I think StarFish is a perfect combination of discipline for quality control and all the regulatory requirements that are there for good reason, but at the same time, porous enough that it’s not siloed departments. If there’s a really good person that’s had experience in an aspect of your project, they might be called in. They might show up at your meeting because they’ve heard about it, they have a keen interest, and can lend an idea that may ultimately be a definitive moment in the development of the product.
When we’re sitting in a room it feels like one team working on one project. We’re all equally invested emotionally in what we’re trying to accomplish. And we certainly believe that what we’ve been working on has the potential to have very significant impact on mental health.
Kenneth Irving (‘Irv’)
Fortitude is focused on concept stage of business development. Rocket Science Health is a private company engaged in the development of medical devices enabling the treatment of mood disorders and neurological diseases.
We needed a company with strong enough development and design capability to assist us where we needed assistance – like linebackers coming in and filling in our holes as needed. We also needed a regulatory compliant facility to build the device and handle all the DMR issues. We got the project done. That is a big kudos.
StarFish in a single word: Excellence. Professionalism.
Director of Development Compliance and Operations
Clerio Vision Inc.
Clerio Vision has developed a Laser Induced Refractive Index Correction (LIRIC) technology to overcome the safety and performance issues with existing refractive surgery, contacts lenses and IOL options.
We had the fundamental components for a new, minimally invasive surgical procedure called thread carpal tunnel release (TCTR). A neurosurgeon colleague suggested StarFish to help make the device suitable for sterile supply to end users, guide me through regulatory requirements, and produce high quality documentation.
StarFish identified a 3rd party contract manufacturer that fit our needs, and facilitated the design transfer. They managed the manufacturing set up and led the product through sterilization and packaging validation activities. The product is now on the market.
Joseph Guo, PhD
Inventor, Engineer of Mechanical Design and Tribology
Specialist of Surgical System for Non-scalpel Surgery
Speaking specifically to individual physicians or health care providers, I would encourage you to bring your ideas to StarFish first. It’s much more difficult than most anyone would realize to take a novel solution to a problem from the drawing board to the bedside.
Based on my experience working with them on multiple projects, I am very confident that StarFish can help successfully navigate the complexities of scientific or regulatory challenges, while providing best in class transparency and integrity, to bring medical devices to life.
To summarize Starfish in one word; I would have to use the word Ideal.
Founder and CEO
Vaid Medical Devices
Vaid Medical Devices
We are a very small organization trying to do way more than we probably should with our staff. We need vendors that can support us in our goals. It’s important for me to have a contract developer that can take ownership of the project that I can trust, and that can make big decisions we don’t need to fix at the end.
The primary purpose of the project is to develop a smaller and more flexible vapor generator with a 90% cost reduction. StarFish is helping Uptake to meet that goal, eventually moving to manufacturing. I liked their company focus on medical devices in development as well as in manufacturing.
StarFish has been very helpful in thinking creatively about the schedule timeline to meet our goals. We had a lot of disappointing interactions with other contract manufacturers and StarFish has made a world of difference.
It’s nice to have a point person in the project manager that I can trust and rely on. I can communicate directly with that person and know that they will disseminate information throughout the team at StarFish and will catch things to make sure they don’t fall through the cracks.
StarFish is certainly growing, but their primary goal is not to have an outsized growth at the expense of their clients. That means at the end of the day we are an important client to StarFish and it really feels that way. They take our needs seriously and it doesn’t feel like we are one small piece of their growth plan.
StarFish in one word? “Boutique”, that really means “Bespoke”. We are ourselves a boutique medical device company. We are very focused on single product platform. We are not a giant diversified company, but we have important things happening here and the size and scale of StarFish matches our size and scale.
Vice President of Research and Development
Uptake Medical® Technology Inc. is a commercial-stage medical device company based in Seattle, WA, USA. Uptake Medical is dedicated to improving the lives of patients suffering from pulmonary disease with vapor ablation.
Everything is done under one roof.
If I had to describe StarFish in one word it would be reliable.
Development Program Lead
Perimeter Medical Imaging
We were looking for a one stop shop. We didn’t want to work with 3 or 4 different sets of consultants. We wanted someone that could help us that had strength in Regulatory, Design, Engineering & Development and also had manufacturing.
