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Diagnostics

Complex diagnostic equipment, instruments, and bespoke remote diagnostic devices and wearables.

Diagnostics Innovation for Modern Healthcare

Diagnostic devices are getting smaller, smarter, more user-friendly, and more powerful. And by better integrating diagnostic data into clinical practice, diagnostics now play a more crucial role in modern medicine than ever before.

But designing and launching a diagnostic device that actually moves the needle—clinically, commercially, and operationally—is another matter entirely. From precision sensing to secure connectivity, every element must perform under pressure. There’s no room for technical debt, integration failure, or slow decision-making. At StarFish Medical, we partner with leaders across the diagnostic spectrum to build breakthrough devices that hold up in the real world—not just in theory.

A healthcare professional wearing purple gloves performs an ultrasound examination on a patient's knee using a handheld ultrasound probe. A medical imaging screen displaying the ultrasound results is visible in the background.

Designing Diagnostics That Matter — When Precision and Performance Are Non-Negotiable

In diagnostics, performance is non-negotiable. Devices must generate reliable, actionable data—seamlessly integrated into clinical workflows.

A single misstep in design or integration can ripple through the system—delaying trials, jeopardizing approvals, and eroding clinical trust.

We take a systems-level, clinically informed approach to every project. Our multidisciplinary teams—including PhD scientists, engineers, and usability experts—collaborate to ensure your device delivers precision, consistency, and clinical value.

A man wearing a white polo shirt and a headset works at a desk with multiple monitors in a brightly lit office with green walls and large windows. The desk has various tools, electronics, and a tissue box, indicating a technical or engineering workspace.

Building Advanced Technologies into Clinically Viable Products

Today’s diagnostic devices often push technical boundaries—novel sensors, advanced optics, AI-driven analysis, cloud-connected platforms. But innovation alone is not enough: these technologies must translate into products that meet clinical needs, regulatory requirements, and manufacturing realities.

When technologies aren’t grounded in execution, innovation becomes risk—not value.

We excel at bridging this gap. Our expertise spans ultrasound systems, implantable diagnostics, ingestibles, wearable sensors, and beyond. We help you transform innovative concepts into market-ready, clinically impactful products—with a focus on risk management, usability, and long-term reliability.

Transforming Data Into Actionable Clinical Insight

The true value of diagnostic devices lies in how data informs clinical decisions. Yet many promising products falter due to poor data integration, cybersecurity vulnerabilities, or unclear clinical pathways.

When insights fail to reach the right user, at the right time, they stop being insights.

StarFish addresses this from the outset. Our software, data science, and cybersecurity teams ensure that diagnostic data is captured, processed, and delivered in secure, interoperable, and clinically useful ways. Whether cloud-enabled, AI-augmented, or integrated with healthcare IT systems, we help you create solutions that turn data into actionable insights—improving outcomes for patients and providers alike.

Four people sit around a conference table in a meeting room. One person is standing, demonstrating a product or prototype to the group, which includes two men and one woman attentively watching. The table holds sample cases and devices.
Three colleagues collaborate around a prototype in a design or engineering lab. A man and two women are engaged in discussion, using whiteboard markers while examining the physical model. The background features a concrete wall and a bright window.

Program Execution Designed for Regulatory, Clinical, and Commercial Success

Bringing a diagnostic device to market demands more than technical excellence—it requires strategic program execution aligned with your business, clinical, and regulatory milestones.

The most advanced systems stall without clear planning, agile adjustment, and full visibility.

Our integrated approach combines agile program management with rigorous quality and regulatory expertise. We ensure alignment across stakeholders, manage risks proactively, and maintain full visibility from design through manufacturing transfer. Whether preparing for clinical trials, FDA or CE submissions, or commercial scaling, we help keep your program on track and positioned for success.

The StarFish Advantage

Trusted partner for diagnostic device development—from early feasibility to global scale.

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Translating Science Into Product

We work at the intersection of physiology, engineering, and data—turning complex diagnostic insight into actionable clinical tools.

You don’t need a translator. You need a team that speaks all three.

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Built for Regulatory, Clinical, and Commercial Realities

Our process is informed by clinical risk, usability, and quality systems—designed to meet the demands of regulators, payers, and providers.

You stay aligned, audit-ready, and launch-capable.

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Usability and Human Factors from Day One

We prioritize real-world users in real clinical environments—designing interfaces, workflows, and feedback systems that improve outcomes.

Because if it’s hard to use, it’s hard to adopt.

