Design & Engineering

We are experts in designing electronic and electromechanical systems for performance, reliability, and regulatory compliance.

Explore the Minnetronix Development Approach

Wherever you are in your medical device lifecycle, Minnetronix’ approach can help you achieve your development, manufacturing, clinical, and business goals.

Software, Electronic and Mechanical Design Expertise Across a Wide Range of Medical Applications

With a singular focus on medical applications, our software, mechanical and electrical engineers develop state-of-the-art technology and products. Our long history in electromechanical medical devices has given our teams specialized skills and abilities that we apply to each project from small implantable devices to large-scale integrated instruments and systems.

Systems Engineering and Integration Expertise

Minnetronix uses a systems approach to the analysis and design of medical technologies that demonstrates both control and agility. Our unique systems-based process and effective program management allow us to tackle and resolve particularly complex systems challenges. We deliver intelligent, practical solutions from design through build, while appropriately balancing cost and complexity. The Minnetronix development process assures that the needs for performance, speed-to-market, and cost-effectiveness are met.

Expert-Level Compliance with Medical Device Requirements

Minnetronix’ engineers are focused on the commercialization of software, mechanical and electronics-based medical devices, primarily Class II and Class III products. Our processes are specifically designed to meet FDA and ISO requirements for design and production controls. Minnetronix is FDA-registered with a full quality management system in place and a track record of seven consecutive FDA inspections resulting in No Action Indicated, the most favorable possible outcome.

All of the products we design and build are subject to international product safety requirements for medical devices. Our engineering team has expertise in EN 60601-1 as well as the associated collateral and particular standards. We have successfully guided dozens of products through compliance testing and registration with safety agencies including UL, TUV, Intertek, CSA and others.

Assess and Evaluate

Medical device development at Minnetronix can start at different stages, based on your program’s status at project initiation. The first step is to assess and evaluate the precise state of development for your medical technology and work with you to determine the best next steps to meet your development, manufacturing, and business goals. Factors include:

  • Current technology assessment
  • Concept, and therapy cost evaluation
  • Clinical and client business goal identification
  • Roles and responsibilities definition

Plan and Define Experience Matters

The initial assessment and evaluation is used as a baseline to further plan and define your specific project. Our program planning leverages Minnetronix’ deep design, development, and manufacturing experience for complex medical devices. We are experts in designing electronic and electromechanical systems for performance, reliability, and regulatory compliance. The result is a comprehensive planning process that adds value and clarity to meet your development and business goals.

Early Research, Development, and Testing

Early research, functional prototype development, and testing help to verify the potential effectiveness of a treatment platform and generate a preliminary assessment of development tasks and costs.

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Early research, functional prototype development, and testing help to verify the potential effectiveness of a treatment platform and generate a preliminary assessment of development tasks and costs. This provides an informed measure of the requirements needed to reach a successful commercialization. Goals of early development include:

  • Testing of existing technology platform
  • Identifying possible development gaps
  • Generating technological project needs
  • Conducting initial cost analyses (development and manufacturing)

Requirements Definition

Device requirements are an important tool used to create detailed descriptions of device functions. These requirements drive all aspects of the device design. Minnetronix works closely with you to identify and precisely describe all of the requirements that will define a successful device for you and your end users.

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Device requirements are an important tool used to create detailed descriptions of device functions. These requirements drive all aspects of the device design. Minnetronix works closely with you to identify and precisely describe all of the requirements that will define a successful device for you and your end users. Key requirements definitional elements include, (but are not restricted to):

  • Functional device system requirements
  • Usability and graphical user interface (GUI) requirements
  • Potential clinical risks: factors identification and mitigation

The System Development Plan

This System Development Plan, created in collaboration with you, uses the outputs from the Requirements Definition Phase as a baseline.  This plan acts as the guiding document for all program activity.

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This System Development Plan, created in collaboration with you, uses the outputs from the Requirements Definition Phase as a baseline.  This plan acts as the guiding document for all program activity. The System Development Plan includes:

  • Comprehensive device requirements
  • Approval strategy (510k, PMA, other)
  • FDA/ISO compliance factors
  • Customer business requirements (timeline and key milestones)
  • Testing plan
  • Estimated program costing and planning
  • Forecasted device manufacturing costs
  • Working program timelines
  • Initial program risk analysis (timing, cost, approval factors)

The defined stages and timing outlined in the System Development Plan assist in effectively managing and providing the specified deliverables.  This ensures appropriate assignment of roles, tasks, and project milestones.  It also identifies priorities and fosters active customer engagement throughout the project.

