Sectra UK and Ireland: The new health and social care secretary should prioritise the integration of genomics into healthcare, leveraging the Genome UK strategy to offer personalised treatments and predict disease risks.

Emphasis on digital transformation and health tech is crucial across the NHS, following the election, with a cloud-first approach that can enhance the interoperability and efficiency of systems and help to improve access to diagnostic tests, imaging and expertise.

Addressing health inequalities, ensuring data security, and fostering innovation through public cloud platforms are also essential. This comprehensive focus will help to modernise the NHS, improve patient care, and prepare for future healthcare challenges.

Jamie Whysall, principal head of healthcare, Netcompany: One of the biggest challenges in the NHS is how to do more with a finite amount of resource and budget – and to balance smart investments that can promote positive change in the short-term as well as elevate citizen and clinician experiences in the long-term.

Investment in new hospitals and large IT systems to bring it together may seem like a heavy up-front investment, but there are step-change approaches available today with proven success in mitigating risk, increasing productivity, and reducing waste costs.

We believe prioritisation should be given to technology that can be used to improve the capacity of existing healthcare systems and the flow of patients through them. That means solutions that can help to optimise, streamline and predict fluctuations in demand and give the healthcare system the agility to adjust across a hospital, an integrated care system level, or at or national level.

Bevin Manoy and Moyra Amess, directors, CHKS: Whatever the outcome of the general election campaign, there is a huge task ahead for the NHS and for the role of health tech. Health services are still living with the impact of Covid-19, with real pressure on the workforce. There are mounting waiting lists, with acuity of patients increasing as people wait longer for treatment.

To address these challenges, we need a strong focus on patient safety and the effectiveness of services in the acute health sector. That means collecting high quality clinically coded data, benchmarking to find out what works and what does not, and assurance services to support professionals in delivering excellent outcomes for patients.

None of this requires huge, new initiatives. If anything, it requires stability, and continuing to invest in the basics of being able to ensure efficient and high-quality services. There are tough decisions ahead, but to address them we need to be smart and to use the tools available to make good decisions.

David Simpson, owner and head of product and partnerships, MEDILOGIK: Following the election, one priority for a new government interested in health tech should be to ensure that large electronic patient record suppliers are forced to fully integrate with the numerous, small, departmental clinical systems that hospitals use. This is a crucial step towards delivering a true, integrated care record, with all the benefits that would deliver for clinicians and, of course, patent safety.

Secondly, national and local projects should be aligned and use the same procurement rules to reduce the conflicting requirements that suppliers tend to face at every stage. And finally, instead of issuing targets, it would be good if policy makers and programme managers could engage with suppliers. After all, we might just have some experience and be able to assist – or even improve! – what they are trying to achieve.

Dean Moody, healthcare services director, Airwave Healthcare: General election campaigns can have a long-lasting impact on health services and the technology they use. A good example is the introduction of bedside TV and telephones to NHS hospitals.

This was a key feature of the NHS Plan that New Labour launched after the 1997 general election. The NHS Plan promised new hospitals and state or the art facilities. But the patient pays model for bedside entertainment and communications was never popular and the units that deliver it have never been modernised.

This general election, it would be great to see one of the parties promise to do away with the patient pays model, and to invest in today’s state of the art health tech. That way, we could not only deliver entertainment, but information and digital services to patients, educating and engaging them to be partners in their own care.

Assad Tabet, senior vice president healthcare, UKI and Europe, Mastek: Reducing health inequalities should be a joint priority for the UK government and the NHS over the course of the next Parliament. Collecting, harnessing, and utilising available data should be at the centre of the strategy to achieve this goal. Ahead of the general election, Mastek is calling all political parties to commit to cross-government data sharing to address data gaps in public health surveillance and drive local prevention efforts.

In particular, the focus should be on the following areas, which have consistently been shown to have a considerable impact on an individual’s health and wellbeing: environmental considerations, such as air quality; housing status, including details on homelessness and those living in damp and overcrowded accommodation; employment status, including details of long-term unemployment, where appropriate; the location of, and proximity to, community and acute health services.

