FDA – piloting a path for digital innovation
Earlier this year the US Food and Drug Administration (FDA) heralded the forthcoming launch of its pre-certification pilot program for new digital health software which it hopes will help revolutionise the regulation of digital healthcare solutions in the US and allow innovations to safely reach the global market in a timely way, to the benefit of end users.
"We need to modernise our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices,” said FDA Commissioner Scott Gottlieb, M.D.
Warming to this user-centric theme, in a July FDA blog post, Gottlieb wrote: "This new program embraces the principle that digital health technologies can have significant benefits to patients’ lives and to our healthcare system by facilitating prevention, treatment and diagnosis; and by helping consumers manage chronic conditions outside of traditional healthcare settings.”
In September, the FDA named the nine participants in the pilot scheme (after fielding interest from over 100 companies). The FDA arrived at the final nine after considering “company size, demonstrated record of quality and organisational excellence, clinical focus area and the risk profile of the product”. The selection process identified companies representing different perspectives and unique approaches to digital health technology development.
“The number of applicants speaks to the significant impact this approach could have on facilitating timely advancement of software that has the potential to benefit health,” says Bakul Patel, associate director for digital health in the FDA’s Centre for Devices and Radiological Health.
The firms that made the cut are Apple, Fitbit, Johnson & Johnson, Roche, Samsung, Alphabet’s Verily, Phosphorous, Tidepool and Pear Therapeutics.
Back in 2015, Apple CEO Tim Cook bemoaned the FDA process, saying that its cycles were too long and hindered innovation and development. Apple has been keen to make further headway in the healthcare space using its Healthkit developer framework so, in May, when Cook was spotted wearing an Apple Watch glucose monitor it hinted at what we may see the company release via the pilot programme.
Fitbit recently teamed up with Dexcom – a manufacturer of continuous glucose monitoring (CGM) systems for diabetes management. Johnson & Johnson has a longstanding presence in this arena with products like OneTouch, Lifescan and Animas. Roche (like J & J) offers a variety of diagnostic tools but its involvement is significant given the Accu-Chek developments and recent acquisition of the mySugr platform for diabetes data. The South Korean electronics giant Samsung has become active in healthcare too, notably partnering with Medtronic to develop next-gen smartwatch connectivity. Verily (formerly Google Life Sciences) is Google’s health spin-off currently working on a smart lens program for ocular devices to correct age-related farsightedness. Phosphorous is focused on the better understanding of the human genome to bridge the gap between DNA and good health.
Howard Look, founder of the non-profit open-data start-up Tidepool, comments: “This is the FDA acknowledging the old guidance for how software technology is regulated wasn’t working, and couldn’t keep up with the pace of innovation we’ve been seeing in Silicon Valley and the consumer world.”
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“We commend the FDA’s Digital Health Innovation Action Plan initiative and the speed with which they are moving towards building a regulatory pathway to bring these important products to patients,” says Corey McCann, President and CEO at Pear Therapeutics, which completes the list of nine participants. Pear Therapeutics is a leader in prescription digital therapeutics which integrate clinically-validated software applications with previously approved pharmaceuticals and treatments to provide better outcomes for patients and smarter engagement/tracking tools for clinicians. Pear’s lead product, reSET®, is an FDA-cleared, 12-week interval prescription therapeutic for Substance Use Disorder, designed to be used alongside standard outpatient treatment.
Dr Marisa Miraldo is an Associate Professor in Health Economics at Imperial College Business School, and expert in public policy with experience working with the Department of Health. “Lengthy regulatory procedures feed significantly into this delay, generating substantial hurdles for adoption and diffusion of innovation,” she explains. “These hurdles are more significant in the context of digital health innovation (versus pharmaceutical) because, with rare exceptions, there are currently no established system level pathways and processes to adopt and embed at scale these innovations in practice. This discourages innovation in general, but evermore in areas such as digital health in which product life-cycle tends to be increasingly shorter when compared to therapeutic innovation,” she explains.
Dr Miraldo believes, from the regulator perspective, the commitment to post-market data collection shared by the innovator can potentially allow real time monitoring of the safety and even value added by these innovations, which is key for streamlining regulatory processes while safeguarding the public interest.
