Interview, NP

“I thought: there’s got to be a better way” Roger Flint on developing SPOT, the Safer Prescription of Opioids Tool, and the Harvard Health Tech Fellowship

For our latest interview, we spoke to Roger Flint. Roger is a Scottish GP trainee and is currently working at Harvard University Medical School in Boston as a Harvard Health Tech Fellow. In addition, he is the CEO and founder of SPOT, the Safer Prescription of Opioids Tool.

Roger chatted to us about his thoughts on health tech in the US, his experiences at Harvard, the story behind SPOT and more.

Health tech and innovations in the US

Broadly, I think there are significant opportunities for health tech in the US. I think that Microsoft’s integration of their Office 365 products with ChatGPT in the form of co-pilots is going to be really exciting. That’s going to mean that different roles such as administrators, secretaries and physicians are going to have access to AI in their daily work – it could assist them in sending letters, for example, or in communicating with patients in a manner which is patient-centric and easily understandable from their perspective. With this move from Microsoft, I don’t think we’ve ever had a time where the barriers to integration of AI and healthcare have been lower. I think it gives us a real opportunity for high-impact, low-risk applications for these AI platforms.

It will also mean that our familiarity with these AI applications, as professionals, will grow; and the wider public will also get more used to them. I think we will see further adoptions as a result.

There are also some significant headwinds for health in the US – there have been some issues with start-up funding and key structural challenges following COVID. We’re seeing workforce shortages, physician and resident burnout, cost pressures on hospitals. These are significant problems, but I believe that they are also opportunities that health tech could potentially improve. do think there are market opportunities in the US at present, particularly in these areas.

Advice for entering the US health tech market

If a UK-based health tech supplier is looking to break into the US market, the first thing they need to do is get over to the US. There’s no substitute for meeting your customer segment in person and making those connections, particularly for more established companies. Identify who your stakeholders are as part of your business model plan for the US and arrange to meet them. I’d also suggest that setting up an office over here – I think that provides a lot of reassurance for US customers, if they feel that they are going to be supported by someone who is US-based.

For start-ups, I’d recommend looking into accelerator schemes. There are a number of very good accelerators in the US. If the health tech supplier can identify the right accelerator with the right opportunity, then that’s a very good way in.

There are challenges around the regulatory environment; for example, making sure that you’ve got enough evidence to gain FDA approval if you are supplying a medical device product. In that instance, it’s good to have a discussion with the FDA to find out exactly what data they will require in order to get approval for your product in the US.

It’s also worth speaking with payers and reimbursement consultants to make sure that whatever you are intending to bring over to the US is going to be reimbursed and most importantly is consumable in a way that is suitable for the US health system.

Harvard Health Tech Fellowship

The Fellowship is based around the Stanford Biodesign course, which has been in existence for about 20 years and has produced approximately 56 companies. It is structured according to the biodesign framework, which means you have a bootcamp with a series of lectures around identifying unmet needs through observation and ethnographic research, business model planning, IP landscaping and commercialisation, as well as other elements such as team-building and team psychology.

We are split into two teams of four – in my team, I’m the physician entrepreneur, and I’m collaborating with three engineers: a neuro engineer, an optics engineer, and a surgical device engineer. The second team has a UK physician, a US physician, a mechanical engineer and a mathematician.

My team’s clinical immersion was at Mass. Eye and Ear Infirmary, in the otolaryngology team. We enjoyed incredible support and access from the entire surgical team, led by Dr Varvares, the chief of Otolaryngology.  We spent  two months observing the whole patient journey, from the moment that they enter the hospital to the moment that they are discharged. We watched surgeries and spent time with patients, nursing staff, surgeons, all members of the multidisciplinary team. The point of this is to try and identify a set of observations about things that you think could be improved – process, technique, tool, even the position of the surgeon of the chair as they’re performing a procedure. We had unparalleled access and our team is grateful to Dr Varvares and his team for their support.

My team recorded approximately 700 observations. The remaining months of the Fellowship involved reviewing these observations as a team, pre-screening them to see if we have interest in taking those observations further. Then we take the remaining observations and create needs statements for each of them. A needs statement is a problem within a population that has an outcome. For example, if we observed a tumour resection (a type of surgery) and we identified that the surgical time was occasionally and unpredictably extended due to intraoperative tumour margin assessment, we could create a needs statement from that. An example needs statement could be ‘a way to accurately determine tumour margins in patients undergoing head and neck surgery in order to improve scheduling of operations’. You’re trying to come up with one sentence that encapsulates the problem that you are considering which includes the problem, the population and the outcome.