What I value the most is the expertise. We feel like we are in good hands. There is a strong sense of confidence when we are able to run things by your team and have them confirm, or ask questions, or tell us that maybe we need to consider something else. We feel like we are checking all the boxes and doing things the right way, the way that we need to be doing them.
Senior Project Manager
Tevosol, Inc. is a medical device company developing the Ex-Vivo Organ Support System (EVOSS™) with the goal of increasing the number of organs available for transplantation worldwide.
I value their innovation the most. Anyone can follow directions. The innovation from StarFish was self-starting innovation. It is very satisfying to find in anyone and to have that level of curiosity and involvement with a project.
StarFish in a word? Satisfying. That’s what popped right into my head. Accommodating, flexible and satisfying.
I’ve dealt with a lot of engineers, but they only do what they’re told. They are not innovative. James and the other people at StarFish have been incredibly innovative and are a critical part of the team as we move forward.
Integrated Surgical is a privately held medical device development company based in Ridgefield, CT. Our core, disruptive patented technologies revolutionize the evacuation of smoke and fluid from the surgical field.
StarFish worked with us to help refine the software front end of our prototype device and fix a number of technical glitches. StarFish had a mix of the missing technical expertise that we didn’t have and the ability to feel like we’re working with extended team members.
Solid. I think it was a solid mix of technical skills, a little bit of artistry, and really good communication and vibe between the teams.
Ari Karchin, Ph.D.
Stasys Medical Corporation
Stasys Medical Corporation is a Seattle based Medical device company spun out of the University of Washington. Stasys’ proprietary technology enables rapid and complete platelet function measures in under 5 minutes. Using a disposable microcard, the Stasys Platelet Function Test can directly diagnose platelet dysfunction via microsensors to provide a complete clinical picture. The Stasys Platelet Function Test is investigational only, not for commercial use.
With a start-up you run lean. That model is always going to be in need of some infusion of resources to tackle bolus of work.
We had a sudden surge of workload and we needed firmware assistance as we just didn’t have the staff on board. The StarFish attitude was “Yes, we understand you are in a crunch. We’re here to help. Tell us what we can do for you.”
For me, that stands out. StarFish is “Can do.”
VP Systems Engineering
Apama Medical is committed to improving the treatment of atrial fibrillation (AF) by developing novel catheter ablation technology.
Once I connected with StarFish, everything came together. It’s been impressive, comforting, and informative.
The trust factor is always there. We were very early on in the patent filing work when I first met with StarFish at that initial stage. I left the meeting feeling completely confident and comfortable that everything would be kept strictly confidential, not go any further, and be fully appreciated.
It has been a great experience. I took the StarFish client quality survey and on a scale of 1-10, I thought, how can I say 9.5 or 8.5 when everything has come together the way it has. It’s been wonderful.”
Biopreme Medical Technologies, Inc.
Biopreme’s needle-free injection device will ensure healthcare worker safety, simplicity of operation, disposability, and low-cost. Our core technology minimizes training procedures and maximizes savings over alternative needle-free injection technologies. The device is appropriate for universal and private healthcare systems, veterinary medicine, life sciences research and the food services industry.
StarFish Medical took my ideas for an intervertebral body cage that is expandable and created an actual device that not only meets engineering requirements and compliance requirements, but meets surgical requirements. They are thorough.
I was looking for people who have actually dealt with implantable devices and had a general idea of what I wanted to accomplish. There are places that can deal with surgical devices, but don’t have a clue regarding my goal or what my device would be used for. When I called and spoke with StarFish, they had a grasp of what I was trying to accomplish pretty quickly.
After conducting a wide internet search, I found there are not many companies that can handle products like mine or that are able to present in a concise way how to get from Step A to Completion. Speaking with someone who understood what I was trying to achieve, understood what was necessary for engineering, and what the compliance issues were– that for me was the deciding factor.
Chief Executive Officer
Dorn Systems was started by Mark Ernst in 2005 to better address the needs of Spine Surgeons and dedicated Spine Practitioners. As a Cornell educated Physician Assistant who worked under the direction of an accomplished Spine Surgeon for 12 years, Mark saw an opportunity to revolutionize this specialty area by forming Dorn Systems and emphasizing premium products and innovative technology, skilled and responsive representation, and added value to a physician’s practice.
