160 South Cypress Street
Orange, CA 92866
United States
Company Description
Fusion Biotec is located in a 15,000 sq. ft. design studio in the iconic Ice house in Old Town Orange, California. Originally built in 1930 as a cooling structure, the building was designed as a cold storage machine to refrigerate citrus fruit, then process the fruit onto the railroad sidetrack for pickup and distribution. The Ice house has since been transformed into a mixed-use facility consisting of offices, artist studios, and residential loft space. We are a two-minute walk from the shops and restaurants in Old Town Orange.
Fusion Biotec considers the site an ideal creative space for our 45+ engineers, that includes:
-
Industrial design studio
-
Electronics design lab
-
Collaborative software development area
-
Mechanical engineering lab and fabrication space
-
Machine shop and optics lab
-
Prototype/clinical unit assembly area and stock room
Fusion Biotec brings together art, science and engineering to create world-class medical devices. We provide best-practice processes in the medical industry to the designs that will drive your commercial success. Our staff has decades of experience providing medical device development services. The founders have come together to redefine how projects are conceived, designed and commercialized. Our strategy is to create and execute elegant, ingenious and cost-conscious designs.
We believe the best engineering starts with smart, creative people using tried-and-true technology. Early work should prove feasibility and reduce technical risk. We use existing technology to decrease development time, and use purpose-built technology to add value, reduce production costs and deliver an iconic design that fits into your budget. We offer a wide range of services to accomplish this:
IDEATION
Our ideation process is a well-defined team exercise to identify and refine product development ideas. The development team, along with invited stakeholders and outside experts, meet to flush out design and development ideas optimized for a specific product. This technique is very effective in early development of a new product as well as at any point, where major design tradeoffs are considered. The process includes: Scoping, Ideation, Refinement, Mockups, Try-storming, Review and Finalization.
INDUSTRIAL DESIGN
Our industrial design lab includes a photography studio and usability discovery room with a separate observation area. We start with concepts and renderings, which can be easily created and modified. This allows for quick turns and iterations that generate additional ideas. In these early concepts, we explore usability, human factors, ergonomics and user interface graphics and placement by providing mockups, which can be 3D printed parts, foam core, display screen simulations, etc. We also explore how the embodiments of various design concepts affect the client’s perception of the product and how well it fits the use environment. This can be accomplished with formative and summative studies. Later, features, concepts, colors, look and feel are presented and distilled into concept refinements. When the best concept refinements are distilled into a final design, we create the 3D models and CAD files.
In addition, we provide wireframes/storyboard and graphics for the user interface. Today, users are familiar with laptop, tablet and smart phone interfaces. They expect an intuitive and user-friendly interface, especially on products that they use every day. This starts with a storyboard and graphics designed for your application and to match your brand. We understand iconic branding!
PRE-DEVELOPED TECHNOLOGY
In the interest of our clients, we do not charge a license fee to use pre-developed hardware and software or lock clients into purchasing our components. We believe platform technology should benefit the development project. Therefore, our clients receive a non-exclusive, royalty-free license for use and have many of our pre-existing technologies incorporated into their devices.
Saving upfront cost is an advantage with pre-developed technology, but not if those savings quickly disappear because of inflated cost of goods or others controlling your software. Having ownership of your product and control over it, is essential. We can provide off-the-shelf or custom solutions, it’s your decision with no hidden agendas. Afterwards, your in-house team or CM can pick up the engineering support and we will help with the transfer. Our goal is to get your product into manufacturing as soon as possible with the least hurdles. Your success is our success!
Fusion Biotec has a proven track record of productizing an idea in record time using our pre-developed technology. We have a number of examples of projects that we completed in four (4) months or less, from paper concept to alpha prototype. One instrument was a blood component therapy treatment for precision medicine in oncology. Fusion started with our electronics and software pre-developed technology and then developed custom electronics, pumps, software, mechanics and industrial design.
Another example is a blood chemistry and immunoassay diagnostic instrument for retail clinics. The project was highly accelerated and was completed from breadboard to alpha prototype in approximately 4 months. The development included a team of over 12 engineers and subject-matter experts. Fusion developed the electronics, software, mechanics, optics, robotics and industrial design.
A final example is a ventilator valve system consisting of 12 injection molded parts. This new valve allowed for transport, manual ventilation and cleaning without the ventilation circuit being opened. Therefore, eliminating contamination in the treatment area and with the healthcare workers. The valve mechanism was designed, molded, tested and transferred to manufacturing in six weeks!
DESIGN & DEVELOPMENT
We exploit the latest technology in the industry to provide every possible advantage to our process. From Agile SCRUM project management to the use of application service provider software, we look for ways to keep overhead low and value high. We employ the best people and the best methodologies. Being in the industry for decades, allows us to appreciate top-performing engineers, consultants, service providers and vendors. Our engineering team consists of software, mechanical, electrical, systems, optical and robotic engineers.
As far as methodologies, we utilize PCBA layout software with built-in libraries, embedded software code with built-in drivers, open-source hardware and software to leverage pre-developed technology and mechanical CAD tools that easily translate into prototyping, machining and manufacturing. Because, we don’t want to re-engineer things, any more than you do!
DESIGN FOR MANUFACTURING
There are a number of engineering methods to reduce costs and improve manufacturability. Designing an instrument for easy assembly and test can reduce product cost and production line issues. It can even translate to a reduction in service time. Engineering can reduce the number of circuit boards, provide purpose-built subsystems, decrease the number of machined parts, design parts for molding, incorporate robust methods for mounting, ensure testability of a PCBA, provide software for a system-wide final test, and create assembly fixtures to speed the production line just to name a few. The appetite for manufacturing process investment, the importance of speeding assembly and test procedures, the number of parts tooled, how parts and subassemblies are tested, how the production will be scaled, all play a role in the design for manufacturing.
PROTOTYPE & CLINICAL UNIT BUILDS
Prototypes are typically used for testing toward the end of the development project. These tests include performance, electromagnetic compatibility, software V&V and system validation.
Once prototypes have successfully passed testing, often there is a need for additional instruments for clinical studies. These instruments are assembled in a separate GMP compliant area, tested and documented before sending to our clients.
Our process is designed to improve the quality and cost of medical devices in production. The effort usually starts with a charter, kickoff meeting and portfolio analysis. After the product is chosen, we coordinate the workshop phase. The output of this phase is individual value engineering (VE) projects for evaluation and approval by management. These VE projects are later completed and cost savings are tracked to report ROI to management.
Portfolio analysis looks for instrument pain points such as low margins, high complexity, quality or obsolescence concerns, high material spend or non-optimized design. This is then put in the context of manufacturing volume, direct material and labor cost.
Workshop analyzes the instrument and its competition. It identifies and prioritizes opportunities for improvement and cost reduction and breaks the effort into individual VE projects. The brainstorming and trystorming process is closely related to our ideation process (see Ideation section above).
Project Engineering executes design, component and process changes identified by the workshop. For design changes, we follow design controls, provide a project plan and follow an Agile SCRUM process.
Final Management reviews value engineering projects, tracks cost savings and calculates ROI.
Outsourcing Directory Categories
In-Vitro Diagnostic Categories
Medical Device Categories
