Tech companies are being asked to help the greater good during the crisis, but can the healthcare system stomach this level of innovation?
An unprecedented effort to develop technological solutions to help mitigate the spread of coronavirus (COVID-19) is underway.
The global tech giants have been mobilised. In the UK, executives from Google, Facebook, Amazon, Apple, Uber and Microsoft, and smaller companies including Deliveroo and Babylon Health were recently summoned to a Downing Street meeting and given a set of technology needs.
The message seems to be starting to pay off. The NHS is working with tech companies to harvest data from the NHS’s 111 telephone service and other sources to predict where ventilators, hospital beds and medical staff are most needed. Global engineering companies including Dyson, Ford, Tesla and General Motors are pivoting towards ventilator design and production. And at the other end of scale, there is a wealth of ground-up activity.
Hackathons and open innovation models are being deployed to match available expertise with the problems that need solving. “Frugal innovation” concepts are helping to design cheaper and simpler ventilators. Hospitals are using crowdsourcing and 3D printing to tackle equipment shortages, including face masks.
Telehealth comes of age
The current crisis may well result in lasting changes to our way of providing healthcare. Healthcare services are being catapulted into the 21st century. The abundant potential to transmit infection within traditional bricks-and-mortar medicine is shining a spotlight on the need to deliver care at a distance unless absolutely necessary. Healthcare – historically backward in adopting remote service delivery methods familiar in banking and retail – is now discovering that digital connectivity is part of the ammunition to fight the pandemic. Telehealth is finally coming of age.
But this creative effort may also run up against the old challenge associated with healthcare innovation – the need for innovators to navigate the complex ecosystem of organisations, regulations, evidence requirements, payment and reimbursement models, and professional silos to shepherd their innovation to successful adoption. The product development risks for innovators remain as high today as they do in times of “business as usual” healthcare.
Healthcare services are being catapulted into the 21st century
Major global companies can support a pivot into new areas – they have the resources to weather product failures. But small startups are in a different position. The crisis is certainly driving much altruistic behaviour through crowdsourced solutions and IP waivers, but ultimately the resulting innovations need to be scaled-up and adopted. In the case of ventilators (or components for ventilators), for example, questions are being asked about the ability of highly localised design and 3D printing manufacturing models to operate at scale with the right sterilisation and other safeguards.
Speed vs. safety
Regulatory bodies such as the FDA in the USA and MHRA in the UK are therefore grappling with the need to balance speed with safety and quality. The MRHA is relaxing some requirements to allow fast-track approval of some medical devices, but maintaining control over quality and safety remains paramount – evidence that a device performs safely as intended is still needed.
And it is here that the promise of rapid creativity runs up against the reality of healthcare innovation the world over. Gathering evidence of clinical efficacy and in-depth health economic evaluation are a particular problem for the small companies that dominate the medical device and diagnostic industries.
Regulatory bodies such as the FDA in the USA and MHRA in the UK are therefore grappling with the need to balance speed with safety and quality
These lack the resources and skills to conduct large scale trials, and even if these were feasible, only assessing a product after it has been developed may lock a technology developer into a design that can only be changed at great expense.
These hurdles must be addressed before healthcare systems can ever hope to develop new approaches to approving new products – something which is key to an efficient response during crises such as we are experiencing today.
In the second part of this article we will look at how COVID-19 could herald new approaches to how innovative new products are evaluated and approved by health systems.
In the second part of this article we will look at how COVID-19 could herald new approaches to how innovative new products are evaluated and approved by health systems.
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