StarFish allowed me to execute probably six months faster because I didn’t have to recruit, integrate and train new talent before I could get them going.
There was an understanding of the medical regulatory environment and quality systems that gave me confidence. Their approach of really trying to understand the clinical problem was helpful.
What we were trying to accomplish had a breadth. It wasn’t just software, it wasn’t just hardware. It was a combination of different skills that needed to be drawn on and StarFish had the bench strength.
We’ve had a great experience. StarFish have been very flexible and driven by making sure we get the solutions we are looking for.
President and CEO
Perimeter Medical Imaging Inc.
Perimeter Medical Imaging, Inc. develops, patents, and commercializes advanced surgical imaging tools that allow surgeons, radiologists and pathologists to better assess microscopic tissue structures during a surgical procedure.
StarFish has the ability to be innovative, practical, and then execute on the design.
You guys deliver. You stick to your timelines, you stick to your budgets, and you get it done. If I had a word that summarized that, it would be the word I’d pick to describe StarFish.
StarFish Medical’s ability to execute is what I value the most. They were really committed to taking on any problem and challenge. Without any real predicate technology to guide them, they solved the problem, addressed the challenge and came up with an executable plan to effect a meaningful solution that resulted in actual functional technology. For us that is incredibly valuable.
We were looking for a firm that was capable of doing not only the engineering work, but also efficiently manufacturing the device. Not large scale manufacturing, but executing prototypes quickly, or in our case 1, 2 or 3-off bench technologies.
Noah M. Minskoff, MD
Chief Science Officer and Chief Operations Officer
InnovoSciences LLC is a privately held company committed to solving challenging problems in healthcare through innovation. Our core focus is identifying areas of unmet clinical need where we feel that we can make a meaningful impact on the lives of patients through the use of new technologies.
We have several projects with StarFish, here are highlights from two:
Pulmonary Drug Delivery
InnovoSciences is currently developing next generation technology for pulmonary delivery of medication. We are focused on providing novel, innovative, and safe devices for effective, controlled, and abuse-deterrent drug delivery. TruMDI is designed to provide clean nicotine delivery to the pulmonary bed via a handheld device, without combustion and the related carcinogenic and toxic byproducts.
InnovoSciences is currently developing innovative solutions that provide surgeons with more effective tools focusing on increasing patient safety and reducing the risks of surgery. The FIRST family of suction technologies allows for simultaneous evacuation of fluid and smoke, improving single-user dexterity, visualization of the surgical field and the health of surgical patients and staff.
When considering design and development partners, two things constantly came up in our discussions: communication and the quality of the deliverables. That was one of the reasons we chose StarFish Medical over anyone else. We just had the feeling the communication would be smooth.
StarFish has a lot of expertise we just don’t have. I’m a broad based facilitator, a very multidisciplinary designer, and kind of a generalist. Having a collaborator with experience in different types of projects, designs and problems was very important.
We wanted a partner who had enough resources and enough people with different types of expertise and experiences to get the ball rolling and be able to look at unusual problems and unusual requirements and have a perspective that might be unique.
StarFish people are able to take an unusual idea and say: “That’s what we want to do—we’re excited about an unusual problem. We want to solve this problem.” That was something we didn’t find with anyone else we approached for this project.
There were several innovative ideas that we worked through during the actual process, and I would say that the quality of the results was heightened by the fact that StarFish was willing to go the extra mile to help us iterate on those ideas and reach a satisfying conclusion.
Chief Project Engineer
The Sensory Perception and Interaction Research Group
University of British Columbia (UBC)
The cost of creating a QMS is substantial for a small company like Clearwater. We definitely got great value. Our work with StarFish Medical enabled us to pass the ISO 13485 inspection and set up our QMS before hiring a full-time quality person.
Matthew Bromwich MD, FRCSC, BSc.
Chief Executive Officer
I am extremely happy with StarFish support while setting up a QMS for Otoharmonics and the Levo System tinnitus sound therapy device. I’ve worked with a lot of QMS people in my life and the StarFish team are the most helpful and easy to work with.
Their knowledge is outstanding; A lot of other QA people simply pretend to know regulatory details and implications while the StarFish team really does. And they are not afraid to admit when additional research is needed.