A man in a pink shirt points at a monitor while guiding a woman seated at a computer in an engineering or tech-focused workspace. Both are smiling, suggesting a mentoring or collaborative interaction.

Agile Execution with Embedded Quality

Our teams combine agile program management with a proven ISO 13485 quality system—driving speed without compromising rigor.

Innovation moves fast. Your quality system should, too.

A close-up of a hand-held medical device clipped onto a person's finger. The device features a purple star logo and appears to be used for measuring vital signs such as pulse or oxygen saturation.

Precision Engineering for Complex Systems

We build diagnostic platforms that integrate sensing, optics, connectivity, and data analysis—engineered to perform in the real world, not just in theory.

No guesswork. No patchwork. Just reliable clinical performance.

Two team members stand beside a whiteboard covered with medical device concept images and design references. They are discussing and placing sticky notes, possibly during a brainstorming or design review session.

Manufacturing-Ready by Design

We design for manufacturability from the outset, ensuring a clean handoff to your CM or ours—no scrambling, no rework, no surprises.

From clinical builds to commercial ramp-up—without reinvention.

Selected Diagnostic Innovations

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Ingestible Capsule for Gut Dysbiosis

Developed an oral capsule with auto location technology for targeted sampling of the gut, providing immediate analysis and results transmission.

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Point-of-Care Stroke Triage Device

Created a non-invasive device to triage critically ill stroke and concussion patients, optimizing treatment and outcomes.

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Smart Orthopedic Implant for Post-Surgical Monitoring

Supported the development of a knee implant that reports on various metrics post-surgery, aiding in customized recovery.

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Ultrasound System for Non-Invasive Liver Disease Detection

Built a console and probe for non-invasive assessment of fatty liver tissue, offering a cost-effective alternative to MRI.

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Heart Rate Variability Monitor with Cloud Analytics

Developed a device for quantifying heart rate variability with cloud-based analysis and reporting.

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Wearable Pulse Oximeter for Home-Based Care

Contributed to the development of a wearable device for remote patient monitoring, enabling treatment from home.

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Trio-Smart® Breath Analyzer for GI Diagnostics

Designed and built an instrument to measure breath levels of hydrogen, methane, and hydrogen sulfide, aiding in the diagnosis of GI illnesses.

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AI-based Optical Device for Dry Eye Detection

Developed a device using proprietary AI algorithms for the detection of dry eye disease.

Explore Our Services

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Product Design & Development

Our multidisciplinary teams transform your medical device from concept to final product.

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New Product Introduction
& Manufacturing

We support clinical trials and facilitate seamless tech transfers with a focus on commercial launch.

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Quality Assurance
& Regulatory Affairs

Navigate complex regulatory landscapes with our integrated approach to quality and regulatory services.

Ready to explore how we can partner together?

Speak with an Expert

TL;DR

  • StarFish Medical helps MedTech teams bring sophisticated diagnostic devices to market with confidence.
  • Our expertise spans imaging, biosensors, AI, optics, and connected diagnostics.
  • We thrive on solving problems with no off-the-shelf solution—and translating bold ideas into reliable products.
  • We deliver both innovation and execution—through clinical validation, regulatory strategy, and design-for-manufacturing.
  • Our partnerships are built on trust, precision, and shared commitment to improving patient outcomes.
A patient lies with eyes closed while a clinician marks dotted surgical lines on her face with a skin marker. The patient wears a surgical cap. Overlay text reads: ‘More than a procedure?’ in bold font on a white highlight box.

Patient-Centered Field Research in Medtech

In this Before the Build episode, Eric Olson and Paul Charlebois reflect on the value of patient-centered field research—and how firsthand observation can reframe design priorities and impact outcomes in profound ways.

loved hand holding a blood vial in front of blurred Chicago skyline. Overlay text says ‘From vial… To Chicago?’ in bold white font on black background.

Laboratory Diagnostics Showcase at ADLM 2025

Each summer, the laboratory diagnostics showcase hosted by the Association for Diagnostics & Laboratory Medicine (ADLM) draws industry leaders to Chicago.

Thumbnail showing a vial of clear contrast agent on the left, with a red dotted arrow pointing to an X-ray image of a skull displayed on a tablet held by a person in a white coat. Overlay text reads “Not approved here?” in bold black and white text.

Understanding Contrast Agents in Imaging

Nigel and Nick explore how contrast agents in imaging support medical device trials and diagnostics. While bones appear clearly in standard X-rays, soft tissues like those in the nasal cavity often require contrast agents to become visible.