A medical professional holds a detailed anatomical model of a human brain while pointing at a specific region with a red pencil. In the background, two computer monitors display MRI brain scans with various cross-sectional images of the brain’s structure and blood vessels. The setting suggests a neurology or radiology environment.

Drug Delivery

Custom solutions for drug delivery devices and combination products.

Your drug is the star. We deliver it with Precision.

In the evolving landscape of cell and gene therapies, biologics, and complex treatment regimens, the method of delivery is as critical as the therapeutic itself.

At StarFish Medical, we specialize in designing innovative drug delivery devices that enhance treatment efficacy, improve patient compliance, and streamline the user experience. Our multidisciplinary team combines technical and scientific expertise with user-centered design to create solutions that bring your therapy to life.

A young child wearing a striped blue shirt uses a nebulizer mask for respiratory treatment. The transparent mask covers their nose and mouth, with visible vapor coming from the device. The child looks upwards while holding the nebulizer, and the background is softly blurred, suggesting a home setting.

Proven Success in Drug Delivery Devices

StarFish Medical has a track record of successfully bringing drug delivery devices to market, particularly those designed for targeted delivery to specific organs or tumors. Our portfolio includes combination products that enhance usability for at-home users and help reduce patient burden.

Whether your therapy targets a tumor, a neural pathway, or a systemic condition, we know how to translate delivery intent into working devices—built to support the demands of users, trials, and production.

Deep Expertise in Physiology and Pharmacology

Our team includes scientists and market experts with deep knowledge of human physiology, drug stability, and pharmacological dynamics. We don’t just understand the mechanism of action—we understand how your therapy interacts with real-world constraints.

That context informs our design and development process, ensuring devices are engineered with the biology, formulation, and clinical application in mind from the start.

Comprehensive Drug Delivery Services

From early concept definition through regulatory submission and clinical build, we align our work with your drug-device trial programming. Our ISO 13485-certified, FDA-registered facilities support rapid iteration and pilot-scale production in-house, with smooth transitions to your preferred contract manufacturer when needed.

You don’t need to coordinate multiple vendors or reset expectations at every phase. We stay with you through critical milestones and build toward what’s next.

Innovative Outcomes for Our Clients

We partner with startup entrepreneurs and global pharmaceutical companies alike to develop drug delivery devices and systems that overcome technical, physiological, and user challenges.

Examples include:

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Portable Nebulizer for Respiratory Drug Delivery

Battery-powered system with high-performance compressor for targeted aerosol delivery.

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Intranasal Device for Direct-to-Brain Drug Delivery

Non-invasive device targeting the olfactory region for needle-free CNS therapies.

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Stereotactic System for Deep Brain Delivery

Real-time, MRI-guided platform for delivering biologics into brain tissues.

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Spinal Cord Stem Cell Injection System

Clinically used system for ALS that compensates for cardiac and respiratory motion during injection.

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Ingestible Capsule for Targeted GI Delivery

Auto-localizing capsule that bypasses stomach acid to deliver drugs in the gut.

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Minimally Invasive Implant for Cell Therapies

Immunoprotective implant for encapsulated cells—without traditional immunosuppression.

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Radiotherapy Infusion Pump

Hospital-based infusion system with UX enhancements for cancer therapy administration.

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Intradermal Microinjection Device

Quick, low-pain intradermal drug delivery for therapeutic and aesthetic applications.

Explore Our Services

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Product Design & Development

Our multidisciplinary teams have all the in-house capabilities to transform your medical device from concept to final product.

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New Product Introduction and Manufacturing

Medical device design and development with a commercial launch focus. See how we support clinical trials and facilitate seamless tech transfers.

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Quality Assurance & Regulatory Affairs

We help you navigate complex regulatory landscapes to achieve commercial success. Explore our integrated approach to quality and regulatory services.

The StarFish Advantage

Trusted partner for drug delivery device development — from early concept to clinical builds and scalable transfer

Our multidisciplinary teams of engineers, scientists, and designers bring the full stack of capabilities needed to solve drug delivery challenges and move confidently from idea to execution.

A team of professionals is seated around a conference table while a woman in a blue blouse stands at the whiteboard, explaining a diagram. The table has laptops and papers, and the atmosphere appears collaborative and focused.

Custom Solutions for Complex Therapies

Combination products demand tailored thinking. We integrate mechanical, biological, and user considerations into a single, unified development strategy.

Your therapy is unique. So is the solution we build with you.

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Aligned with Your Milestones

We adapt deliverables to your clinical and business goals, from IND-enabling studies to investor pitches.

We don’t just meet deadlines—we help define them.

Top-down view of three people at a white table examining electronic device packaging, including tablets, chargers, and protective cases.

Human Factors & Usability, Built In

From day one, we embed industrial design and usability into your product strategy.

No retrofits. No compromises. Just devices that work for real users.

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Agile + Scientific = Executable Innovation

Our agile development process is grounded in scientific rigor and supported by a robust quality system.

You get the creativity of a startup with the discipline of a manufacturer

Two colleagues collaborating in front of a whiteboard covered with printed images and sticky notes, discussing design concepts or project ideas.

Manufacturing That Scales With You

We offer rapid prototyping, cleanroom builds, and seamless CMO transfer planning.

Start small, scale smart, and stay in control.

Two scientists wearing lab coats and blue gloves working with precision instruments in a laboratory setting, focusing on mechanical or materials testing equipment.

Scientific Insight Drives Better Engineering

Our PhDs and bioengineers collaborate to ensure biological compatibility and device performance are never at odds.

You won’t need to translate between science and engineering—we already do both.

Clinical-Grade Builds Without the Wait

Drug delivery devices often need to be built under cleanroom conditions for preclinical or clinical use. Delays in facility access, inconsistent quality, or handoffs between vendors can jeopardize your trial timeline.

That’s why we maintain ISO-certified, FDA-registered manufacturing facilities in Irvine, Toronto, and Vancouver — enabling faster prototyping, compliant clinical builds, and smoother tech transfer to scale-up partners.

Our infrastructure includes:

  • Class 10,000 cleanrooms for clinical-grade assembly
  • BSL2 laboratories for safety and performance testing
  • Pilot-scale manufacturing to support early trials
  • Custom IQ-OQ-PQ protocols for regulatory compliance
  • Integrated transfer to large-scale contract manufacturers

Explore Other Sectors We Serve

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Diagnostics

From lab-on-chip to connected home tests, we help diagnostic innovators bring accurate, accessible technologies to market.

A woman sits still while a medical professional wearing blue gloves adjusts a diagnostic imaging or eye examination device positioned around her face.

Therapy Devices

From emergency response to chronic care, we develop therapy devices that improve patient outcomes and meet rigorous regulatory standards.

Ready to explore how we can partner together?

Let’s talk about what’s next for your program.

TL;DR

  • StarFish Medical is a trusted partner for complex drug delivery device development.
  • We specialize in combination products that integrate technical, biological, and usability challenges.
  • Our in-house facilities support early-stage development through clinical builds.
  • We bring together deep scientific expertise and practical engineering know-how.
  • Proven experience across drug classes, delivery routes, and therapeutic areas.
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.

A hospital patient lies in bed with a blurred background of medical equipment; bold text reads “Empathy in Design” across the top.

Translating Emotion into Empathetic Medical Design

What does empathetic medical design really look like in practice? Eric and Paul discuss how emotional insight from field research can profoundly impact the design of medical devices