Open the box of a medicine and wrapped across the blisters of drugs is a piece of paper. If it’s an off the shelf medication many of us casually discard the small black and white sheet without a thought. So you may be interested to learn that this simple sheet of paper is not just the blurb from the manufacturer, it is a highly regulated text.
Regulation of pharmaceutical literature is just one of a myriad of responsibilities for the Medical Healthcare Products Regulatory Agency (MHRA). CIO for MHRA John Quinn and I sit surrounded by literature of a different kind in a meeting room at the government agency’s Victoria, London headquarters. This literature is promoting the new technology platforms MHRA has standardised on under Quinn’s leadership, including Microsoft Office 365 and Oracle Fusion.
“We are the equivalent of the FDA,” Quinn explains comparing MHRA with the Food and Drugs Administration in the USA, which has gained international repute. “But we don’t do food,” he adds.
The MHRA regulates medicines, medical devices, the literature and as the regulator is also in effect the police force for the medical community, inspecting manufacturing facilities for quality and tracking down illegal drug production or distribution. At present MHRA standards are widely adopted across the EU and very well respected.
“A UK medicine regulation is worth something,” Quinn says. Brexit could be an opportunity for the organisation, although it is not without its challenges.
Whatever the future holds for MHRA and the nation, Quinn and his team are preparing a service re-design, with an office move to Canary Wharf along the way.
“This is an opportunity to re-design our services around the customer. A regulator talking about its customers is odd, but we have some very important stakeholders; patients, GPs, the medical industry and ministers,” he says of just some of the citizens the MHRA serves.
“So we will redesign our services so that the industry will self-service,” he says of one development taking place.
“Data silos, out of date processes, big systems that have not been updated and different technologies, we have probably had them all and it is a problem statement that the community will recognise. The challenge is how do you unpack that safely and transition it to take advantage of modern technology and methods,” Quinn says of taking the existing estate of the MHRA and in affect turning about face so that customers can self-service.
“We can’t afford the large systems integrators (SI) model, so the world we have got into is to focus on the business architecture. In the past MHRA has not had that approach,” he says of modelling the organisational processes. Quinn adds that he and his team have been working on business capability mapping using the methods developed by industry expert Simon Wardley and it has achieved a great deal in providing assurance to the organisation that the primary suppliers are meeting the needs of MHRA. User journeys and personas have been linked to the capabilities of the organisation. Former CIO turned Gartner analyst Ian Cox recently referenced MHRA’s use of capabilities in designing IT operating models in a research report.
A focus on the business architecture and helping the organisation become customer facing means “the service is to be the implementation team for systems and to support business change,” Quinn says of how the technology team has changed.
“Much of our work will be teaching product ownership, data ownership and managing the change journey,” he says.
“We have fixed the target operating model (TOM) and in parallel we have done a piece of work on business demands,” he says of giving everyone in the organisation a greater understanding of technology supply and demand. “The focus of my time is not to be a technology delivery function,” he says.
As a result of this the supplier map has changed too with an increase of SME suppliers. Quinn has a balance of major providers such as Oracle and Microsoft for the Office 365 platform, Appian and Mulesoft as well as Tibco. MHRA is an early adopter of the Oracle Fusion platform which Oracle Consulting helped implement as MHRA had to get off a burning platform. As a result Quinn has placed large parts of the MHRA infrastructure in the cloud with the Fusion and Office 365 implementations.
Healthcare is considered one of the most exciting sectors for the adoption and development of the latest wave of technologies such as wearables, Internet of Things (IoT) sensors, data analytics, artificial intelligence (AI) and machine learning. MHRA is therefore bound to become a highly influential organisation on these technologies.
MHRA already regulates medical devices like stents that are inserted into passageways to keep them open and restore the flow of blood or other fluids, for example, ingestible sensors to monitor adherence or even replacement hips may have an IoT element to them and that data could be used in medical claims.
“We have an innovation office that works with the medical industry,” he says as the MHRA prepares itself to be one of the world’s first regulators of digital health products. Our interview took place on the same week as the Natural Cycles App for predicting ovulation and marketed as a family planning product was headline news.
“This will be a challenge. But it is back to the risk appetite and people making health decisions via a borderless web,” Quinn says of how digital is creating a new healthcare landscape. The CIO adds that his focus on a new service model is central to MHRA having the data and processes in place for the adoption of these technologies.
Quinn’s journey to the CIO role is distinct. Following university he became an information manager, a form of librarian. Many of us recall institutional libraries. Any organisation that needed access to accurate information for research, corroboration and decision making had a library and a well respected librarian or two running it. As a cub reporter on a daily regional newspaper my early career was helped no end by the library team at the Cambridge Evening News. The librarian curated not only key information resources, but also ran a brilliant cuttings library where you’d check the back story of every leading sports or business person you had to interview. The internet swept the library away from many organisations and key suppliers such as Thomson Reuters and Lexis Nexis have become digital businesses with strong subscription models.
“I stumbled into it as a job and found it really interesting and especially electronic information,” along the way Quinn found himself in the public sector and then technology via project management roles. We reminisce about the library sector, but as Quinn points out, the latest wave of technologies and thinking demonstrate that we have gone full circle. In the early years of this century the information and library teams of organisations were focused on harnessing internal information, dubbed knowledge management (KM) at the time as the first waves of – dare I say it – big data occurred. Organisations became aware of levels of knowledge its individuals possess and looked for ways to harness that. Understandably organisation became concerned that information was becoming hard to track. The advent of good search technologies temporarily replaced concerns about KM, but today reports such as Forrester’s Information Workplace and the hype around the digital workplace show a renewed need for knowledge management.
“The answer has often been a single repository. That can be sensible, but the world is not like that, so you have to connect your data,” Quinn says; adding that the importance of good metadata has not gone away. “Getting the right information to the right people at the right time is key.”
“The knowledge community has been subject to efficiencies. But the hashtag is a cataloguing exercise, so we are all librarians now. Search has become de facto and Office 365 is the technology that has commoditised knowledge management.”