Biolinq, Inc.

“When you start democratizing or decentralizing technology, you have to be very thoughtful about who you partner with,” said Michael Springer, in a recent interview with MD+DI . Speaking about overmolded needles and the accelerating demand driven by GLP‑1 therapies, CGMs, and even neural devices, he offered a clear caution: “Most importantly, don’t try to do it yourself.” Springer, a Medtech innovation and commercialization leader, works closely with startups, clinicians, and OEMs to accelerate the path to market for breakthrough technologies. He also serves as a Medtech consultant for Forj Medical , a contract development and manufacturing organization focused on advancing next-generation manufacturing solutions for minimally invasive and devices. At MD&M West , he will present “ The Needle Boom: Scaling Overmolded Needle Manufacturing for the At Home Care Revolution ,” where he will share how manufacturers should think about scaling precision devices for a rapidly changing home healthcare landscape. He believes companies can learn from startups, particularly in how they approach manufacturing differently. “You have to ask whether you’re simply good at making needles, or whether you truly understand how needles behave as systems evolve,” Springer explained. “That’s the difference between a manufacturing company and a process engineering company.” Springer noted that this distinction is central to the work he supports at Forj Medical, where integrated design-through-manufacturing teams help customers anticipate scale from the earliest stages. Below, Springer shares his perspective not only on overmolded needles but also on the broader shift toward scaling medical devices for home use and what it takes to do it well. Let me start off by asking why is this topic important for medical device manufacturers? Springer: With the rise of GLP1s, single-use consumables, and vaccination-driven injections, needles are back in focus. But this conversation goes well beyond needles. When devices move from hospital to home to consumer scale, many of the same patterns appear. Across wearables, brain-computer interfaces (BCIs), drug delivery, and implantables, signal paths and fluid paths get smaller, while tolerance for failure goes to zero. Needles are a great example of a broader trend. Manufacturing is no longer downstream—it’s part of the invention itself. If you look at who is entering this space today, ranging from large pharma to glucose monitoring companies, it’s becoming clear that success requires far more than understanding the needle alone. Needles appear simple, but they are complex to manufacture at scale. Take a startup like Biolinq, a company working with micron-scale sensing elements that function similarly to needles. It raises a fundamental question: what actually defines a needle? That challenge forces the industry to rethink assumptions. Many established companies are comfortable saying, “This is how we’ve always done it.” The real question is whether that approach keeps you ahead of the curve, or already behind it. As medical devices increasingly enter the home as part of daily life, the shift is profound. It’s comparable to moving from desktop software to mobile apps. Everything becomes decentralized. When choosing partners, it’s not enough to ask whether they can make a needle. You also must ask whether they understand home-use environments. There are hidden physics and scaling challenges that startups are often solving first. That’s one of the reasons I work with Forj Medical. Their global footprint and integrated engineering-to-manufacturing ecosystem is built to support devices as they move from early development into high-volume use markets. My view is that if you’re not working with new companies pushing these boundaries, your design and manufacturing perspective becomes limited. There are many excellent engineers and manufacturers, but the pace of change demands constant challenge and strategic alignment. Can you briefly explain what overmolded needles are and why they are so important in the home-care sector? Springer: Overmolded needles are more reliable and more precise than glued needles, especially when devices are used unsupervised at home. Home-use devices live in the real world. A hospital is not the real world. When you remove trained operators and controlled environments, expectations rise dramatically. If something doesn’t work at home, users lose trust quickly. They stop wearing the device or stop taking the medication. That’s why human-centered design becomes critical. Overmolded needles support reliability, longevity, and trust. As devices continue to shrink, overmolding presents new technical challenges, but it remains essential for reliability at scale. Companies like Forj Medical, which specialize in microscale molding, electromagnetic sensing, and full system technologies, are increasingly being asked to solve these challenges earlier in the development cycle. Who should come to your session? Springer: Ideally, attendees leave with something that resonates and something that challenges how they think. The irony is that final decision makers often don’t attend sessions like this. If an engineer and a manager attend together, they can continue the conversation back at their company. They can ask, “Is this real? Are we seeing this already?” The session is for people who are allowed to take calculated risks through strategic decisions. It’s about understanding your risk profile, how you partner, and how you outsource as technology evolves.  Forj Medical has been navigating these exact questions as they prepare customers for scale. What are the main messages you would like your attendees to take away from your session? Springer: First, it’s never too early to get help. This session is for teams who don't just want to launch a device, but they also want to survive scale. Many of the best projects fail early, pivot, and eventually find their path. That process often requires outside experience. Asking for help is not failure—it’s a strategic decision. Second, scale must be designed in from the beginning. Scale is where most devices fail. Working with a CDMO like Forj Medical can help teams design with scale, manufacturability, and global production in mind from day one. If someone leaves and decides to send one thoughtful email or start one internal conversation, that’s a win. Michael Springer will present, “The Needle Boom: Scaling Overmolded Needle Manufacturing for the At Home Care Revolution,” on Tuesday, February 3, from 1:15 to 2 p.m. in Room 206AB.

