Oct 05, 2021

Rangle: the power of software innovation

software
pharma
Compliance
medicaldevices
6 min
Rangle: the power of software innovation
Brendon Montgomery at Rangle explains the incredible potential of Software as a Medical Device (SaMD) technology

Brendon Montgomery is the SVP for Global Business Development at Rangle, a Canadian software company with offices in Amsterdam, where Montgomery is based today. Rangle works with clients in a variety of industries, helping them to implement digital strategies. 

"My job is quite interesting from a business development standpoint" he says. "My day-to-day includes spending time with healthcare and pharmaceutical companies, but also airlines, financial institutions, and technology organisations. My role is to help create a path for them to move from where they are today, to where they want to be." 

Common challenges across these industries include developing capabilities so they can migrate to modern technologies, and managing a shift from websites to platforms and digital products. "This is not only universal across industries, but is universal around the world” Montgomery says. 

In terms of healthcare specifically, he cites two broad areas for digital products and platforms: so-called companion applications, and medical devices. 

"Companion applications are about tracking and monitoring wellbeing and the progress of a condition. A lot of these are consumer-facing applications that are publicly available. For example biometric tracking, when you go for a run and you get some of the data back to tell you how you're doing from a health perspective. They're also informational. For example they can help people cope with some of the symptoms that they might be feeling, and provide information much like a website does."

While companion apps are on the rise, an area that has progressed significantly in recent years is the Software as a Medical Device (SaMD) field. "These are web or mobile applications that are actually used for medical purposes" Montgomery explains. "They're highly regulated. This is a new area because medical devices for the large part have been hardware-based. SaMD can be an addition, a compliment to a hardware piece, or sometimes standalone technology.  An example of that is a software application that connects with hardware to deliver insulin to a diabetic patient. In the past that was a manual process in which you would use a pump or other hardware." 

These advances also mean new compliance and regulations that must be adhered to, and Montgomery explains how Rangle helps healthcare organisations navigate this: "It's been our experience that it is less of a tooling thing and more about a process. It  actually takes a wildly different approach from a process perspective. 

"We developed a process we call compliance by design. This is an effort to extend the idea of digital cross-functional teams into the compliance group. Digital team best practices are largely born out of tech companies in Silicon Valley,  and they might be using agile software development for example. These have had difficulty getting extended into healthcare arenas because of the regulatory requirements. There's usually an immediate blocker to say that it isn't going to work because of the regulations.  

"What we found is that's actually not true. It doesn't mean there isn't work to be done, but there's just more additional stakeholders that need to be included.

"Compliance by design has a governance structure that we recommend to achieve this, and it's largely about bringing the compliance requirements into the software development process. What that does really well is help the digital teams that are building these products and services, understand that landscape and become empowered to solve for it.” 

A common problem is leaving compliance till the end, he says. “We often see that compliance and regulatory requirements mirror quality requirements in traditional software development, meaning they always get left till the end. It becomes a checkbox to say, let's build it first and then see if it's compliant later, which doesn't really make sense. But the compliance team hasn't been invited to the table before and haven't been included in software development, so they don't understand how the process works at all. Having an intentional structure to bring compliant stakeholders, but also regulatory requirements into  software requirements can achieve great things." 

Rangle are leading this innovative approach, and Montgomery says that while nobody would argue with this way of working, it typically hasn't been happening. "Everyone will say, of course we're trying to include compliance, of course we need to bring compliance requirements into our process and we should be following regulatory guidelines from the beginning of the project, not just at the end. But when we actually start to explore what the current landscape looks like it's not always happening."

"Not to over-simplify the process, but it's largely intent-based" he adds. "It's about being intentional setting up that process, saying who's going to sponsor the organisation, are we going to form a steering committee to do this? Where Rangle provides a lot of value is looking at how tactically that is done, so what does a compliance requirement look like and how does that get added. Software developers and product designers don't have a compliance and regulatory background, so Rangle's  compliance by design process has been very helpful in giving people a framework." 

Some of Rangle’s clients range from the fast-growing digital healthcare startup Hims & Hers to leading global pharmaceutical companies. When asked about some of the work Montgomery and his team are most proud of, he describes an app that measures blood glucose levels. "It's the world's first app that determines blood glucose ranges by taking photos with a phone camera, without the need for a blood glucose metre. It's designed to help non-insulin dependent people who have type two diabetes, or pre diabetes, live healthier lives in between their doctor or healthcare provider visits. This app is a great example of SaMD, using mobile or web technology to provide medical services to patients."

Another application that really inspired the team is an app designed for developing countries in south east Asia and central Africa.  "These are areas of the world that are developing, but they have access to mobile devices. Typically they have to take their test strips to a pharmacy to be checked, which is inconvenient especially if they're living in rural areas. Because of this a lot of people simply just don't keep track of their blood sugar. Test strips can be incredibly expensive to distribute to patients who need them. With this application, the blood glucose metres become readily available, and people can do their testing at home, whenever they like, using their smartphone.

"There's an incredible reach that SaMD can have, without standing up healthcare practices or doctor's offices in every area of the world” he adds. 

Over the next couple of years Rangle is focusing on the EU market, and also concentrating on healthcare.  "The healthcare space is really important to us" Montgomery says. "We understand that it's a tremendous market opportunity and a good business choice. But second to that, our mantra within the organisation is building the right thing the right way, and we have a particular focus on doing work that has a positive impact on the world. 

"We have a bit of a unique model for a consultancy firm because all of our team members are full time employees, while many of our peers use contractors and freelancers that they hire when they win client work. Those people then disappear after the project is done.  We feel that we have a tremendous benefit by onboarding people into the Rangle culture and our way of working. But with that comes a very high expectation from our team members that we're doing good work.  The healthcare industry is probably the number one example of where our staff want to work, and they want us to form partnerships and bring in clients into this space because they feel really good about the work they're doing."

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