In addition, the System Development Plan establishes refined estimates of program cost, which are vital to generate project budgets and set shared goals for deliverables throughout the program.

Design, Develop, and Integrate A Clear Path Forward

Our proven development approach leverages our medical device engineering, manufacturing, and quality knowledge to bring your medical devices to market in a timely matter. Our team works with your team to successfully generate designs that are highly functional, reliable, and meet all of your device requirements.

Initial Design and Development

During initial design and development, Minnetronix’ engineering teams generate hardware, software, electrical, and electromechanical models for evaluation and testing. These functional models are typically an open, “fillet” version of the proposed hardware with internal components accessible and exposed.

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During initial design and development, Minnetronix’ engineering teams generate hardware, software, electrical, and electromechanical models for evaluation and testing. These functional models are typically an open, “fillet” version of the proposed hardware with internal components accessible and exposed.

Functional models are used to reduce project risk and support both hardware and software development. Additionally, the working models prove out principles of the device to ensure requirements can be met.

Systems Integration – Representative Prototypes

Integration of all subsystems is critical to ensure a logical, efficient design that can be validated to meet requirements, verified, and built. Performing detailed systems integration work early on and throughout the design, reduces risk, improves reliability, and potentially helps control component and manufacturing costs.

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Integration of all subsystems is critical to ensure a logical, efficient design that can be validated to meet requirements, verified, and built. Performing detailed systems integration work early on and throughout the design, reduces risk, improves reliability, and potentially helps control component and manufacturing costs.

During Systems Integration, representative prototypes are developed, in the actual device housing and structure. These prototypes are intended to meet all reliability, safety, and manufacturability requirements. Special attention is given to the performance of any connected or disposable components, to ensure they perform as designed and properly integrate with the device.

Although not yet suitable for commercial manufacturing, such prototypes are frequently used as investigational devices in clinical trials, and for regulatory evaluations and clearances.

Program Tracking and Documentation

The program tracking and documentation phase captures key aspects of the development process in a systemized, collected body of records.

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The program tracking and documentation phase captures key aspects of the development process in a systemized, collected body of records. Our rigorous System Development Plan and world class documentation and quality systems provide many benefits, including:

  • A device design that meets all established requirements
  • Prototypes with documentation to serve clinical study and/or regulatory evaluation requirements
  • A clear path for transfer into manufacturing
  • Compliance with regulatory and quality standards at every stage of development

Vital Link, our proprietary customer portal for the Minnetronix Electronic Data System, is a sophisticated, web-based system that allows customer access to the electronic records such as the design history file (DHF) and the Device Master Record (DMR) for specific projects.

Learn More About Vital Link

Pre-Manufacturing Builds, Verification and Testing A Focus on Requirements

Pre-manufacturing or ‘pilot’ builds help to demonstrate that the device design does what it is intended to do, meets all design and regulatory requirements, and is ready to move to a manufacturing environment. Minnetronix’ rigorous verification and testing methodology guides the process for pre-manufacturing builds.

Pre-Manufacturing Builds

Once all device requirements have been met in the design phase, small pre-verification builds are completed. These fully functional devices can potentially be used in additional clinical trials or for final regulatory reviews.

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Once all device requirements have been met in the design phase, small pre-verification builds are completed. These fully functional devices can potentially be used in additional clinical trials or for final regulatory reviews. Devices at this stage are carefully evaluated and documented until the final design is approved for formal testing.

Collaborative reviews and approval processes ensure that the design meets all regulatory requirements and that a complete design history file exists.

Verification

Formal Design Verification Testing (DVT) of the design is the final step before moving a device into manufacturing.

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Formal Design Verification Testing (DVT) of the design is the final step before moving a device into manufacturing. DVT includes:

  • Functional performance against the design requirements
  • Safety compliance per the design requirements and industry standards
  • Review and completion of all documentation prior to manufacturing transfer

Testing Resources

Comprehensive testing includes safety, environmental, EMI, and functional verifications. This ensures that the device meets all established industry, scientific, and regulatory standards to pass the Design Verification Testing.

