The point-of-care diagnostic market exploded in 2020 and isn’t looking back. But becoming a market leader requires building a great product and commercializing as quickly as possible.
In a suddenly crowded vertical, established medical device companies have an edge when it comes to supply chain stability and distribution capacity. One of J-Pac’s customers, a British startup pioneering a device with lab-level diagnostic power in a portable box, has its own competitive advantage: agility.
“With a bigger company, you will take years to do the things we can do in months,” said their lead engineer.
If competition beats the British diagnostic startup to market, they’ll face a steep hill to profitability. That’s why speed is key. But while their speed is impressive, it poses significant challenges to suppliers. And for a company built to move fast, suppliers that can’t match their pace only hold them back.
J-Pac met their challenge despite early struggles working through builds of ever-changing designs. J-Pac’s logistical flexibility allows their customer to maintain speed, and their robust process control measures provide confidence headed into Verification and Validation prior to FDA submission and production at scale.
Many suppliers, few right-fit partners
The British startup’s point of care diagnostic device delivers results in less than 20 minutes. It’s built for applicability across a range of markets, but they’re targeting the cardiac market first.
Their lead engineer’s mission? To find a blister manufacturing partner for her microfluidic cartridges, which hold a series of uniquely shaped blisters containing diagnostic reagents. Without the capabilities in-house, the startup needed an outside partner.
In the early stages of product development, the startup worked with a contract manufacturer that specialized in small runs and prototype manufacturing. Built to work to in ever-changing designs and fluid processes, that partner couldn’t contract-manufacture a device at the scale required for commercialization. They weren’t meant to be a manufacturing partner all the way to market and beyond.
“This involves sensitive reagents,” she said. “It’s not that easy to say, ‘I’ll invest a lot of time here working with this supplier and then I’ll move and go and work with that supplier.’ They didn’t have the capacity, so we moved on.”
The lead engineer knew the primary challenge for a manufacturing partner would be adapting to the startup’s speed. “I have feedback from different suppliers that they sometimes struggle to cope with us.”
This would be especially true during preparation for process qualification: She needed a partner built for at-scale production, not product development. She didn’t want to go through qualification twice, so she needed a long-term partner capable of producing millions of blisters.
“This involves sensitive reagents,” she said. “It’s not that easy to say, ‘I’ll invest a lot of time here working with this supplier, and then I’ll move and go and work with that supplier.’ They didn’t have the capacity, so we moved on.”
The blister market for pill packaging boasts an abundance of suppliers of all kinds — finding the right fit is simple. But microfluidic blister manufacturing is highly technical and lacks a mature supply chain. There’s little standardization when it comes to tooling, and many suppliers lack trust-building track records.
The lead engineer considered more than ten potential partners. She wanted:
- Robust process control and quality control systems in place
- Production capacity for 15,000 test run blisters, eventually scaling up to millions
- Strong, responsive communication
- A sense of urgency — they should be doing everything they can to be fast.
And then she found J-Pac Medical.
A logistical fit builds trust with flexibility
The lead engineer chose J-Pac because they met her key qualifications and moved quickly. She ordered sample blisters from J-Pac’s simple online store, and the relationship kicked off from there.
“With J-Pac, they were fast, also. It was the first company I was able to order samples from. That was really something. It was very easy to get the first samples just filled with water or dyed liquids, which was not very easy in other companies.”
J-Pac also proved more resourceful than competitors. Instead of requiring the startup to send reagents for the blisters across the Atlantic, they source identical formulations domestically. This cuts customs delays — allowing them to maintain pace while adjusting and improving their in-house formula.
Logistical flexibility fights off slowdowns in more ways than one. For the startup diagnostic company to maintain a breakneck pace, they need to continue prototyping with their original manufacturing partner. Information exchange causes logistical delays in many vendor relationships.
Some companies solve this problem by plodding forward more methodically and pushing back a target commercialization date. The diagnostic startup won’t be giving up their competitive advantage so easily.