Chris Goldie, chief executive, Vertex UK: Every health tech vendor will argue that the digitisation of the NHS must top the new health and social care secretary’s agenda.  Considerable progress in digital strategy and implementation has already been seen, especially in areas such as diagnostics.

Building on this momentum in ways that maximise available innovation, will require a focus on modernising procurement approaches within the health service. Framework contracts and tender stipulations can make it hard for innovative start-ups to work with systems and trusts on valuable, cost-effective solutions.

We believe that to truly advance NHS digitisation, the new health and social care secretary needs to have the process of doing business with the NHS high on their agenda. It urgently needs to be reformed, to support British startups with solutions that can truly enhance patient service delivery.

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Shane Tickell has been working in the health tech industry since the late 1990s. He is probably best known for his long career at IMS MAXIMS, where he worked for 13-years, predominantly as group chief executive officer. However, he left IMS MAXIMS four-years ago “to pursue a wider agenda.”

“I wanted to work on data,” he says. “I want to be able to bring data together from conception to end-of-life, in real-time, with good governance, safely, so people can use it to provide great care and then, anonymised, use it for population health management and research.”

A thrilling future for data  

To this end, Shane is now chief executive of three companies including Temple Black, “a strategic company that is bringing together data to take advantage of quantum computing,” and Voror Health Technologies, which is developing an open healthcare data platform on the AWS cloud and Endeavour Predict that provides risk scores for major diseases such as Cardio Vascular, Cancer, Diabetes.

“When I started in the industry, we knew about 80% of healthcare decisions involved pathology testing of some kind and that about 73% involved radiology,” he says. “We also knew that about 90% of those results would be safe and in-line, so the majority of patients were seeing their consultants and GPs for reassurance.

“We started introducing algorithms to let clinicians focus on the other 10%. And we’ve had some  significant success with that. But now we’ve codified a lot more information. We’ve started work on uncoded information, and we have large language models coming along to help us make sense of it.

“So, I think the next ten-years will be thrilling. If we get this right, we can tackle the backlog, by taking the people out of the waiting list that don’t need to be on it, and we can start to tackle demand at source, by addressing the social determinants of health, meaning we can start to predict, prevent and personalise care.

“We need to do it, because we all know there is a global shortage of funding and workforce. The only way through is to use technology. That’s why I came into the industry.”

Speaking up for the health tech industry

As if that wasn’t enough to be going along with, Shane has also been putting back into the industry itself. For the past two-years, he has been chair of the Frontline Digitisation Forum; a joint NHS England and techUK hosted body for electronic patient record vendors involved in the latest bid to complete the digitisation of acute trusts.

And for the past four-years, he has been vice chair of the techUK health and social care council; becoming its chair in January. His background plus these experiences have convinced him that the NHS needs to think about how it does business; and it needs to give more priority to small and medium enterprises.

“For the first six-months, frontline digitisation was great,” he said, “and then we lost our way. We had volatile funding and inconsistent leadership messages.

Then we saw some major contracts in other areas awarded to a few big companies, when we know that SMEs are the largest employer of people in the UK, and a major driver of innovation.

“There are ways for the NHS to encourage SMEs, but one of the challenges is funding. Big IT projects tend to require capital funding, and that inevitably gets clawed back when finances get tight. Yet, every year, trusts roll-over IT contracts with an RPI uplift, so they pay more and more for technology that is aging,  not necessarily keeping up to pace with the revenue increases associated each year. You could say this is money that could be better spent with emerging technology that is frankly better value. But change is hard!

“So, we need to get into the commercials. We need to find new revenue models to enable us, as a country, to buy technology that is more innovative. With the move to cloud, we should be able to do it. AWS, Microsoft Azure, Google and the rest of them are moving to a pay-as-you-go model, and we need to talk about the NHS following suit.

“Among other things, that would take decision making away from the whim of health secretaries and their appointees. At the moment, you get a new health secretary, and they have an idea, and it can lead to a programme with implications that last for ten-years.”

Standing up for SMEs

Shane feels frontline digitisation is back on track; but there is still a lot of work to be done to encourage SMEs, both at the NHS and the industry level. On the NHS side, he argues the health service needs to understand the mechanics of doing business as a small company.