While the healthcare industry appears to be embracing the pathway to market opportunities the Pre-Cert programme could offer, there are institutions keen to offer words of advice and caution. In its open letter to the FDA, the Medical Imaging and Technology Alliance (MITA) – the leading organisation and collective voice of medical imaging equipment, radiopharmaceutical manufacturers, innovators and product developers, representing companies whose sales make up more than 90% of the global market for advanced imaging technologies - commended the FDA for taking proactive steps for the regulatory review of software products. MITA hoped the FDA would “use the pilot to explore the use of external conformity assessment bodies (e.g. IECEE) for software development and change controls using relevant existing international standards”.
Despite concerns voiced about the FDA program by some institutions such as MITA, Dr Miraldo is certain we’ll see a positive impact. “It will enable a dialogue between regulators and innovators enabling them to direct their strategies to key areas of value, minimising risk and maximising their chances of raising funding,” she argues, believing payers should also be included in this dialogue to formally incentivise innovation, not only on digital health but in pharma as a whole.
Creators of SaMD (Software as a Medical Device) products like the Canada-based Macadamian – a user experience design and software development company focused on the development of healthcare solutions – is excited about the potential less regulatory oversight will bring for smaller and more nimble companies, like theirs, to compete in the same space as larger corporations.
“With the advent of more complex solutions, like our My Diabetes Coach which leverages machine learning and artificial intelligence, the software and the medical device are merging,” says Macadamian’s Internet of Things (IoT) Director Timon LeDain. “The FDA has implemented the pre-certification pilot program to balance risk management with the agile development process. Software has shown itself to be capable of looking at a medical image and providing a diagnosis that matches or exceeds what experts could achieve.”
Macadamian has also worked with the likes of Transcendent Technologies on projects such as the forthcoming Lifepod – an Amazon Alexa-powered virtual caregiver and digital health assistant – and specialise in creating connected healthcare solutions. LeDain observes innovations can take years to reach the market, affecting manufacture, marketing and sale, with the increased cost ultimately transferred to the consumer. He thus applauds the opportunity to improve patient outcomes with the reduced regulatory burdens of the FDA program while driving down the costs of delivering healthcare.
“The pros outweigh the cons and demonstrate the FDA is aware of its impact on healthcare innovation and is looking at ‘out of the box’ approaches to address this,” he says. “Some might argue the pendulum could swing too far towards the deregulated space with potential adverse health events as a result, but I don’t see this outweighing the benefits. There’s already proof unregulated products like the Apple Watch and Owlet Care’s baby monitor have saved countless lives by providing consumers with information they previously never had access to.”
How UiPath robots are helping with the NHS backlog
The COVID-19 pandemic has caused many hospitals to have logistical nightmares, as backlogs of surgeries built up as a result of cancellations. The BMJ has estimated it will take the UK's National Health Service (NHS) a year and a half to recover.
However software robots can help, by automating computer-based processes such as replenishing inventory, managing patient bookings, and digitising patient files. Mark O’Connor, Public Sector Director for Ireland at UiPath, tells us how they deployed robots at Mater Hospital in Dublin, saving clinicians valuable time.
When Did Mater Hospital implement the software robots - was it specifically to address the challenges of the pandemic?
The need for automation at Mater Hospital pre-existed the pandemic but it was the onset of COVID-19 that got the team to turn to the technology and start introducing software robots into the workflow of doctors and nurses.
The pandemic placed an increased administrative strain on the Infection Prevention and Control (IPC) department at Mater Hospital in Dublin. To combat the problem and ensure that nurses could spend more time with their patients and less time on admin, the IPC deployed its first software robots in March 2020.
The IPC at Mater plans to continue using robots to manage data around drug resistant microbes such as MRSA once the COVID-19 crisis subsides.
What tasks do they perform?
In the IPC at Mater Hospital, software robots have taken the task of reporting COVID-19 test results. Pre-automation, the process created during the 2003 SARS outbreak required a clinician to log into the laboratory system, extract a disease code and then manually enter the results into a data platform. This was hugely time consuming, taking up to three hours of a nurse’s day.
