Our healthcare clients do amazing work on complex designs with strict oversight and regulations – which are necessary to ensure medical products are safe and efficacious. But when we collaborate, our combined teams can greatly accelerate programmes, prompting the common question: “What are we doing to move so fast together?”

Having worked on hundreds of projects, we have seen some patterns that consistently help an innovation team move quickly. There are three common elements that support rapid progress:

• Good project management processes and culture
• A focus on resolving the programme unknowns through early prototyping and testing
• Supportive quality management structures

Let’s look at each in of them in more detail.

Good project management processes and culture

Managers of fast and effective teams tend to ensure that there are four key building blocks:

1. Feasible goals – ambitious goals are great but there should be a believable pathway and support that adapts to evidence to help reach the most important goals
2. Trusted workstream leaders and decision makers – so informed decisions can be made rapidly, communicated effectively and not revisited unnecessarily
3. Unanimous purpose – goals that are unambiguous, worthy and supported by key sponsors, whether driven by commercial pressures, new user and clinical insights or regulatory change
4. A healthy tolerance for uncertainty – this enables ambition, empowers the team to identify and manage development risks as early as possible, and means that the team (and sponsors) are not easily discouraged by the slippery patches (unexpected learnings) that many fast projects hit.

Prototype early, often and at an appropriate fidelity

Creating and testing prototypes as early as possible drives learning and produces evidence and confidence for development decisions at every stage. By prototype, I mean any tangible embodiment of an idea from which we can gather realistic feedback. Getting creative prototypes (sketches, models, storyboards, interfaces, etc.) in front of users reveals insights and unforeseen variables, gets everyone on the same page about complex ideas and clarifies key assumptions. Doing this early, often and at appropriate fidelity to answer the questions at hand (starting with low fidelity and building from there) is critical to exploring the solution space fully, informing analysis and sidestepping cycles of deliberation. By focusing on key uncertainties, iterations of prototypes will avoid delays and the cost overruns often caused by ‘sweeping these difficulties under the carpet’.

Supportive quality management system

It’s important to design quality management structures that support the first two elements –  as well as helping to assure the quality of your deliverables and supporting the building of your design history file for regulatory compliance. For example, can teams support the manufacture of short-run prototypes for testing in a clinical environment? Can the creation of ‘design inputs’ evolve with evidence from prototype testing? Are there protocols for non-clinical user studies that do not have significant risks? Does properly referenced documentation enable you to adopt evidence-based changes without massive documentation rework? Processes that insist on a ‘right first time’ project structure will typically restrict speed and slow the pace of learning without improving specifications in the end.

These three elements will come more naturally to some – but we believe that any organisation can adapt these insights gradually into their own innovation approach. Give it a try!

The consumer health sector is expanding fast. From its traditional base, the category has exploded to deliver a myriad of products for consumers to manage everything from personal health and hygiene to fitness and pampering treatments.

This explosion has several directions. Established healthcare companies which have an appetite to build more ‘sticky’ customer relationships and new revenue streams are adopting techniques from the fast-moving consumer goods markets – such as psychology, brands and sensory dynamics – to build revenues. Meanwhile, consumer goods companies are keen to exploit their established brand equities and credibility to deliver new wellbeing products. Digital technology is also opening the door to disruptive opportunities for tailored personal health experiences – such as systems that identify almost imperceptible, long-term changes that underpin self-diagnosis and treatment. A plethora of start-ups is taking full advantage in fields such as fertility, sleep and stress management. At the other end of the scale, Amazon’s increasingly clear interest in strategic healthcare partnerships is making some of the established industry leaders nervous.

The underlying drivers of this growth include an affluent ageing population, the so-called ‘grey pound’; shrinking public healthcare budgets limiting access to conventional healthcare; conventional healthcare moving from the clinic to the home to save cost; and increasing consumer awareness of what’s good and bad for our health, driven by the media and the power of the internet. These factors are growing an appetite for new tools that enable self-diagnosis and therapy.

A feature of this market is the complex international regulatory landscape, and the significant additional costs and timescales associated with bringing regulated medical devices, diagnostics and pharmaceuticals to market. For example, therapeutic options may be fully licensed pharmaceuticals, over-the-counter medicines, unlicensed under ‘grandfather’ rules or just foods – resulting in consumer confusion and questions over safety, efficacy and therapeutic claims.

For example, the flood of Chinese e-cigarettes emerging onto the market in the last 10 years gave consumers a heralded ‘reduced-risk’ alternative to tobacco but with little in the way of quality standards or evidence to support that assertion. The European Union Tobacco Products Directive took some time to catch up and establish a base line for product safety – and, in the US, the regulatory landscape is still in flux.

Public perception is changing, too, about how and where products should be used. Carbamide peroxide – less glamorously known as urea peroxide – was developed and patented in 1989 as a professional tooth whitening treatment. It transitioned 0ver the following 20 years into a range of products sold for use at home. Public fears, it would seem, have been allayed by the easy access to these products that are often promoted by small companies with little to lose, using low-cost marketing strategies – and the products are not without potential dangers when you consider the high concentrations of peroxide being applied to the mouth.

Another example is the ‘sexual wellbeing’ category that has become mainstream as ‘sex toys’ arrive on our supermarket shelves. Devoid of regulation, only three therapeutic vibrators meet Food and Drug Administration requirements for specific medical applications, although some of the most responsible manufacturers are taking voluntary steps to ensure product safety to protect their customers and brands – for example, by using phthalate-free, medical-grade polymers and offering product cleansing solutions. But as the recent $3.75m connected We-Vibe data protection breach shows, the risks to users from such devices can be digital as well as physical – highlighting why consumer healthcare businesses need high standards that may be outside their governance capabilities.

Another factor to consider is that the new European Medical Devices Regulation suggests that ‘consumer health’ may not even exist as a sector in the future – as all devices will be considered medical devices if they look like a medical device.

A technical ability to deliver a new product to market is only one element of a landscape of commercial challenges facing the emerging wellbeing category. People increasingly want to manage their own wellness and they deserve to be able to choose from honestly marketed, safe, effective and increasingly tailored products and services. The brands that win will do so through exemplary science, design quality and standout user experiences that deliver against real unmet needs, underpinned by a responsible approach to commercialisation.