Then we go through all the needs statements and rank them according to a rubric that we create using the biodesign methods. The rubric looks at things such as effective population, market opportunity, resources, competitor landscaping, team interest. Once we’ve ranked all those needs statements, we take the top needs statement and brainstorm around potential solutions to those needs. After that, we narrow all those solution ideas down into one or two concepts.

That’s the process – the Fellowship ends at the point at which you have developed a couple of concepts to your top-ranked unmet needs. Those concepts can then form the basis of a spinout. At present, my team is working on a very promising unmet need around screening for diabetic retinopathy, so we’ll see where that takes us.

Safer Prescription of Opioids Tool (SPOT)

SPOT is based on a problem that I identified in foundation year one whilst training at NHS Tayside.

Two weeks after graduating from medical school at Dundee, I had a very difficult experience. I was on call for an evening shift covering 130 patients over three wards; I was constantly being contacted by colleagues to look after patients, to review them, to prescribe and so on. One of the patients I was asked to see was a lady who had had a stroke and was at the end of her life. Her palliative care plan included opioid analgesia to manage her pain, and she was receiving that through a PEG (percutaneous endoscopic gastrostomy) tube. I was asked to see her because her tube became blocked and she wasn’t able to receive the pain relief that had been prescribed to her.

I went to see her and looked at the medication she was taking. The resources that were available to me were a calculator and a booklet with conversion tables for opioids. It’s a two-step process – you convert the patient’s current opioid dose into an oral morphine equivalent dose, and then you convert that oral morphine equivalent dose to the medication that you want to prescribe. In this instance, because the lady wasn’t able to take oral opioids through the peg tube, I was asked to switch her over to subcutaneous pain relief. Bearing in mind, I was tired, constantly interrupted and had only been practising for two weeks.

The last thing I wanted to do was cause the patient harm by either under or overdosing her. I called up my registrar to ask for help and unfortunately they weren’t able to help me because they were too busy. I did the calculation that I thought was correct, but I didn’t have the confidence to prescribe it to the patient because I thought that there was the risk of causing her harm if I was wrong. So I had to do nothing and just wait until the next team arrived some hours later to support me to perform this opioid conversion. I thought: there’s got to be a better way.

Over the next few weeks, I engaged a web developer to create a website for me that would do these calculations and double check them from a prescriber’s point of view. I presented that in Dundee and Prof. George, the professor of clinical pharmacology identified that this was a tool with promise to support colleagues. He put me in touch with Dr Scott Jamieson and Dr Deans Buchanan to help me. We succeeded in gaining funding from Pam Levack and PATCH (Palliation And The Caring Hospital) to create SPOT to allow prescribers to use it from their mobile phone.

We clinically validated SPOT with funding from the Digital Health and Care Institute at a multi-centre, three-site trial in NHS Tayside. We showed that it improved prescriber confidence and adherence to best practice guidelines when prescribing opioids. Subsequently, we CE-marked it under the medical device directive and with some funding from Innovate UK and created a third iteration, which is now available to download from the app store.

At the same time, SPOT, was used as an exemplar to create NHS Scotland’s Quality Assurance Framework for Medical Devices and Apps, and was one of the first six apps to go through the framework and process.

SPOT was subsequently recommended for national adoption in Scotland by the Scottish Partnership for Palliative Care, and endorsed by the Scottish Palliative Care Pharmacists Association. SPOT was also included in the Scottish government’s policy document for COVID-19 response.

Following a year-long commercial trial at NHS Borders, SPOT is now available through Class Professional Publishing. It’s been used over 2,000 times to support prescribers in the same position that I found myself in. The team was presented with the Dundas medal last year – a medal to celebrate teams that have made a significant difference to palliative care in the hospital setting.

There are always more ways to develop the SPOT platform, to support prescribers with other challenges, so that’s our plan for the future. We’ll continue to build on that.

I am incredibly grateful for all of those that have supported me in my journey. Without their support, SPOT would not have been created, and we would not have had the opportunity to support prescribers and positively impact on patients at scale.

Many thanks to Roger for sharing his experiences.