Nima sensor engineeringBefore we began shipping, we put Nima through several rounds of product testing and user beta testing. As a hardware company, we knew that issues would arise with our product – there were issues that we could predict, but also unknown issues – doing these pre-production prototype builds was a way to ensure that we fixed the known issues and identified as many unknown issues as possible. Regretfully, this week, we announced a shipping delay for Nima pre-orders due to an unforeseen production issue. I want to pull back the curtain to provide more insight into how we deal with unpredicted issues – or “unknown unknowns” – when they arise.

At Nima, we follow this process when reacting to product issues:

  1. Do everything in our power to ensure a high-quality, trustworthy product
  2. Investigate causes and develop solutions
  3. Proactively communicate information when we have it to our customers

Before diving into the shipping delay, one example of how we worked through a manufacturing issue from our pre-production builds was the desiccant pouch that is included in each capsule package. The chemistry within the capsules is sensitive to environmental humidity, so a high-quality desiccant is important. We tested desiccants from two different suppliers during our pre-production builds and learned that one of them was faulty and didn’t work properly. We put in process control measures and quality control checks to prevent any desiccant issues from happening in production, thereby eliminating this “known issue.”

Once we had gone through all our internal tests, checks and toll-gates, we began shipping our first pre-orders of Nima at the end of September. We implemented what we call a “slow roll” (first shipped five units, then 30, then 50 and so on) to ensure all our fulfillment systems worked smoothly and, more importantly, to include an extra level of quality control. This extra step ensures that we can evaluate that our units in the field are working up to our standards as we scale up production. The first shipments of Nima have been met with amazing feedback – people have been testing their food for gluten at home, while traveling, at restaurants and at friends’ houses. Seeing Nima in the wild is one of the most rewarding and fulfilling things I’ve ever been a part of. We’re making a significant positive impact in people’s lives, and what’s more, people love Nima!

Nima capsule engineeringWhile doing our final quality control check on our most recent batch of capsules, we discovered a production issue causing leaks inside of the capsule, which would render the capsule ineffective. We immediately put production on hold and evaluated how many units this impacted – thankfully, due to our “slow roll” strategy, we were able to catch this issue before the faulty product shipped.

One of our company values is “be scientific” – we firmly believe in taking a scientific approach to problem solving. In this situation, that means two things: using the scientific method to design the right experiments to validate that we were getting to the correct root cause; and breaking down the issue to a chemical and materials level to understand the physics of the interactions that could happen in the system that we have.

By taking this scientific approach, we are able to validate where and why the issue arose, both theoretically and via experiment. In this case, as we scaled production and began building bigger lots, one of the components in our supply chain changed and was no longer produced to our quality standards. This component led to corrosion of a seal within the capsule, causing it to leak and the product to fail.

Another company value that we have is “be transparent” – as part of that, we believe that transparent information must be accurate and helpful. In this situation, we ran through this scientific investigation process to ensure that we knew what our root cause was and the impact that would have on production. Transparency also means that we proactively update our affected customers and backers once we have all the pieces of data to understand the issue.

Once we identify a root cause, a change needs to be implemented, tested and validated. We are in the process of sourcing a new supplier, designing experiments and quality control checks to ensure that the new component fixes the issue, and looking at long-term updates that we can implement to add redundancy and future preventative measures.

Nima capsule testingOnce we implement a fix and build small batches of functional product, scaling up production requires excellent process control and quality control. Process control ensures that the same product is built every time, and quality control will check to validate that the finished product meets specification. Our quality control caught this issue in time, but we are doing a review to find if there are any gaps where we can improve. Along with fixing and updating our product, we’re committed to fixing and validating an updated process control as we resume production to make sure quality is maintained at every step of the supply chain.

Making the decision to stop production and stop shipments is not taken lightly, and our team checks in every day to discuss progress, next steps and additional resources needed. We consider quality the highest priority for our products and have the customer’s best interest at heart. We continue to pledge to deliver trustworthy, life-changing technology to those who need it.

Scott Sundvor is the co-founder and chief product officer for Nima.