The Colon Capsule

Home and community-based delivery of endoscopies utilising swallowable capsule cameras. Advanced Connectivity allows consultation between patient and clinician during the procedure and then efficient transfer of diagnostic imagery.

What is the problem to be solved?

Bowel cancer is one of the few cancers that is completely curable if detected early. Detection is based on spotting polyp pre-cursors, traditionally using a videoscope device involving a tube insertion at a clinic and requiring a suite of equipment and several staff. The process is invasive, costly and many polyps are missed by operators (the equivalent of the x-ray machine at airports, humans can get tired, distracted or for other reasons miss important images).

There is currently a backlog of over 300,000 endoscopies in the UK. More clinics are being built but at nothing like the required rate. Around 45,000 people are diagnosed every year and close to 20,000 of those will die because detection is too late. From a patient perspective there is a keen desire for early diagnostic options. From a cost perspective treating cancer late (Stage 4) costs the NHS £10,000 more than if identified at Stage 1, so just for those that sadly die from the disease this is a £200 million cost.

The current diagnostics cannot scale rapidly and suffer from other challenges – many patients turn the procedure down because of its invasive nature, disinfection regimes (particularly post-covid) are costly and not environment-friendly, clinics are generally situated at large hospitals creating travel challenges for patients especially in remote and rural communities. 

There are barriers to new alternatives which are not unique to this pathway. Clinicians may be resistant to the required change especially when it fundamentally changes their role. NHS England often takes far too long to pilot and test new technologies many of which, particularly when driven by SMEs, then fall by the wayside. New solutions often seem expensive when trialled at small scale but then become cost-efficient at scale.

The NHS and private healthcare providers are all affected by this problem. Funding new endoscopy clinics requires capital expenditure and several private providers have entered the market to fund new facilities, but the NHS-private sector relationships are not always easy to establish and sustain. One barrier is a fear that NHS staff will be attracted away to work with private providers.

Useful links: 

Bowel Cancer UK

Cancer Research UK

NHS

Schematic of a traditional endoscopy clinic

Schematic of traditional endoscopy clinic set-up (courtesy Owen Epstein, Royal Free Hospital, London)


What is the solution to the problem?

Swallowable cameras – colon capsules – have been available for over fifteen years but of the 2 million endoscopies undertaken in the UK each year only around 50,000 are colon capsule (CCE). Part of this may be clinician resistance but the reality is that the benefits come when the procedure is available away from the clinic.

Following a successful trial in the Highlands of Scotland in 2016/17 a subsequent national rollout of community-based (not at home) CCE has resulted with thousands of patients adopting the procedure. The early trials were based on utilisation of satellite connectivity to transfer data, around 400,000 images per patient (1.5-2.0Gb) to remote centres for analysis. NHS England has not yet followed suit but in any case, the transformational solution is home delivery.

In 2021/2 the DCMS 5G Trials and Testbed programme provided c£400K of funding to support the development and piloting of a complete home delivery solution – IntelliGI. Trialled with live (sic!) patients in Coventry the process works and is exceptionally well-received by patients and clinicians alike. In the West Midlands, utilising £2.9 million of DLUHC funding the solution is being offered to thousands of patients and the hope is this will spur national adoption.

The whole process is dependent on reliable connectivity – it requires connection to a remote clinician up to and including swallowing the capsule and reliable transfer of the capsule images. 

The connectivity solution is likely to differ from remote areas of Scottish Highlands (satellite/5G) or in large city areas but reliance on patients own connectivity solutions is not generally deemed appropriate. This is partly because of the potential inequalities in service performance and the challenges this creates in aggravating care delivery inequalities, but also because many patients may be frail, and elderly and it is deemed potentially intrusive to attempt to utilise their connectivity. It isn’t because Wi-Fi on a fibre backhaul is unable to support the imaging data volumes.

The NHS, and patients, also worry about the security of patient data resulting from using Wi-Fi.

There are no special or demanding power requirements for the IntelliGI box which contains only a tablet and a MiFi and a patient-worn belt in which sits a smartphone-based recorder for capturing the images. From a safety perspective, the challenges of swallowing a camera relate to potential choking and the dehydration potential during the procedure. Both are mitigated by ensuring a local carer or relative is alongside the patient.

This is a solution which could work with a range of networking options, and whilst each will work technically, there are advantages to each:

  1. Wi-Fi + Home Broadband.  For: Widely available and national capacity is improving through Project Gigabit.  Patient already funds this route, and it will suffice for many users.      Against: It isn’t especially secure and fails the Digital Divide test.
  2. 4G Public Network. For: Widely available and a 4G dongle can be easily and cheaply packaged with the device.      3GPP security is excellent, but the public 4G networks will be slow to transmit the image data and will hit capacity issues if much use is made of the service.
  3. 5G Public Network. For: 5G now covers 90% of the UK population.  Against: this is currently non-stand-alone (NSA) so suffers the same disadvantage as the 4G network until 5GSA rolls out over the next year or so. 
  4. 5G Private Network.  For:  5GSA has the capacity, security and SLA guarantees to support the full service.      Against: network would be locally provided by an MNO or Neutral Host provider – so would not provide a national service on their own.

Blend of all the previous options is the best option overall, taking advantage of the evolving marketplace for these services.

