Product design for medical devices or consumer health tech can be a daunting — and treacherous — climb. Here’s how roadmapping can minimize the risk!
Suppose there’s a medical startup developing a game-changing medical device. After a seed round, the company budgets $1.2 million for product development over 12 months. Their team debates whether to go with a wired or wireless solution for the device. Each has their merits. The team decides to go forward with exploring both options because all the stakeholders can’t quite agree. After developing both solutions, the company explores their regulatory pathway. They learn that there are no predicate devices that are wireless. To get FDA approval the device has to be wired. The project ends up costing $5 million. It takes two years to develop both options, only for the company to find out at the end that they needed to go with a wired solution from the start.
This isn’t an academic story — it’s one that a Cortex client experienced in a past life. And it’s a particularly painful example of how unforeseen risks can completely derail a company’s product development process.
“Hardware is hard” (as the old saying goes) mostly because it’s risky. These risks come from the huge amount of unknowns at the outset. A small company that hasn’t brought a product to market before might not know all the steps involved, or where to start. A larger company might know how the journey should go, but still might not see roadblocks lurking in the shadows. Not just the known unknowns, but the unknown unknowns.
Either way, the annals of product design are littered with stories of companies laid low by unforeseen risks like the example above.
We incorporate product roadmapping into our Design for Commercialization (TM) process, to create a pathway to predictable outcomes that saves companies time, money, and headaches.
What is Product Roadmapping™?
A roadmap is an introductory phase 0 in our product development that provides a concrete plan to create focus at the outset of development. Our own roadmapping methodology, Basecamp by Cortex, involves exploration, validation, de-risking and strategy around:
- Human factors
- Technical feasibility
- Regulatory and quality concerns
- Manufacturing, commercial, and logistics planning
All within a tight timeline. In short, a roadmap is an opportunity to step back, gather your supplies, and take a good look at the mountain ahead before you start the climb.
From our perspective, here are a few of the biggest advantages companies gain by roadmapping:
1. Roadmaps reduce risk by uncovering and mitigating unknowns before you start development.
As we wrote about in our design guide, “How to Create Profitable Products,” it pays to think about all the phases of product development (research and ethnography, concept development, prototyping, production, manufacturing, regulatory) at the outset. Product design is a sequential process, but early decisions have a long tail.
Here’s an example: a client comes to us with an exceptional device they’ve developed, looking for help with manufacturing strategy. But the device they’ve designed is way too expensive to manufacture for the cost the market will bear. Now, to produce the device, the company needs to go back and completely re-evaluate the design — at a tremendous cost of both time and money. This is one example of the many risks that happen when you treat product design as a purely sequential process, without considering the whole process up front.
A roadmap considers manufacturing (e.g. vendor analysis, commercialization, logistics validation) — among the many other factors listed above. It can help you take stock of everything that’s known and unknown for all these factors before you invest considerable time and resources towards development.
It’s important to mention that a roadmap won’t ever eliminate all the unknowns — there are always new challenges uncovered along the way. But it allows your team to be more agile by expecting the unexpected, and anticipating moments when you might need to pivot before or when they arrive, not months later.
2. Roadmaps allow for a more predictable budget.
Product development has two budgets: money, and time. If your company has milestones around grant funding tied to particular dates, your time budget is almost as important as — if not more important than — your monetary budget.
Projects often come through our doors with an overall budget, but many unknowns about how much time and money each phase of development will cost. A founder might say, “I have X dollars and Y months to develop the product,” without knowing how much of that time and money to allocate towards prototyping, design for production, or manufacturing.
A good roadmap will provide the analysis you need to break out more accurate budgets for every phase of development. It allows us, as a design and engineering firm, to provide a more accurate quote up front. This is especially true for the later stages (e.g. production design, manufacturing). If you start the project having validated vendors, regulatory requirements, and the overall pathway to market, there will be fewer budgetary surprises later on.
3. Roadmapping saves time and money in a measurable way.
Product design is a tree with many forking branches. And every branch — every design direction, every regulatory or manufacturing strategy — represents thousands of dollars and weeks or months of development. The sooner you can determine which branches won’t bear fruit, the more time and money you’ll save in your development.
As per our medical company example above, a product roadmap would uncover that there are no predicate wireless solutions for the company’s device, and make the pathway to regulatory approval clear. With the focus provided by a roadmap, the company would have been able to move forward confidently with the wired solution.
4. Roadmaps can help you feel out the relationship with a design and engineering firm to make sure you speak the same language.
Engaging a design and engineering firm like Cortex is a big decision. The bigger the project, the higher the stakes. You don’t want to get six months into a project before realizing that you and your design partner aren’t on the same page. Roadmaps offer a digestible engagement that lets you do an initial collaboration to make sure that your working style and priorities will align at every later stage of the process.
A roadmap is often an on-ramp to a big engagement with a firm, but it doesn’t have to be. A good roadmap is product-specific, but firm-agnostic. The holistic analysis it provides should be useful even if you decide to go with another firm, or develop the product in-house.
5. Roadmaps can uncover insights to help you future proof your product.
The industries we work in – health technology and medical devices – move extremely fast. Development has a long lead time, and components go obsolete. This represents a huge risk.
Here’s an example: we were recently quoting a medical project. As part of our Basecamp study, we evaluated the product requirements document and realized that a crucial chipset would be end-of-lifed in two years — for a project that had a two year development timeline.
A roadmap can help derisk the component and product lifecycle to ensure that you’re able to leverage the latest technology, while also setting up electronics builds that can be component-agnostic to incorporate what’s coming down the line.
If you want to learn more about product roadmapping and what it can offer your process, reach out to James Chalmers, our Partner & Strategy Leader who is spearheading this initiative for Cortex and graciously offered his insights for this article.