“SMEs need to win business, to maintain the confidence of their investors, and build the confidence of their customers,” he says, adding that from personal experience, when this doesn’t happen “they get dragged into a horrible cycle, where they can’t invest in their products because they have no customers, and they can’t get customers, because there’s no guarantee of development.”

Hence his call for a hard conversation “on the commercials.” On the industry side, he argues companies need to face up to what he calls “the elephant in the room” – the dominance of large, often US companies in the UK health tech industry, and their tendency to crowd-out or buy-up their smaller counterparts.

“As chair of techUK, I want to have some really robust conversations with people and point to the elephant in the room,” he says. “I want to bring together the big and the small suppliers, so the big companies can’t stifle innovation by starving the small ones of resources and making them vulnerable. We all need to work together and I have made my chairmanship of 2024 all about inclusivity”

Tough times, thrilling future

That’s particularly the case at the moment, when the health tech market is tough. Outside frontline digitisation, and one or two other large programmes, like the roll-out of summary care records and the deployment of ‘next generation’ technology at radiology and pathology networks, little seems to be happening.

And with the NHS bogged down with waiting lists and facing a significant financial crisis, that is unlikely to change ahead of the general election. But Shane insists the future is bright, as long as the health tech industry is confident – and business like.

“I can see a way through this,” he says. “When I started at techUK, we would talk about what the NHS wanted, and suppliers would try and deliver it; only for the finances and the requirements to change. What we need is a dialogue, where we say to the NHS: ‘this is what we can do for you’ and we learn ‘this is how we need it to be deployed to be effective.’

“And that will only work if the industry is inclusive. Then, we need organisations like techUK to work on things that will support the whole industry, like standards, and we need to get the commercials sorted.” It won’t be easy, he admits; but it should be possible – and if it happens, it will lay the foundations for that “thrilling” data-driven future.

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The Highland Marketing advisory board last discussed adult social care in April 2021; a year into the Covid-19 crisis that had demonstrated its value – while highlighting some of its challenges.

The sector had gone into the pandemic facing a chronic shortage of funding and staff, while the Covid-19 response highlighted that care homes and domiciliary providers lacked wi-fi, electronic health records, effective communications, and monitoring technology.

Not enough of the vision thing

When Boris Johnson took over as prime minister, he promised to “fix” the crisis in social care “once and for all.” In December 2021, as his government reluctantly prepared for its third lockdown, it issued a ten-year “vision” for the sector.

‘People at the Heart of Care’ came with a headline pledge that people would no longer need to sell their houses to fund their care, and that £1.5 billion would be invested in housing, workforce and technology. Two years on, the Commons’ public accounts committee found this has fallen well short of a fix.

Days before the advisory board revisited its discussion of social care and technology, the PAC warned the promised funding had been scaled right back and the government no-longer has a roadmap, milestones or targets for the sector after March 2025.

Meanwhile, adult social care now accounts for as much as 70p in every pound of council funding, pushing an increasing number towards bankruptcy. Brexit has not helped vacancy rates, which have reached 152,000. Providers are struggling with the cost of fuel, heating and food. Yet, almost inevitably, demand continues to rise.

Digital social care records: two thirds of the way there 

There have been some positives in the past three years. Integrated working is still on the agenda, even if progress has been slow, with NHS England and integrated care systems focused on finances and waiting lists.

The government has launched a plan to develop the domestic care workforce, with a new, accredited qualification, and a career structure with defined job roles. And there has been some progress on digital.

In fact, Claire Smout, head of digital skills at Skills for Care, told the advisory board that the £100 million ‘People at the Heart of Care’ earmarked for digital skills and technology is one of the few pots of funding that have not been raided and are still being spent.

The money has gone into three areas, starting with digital social care records. Smout said Care Quality Commission figures suggest “about 67% of care companies now have a digital social care record of some sort.”

Money has also gone into ‘digital readiness’ such as wi-fi provision, cyber security, digital skills and training, and into care tech pilots, ranging from using AI to help with scheduling, to installing Alexa and other voice-activated devices in people’s homes.

