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Baebies

<p>Baebies had developed a near-patient diagnostic platform capable of performing critical blood screening for newborns within minutes, using just a tiny sample. Unlike traditional lab-based tests that take days, the FINDER platform was designed to deliver rapid, reliable results at the point of care, supporting faster diagnosis and improving early outcomes for infants around the world.</p>
<p>In the U.S., more than <a href="https://www.ncbiotech.org/news/baebies-delivers-landmark-10-million-newborn-screening-tests" target="_blank">1 in 300 babies</a> are born with a condition detectable through newborn screening. Early diagnosis can mean the difference between life-altering intervention and irreversible harm, making speed, access, and usability mission-critical.</p>
<p>The FINDER platform wasn’t just a technical innovation. It was a chance to redefine what near-patient newborn testing could feel like. Delve helped Baebies turn breakthrough microfluidics into an intuitive, clinician-friendly device that hospitals could adopt with confidence.&nbsp;Our work went beyond interface design—we helped evolve a working prototype into a more intuitive, clinically usable system, working across digital interfaces, physical touchpoints, and clinician workflows, and validating those improvements through usability testing.</p>

<p>We've been developing medical devices to meet rigorous standards for 55 years.</p>

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<h2>From Technical Breakthrough to Market-Ready Diagnostic Platform&nbsp;</h2>
<p>Baebies had developed a powerful microfluidic platform for newborn screening—but to succeed in a clinical environment, the product needed more than cutting-edge science. It needed to deliver fast, reliable results in real-world settings, earn regulatory approval, and gain the trust of time-pressed clinicians.&nbsp;</p>
<p>This was the business problem Delve helped solve: transforming FINDER from a promising prototype into a manufacturable, intuitive, and regulatory-ready product. Our design and engineering teams worked across hardware and digital to ensure the experience fit clinical workflows, supported FDA and CE approval, and could scale.</p>
<p>It was a critical step in helping Baebies bring a category-defining diagnostic product to market.<br></p>

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<h2>Overcoming Barriers to Adoption: Workflow Friction, Regulatory Risk, and Clinician Trust </h2>
<p>Near-patient newborn testing is fast-paced, emotionally charged, and deeply personal. Any friction in the experience—from confusing workflows to intimidating interfaces—can slow adoption and create risk. Baebies needed a solution that would: </p>
<ul><li>Deliver rapid, lab-quality results at the point of care </li></ul>
<ul><li>Minimize training and onboarding time for clinical staff </li></ul>
<ul><li>Support regulatory approval with safe, reliable operation </li></ul>
<ul><li>Reflect the emotional sensitivity of working with newborns and families </li></ul>
<p>To achieve that, the FINDER platform had to go beyond technical accuracy. It had to become an intuitive, elegant tool that seamlessly fit into hospital workflows—and inspired confidence from the first interaction. </p>
<p> </p>

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<h2>How Strategic Design Enabled Clinical Trust and Regulatory Success</h2>
<p>With Delve’s design and engineering support, Baebies achieved an extraordinary technical feat: a near-patient diagnostic platform that delivers lab-quality results in ~15 minutes from just a 50 µL blood sample. The system is compact, cost-efficient, and supports multiplex testing—enabling hospitals and labs to scale rapid diagnostics within existing workflows.</p>
<p>But technical performance alone wasn’t enough. To succeed in real clinical environments, FINDER needed to deliver intuitive use, streamline workflows, and meet regulatory demands without friction. That’s where Delve’s strategic design approach made the difference—accelerating development across three critical areas:</p>
<h3>1. Designing for Clinical Confidence and Ease of Use </h3>
<p>Through human factors research and workflow mapping, we uncovered key friction points that could slow adoption. We redesigned the interaction flow to reduce cognitive load, simplify user prompts, and clarify test progress at a glance—helping nurses and lab techs feel confident, even in high-pressure moments. </p>
<h3>2. Seamless Hardware-Digital Integration for Real-World Use</h3>

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<p>Developing next-gen medical devices with hardware-software interactions requires a new, holistic development methodology. Explore the process we used to develop a cohesive digital/physical experience for the Baebies FINDER.</p>