President & CEO
Encouraging a company to go down a development path that is realistic from a design, regulatory, and indication for use perspective is really important. StarFish Medical identified major risks in developing the medical device and made sure we tackled those first. They understand small details which go into developing a medical device that a first time research team wouldn’t consider.
Working with StarFish provided us access to lots of talented engineers—electrical, biomedical, mechanical, and software—and structured project management. Our microbiome sampling project and prototype had been going on for 4 years. We handed the project to StarFish and have made great progress since.
They took a very methodical approach based on determining indication for use that helped us identify new peripherals, add functionality and enable manufacturability.
Mitchell Lawrence Jones MD, PhD
Chief Scientific Officer
Our experience was excellent. StarFish always had an answer.
StarFish Medical helped us solve our production line challenges enabling us to deliver products in a timely manner, consistently around the world. We liked that the StarFish solution was future-proof, poising us for growth.
We were looking for people who could speak our language in terms of technical aspects, yet be flexible enough to adapt to our system as it changes over time. We’re used to shifting gears quickly so we wanted a partner that could shift as easily when we make a decision.
The StarFish team are very responsive and responsible individuals with a good work ethic– they are trustworthy and helpful.
Director of Production
Zengar Institute Inc.
StarFish has the knowledge and expertise to get the job done.
Christie Consulting Services
What surprised us with StarFish was their willingness to become part of our team.
VP Business Development
eVie Health Technologies
StarFish Medical played a critical role in our ability to produce an alpha-prototype for validation. In an incredibly short time, and very cost effectively, StarFish engineers help us develop an instrument that completely changed the way our company is perceived… We will certainly work with Starfish again.
Dr. Andre Marziali
I cannot recommend StarFish any higher … they are skilled in design all the way through manufacturing.
Home Dialysis Plus
In a lot of cases you end up going to several different firms to get that holistic approach to design and development. We were able to come here to StarFish and it’s all here in one very tightly woven company. The value that we get for the money invested is extremely high.
StarFish understands the unique needs and requirements of designing and manufacturing a medical device for sale into a regulated environment.
Paul Cataford, CEO
Zephyr Sleep Technologies
The people [at StarFish] lay awake at night, wondering how to make my product better… we’re on the same team. It’s just been a phenomenal relationship. I feel like they’re an integral part of my team.
William Walker, President
The Starfish team was excellent to work with – very professional and flexible in meeting our company’s specific requirements.The project manager took an active role in managing the transition from our engineering team to their manufacturing group and helped keep us on track to deadlines and deliverables.
Ondine Biopharma Corp.
At Voyage Medical, a venture funded private company, we were developing an endoscopic cardiac electrophysiology ablation catheter. We were faced with upgrading the electronics of our clinical prototype to meet both functional and regulatory requirements. After a search we picked StarFish Medical due to the breadth of their technical capabilities. They helped us with system architecture, electronics and firmware. They also did verification testing of our system and helped us upgrade our quality management system to meet IEC60601 ed3 requirements. We were very happy with the results and I would strongly recommend StarFish Medical.
Thilaka Sumanaweera, PhD
Sr. Director R&D
Voyage Medical, Redwood City, CA
I commend you for your vision in looking well ahead to regulatory and contract assembly issues, as well as a decision to concurrently develop key prototypes. This ultimately led to a successful design concept. All initial design requirements were satisfied.
Koven Technology Canada Inc.
StarFish and its employees demonstrate a thorough understanding of how to lead, guide, or advise on innovative engineering projects, while applying sound Quality Management System practices to all aspects of a project, regardless of size and scope. They manage their team and assist your team ensuring sound engineering and project management principals are followed, while avoiding unnecessary paperwork and bureaucracy.
Nathan Ayoubi, B.Sc., MCPM
Rostrum Medical Innovations Inc.
StarFish Medical is very knowledgeable in regulatory and quality assurance. StarFish personnel went above and beyond the scope of our work by freely sharing advice and helping us gain “medical device thinking.” Their team explained core concepts clearly with lots of useful examples and templates. StarFish helped us customize our quality documents and easily accommodated our evening availability.
Julian Bromwich, BSc
Chief Technical Officer