Being in China when COVID-19 hit might not seem like a stroke of good luck, but it paid off for Lura Health’s sensor miniaturization efforts.
Without a physical presence in Shenzhen, the minature sensor startup might not have been able to line up a battery supplier willing to take on the demanding needs of Lura Health’s saliva sensor, said co-founder and CEO Daniel Weinstein.
“Supply chain right now is super difficult. Vendor agreements are pretty crazy. [Just about] every PCBA house in the country is backed up with a huge backlog,” Weinstein said in an interview with Medical Design & Outsourcing.
“Our strength as a company is trying to find ways to beat the odds that are against companies — especially startups — in this industry,” he continued. “We’re on the very bottom of the food chain, and we embrace that. Yeah, it gives us a lot of headaches, but we’ve doubled down on really trying to get creative on how to navigate that to keep to timelines.”
The importance of supplier relationship-building is just one lesson Weinstein offered for other developers of miniaturized implant sensors.
1. Look for medtech trends and find a way in
Lura Health identified three main medtech trends while developing its miniature sensor technology: noninvasive testing, wearable technology, and usability.
While blood’s long been the gold standard for testing, it still requires a skin puncture. And though sweat monitoring is showing potential, it’s difficult to obtain continual reads. Optical sensors are also promising but it’s not clear when that technology — like the watch-based glucose monitoring Apple’s been working on for more than a decade — will become reality.
Saliva testing is already a booming multbillion-dollar industry, ranging from disease diagnostics to genomics. But it’s mostly one-time testing rather than continuous monitoring.
“There’s a big market already for point-of-care salivary test with a tube sent to a lab. But we see the inevitable conclusion of this space transitioning to a wearable system,” he said.
In order to be useful and justify their cost, wearable, noninvasive monitors need to be easy to use — and easy to get on or inside patients.
“Patients with chronic conditions that need continual monitoring are dealing with a lot of challenges anyway. They don’t need medical devices to introduce even more challenges to try to address their challenges,” he said. “… Because of the universality and prevalence of existing dental devices, because of the ease of access to a dentist — maybe even more so than a doctor — because of the long-term sensor capabilities in the mouth as a long-term device rather than on the skin or something else for compliance, we think that saliva diagnostics in wearables are an avenue to give the patient a tool that doesn’t add any more complexity or pain points than they already have.”
2. ‘Solid state’s the future’
Weinstein is bullish on solid state battery technology for sensor miniaturization.
“I think solid state’s the future,” he said. “If anybody disagrees, I would point them to Abbott’s recent recall of 4.2 million devices where the lithium polymer cells were overheating and catching fire on some of their receivers.”
Solid-state batteries are less reactive and less prone to combustion when punctured than lithium batteries, he said.
Lura Health was among the first recipients of Ilika’s new Stereax M300 stacked batteries this year. Weinstein said Lura Health’s sensors will likely use those solid state batteries when they become available in bulk sometime next year.
3. Surface-mount technology, stacked electronics and simulations
Surface-mount technology (SMT) is crucial as a standard for developers of miniaturized sensors, Weinstein said.
“Minimizing manual assembly methods and maximizing assembly that can be compatible with standard SMT machines will save a lot of costs and labor and is important to consider from the beginning,” he said.
Developers of miniaturized sensors should already be thinking of how to take advantage of automated manufacturing anyhow, since machine control is going to be required for just about everything at that small scale.
Another trend gaining steam is stacking electronics. Especially in miniaturized devices and components where space is already in short supply, there’s a limited area for electronics on the horizontal plane.
“Utilizing that vertical space more is important,” Weinstein said.
And you can’t just design one part of your device in isolation anymore.
“It’s becoming more and more of a liability to design in silos,” Weinstein said. “Ultimately you want everything to come together in one picture, from heat transfer simulations to RF simulations to flow-through simulations. And it’s just more and more important to get that all in an integrated design stack.”
4. Build supplier relationships
A physical presence in Shenzhen helped Lura Health find a battery supplier in China despite overwhelming rejection from other potential partners.
“If we reached out to 20 vendors, we got no quotes from 19 of them, and one just happened to be able to do it and give us a shot — maybe begrudgingly, but we were also in China, so we used that face-to-face relationship to do that,” Weinstein said.
Through venture capital firm SOSV’s Hax hardware accelerator, Lura Health arrived in Shenzhen just a few months before the COVID-19 pandemic.
“When we got there, none of the big manufacturers that we needed would talk to us because we were low volume, low MOQs. We were just annoying to them. We needed the best suppliers because they were the only ones with the capabilities we needed.”
Then the pandemic hit, and suddenly contract manufacturing managers that “previously blew us off” were showing up in their Teslas to take the team to factory tours and dinners. Weinstein said.
“For assembly and production, that was great. For the battery supplier, it was still really tough because … the parameters of the product were ridiculous. It exceeded all of their miniaturization specs. All of them were really hesitant to even attempt to quote it, and none of them did except one company.”
They developed a hand-rolled, hand-sealed lithium polymer cell prototype that Lura Health will use to power the next-generation units for FDA review. At 10 mm by 4 mm by 0.9 mm, Weinstein said it is the smallest of its kind.
But the tradeoff of smaller batteries in sensor miniaturization is smaller capacity, and Lura Health needed a way to wirelessly recharge the batteries.
The solution came after Weinstein met the co-founder of Resonant Link through the Forbes 30 Under 30 network and learned about their latest high-efficiency wireless charging technology while exchanging messages on Slack.
“We were the perfect use case. … We need it as small as possible, no heat generation, as efficient as possible, as fast as possible,” Weinstein said.
Their collaboration resulted in the smallest charging coil Resonant Link has ever produced, and Lura Health now uses it for wireless recharging of its device.
“We’re thoroughly convinced that’s the only way in the world that we could have done it,” Weinstein said.
Relationships are more important than ever because supply challenges are greater than ever, he said.
“As a startup, it might be impossible to hit the anticipated lead times, but you should never know that there’s going to be a delay on the day that it was expected. You should know it ahead of time. And if it’s a critical supplier, you should be at their factory in person, on a plane, talking with the team. You shouldn’t be trying to get them over email.”
Related: Tips and red flags to help you select a medtech contract manufacturer
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