<p><a href="https://www.delve.com/insights/a-better-way-to-develop-a-medical-device-with-digital-and-physical-elements" target="_blank">We collaborated across industrial design, engineering, and UI/UX teams to create a cohesive, elegant experience</a>—from the blood sample input to the on-screen display. Real-time prototyping across hardware and software allowed Delve to rapidly refine usability and ensure a seamless, clinician-friendly experience at every touchpoint. Thoughtful industrial design helped minimize the device’s footprint, while digital microfluidics and custom UI components were refined to make key actions feel natural and stress-free.</p>
<h3>3. Design Decisions That Supported Clearance, Safety, and Scale</h3>
<p>Delve’s cross-functional approach ensured that design decisions supported manufacturability, safety, and regulatory clarity. Our prototypes and documentation directly supported Baebies’ path toward <a href="https://baebies.com/baebies-receives-fda-510k-clearance-for-g6pd-test-on-finder-platform/?utm_source=chatgpt.com" target="_blank">FDA 510(k) clearance</a> and <a href="https://baebies.com/baebies-announces-submission-of-510k-to-u-s-fda-for-glucose-6-phosphate-dehydrogenase-on-finder/?utm_source=chatgpt.com" target="_blank">CE Mark certification.</a></p>

<h2>From Hospital Adoption to Strategic Acquisition <br></h2>
<p>With Delve’s support, Baebies transformed FINDER from a promising prototype into a market-ready platform that enabled clinical adoption—and business growth.</p>
<ul><li>Adoption by hospitals across the U.S. as a trusted near-patient diagnostic platform</li><li>Over&nbsp;<a href="https://www.ncbiotech.org/news/baebies-delivers-landmark-10-million-newborn-screening-tests" target="_blank">10 million test units delivered to labs</a> between 2014 and 2021—including 3 million in 2021 alone—demonstrating the system’s ability to scale and support high-volume screening efforts</li><li>Recognized across multiple design competitions, including the <a href="https://meeting.myadlm.org/conference-program/disruptive-technology-award/past-competitions/2020" target="_blank">AACC Disruptive Technology Award</a>, <a href="https://www.mddionline.com/ivd/medical-design-excellence-awards-2021-finalists-testing-and-diagnostic-products-and-systems" target="_blank">MDEA Finalist</a>, and second place in the <a href="https://www.dmi.org/page/2021DVAWinners" target="_blank">DMI Design Value Awards</a></li><li>The platform’s versatility was further proven when it was granted <a href="https://www.businesswire.com/news/home/20210406005309/en/Baebies-Announces-FDA-Acknowledgement-of-Emergency-Use-Notification-for-FINDER-1.5-Instrument-and-FINDER-SARS-CoV-2-Test-RT-PCR-within-17-Minutes" target="_blank">Emergency Use Notification by the FDA</a> for COVID-19 testing in 2021</li><li>In 2025, FINDER received <a href="https://www.news-journal.com/baebies-receives-fda-breakthrough-device-designation-for-first-point-of-care-heparin-monitoring-test/article_5ab767ec-e1a2-5d31-a373-7f1141d8f4f4.html" target="_blank">FDA Breakthrough Device Designation</a> for the first point-of-care heparin monitoring assay—positioning the platform to expand into the multi-billion-dollar coagulation testing market</li><li>FINDER helped position Baebies as a category leader in pediatric diagnostics—contributing to continued growth, investor confidence, and the <a href="https://www.lacar-mdx.com/en/news/17_press-release-lacar-mdx-technologies-acquires-baebies-incs-newborn-screening-division-in-the-us" target="_blank">strategic acquisition of its newborn screening division by LaCAR MDx Technologies</a> in 2025<strong></strong></li></ul>
<p>FINDER’s success wasn’t just a technical milestone—it was the result of strategic design decisions that enabled Baebies to lead in a critical care category.</p>

<p>Delve helped Baebies evolve a working prototype into a diagnostic system clinicians trust—by simplifying workflows across the physical and digital experience.<br>
If you're building a near-patient diagnostic product for clinical use, <a href="https://www.delve.com/contact" target="_blank">let's talk.</a><a href="https://www.delve.com/contact" target="_blank"></a></p>

<p>Delve helps medtech teams define the opportunity, envision the solution, and build systems ready for clinical trials, regulatory approval, and commercial success.</p>

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<p><strong>If you’re building a complex medtech device, this case study will show how early design decisions—from workflow to manufacturability—can make or break clinical adoption. Learn how Delve helped Baebies launch a diagnostic platform that’s now FDA-cleared and used in hospitals across the U.S.</strong></p>

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Baebies: Rapid, Intuitive Newborn Screening

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<p>Vamsee Pamula, Founder/President, Baebies </p>

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Baebies: Rapid, Intuitive Newborn Screening

Designing for Adoption: How Baebies Turned a Breakthrough Diagnostic Into a Clinician-Ready Product

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