Because J-Pac proved logistically flexible, the lead engineer isn’t caught waiting on vendors struggling to get on the same page. She’s able to keep using their speed to her advantage.
And the teams enjoy working together. She appreciates inside sales manager Kim Fall’s attitude and kindness. Engineering programs coordinator Kayla Smith and packaging engineer Brianna Atwood work through builds with her frequently, and senior vice president of operations and engineering Phil Littlefield gets involved when timelines start to look particularly tight.
“I know it’s not been easy,” she said. “But I think it has been fun, honestly.”
Meeting logistical chain demands is one thing. Keeping up with the startup’s internal speed poses an entirely different obstacle for a manufacturing partner.
Yin and yang meeting the challenge
The lead engineer knew J-Pac Medical was the perfect partner for the future. But she didn’t know whether they were perfect for the present.
At this point-of-care diagnostic startup, designs change quickly, documentation is produced only when necessary and teams are more focused on development of a product than a quality control system.
By contrast, J-Pac prefers producing robust documentation and manufacturing developed products at scale, putting it at odds with the chaos of constant change and slim process control favored by this British diagnostic startup.
“Everything needs to be signed off. Everything needs to be controlled. And that is very good — though not at the early stage — because it’ll help us, and it gives us the confidence that when we are in production, we won’t expect to receive a lot of failed batches because things were off that control. We’ve seen they really have things under control, so it’s very good.”
“They struggled a bit while we were changing the design because it changes very, very fast,” the lead engineer said of J-Pac. “So you talk with us one week, and you talk with us two weeks later and things have changed a lot.”
She didn’t expect their partner to have it easy. J-Pac proved themselves by meeting an unavoidable obstacle with dedication and urgency. The initial challenge ran two ways when J-Pac’s process control systems tested the startup’s ability to produce important documentation.
And the lead engineer sees that struggle as a built-in side effect of J-Pac’s strengths. “I’m absolutely sure J-Pac is the best supplier when you have everything stable and you freeze your design,” she said.
“We really made an effort and tried to get everything as organized as we could with the pace we have, to transfer to them the information,” she said. “We were not always very successful.”
She knows J-Pac’s meticulous system works to their advantage — it’s a huge reason why she trusts them as a partner moving forward. J-Pac’s trustworthy manufacturing process strengthens their product today and will reinforce their FDA verification application.
“Everything needs to be signed off. Everything needs to be controlled,” she said. “And that is very good — though not at the early stage — because it’ll help us, and it gives us the confidence that when we are in production, we won’t expect to receive a lot of failed batches because things were off that control. We’ve seen they really have things under control, so it’s very good.”
That two-way challenge elevated both companies, and their weaknesses aren’t holding the diagnostic device back. Their strengths power it forward.
Keeping and building momentum
The diagnostic startup knows it is a challenging partner. But the lead engineer appreciates the collaboration between her team and J-Pac’s in pushing toward a shared goal. Dedicated customer service, engineering, and project management teams allow the partnership to push through any obstacle.
“Kim is very nice. Kyla and Brianna are always very helpful,” she said of the J-Pac team. “Phil joins some of the meetings — in particular, if we have some stresses with the timelines…”
With production qualification well underway, she hopes to see the point-of-care diagnostic device beginning the verification process in just a few months.
“In the end, we always find a way. And Phil is very good at that. He always finds a way and comes back and reviews the schedule or adjusts it or finds a way around how we’d do something.”
The end result: a point-of-care diagnostic start-up confidently speeding to market thanks to a partnership between agile innovation and trustworthy manufacturing.
Need a blister manufacturing partner to help you get to market and beyond?
The path to commercialization challenges every point-of-care diagnostics company in one way or another. Find a partner that can help you leverage your strengths by bolstering your weaknesses, and you’ll approach commercialization quickly and reliably.
Due to our flexibility and broad set of capabilities, a lot of diagnostic companies see us as a right-fit blister manufacturing partner. Book a call to learn whether we can help your company get to market and scale profitably.