Inside the Build: Saving Newborns

Featuring: Greta Paal, Manufacturing Engineer, Rebecca Snell, Manufacturing Operations Manager, Denise Nelson, Operations Engineering Director

“It looks so clean, so simple, so compact. When you pull the cover off, the inside of that thing is absolutely wild.”

Welcome to Inside the Build, a podcast series that dives deep into how Forj Medical solves complex manufacturing challenges, told by the people whose knowledge, expertise, and ingenuity make Forj Medical the partner medtech companies trust when the technology is complex and the stakes are high.

Where the project started

The device is a nitric oxide delivery system used on preterm newborns to support lung development in the first hours and days of life. Internally the program is called Raptor. On the floor it became “saving babies,” which started as a rally cry and stayed as the reason people showed up.

Forj brought the program in as a Gen 2 device. The customer moved quickly toward Gen 3, which put the team in an unusual position. The experienced operators had to be split into two groups, half building Gen 2 and half building Gen 3, running in two cells on opposite sides of the building. Demand for both was climbing at the same time, and over one nine-month stretch the program ran at the maximum output the team could produce.

The console itself is not a simple build. Roughly a thousand line items on the bill of materials, ten subassemblies, and about 40 hours of touch time. From the outside it looks clean, simple, and compact. Under the cover it is one of the densest products in the building.

Turning one eight-hour build into five half-hour ones

The original process put one operator at one bench and asked them to build a complete console. That was an eight-hour build. If the operator hit a problem or ran out of shift, the device sat partly finished into the next day, which is a quality risk on its own. Most of those hours were spent manually routing tubing through a very full box and installing components in an order that had to be right every time.

Working with the industrial engineering team, the build was split across five stations with roughly a half-hour cycle time each. An operator now runs the same sequence 16 times in a day instead of once. Consistency improved, training got faster, and the variation that comes with an eight-hour solo build came out of the process.

That work was Forj’s first real deep dive into takt time, line balancing, and gated cycle times, and those tools have been reused on every program since. Product flow was rebuilt around subassemblies with controlled WIP, and design for manufacturing work went in alongside it to make the product easier to build rather than only easier to schedule.

Not wasting the crisis

The Gen 2 to Gen 3 transition created a gap. The engineering and design work was going to take months, and the team decided not to spend those months waiting.

Everything inside the team’s control got fixed first. Line layout. Bin sizing. Tooling. Material presentation. Workflows. Four line moves happened in a single year. Visual factory work made it possible for any operator to walk up and know which bench to sit at, what is staged, and where the line is short. By the time the design work landed, the floor was ready to receive it.

The transition itself was run deliberately. Changeover points for each subassembly revision were planned to limit scrap, trials of ten subassemblies per configuration were run and flowed through before full changeover, and procedures were rewritten with the operators who use them rather than at them. Operators building a device every day know where a written step is going to confuse the next person.

Testing earlier instead of at the end

For a long time the process was to build the whole console and then find out whether it worked. Testing on these devices takes a long time, so a failure at final test is expensive in a way that compounds.

Historical failure data pointed at the specific subassemblies producing the most trouble, and the team built testers to screen those before they ever went into a console. Operators fill out scan sheets on every failure, which produces consistent data on what is actually happening on the line. That data goes into a monthly Pareto review with the customer, and the top failure modes get traced back to a process step, a part, or a supplier.

Some of that work goes deep. One failure mode the team had seen before started appearing at a rate nobody had seen before. Engineers spent full days on the floor with technicians and operators isolating which part of the build or test was driving it, then worked back through supply chain to the component level, down to specific components on the PCBs, to understand why they were not behaving consistently. Narrowing it down was the hard part. Fixing it permanently, with the supplier and the customer, is still in progress.

Getting the floor to want the line

Early on, people did not want to work this line. It was the hardest build in the building, it had eyes on it every hour of every day, and nobody wanted to be the person who caused a quality issue on a device that keeps newborns alive.

The change started with telling people what they were building and who it was for. Then came daily engagement that did not let up: a support team standing up every morning, an operator team standing up every morning, and the same three questions every day. What is going well. What is not. What do you need. The more of those asks that got answered, the more the floor trusted the process, and the more the team started solving problems together instead of escalating them.

Wins got celebrated in public with a monthly event the rest of the company was openly jealous of. Within a few months, people were asking to be assigned to the line.

Accountability carried the rest. Roughly 100 people had to deliver on schedule, from materials arriving on time to the line clearing devices for DHR work. Quality is often used as the reason to slow down. On this program the standard was that it has to be right and it has to hit the date.

Proof that it was sustainable

Every change was made against two questions, quality and scalability, on the assumption that the 50 people building the device today could be 50 different people tomorrow. The test came when demand paused and the line went quiet for six months.

When the next large order arrived, plenty of people asked whether the team was really ready. The line restarted from a standing start and delivered. Documentation, layout, and process had held well enough that startup did not require rediscovery.

The other measure came from the customer. After the last line move, they visited, and asked whether they could borrow the team to help set up their own factory.

What’s next

Gen 4 is in design now, with manufacturing and operations engaged in that design work from the start. The goal is to build in the automation, error proofing, and simplification that were retrofitted onto Gen 3, so the production transition is smoother than the last one.

Closer in, the line is expanding again for a larger order, which means revisiting bench count and subassembly capacity. Manual steps are the other target. Test data is still recorded by hand, which is slow and leaves room for error, and capturing it electronically is high on the list. The framing the team uses on the floor is good, better, best. The process is good. It has been made better. That does not stop.

This has been Inside the Build, a podcast series by Forj Medical, where we’re shaping the future of life-saving devices, one build at a time. Thank you for listening. For more information, visit us at forjmedical.com.