UiPath software robots are now responsible for this task. They process the data in a fraction of the time, distributing patient results in minutes and consequently freeing up to 18 hours of each IPC nurse’s time each week, and up to 936 hours over the course of a year. As a result, the healthcare professionals can spend more time caring for their patients and less time on repetitive tasks and admin work.
Is there any possibility of error with software robots, compared to humans?
By nature, humans are prone to make mistakes, especially when working under pressure, under strict deadlines and while handling a large volume of data while performing repetitive tasks.
Once taught the process, software robots, on the other hand, will follow the same steps every time without the risk of the inevitable human error. Simply speaking, robots can perform data-intensive tasks more quickly and accurately than humans can.
Which members of staff benefit the most, and what can they do with the time saved?
In the case of Mater Hospital, the IPC unit has adopted a robot for every nurse approach. This means that every nurse in the department has access to a robot to help reduce the burden of their admin work. Rather than spending time entering test results, they can focus on the work that requires their human ingenuity, empathy and skill – taking care of their patients.
In other sectors, the story is no different. Every job will have some repetitive nature to it. Whether that be a finance department processing thousands of invoices a day or simply having to send one daily email. If a task is repetitive and data-intensive, the chances are that a software robot can help. Just like with the nurses in the IPC, these employees can then focus on handling exceptions and on work that requires decision making or creativity - the work that people enjoy doing.
How can software robots most benefit healthcare providers both during a pandemic and beyond?
When the COVID-19 outbreak hit, software robots were deployed to lessen the administrative strain healthcare professionals were facing and give them more time to care for an increased number of patients. With hospitals around the world at capacity, every moment with a patient counted.
Now, the NHS and other healthcare providers face a huge backlog of routine surgeries and procedures following cancellations during the pandemic. In the UK alone, 5 million people are waiting for treatment and it’s estimated that this could cause 6,400 excess deaths by the end of next year if the problem isn’t rectified.
Many healthcare organisations have now acquired the skills needed to deploy automation, therefore it will be easier for them to build more robots to respond to the backlog going forwards. Software robots that had been processing registrations at COVID test sites, for example, could now be taught how to schedule procedures, process patient details or even manage procurement and recruitment to help streamline the processes associated with the backlog. The possibilities are vast.
The technology, however, should not be considered a short-term, tactical and reactive solution that can be deployed in times of crisis. Automation has the power to solve systematic problems that healthcare providers face year-round. Hospital managers should consider the wider challenge of dealing with endless repetitive work that saps the energy of professionals and turns attention away from patient care and discuss how investing in a long-term automation project could help alleviate these issues.
How widely adopted is this technology in healthcare at the moment?
Automation was being used in healthcare around the world before the pandemic, but the COVID-19 outbreak has certainly accelerated the trend.
Automation’s reach is wide. From the NHS Shared Business Service in the UK to the Cleveland Clinic in the US and healthcare organisations in the likes of Norway, India and Canada, we see a huge range of healthcare providers deploying automation technology.
Many healthcare providers, however, are still in the early stages of their journeys or are just discovering automation’s potential because of the pandemic. I expect to see the deployment of software robots in healthcare grow over the coming years as its benefits continue to be realised globally.
How do you see this technology evolving in the future?
If one thing is certain, it’s that the technology will continue to evolve and grow over time – and I believe there will come a point in time when all processes that can be automated, will be automated. This is known as the fully automated enterprise.
By joining all automation projects into one enterprise-wide effort, the healthcare industry can tap into the full benefits of the technology. This will involve software robots becoming increasingly intelligent in order to reach and improve more processes. Integrating the capabilities of Artificial Intelligence and Machine Learning into automation, for example, will allow providers to reach non-rule-based processes too.
We are already seeing steps towards this being taken by NHS Shared Business Service, for example. The organisation, which provides non-clinical services to around two-thirds of all NHS provider trusts and every clinical commissioning organisation in the UK, is working to create an entire eco-system of robots. It believes that no automation should be looked at in isolation, but rather the technology should stretch across departments and functions. As such, inefficiencies in the care pathway can be significantly reduced, saving healthcare providers a substantial amount of time and money.