Useful Links:

Usage in Scotland

IntelliGI box

Introductory video

Image
Health

Intelli GI box delivers hub and spoke model for community and home delivery


Commercial model (Business Case)

The direct cost models here flow from the cost of late detection, which is of the order of £200 million for current mortality levels as mentioned in the problem statement. Providing ‘connectivity in the diagnostic box’ enables a home delivered CCE to be carried out less expensively than a clinic visit but when Polyps are detected a follow-up procedure can be required. It is straightforward to show whole system cost savings for the NHS.

The savings can only be realised if there is a wholesale shift in culture and acceptance of capsule as a reliable diagnostic tool for identifying polyps early and cheaply without the need for costly clinic-based procedures. Scaled adoption will further reduce the cost of the procedure because current low volumes mean component costs (e.g. cameras, belt-based recorders) have relatively high unit costs.

Further interesting cost-models result from establishing the broader use of the installed connectivity [the classic stacked use case]. The diagnostic box has both community (eg GP practice) and home delivery options which make it suitable for multiple conditions and pathways – diabetes management, COPD, hypertension for example. The cost models that need to be worked up would demonstrate a much greater rate of return. Elsewhere, as part of the Liverpool 5G Health & Social Care use cases, a sensible business case for sustainable network operation was shown to make sense if they included education use for children and youth in the ward, and it is critical to be equally creative here about adjacent use cases.

To date the funding for initiatives in England has been dominated by grants – SBRI, NIHR, Innovate UK, DCMS and DLUHC have all contributed. The NHS needs to fully understand the cost models, the broader pathway benefits, and the clinical implications to deliver sustainable change. Funding needs to come directly from the NHS for sustainable change and is a mix of CAPEX on the diagnostic boxes and OPEX but the latter is merely a resourcing shift from current clinic-based procedures.

 

Cost Modelling – is at early an stage because of the complexities of whole system cost savings. We will update this section as more data from the current rollouts of home-delivery become available, and we are looking to build a dynamic model For now, we look at the key modelling parameters and their impact:

Key Parameters

  • Direct Costs: we want to demonstrate that a community delivered capsule endoscopy has a lower direct cost than a traditional endoscopy. This is currently true with capsule costs at around £500. But volumes and market competition will continue to drive this comparison in favour of capsule
  • Treatment Costs by Stage of diagnosis – the aim of volume use of capsule is to detect earlier and reduce costs, and deaths, post-diagnosis
  • Follow-up endoscopy rates – careful cohort selection reduces the failure rates (incomplete endoscopy) for capsule but the rate at which positive capsule tests then result in the need for a follow-up endoscopy drives additional cost
  • Backlog Numbers – the inability of clinics to tackle backlogs increases the risk of late diagnosis and so the scaling of capsule to tackle the backlog is a key parameter.
  • Diagnostic yield - the detection accuracy of capsules is improving with AI enablement to improve early diagnosis.

Benefits

  • Earlier detection of polyps, detecting bowel cancer earlier, saving lives
  • Significantly reduced costs to NHS by treating cancer early.
  • Less invasive process, accepted by more patients.
  • Local provision avoiding travel requirements and as a side benefit a positive environmental impact.
  • Less time out of work for patients, and less time for them spent in dangerous hospitals.
  • More reliable outcomes from AI processing the scans versus fallible humans (but noting Horizon we need to remain vigilant that the NHS does not over-trust the AI)
  • Reduction in the backlog of patients waiting for endoscopies allowing key NHS resources to be focused more productively. 
  • Less environmentally unfriendly chemicals used/disposed in disinfecting clinics.
  • Opportunity to influence and improve a wide range of critical clinical pathways through advanced connectivity availability.
  • Opportunity to build a service that is open for and further services in the future.
  • Resulting ‘Stackable’ use cases will accelerate broader connectivity adoption.

Lessons Learnt 

Do:

  • Be willing to try every grant-funding scheme available, and start work on finding the long-term funding needed, including from the private sector.
  • Find innovative SMEs that are prepared for a long journey with technology/products that are ready to scale. There isn’t time for low-TRL experiments, 
  • Be ready to help SMEs find funding partners with deep enough pockets to sustain them through that long journey. 
  • Consider using Adoption Readiness Levels to determine who you should select.
  • Assemble supportive consortia preferably with leadership who have been through this journey before, and it can be very helpful if they have worked together previously since mobilisation can waste crucial months of spending/delivering time.
  • Explore financial/procurement routes that enable SMEs to work with large corporates.
  • Find champions (clinicians here) that are prepared to drive with you and battle against naysayers.
  • Find non-clinical leaders to champion/steer the programme through the procurement and adoption complexities that plague health & Social Care provision.
  • Bring procurement and business case expertise into your team – these will be critical to buying a sustainable commercial service.

Don’t:

  • Be put off by the naysayers.
  • Assume a particular connectivity solution.
  • Leap to an early solution prematurely.
  • Set up for yet another pilot – this needs to be built in a manner that is capable of national rollout to support more than just CCE, so we will need support from CPNI and other security/resilience conscious agencies.
  • Create a one-service solution – this must be extensible to allow lots more care pathways/services to be added, and for it to grow geographically. 
  • Be tied to any one provider/technology – the solution needs to be capable of delivery using any network provider and technology vendor.