Our Services

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We provide a wide array of services that include early concept feasibility studies and systems engineering analysis through to the development of production-ready prototypes, clinical units for FDA (510)k approval.

The services we provide include:

  •   Mechanical, Electrical, Software and Usability Engineering 

  •   Industrial Design  

  •   Systems Engineering 

  •   Value Engineering  

  •   Optics Design (Fluorescence detection, cameras, etc.)

  •   Usability (Human Factors) Engineering  

  •   Market and IP Assessment

  •   Regulatory Assessment and Planning

  •   Compliance Assessment and Testing

  •   Complete FDA ready design packages

  •   Disposables Engineering

  •   Prototype and Clinical Unit Assembly and Test

  •   Contract Manufacturing Assessment and Recommendation

  •   Transfer to Manufacturing Support

At Fusion Biotec, we celebrate the fusion of art, science and engineering and the creative process involved to conceive and commercialize medical products. We are experts in developing complex analytical instrumentation for molcular and immuno-diagonstic market. We’ve helped numerous clients with their FDA technical files. We also provide intellectual property and marketing assessment, useability engineering, regulatory planning and compliance testing.  With our knowledge of the device industry, we can provide contract manufacturing evaluations, recommendations and transfer support to best fit the needs of your product.

 

How do we do this in our design process?  We start by integrating the art of Industrial Design into the development process from day one until the release of the finished product. We do this by employing our Ideation process.

 

The Fusion Ideation process is a multi-day 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 the early develop of a new product as well at any point where major design tradeoffs are to be considered, such as encountered in the development of a complex new instrument as well as in value engineering.

Ideation

Concept brainstorming with team

Grouping and down selection of ideas

 

Concept Refinement

Grouped ideas into concepts

            Consider alternate approaches

            Improve reliability

            Ease of manufacturing

 

Continued refinement of mainstream concept

            Foamcore mock up built

            Try-storm for unknowns

            Review and Q&A

Critical component selection and costing

Finalization of concepts  

Using Agile engineering processes, a project is done in a series of short, 3 week sprints.

The end of each sprint is an opportunity for the stake holders to review progress and offer input. This transparent process is the key to making continuous and meaningful progress. 

Here is a diagram of the Scrum process we use:

 

 

 

Behind the scenes, the various design tools integrate within our network. This network includes component parts, documents and processes all linked back into a common ERP database. With the system designed in the right way, it will not only drive and document the process of development (very important for regulatory reasons) but will also support the engineers with team-wide data that often gets lost today.  Done correctly, the engineers want to use it and it makes their jobs easier while decreasing design time and insuring a quality design.

 

 

 

  

 

 

 

Art is everywhere.  A beautiful medical device just makes sense.

User friendly. Safe. At Fusion, art plays a major part in the design process. Art is not just visual.  Good engineering is an artform as well.  We like simple, elegant solutions whenever possible.

 

  • Concept creation and innovation

  • Unique solutions for real user needs

  • Mock-ups and samples

  • User studies

  • Iconic designs that promote brand identity

  • Conceptual drawings, simulations, mock-ups, renderings and 3D models

  • Artistic involvement from idea to prototype to commercialization 

 

Without Science, art is just something to look at.  We take the science seriously. Micro-fluidics, PCR, fluorescence.  We understand the science behind your instruments.

 

  • Experienced in-vitro diagnostics methods, ELISA tests and detection techniques

  • Molecular diagnostics, sample preparation and PCR

  • Low light level acquisition and amplification

  • Fluorescence, chemiluminescence and spectroscopy

  • Micro and nano fluidics

  • Image capture via microscopes, CMOS, line-scan and CCD cameras

  • Auto-focusing and image reconstruction

  • Physics of motion, temperature flow analysis 

 

Electronics enables function.  Embedded computers, analog sensors, motor drivers, amplifiers. We've designed these circuits for years.  We get it.

 

  • Electrical system architecture

  • Analog and digital design

  • PCB Layout

  • Embedded microprocessor, microcontroller 

  • CAN Bus and DSP design

  • RF generators, motor control, optical isolation 

  • High voltage power supplies

  • Optics, robotics, sensors and feedback systems

  • Wireless, remote sensing and measurement systems

  • Laser nephelometry, turbidity, colorimetric

  • Spectrophotometer techniques

  • Fluorescent microscopy image capture

  • Photomultiplier and low-light photodiode sensing experience

Fusion Core Processor Module
Custom Application Board
 

Software brings the functions to life.  User intefaces, touchscreen controls, realtime systems, LIS and wireless. We've designed small hand held devices up to floor standing automated diagnostic instruments.  Software always includes embedded test features.  All of our  designs follow FDA design control processes.

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  • Software Design Controls

  • High level applications and embedded firmware 

  • Embedded Software, real-time operating system interfaces, controls, and robust IO Centric subsystems

  • Application Development: embedded Linux, Windows, iOS or AndroidFrom low-level firmware development to sophisticated application and web tools.