WILMINGTON, Del.--(BUSINESS WIRE)--Amalgam Rx, Inc., a leading provider of AI-powered software for regulated medical devices, announced its collaboration with Biolinq Incorporated in developing the digital backbone for Biolinq Shine™, the first fully autonomous, needle-free glucose sensor recently granted De Novo Classification by the U.S. Food and Drug Administration (FDA). Amalgam Rx announced its collaboration with Biolinq Incorporated in developing the digital backbone for Biolinq Shine™, the first fully autonomous, needle-free glucose sensor recently granted De Novo Classification by the FDA. Biolinq Shine marks a major step forward in establishing a new category in continuous glucose monitoring, and Amalgam’s scalable software platform played a key role in enabling rapid software development to support Biolinq’s regulatory timelines. The same architecture that powers Biolinq Shine’s secure, real-time data capture and mobile app feedback will support Biolinq’s broader multi-analyte ambitions, including expansion into additional biomarkers beyond glucose. “As our software platform partner, Amalgam’s speed of execution contributed to a successful regulatory submission for Biolinq Shine. Their extensible architecture aligns with our roadmap to expand the biowearables market and to support growth in new healthcare verticals over time,” said Rich Yang, Chief Executive Officer of Biolinq. “We’re incredibly grateful for Amalgam’s shared mission and talented team.” “This milestone exemplifies what’s possible when biosensing innovation meets intelligent software,” said Amalgam president, Chris Bergstrom. “Together, we’re redefining how people can understand and act on their health -- establishing a blueprint for how software and sensors can evolve together to enable personalized care at scale.” The Amalgam platform is designed specifically for regulated healthcare applications, providing: Modularity and scalability across use cases, diseases, and geographies Secure, compliant data architecture that meets MDR and FDA standards Integration readiness for connected devices and other third-party sources Audit-ready oversight with end-to-end traceability and monitoring This collaboration demonstrates how strategic partnerships between hardware innovators and software specialists can bring safer, smarter, and more accessible connected health solutions to market. “We’re proud to support Biolinq’s vision of improving metabolic health for millions of people,” added Ryan Sysko, CEO of Amalgam. “Together, we’re setting the standard for digital-enabled biosensors that are both clinically meaningful and commercially scalable.” About Amalgam Rx Amalgam Rx empowers patients and providers to make the best decisions possible—within clinical workflows and in everyday life. With a modular SaMD platform, EHR solutions, and Medical-Grade AI, Amalgam partners with global life sciences companies, health plans, and providers to reimagine care delivery. Today, Amalgam’s AI-powered solutions support nearly 10 million patients across four continents and have enabled more than 70 million clinical decisions. Learn more at www.amalgamrx.com. About Biolinq Incorporated Biolinq Incorporated is a healthcare technology company pioneering precision multi-analyte wearable sensors to improve metabolic health. The company’s biosensor platform is designed to inform and inspire with unparalleled simplicity to support healthier living. With microsensors that reside just below the skin's surface, Biolinq is redefining the future of continuous biosensing. The company is headquartered in San Diego, CA. For more information, please visit www.biolinq.com.

The FDA\'s de novo clearance pitches the Shine sensor as providing a more qualitative view of the user’s glucose ranges and trends. \n After raising $100 million in venture capital funding earlier this year, Biolinq has obtained a groundbreaking green light from the FDA for its needle-free continuous glucose monitor. The Shine system, which also tracks activity and sleep data, will initially be targeted at individuals with Type 2 diabetes. The reader employs microsensors placed in the topmost layers of the skin, which the company describes as being up to 20 times shallower than filament-based CGMs that require a subcutaneous introducer during placement and setup. Biolinq also bills its sensor as virtually painless and autonomous, with the coin-sized forearm patch providing real-time feedback on glucose levels via its own color-coded LED display, allowing it to be used without a paired smartphone app. The agency’s de novo clearance pitches the Shine sensor as providing a more qualitative view of the user’s glucose ranges and trends—not as a CGM that supplies the quantitative measurements used to calculate insulin doses. “Biolinq Shine is a first-of-its-kind biosensor designed to support metabolic health for people with diabetes who are not dependent on insulin,” Biolinq Chairman Dan Bradbury said in a statement. “By automatically tracking glucose levels, physical activity and sleep information, this technology offers meaningful insights that can encourage healthier choices every day.”“The entire Biolinq team is thrilled about this regulatory milestone, which is a testament to the outstanding work by our team,” added CEO Rich Yang. “We are grateful to the FDA for its rapid and rigorous review in establishing a new category of wearable biosensors.” In April, the San Diego-based company announced a $100 million series C round, stating that it would help launch its commercialization plans. Biolinq has also been developing an electrochemical microsensor array that tracks lactate and ketone levels, in addition to glucose monitoring—however, the initial FDA clearance only covers glucose monitoring.“As long-standing supporters and investors of Biolinq, Alpha Wave remains confident in their ability to deliver on a bold, innovative vision for biowearables,” said Rick Gerson, chairman of Alpha Wave Global, which led the company’s series C as well as a $58 million round in 2024. “Biolinq is on the path to redefine how society thinks about cardiometabolic health and wellness, driving the next wave of innovation with a profound multi-analyte biosensor platform.”