Data and interoperability standards 

Even so, there’s a lot left to do. There are 18,000 social care providers in England, and while there are some large chains, many are small and simply cannot afford technology. “We’ve got small providers who cannot afford to put the infrastructure in place for digital social care records,” Smout said.

“They struggle to find investment for the wi-fi, or the tablets, never mind the licences. So, over the next two to three years, there’s likely to be a cross-over where we have some care providers that are paper-based and some that have moved on electronically.”

At the same time, the CQC doesn’t have a definition for digital social care record, so it’s not clear what systems that 67% of providers have deployed. Smout’s colleague and advisory board member Jane Brightman said an assurance framework has been developed to address this and drive-up quality.

This will be issued against a background of policy activity to address data quality and interoperability. An updated Care Data Matters strategy has been issued to make sure data can be captured once and used many times.

While, days after the advisory board meeting, the DHSC issued a prior information notice for an interoperability platform and services to share data with health providers and shared care records.

Strategies to recruit, retain, and upskill the workforce 

On the training and skills front, Skills for Care has been commissioned to develop a Digital Skills Framework for its sector. Smout said it covers seven areas, ranging from ethics to cyber security and data management.

Each area sets out the skills that anybody working in social care should have, while another sets out the skills that those in more senior positions require. The framework has a learning and development framework attached to it, with a free e-learning platform holding videos and other resources, and a database of training providers.

“The framework has been developed with the sector,” Smout stressed. “It’s very interactive, and it’s not designed to sit there, gathering dust.” Nor is it being developed in isolation from other workforce initiatives. The DHSC is working on a strategy for digital, data and technology (DDaT) staff.

While Skills for Care has been tasked by its sector with developing an adult social care workforce strategy, as the government has not commissioned one.

Brightman said the strategy, which should be published in July, will cover one-to-five years and five to 15 years, so it can address immediate challenges – such as the collapse in apprenticeships – and longer-term ones – like creating new digital roles to support new ways of working.

How far will the money stretch?

With all this going on, it’s clear the digitisation of social care still has some way to go. And advisory board members questioned whether there is the money to do it.

Neil Perry, a consultant and former acute trust chief information officer, noted that £100 million is just 5% of the money the NHS is putting into its frontline digitisation programme to implement and upgrade electronic patient records.

“The breadth of social care, the number of places in which it works, it can’t be any simpler than the NHS, surely?” he mused. “So, the question is: how is that £100 million going to stretch?”

“The positive is that social care is a greenfield,” Brightman said. “We haven’t got some of the structural problems with technology that the NHS has got. “We’re not years down the line with long, unwieldy contracts with our suppliers.”

Having said that, she acknowledged that with 18,000 providers to cover, the government has effectively said: “we can’t do all of it” and: “we can only put a little bit in.” And that will run out at the end of the three-year spending review period next March.

Finding drivers for adoption 

Andy Kinnear, another consultant who formerly worked for an NHS commissioning support unit, admired how far that “little bit” had been stretched. “You’re getting these dreadfully meagre crumbs off the table, so the fact that you are still smiling and so positive is an incredible achievement,” he said.

But in the absence of funding, he wondered what other drivers are available. Smout said a lot of impetus will come from the Care Quality Commission, which has issued guidance suggesting providers will need to adopt digital social care records to remain ‘good’ or ‘outstanding’; and instructing them to complete the Data Security Protection Toolkit.

Skills for Care is also looking at how it can drive the skills and training agenda by building these into other frameworks. “The new care qualification, for example, will be available for new staff, so how can we make sure digital skills are embedded into that – and into some of the other mandatory training that people have to do?” she asked.

Finding solutions, engaging policy makers

Both Brightman and Smout stressed that finding practical solutions is essential to keep ministers and Treasury officials on board. “What I have learned is that the government just doesn’t listen if we go in cap in hand, saying social care is a nightmare, and you need to fund this, this and this,” Brightman said. “So, what we’re trying to do is come up with positive solutions they can work with.”

James Norman, a former acute trust CIO who now works on the supplier side, accepted the point, but wondered if things would change with a change of government. “What about Labour,” he asked: “Do they give any indication of funding this?”

Brightman said the party seems to be interested in a National Care Service, but its immediate priorities are likely to be a new offer on pay, to attract and retain more staff, and further investment in digital.

