Therapy Devices
Devices and instruments that treat patients inside or outside the clinic.
Cutting-edge therapy devices brought to life
Devices and instruments that deliver critical care are vital in the healthcare journey. From ventilators and dialysis machines to surgical equipment, these technologies provide life-saving support during in-hospital emergency care. In recent years, there has been a growing demand for devices that enable therapy closer to the patient, whether at home or in out-of-hospital settings.
Enhancing Patient Care Inside and Outside the Clinic
StarFish Medical can help you we design and develop your therapeutic devices for any use case, be it traditional healthcare settings or home use. With our extensive experience in life-saving technologies, we excel in creating, testing, and delivering critical care devices across a spectrum of sectors
Simplifying Healthcare with User-Friendly Devices
Our expertise in therapeutic devices encompasses the development of portable devices for both healthcare professionals and home users, with a strong emphasis on user-friendly interfaces and direct-to-consumer therapeutic solutions
Advancing Medical Fields with Cutting-Edge Technology
With deep expertise in ventilators, thermal ablation, dialysis, ophthalmology, brain stimulation, and aesthetic medicine, among others, we combine technical innovation with human factors and industrial design principles. This synergy allows us to develop bespoke solutions that truly improve patient outcomes.
Ensuring Reliability with User-Centered Design
We recognize the importance of reliability in delivering critical care when it matters most. Guided by a user-centered design approach, we transform visionary ideas into high-performing therapy devices that provide exceptional value to healthcare providers, patients and consumers alike. Grounded in appropriate levels of risk management, we ensure your products incorporate advanced technology and exceed your expectations.
Technical Program Management with Visibility to Manufacturing
Delivering Comprehensive Solutions with a Multidisciplinary Approach
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.
Aligning with Your Business and Clinical Goals
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.
Committed to Quality and Timely Delivery
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.
StarFish Successes
We partner with startup entrepreneurs and leading medical device companies to develop a wide range of devices and instruments. These are a few of the highlights. To get the full story, review the case study or contact us for details.
Emergency Room Ventilators
We designed and built a certified ventilator within a 6-month timeframe as a response to the pandemic. The ventilator is easy to use, manufacture, and can be used in emergency situations. Subsequently, we have developed a ventilator for use in pediatric patients.
Laser-induced Eye Color Change
We developed an instrument to permanently reveal underlying eye coloration using laser treatment. This surgically non-invasive treatment is performed in a doctor’s office in less than a minute per eye per treatment.
A new platform for Cool Sculpting
We supported the design and development of a new cool sculpting instrument. This device represents a new aesthetic medicine platform for a variety of skin treatments.
Photo biomodulation for treatment of ocular disease
We developed an instrument for non-invasive treatment of ocular disease. This instrument is commercially available, and we support ongoing manufacturing of the product on market.
Digital Health Device for treatment of tinnitus
We developed and built the first Apple hardware Class II device cleared by FDA. The device provides patients with sound therapy that reduces the symptoms of tinnitus.
FAST1® Intraosseous Infusion System
We supported the design and development of a new intraosseous infusion system. The system is designed for use in the sternum during adult and adolescent emergency intervention.
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
From conceptualization to prototype development to manufacturing support, our multidisciplinary teams of PhD scientists and engineers work together to exceed your expectations.
Here’s what you can expect when you partner with us:
In-House Usability Testing and Human Factors Engineering
Our team takes a user-centric design approach that emphasizes understanding user needs and requirements. This insight guides our industrial design, optimizes human factors, and informs usability testing evaluations, ensuring that we create the right solution for the appropriate user.
Engineering Informed by Science
Our leadership team includes scientists and engineers with a deep understanding of the underlying physiology and therapeutic principles. Our technical experts understand the interplay between science and engineering that is required to provide optimal care all the time.
Your Milestones, Our Mission
We align our deliverables with your milestones. Whether you need a device ready for preclinical or clinical trials or for the next fundraising round, we’ll get you there.
Agile Program Management
We combine agile project management with scientific methods to meet your clinical objectives. Proven processes and a rigorous quality management system (QMS) are embedded in everything we do.
Design for Seamless Manufacturing
We use a design-for-manufacturing process to ensure your product—no matter how complex—will be ready for manufacturing and assembly. To minimize transitions, we build devices for clinical trials in our dedicated class 10,000 cleanrooms. If needed, we also support transfers to a large contract manufacturer of your choice or to one of our dedicated partners.
Our Facilities
With ISO-certified facilities in Irvine, Vancouver, and Toronto, StarFish Medical is well-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
- Support for Pilot-Scale Manufacturing and Clinical Trials
- Support for Transfers to Contract Manufacturing Partners
Explore Other Sectors We Serve
From remote diagnostics to powerful imaging systems, we design and develop diagnostics for use inside or outside traditional healthcare settings.
Our team creates innovative devices that combine your drug with optimal delivery methods for the most effective treatment.
Latest 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 move your therapy device forward?