  • RTOS’s:  FreeRTOS, SafeRTOS, uC/OS, THreadX, RTX Keil, VxWorks, QNX

  • OS's and Frameworks:  Linux, Windows, Android, iOS, QT, QML, Twisted, Angular JS, jQuery, Polymer,  SQLite, .NET, HTML5

  • Languages:  C,  C++,  C#, Objective-C, Java,  Java Script, Python, HTML,  Swift,  SQL

 

Core IP exists to quickly turn concepts into reality.

  • Drivers and Controls:  Peripheral Drivers, OS porting,

  • Temperature Control, Fluidics, Motor Control

  • Communications:  TCP/IP,  TCP sockets, Web sockets,

  • USB, WIFI, Bluetooth, CANBus, RS232, IEEE448

  • Protocols:  LIMS HL7, ASTM, MODBUS,

  • GPIB SCIP, MQTT, HTTPS, SSL

Fusion Reactor is our prototype software tool that enables

your device to have extraordinary test and connectivity

capabilities. Reactor is designed to provide a gateway into

the hardware running Fusion-Biotec’s core firmware. It was 

developed in Python, which enables you to implement

easy-to-use scripting capability to better test firmware

functionalities. The Reactor exposes everything the

firmware does with the hardware, so that system can be

instrumented, tested, and tuned easily by non-software engineers.

Fusion's Core Firmware is a validated, real-time embedded codebase designed to meet the safety critical needs of medical devices. It is the heart of every firmware project developed by Fusion-Biotec. The embedded core provides the glue between Reactor and the rest of the device firmware. Fusion Core is a combination of pre-developed device drivers, Inter/Intra communication layers, and codebases designed specifically for needs of medical devices.

 

 

 

 

 

 

 

 

 

 

 

 

 

Reactor's user interface includes controls to enable I/O functions, reads sensors and graph data in realtime.  Reactor is Python based and it’s easily configurable to develop customizable python scripts to setup a completely automated regression test system for your device. If your team is not comfortable writing the script, we’ve made an easy user interface to let you build/edit your own scripts in seconds.

The Fusion Core is architected in a way that enables your embedded software to also run on a PC platform (Windows, Linux or MacOS). Running your code on a PC allows you to develop simulators for your embedded target easily. It also enables you to unit test your firmware code which paves the way for implementing continuous integration to streamline your development.

Why is using Reactor important for Device Development?

Designing a system including an embedded piece from scratch can be a time consuming process. Implementing device drivers, communicating between different parts of the system, testing and developing the firmware can take months. The Fusion Core and the Reactor in tandem create a solid foundation to help the development team take a huge leap forward in your device development endeavor.

 

Mechanical systems keep it all together.  From creating a complex robotic instrument or implementing a beautful enclosure, it's all part of the job.

 

  • Electromechanical integration, housings and enclosures

  • Injection molding, sheet metal, thermo-formed components

  • Cast metal design

  • Rapid 3D printed prototyping

  • Plastics tooling design

  • Fluid handling systems

  • Temperature control systems

  • Mechanical design includes motor driven actuators and linkages

  • Plastic components and consumables

  • Product simulation for analysis and optimization

  • Supplier sourcing and management

 

Value Engineering is a corner stone of our design experience and these ideas can be used for new designs as well as a way to extend the life of older products.  Many established companies have legacy instruments, which are still in demand and will be manufactured for the foreseeable future. 

 

If these instruments have:

  • Manufacturing quantities above 200/year

  • High complexity

  • High incidence of complaints

  • Obsolescence issues for components or sub-systems

  • Single-source materials or sub-systems

  • Non-optimized design with high material cost

  • Margins that are too low

  • Difficult supply chain

  • Are difficult to manufacture or service

 

Value Engineering (VE) can provide a solution.  Why is Value Engineering important?

  • Your business is sub-optimized when cost-reduction efforts overwhelm internal R&D resources.

  • During development, often quality and time-to-market are emphasized over cost, resulting in a less-than-optimized product.

  • 20% – 30% cost reductions can often be achieved, depending on the status of the instrument.

  • Rapid technology advances make original methods, technology and components costly or obsolete.

  • Often VE provides additional supply chain cost reduction opportunities.

  • This isn’t a typical activity in most organizations.

The Value Engineering Process

Portfolio Analysis

  • Identify and prioritize top opportunities by business and product

  • Estimate of total opportunity and required resources

Value Engineering Workshop

  • Structured tear down workshop by product 

  • Create project list prioritized for impact and ease of execution

Project Completion

  • Execute design and process changes identified by workshop

  • Track cost savings

Other Services

Fusion Biotec provides more than just engineering outsourcing and support.  Depending on the client’s needs, we also provide systems engineering, design control processes, EMI design and testing, clinical units for system verification and assistance in development of your technical file for FDA submission. 

 

In addition, we have a wide range of talented consultants that provide specific medical device expertise.  Our consultants have experience in medical device and in-vitro diagnostics marketing and communication, FDA and UL regulatory planning and execution, medical device reimbursement assessment and strategies, compliance testing and certification, and medical affairs.

Copyright 2017 Fusion Biotec, Inc.