On top of everything else discussed, Kinnear suggested the party should look for ways to commission new, digital models of care and to put care tech into the hands of users, so they can access some of the self-serve functions that have become common in banking, shopping, and other sectors.

“Health has been slow and clumsy to move in that direction, but there must be opportunities to rethink social care in the same way,” he argued. Brightman and Smout said some councils are already talking about a “frank conversation with citizens” about how to share responsibility for health and social care.

Time to tackle funding

Whatever Labour decides on structure, workforce and digital, it will need to address funding. After all, Ian Hogan, CIO at a community and mental health trust pointed out, social care is an investment.

A failing social care sector leads to delayed discharges from hospital, makes it harder for people to return to the workforce, and means people live less full lives than they could. Or, as he summed up: “Poor social care leads to poor healthcare, which has a direct, knock on effect on all of us.”

David Hancock, a consultant who previously worked for major EPR and SCR companies, agreed. “In 2015, [former NHS chief executive] Simon Stevens said that if he had more money, he would put it into social care,” he said. “It didn’t happen then – but it needs to happen now.”

About the Highland Marketing advisory board 

The Highland Marketing advisory board includes: Jeremy Nettle (chair), formerly of Oracle and techUK; Cindy Fedell, regional chief information officer at North western Ontario Hospitals, Canada; Nicola Haywood-Cleverly, CDIO for Lincolnshire Police, NED at MerseyCare NHS FT and former CIO for Integrated Care Systems; Andy Kinnear, former director of digital transformation at NHS South, Central and West Commissioning Support Unit and now consultant at Ethical Healthcare; Ravi Kumar, health tech entrepreneur and chair of ZANEC; Dr Rizwan Malik, consultant NHS radiologist & director of SMR Health Tech Consultancy; James Norman, EMEA health and life science director, Pure Storage; Ian Hogan CIO at the Leeds and York Partnership NHS Foundation Trust; Neil Perry, former director of digital transformation at Dartford and Gravesham NHS Trust and now director at Synergy Digital Health Innovation; David Hancock, digital health strategist specialising in interoperability; Jane Brightman, director of workforce strategy at Skills for Care; Natasha Phillips, former national CNIO and now founder of Future Nurse. 

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The pharma industry continues to be in a state of flux. Merger and acquisition activity remains rife, new Regulatory updates are being rolled out all the time, and companies are still reviewing supply chain security following the pandemic, the ongoing situation in Ukraine and economic uncertainty.

Meanwhile a whole raft of patents are expiring, triggering a rise in biosimilar manufacture. As new molecules pass through the pre-clinical stage and move towards clinical trials, developers must consider formal requirements including Quality GxP measures as part of their Clinical strategies.

As we approach the end of 2023, and companies finesse their roadmaps for 2024, there are five priorities vying for attention.

1. Embed risk-based decision-making.

Regulatory updates have been coming thick and fast in Life Sciences in recent years, in step with the accelerating pace of change in the industry. One of the most notable changes for drug manufacturers in 2023 has been the updated ICH Q9 guidance on quality risk management. This provides important new impetus around the development of robust, fit-for-purpose quality risk management plans – in other words those which positively position companies to spot and mitigate issues in advance.

Although many companies consider themselves to have good quality risk management programmes in place already, because they are performing a lot of risk assessments, this perspective is too reactive and compliance-driven. The real question is whether existing measures are really working for the organisation, in making it possible to anticipate and mitigate risks before they occur.

The point of the updated guidance is to remind manufacturers of the purpose of quality risk management, so that they embed risk-based decision-making into everything they do.

2. Mitigating supply chain risk.

Although the COVID-19 pandemic is now largely behind us, there is no room for complacency. Added to the impact of this and other future global health events on the need for ready access to vaccines and medicines, the disruption caused by wars in Ukraine and now Israel, as well as growing economic uncertainty, provide a further reminder of how fragile supply can become where key sources are remote and there aren’t adequate contingencies.

