Diagnostics
Complex diagnostic equipment, instruments and bespoke remote diagnostic devices and wearables.
Cutting-Edge Diagnostic Solutions 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.
At StarFish, we design and develop state-of-the-art diagnostic devices and instruments for hospital and remote settings, ensuring they meet the highest standards of quality and performance. We are fully committed to the trend of bringing diagnostics closer to patients, recognizing the critical importance of connectivity, data management, and seamless integration into clinical decision-making processes. Aligned with up-to-date market trends we are keenly focused on building the right product for your application.
Specialized Expertise in Advanced Diagnostics
Specializing in ultrasound devices, optics, sensors, and implantable diagnostics, we merge technical and scientific principles to create custom solutions that positively impact patients’ lives.
Solving Complex Technical Challenges
We thrive on resolving complex technical challenges for products that need bespoke and novel solutions. Starting with a user-centric design approach, we transform visionary ideas into high-performing diagnostic products that maximize value for healthcare providers and consumers.
Enhancing Health Outcomes with Data
Recognizing that the real value of diagnostics lies in the data they generate and how that data improves health outcomes and clinical decision-making, our software engineers and data scientists work in tandem to ensure seamless data management, cloud connectivity, cybersecurity, and compatibility with data systems.
Pushing the Boundaries of Innovation
When you want to push the boundaries of innovation, leverage our seasoned engineers and experts in science and medicine. We focus on effective risk management to ensure your products incorporate advanced technology and exceed your expectations around reliability, usability, and compliance.
Technical Program Management with Visibility to Manufacturing:
At StarFish, we understand the critical importance of seamless integration between technical program management and manufacturing. Our approach ensures that your diagnostic devices are not only designed and developed to the highest standards but also smoothly transitioned into production, maintaining quality and efficiency throughout the process.
Multidisciplinary Expertise
To ensure your diagnostics meet the needs of all stakeholders, our multidisciplinary approach brings together technical and scientific expertise. Our PhD scientists possess a deep understanding of both the underlying technology and market dynamics, guaranteeing fully informed and effective development.
Understanding Your Objectives
We prioritize taking the time to understand your business, technical, and clinical objectives while respecting your timeline. Our dedicated project and program management team ensures that your project progresses according to both internal and external milestones, keeping you informed throughout the process.
Commitment to Quality and Timeliness
We are committed to maintaining superior quality standards, accuracy, and on-time delivery, even as we transition into manufacturing. When you need to scale beyond clinical trial requirements, we are here to support you. We manage smooth design transfers to your chosen contract manufacturer or one of our dedicated partners.
Innovative Client Solutions
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.
Point-of-Care Device for Stroke Triage
Created a non-invasive device to triage critically ill stroke and concussion patients, optimizing treatment and outcomes.
Smart Knee Implant
Supported the development of a knee implant that reports on various metrics post-surgery, aiding in customized recovery.
Ultrasound for Fatty Liver Disease
Built a console and probe for non-invasive assessment of fatty liver tissue, offering a cost-effective alternative to MRI.
Heart Rate Variability Diagnostic
Developed a device for quantifying heart rate variability with cloud-based analysis and reporting.
Wearable Pulse Oximeter
Contributed to the development of a wearable device for remote patient monitoring, enabling treatment from home.
Trio-Smart® Breath Analyzer
Designed and built an instrument to measure breath levels of hydrogen, methane, and hydrogen sulfide, aiding in the diagnosis of GI illnesses.
Optical Analysis for Dry Eye Disease
Developed a device using proprietary AI algorithms for the detection of dry eye disease.
Explore Our Services
Our multidisciplinary teams transform your medical device from concept to final product.
We support clinical trials and facilitate seamless tech transfers with a focus on commercial launch.
Navigate complex regulatory landscapes with our integrated approach to quality and regulatory services.
The Starfish Advantage
Engineering Informed by Science
Our leadership team includes scientists and engineers with a deep understanding of physiology and diagnostic technology, ensuring accurate results.
Your Milestones, Our Mission
We align our deliverables with your milestones, whether for preclinical trials, clinical trials, or fundraising rounds.
In-House Usability Testing and Human Factors Engineering
Our user-centric design approach ensures we create the right solution for the appropriate user.
Agile Program Management
We combine agile project management with scientific methods to meet your clinical objectives, supported by a rigorous quality management system.
Design for Seamless Manufacturing
Our design-for-manufacturing process ensures your product is ready for manufacturing and assembly, with support for clinical trials and transfers to contract manufacturers.
Our Facilities
- ISO-Certified Facilities: With locations in Irvine, Vancouver, and Toronto, we are equipped to produce enabling technologies in-house.
- Advanced Rapid Prototyping Capabilities
- BSL2 Laboratories for V&V Testing
- ISO 13485-Certified Facilities
- Class 10,000 Clean Rooms
- FDA-Registered Flexible Manufacturing Facility
- Support for Custom IQ-OQ-PQ Procedures
- Pilot-Scale Manufacturing and Clinical Trials
- Transfers to Contract Manufacturing Partners
Related Resources
Overview of tools for Root Cause Analysis is an important tool in medical device development and manufacturing.
Predetermined Change Control Plans (PCCPs) Draft Guidance with Implications for Medical Device Manufacturers and regulatory framework
Ready to explore how we can partner together?