Yes, Agile can work in Medtech

It takes many years and millions of dollars to bring medical devices to market. Regulations play a huge role: health technology manufacturers must meet a number of requirements to get devices approved – otherwise they risk wasting their investment.

High failure costs encourage many manufacturers to take a methodical approach to development, focusing primarily on regulations. But the trade-off is patient care. The slower the pace of drug development and approval, the longer patients are left without treatment options that could dramatically impact their lives.

Manufacturers need a way to get products to market faster without creating regulatory risk. Yet many are hesitant to adopt the Agile methodology: it may seem too risky for a highly regulated environment.

However, with some adaptations, Agile can work in this space. Here I will share three tips that will help you leverage the benefits of Agile in health technology production.

1. Identify your viable, minimally regulated product

There is a common saying in the healthcare industry: there is no such thing as a regulated MVP.

That’s true, in a sense. You cannot bring your product to market until it receives regulatory approval. And it won’t be approved until it’s almost complete. More often than not, this process involves clearing sky-high regulatory hurdles and can lengthen the waiting time for issuance.

But what if you could lower the barrier to acceptance? Enter a minimally regulated viable product (or MRVP).

As the name suggests, this concept bases product development on the feature set with the lowest regulatory burden. These functions are often simpler and faster to build. What’s more, they are still very valuable to your users.

For example, let’s say you’re building a diabetes management app that collects and analyzes data from a wearable sensor. It also allows users to track diet, activity and other health data in one place.

Some features – such as diet and activity tracking – are subject to little (or no) regulatory burden. However, they may still impact patient outcomes. You can set this feature so that your MRVP delivers a release quickly.

But speed to market isn’t the only benefit. By implementing MRVP, you can deliver value to patients faster while building brand loyalty for your product. By learning from these users, you can iterate to better meet their needs.

2. Make regulatory burden a vector of your action plan

Effective Agile development in health technology uses regulatory burdens as a vector throughout the product roadmap. In other words, you can assess the load on each feature set to prioritize and plan development.

For example, suppose you have five different feature sets:

• Diet and activity tracking
• Continuous integration of glucose monitors
• Medicines management (recording, reminders, etc.)
• Telehealth communication (for example via secure chat)
• Personalized care recommendations

Their regulatory burden can be compared to other factors, such as development complexity and their centrality to the product. You can then load your valuable but lighter lifts from the front and eliminate your dependence on the heaviest lifts. Along the way, you can keep track of feature sets in parallel so they’re ready when you need to release them independently.

This approach allows you to bring more features to market in less time than a traditional roadmap. It also allows you to achieve relatively quick victories. You may find that users value certain features more than you expected. You may also discover that they are using these features in new ways, which could impact the further development of your product. Each insight builds momentum towards a successful end product.

3. Focus on the freedom to release

According to the Agile principle, the best indicator of progress is working software. This thinking can be applied to many medical devices. However, to create working software, it is important to embrace “release freedom”: the ability to release new features with minimal friction.

This may sound counterintuitive in an environment where there are as many regulations as medical care. However, the steps we’ve discussed so far help prevent regulations from becoming obstacles.

For example, with MRVP you can plant a flag in the marketplace. With each release, you can strengthen your brand among existing users and expand it to new ones. The feedback you collect along the way – for example through product reviews – can both inform future development and serve as valuable social proof to help attract new users.

Conclusion? The freedom to spend ensures constant progress – which is much better than months of downtime.

Prioritize patients with a flexible development cycle

It is worth emphasizing that regulations regarding medical devices are not the enemy: they ensure patient safety at every stage of their use. Still, it is important to balance regulatory requirements with patients’ immediate care needs. And slow progress can delay effective treatment for years.

With an Agile approach, you can accelerate the full product development cycle, from idea through execution to release. This means patients see value faster, and you can see a return on your investment faster.

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