Sourcing of active pharma ingredients (APIs) represents a particular point of risk for medicinal product manufacturers. In the case of Advanced Therapy Medicinal Products (ATMPs) including cell, gene, tissue-engineered and somatic-cell therapy medicines, excipients (non-active ingredients) and other raw materials might be unusual and single-sourced from a far-flung country, yet essential to manufacture.

To avoid supply chain-based risks, where an individual manufacturer’s demand is only for very small volumes/of low overall value, it may be necessary for manufacturers to join forces to shore up their supply routes, if they can find a way to do this without compromising their intellectual property. Banding together to boost combined demand could help build the business case for alternative suppliers to enter the market, for instance.

• Addressing consumption.

Environmental, social and corporate governance (ESG) is high on the agenda for most industries today. However the biologics industry has a mixed relationship with environmental sustainability, given the need for low bioburden or sterile manufacturing which currently favours the use of single-use consumables from a patient safety perspective.

Yet pharma does need to address its consumption of single-use plastics, broadening its focus from patient safety in a vacuum to include wider protection for the environment, with a consistent end-to-end strategy that leaves no room for accusations of greenwashing. Although patient safety will always be paramount, which inevitably influences contamination control throughout transportation and storage, there need to be a balance – so that measures that are keeping patients safe are not contaminating entire communities.

• Design quality into processes.

As patents on a whole raft of established drugs expire, we continue to see a rise in the manufacture of biosimilars. As new molecules pass through the pre-clinical stage, into clinical trials and beyond, developers must consider formal requirements including quality and GxP measures as part of their clinical and then commercial strategies.

For companies to position themselves as major shareholders in new markets, they need to design quality into their processes up front. Understanding how they would ideally commercialise the finished product, and keep quality considerations aligned throughout, can be pivotal in getting to market faster, for instance through the right partnerships, e.g. with Marketing Authorisation Holders,  licence holders, and organisations providing strategy and scientific advice.

• Attracting the right people.

The global skills crisis is as evident in Life Sciences as in so many other markets, and it is incumbent on the industry, as well as on education institutions, to be proactive in addressing the growing gaps in both capability and career mindset among upcoming generations of teams, particularly those in scientific disciplines such as microbiology.

Younger team members, who have grown up in the ‘gig economy’ have more of an expectation that they will move around to gain a broad spectrum of experience, and this can pose problems where skills, experience and staying power are key to maintaining consistently high standards in quality and risk management. This means seeing through difficult projects so that they recognise and can pre-empt future issues, for instance. In cell therapy, for example, products by definition can’t be sterilised, so it is vital that nothing can get into a product while it’s being manufactured. The people who specialise in ensuring this are the microbiologist and the sterility assurance and the biotech personnel – yet those experts are in short supply.

Rather than continuing to push up salary expectations, the industry needs to work with education establishments to encourage a greater understanding of this industry and the exciting opportunities it presents, so we can attract not just keen scientists but also lateral thinkers, people that can connect the dots across different functions, rather than just concentrating on one thing.

The powerful combination of AI and great data

Finally, linked to the theme of education and with a glimpse into the near future, the whole emergence of AI will be a major area to watch going forward. But this needs to start with spending time educating people about what AI really is, and its potential in the product development space. That could be in predictive chemical modelling for chemical reactions, so that teams can more precisely pinpoint the experiments that may be needed for formulation or drug development.

Start with a focus on quality risk management – and risk management in general – to help exploit the full potential of company information. Add AI into the mix, along with validated data, to help streamline choices and reduce risk.

About the author

Kate Coleman is VP of Quality at Arriello. She has over 20 years’ experience in Quality Assurance, Sterility Assurance and Microbiology Quality Control, and has worked across ATMPs, Biologics, Sterile Fill Finish, Vaccines, APIs and Oral Dose platforms.

Over her career to date, Kate has served as a practising QP, Principal Consultant, and qualified Lead Auditor. She is also a subject matter expert in Risk Management, New Facility Design/Start Up, Quality Control and Sterility Assurance. In her previous role before joining Arriello, she was Senior Director for Quality Management and Compliance, and Head of QMC.

Kate is particularly passionate about the interdependence of Regulatory and Quality, as companies develop their strategies and processes and look more holistically at what they need, rather than operating in silos.

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