Last week at our second SaMD meetup, we discussed how to apply agile product management strategies to building and validating digital therapeutics.

Here are three key takeaways from the event, addressing:

  1. Why do most organizations fail from the start?
  2. Why is it so hard to be agile in SaMD?
  3. What makes your SaMD sticky?

1️⃣ Why do most organizations fail from the start?

So many entrepreneurs do a fantastic job securing funding. They have a great idea, raise money, and design the aspirational look and feel of their product, but then they need someone to build it for them. So they ask Rangle: "Can you build this for us? If so, how much will it cost?"

Usually, we answer that we can build the product for them, but that their idea will likely fail because their product scope is too broad, and they haven't validated the idea with potential customers, which is the most important step.

Organizations that build and launch successful products on the market usually fall in love with the problems, not the solutions. This is a fundamental shift in the way we look at product opportunities.

There are many different ways to validate your idea, which might feel a bit scrappy for folks working at large organizations. For example, you could create a product landing page, run a marketing campaign, and measure traction. How many people are visiting your page? How long do users spend on your website? How many subscribe? You can also start a crowdfunding campaign to validate the need for your idea and how many people are willing to chip in to make it happen. Even at an early stage, if your idea resonates with people, you’ll see traction.

Another important step that many organizations skip is developing a well-thought-out business model. When defining the scope and creating go-to-market strategies for products, we are looking for how we can drive traction, how we can drive people to come back and use the product, and how we can find tangible evidence for a working business model.

One reason enterprises may skip business model discovery is that they’re not building a SaMD to generate revenue. However, a key aspect of having a business model is also about measuring and demonstrating true value and impact to your stakeholders.

Here is a high level process we see often work to find a problem-solution fit.

2️⃣ Why is it so hard to apply agile in SaMD?

The reason why so many SaMD product launches are delayed is that organizations get stuck in a loop: preparing and submitting regulatory documents, waiting for review, preparing revisions and responses to regulators’ comments, waiting for the next review cycle, and so on. Regulatory and compliance processes are often at odds with the agile edict to continuously evolve your product.

Product managers are crucial to successfully developing SaMD products. Working with good product managers who understand agile principles, relevant regulatory requirements, and the business you are in could save you millions of dollars and years in time-to-market.

Ultimately, product managers influence which regulatory pathway to go through and which requirements to adhere to by:

  • Creating the product strategy
  • Leveraging well-established clinical associations
  • Scoping the MVP and product iterations
  • Slicing and prioritizing features

With clever product positioning and feature design, product managers can go through the regulatory validation cycle with smaller feature sets at a time.

To obtain and maintain the target medical device classification at launch and subsequent product iterations, while continuously scaling the code, you need to build an evolvable product.

We created and work by Compliance by Design principles, which apply agile to software development for highly regulated markets. Learn more about Compliance by Design and how we applied agile to SaMD for a global pharmaceutical company, accelerating their product launch timeline from two years to nine months.

3️⃣ How do you make your SaMD sticky?

Customers today have an abundance of choices. When they encounter a half-baked product, they don’t become beta testers and give you feedback. They leave.

Without customer feedback, it’s easy to fall prey to the “build trap,” where you feel you’re one killer feature away from success. You exhaust time, money, and effort building something no one wants, learning too late what customers actually want. This is why any new product development initiative should focus on traction as the primary metric.

Traction isn’t about being the first to market, but the first to market adoption. Traction is evidence that people care about your idea. More importantly, traction is evidence of a working business model.

Traction is measured differently at every stage of the product life cycle. In the MVP stage, traction is all about stickiness, which drives user engagement and retention. Without stickiness, you do not have a working business model.

There are two aspects to optimizing for stickiness: 1) upfront optimization and 2) post-launch optimization.

Upfront optimization

Optimizing for stickiness starts with a product manager's understanding of the target users’ motivations and behaviours. When scoping product features, a product manager needs to identify and prioritize elements that increase usage and value. When scoping an MVP, a product manager needs to prioritize making a product lovable and functional. There is a trade-off between optimizing for stickiness upfront and time-to-market.

Post-launch optimization

Many product managers forget to continue optimizing for stickiness after launching an MVP. Instead, they focus on new feature development. We recommend that you optimize for stickiness and product-market fit before starting to scale your product.

You should evaluate:

  • How many people are coming back to your SaMD and using it?
  • How is your product performing across different channels?
  • How are people using and interacting with your product?
  • What features are they using?

Run small, tangible experiments and A/B tests to optimize product design, user experience, and market positioning. For example, does placing a button somewhere on the screen drive more conversion? Does changing a component’s colour enhance usage? Does advertising the product in a different tone of voice attract more people?

You have to keep finding knots and optimizing your product post-launch to improve product-market fit and maximize stickiness. It doesn't matter how much upfront work you’ve done: it won’t be perfect the first time.

Want more?

Another very important phase that is also often overlooked by organizations is optimizing regulatory processes. We have previously addressed this challenge in another article: How do you clinically validate your product and build regulatory traction?

📺 Watch the full recording of our meetup and access our Mural board!

To learn more about SaMD, check out our SaMD knowledge hub and articles.

👉 You can also contact us to let us know if there’s anything you’d like to chat about.

Hope to see you at our next SaMD meetup!