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Comprehensive testing includes safety, environmental, EMI, and functional verifications. This ensures that the device meets all established industry, scientific, and regulatory standards to pass the Design Verification Testing.

Most testing is done in-house at Minnetronix; however, some specialized test procedures are coordinated with an accredited or certified laboratory when required. If an outside facility is used for testing, Minnetronix works with the customer to select the appropriate facility from our list of qualified testing vendors. This ensures compliance to our Quality Management System requirements.

Manufacturing Transfer and Production Seamless Transitions and Quality Builds

Minnetronix manufactures most of the devices we design for our clients. Our development approach includes early involvement of Minnetronix’ manufacturing team in order to ensure a smooth transition into the production environment.

Manufacturing Transfer

Upon completion of all Design Verification Testing and regulatory approvals, the design is ready to move to commercial production. All of Minnetronix’ manufacturing occurs at the company’s campus in St. Paul, Minnesota.

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Upon completion of all Design Verification Testing and regulatory approvals, the design is ready to move to commercial production. All of Minnetronix’ manufacturing occurs at the company’s campus in St. Paul, Minnesota.

Minnetronix’ System Development Plan leverages our extensive experience commercializing device designs to seamlessly bring your design into a production environment. Our manufacturing engineering, supply chain, and quality teams work with the development group at all key stages of development. This helps assure that all materials, assembly procedures, testing processes, and documentation are in place. Coordinated planning between design and production generates positive results. Examples include:

  • Early coordination between design engineering and manufacturing ensures Design for Manufacturability and a smooth transfer to production. This reduces cost and avoids lost time.
  • Coordinated supply chain planning can reduce cost and ensure component availability

Production

Minnetronix’ manufacturing operations are structured for responsiveness, scalability, and application of lean production practices.

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Minnetronix’ manufacturing operations are structured for responsiveness, scalability, and application of lean production practices.

Our configurable manufacturing cell model is immediately apparent on our assembly floor, with well-organized production cell designs.

Design personnel are co-located with our manufacturing team, facilitating ongoing support.

Supply Chain Management

Minnetronix’ experienced supply chain team sources components, aggressively negotiates costs, and works with our supplier quality team to actively manage our vendor base. Comprehensive inventory systems and management help ensure all components are ordered, received, and in stock when the next production run is scheduled.

Service, Maintenance, and Total Product Management Optimizing Device Value

Minnetronix’ medical device support does not stop at manufacturing. In addition to repair and depot service needs, some devices frequently undergo software updates, require periodic service, or may have revisions driven by component obsolescence or iterative functional updates over time. Our engineering and manufacturing teams work together, providing comprehensive service, maintenance, and total product management.

Service and Maintenance

Minnetronix provides full service and repair support to keep devices functioning optimally. Our knowledge and understanding of every element of the device design, documentation, design history, and assembly gives our service team the background and technical foundation needed for efficient and responsive depot service and maintenance.

Total Product Management

Through our collaborative approach, we help you identify and mitigate post-market product performance issues, providing you with actionable analytics, insights, and solution recommendations for your current devices, and enhancements for your next-generation designs.

Continuation Engineering and Next-Generation Development Making the Future a Successful Reality

Devices often require design updates over time. Minnetronix’ continuation engineering services help keep your current devices up-to-date and performing in the field. We can also assist you with expert evaluation, research, and planning to drive your next-generation device development.

Continuation Engineering

Minnetronix’ continuation engineering services ensure devices remain up-to-date and operating to meet your goals.

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Continuation engineering activities include but are not limited to:

  • Component obsolescence replacement
  • Iterative device revisions
  • Software updates and subsequent systems integration
  • Product performance updates
  • Response to changes in regulatory, industry or other market requirements

Next-Generation Development

Many Minnetronix customers engage with us at the earliest stages of new or next-generation product development.

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Many Minnetronix customers engage with us at the earliest stages of new or next-generation product development. Our shared technical experience and design history help to drive new device development, including:

  • Emerging requirements identification
  • Previous generation functional analysis
  • New technology advances
  • New features/functions
  • Current market preferences/requirements
  • Regulatory environment and strategy
  • Obsolescence, replacement, and/or service continuation strategy

We employ our deep engineering experience, technical knowledge, quality systems, and manufacturing capabilities to help you meet the clinical objectives and business goals of your next-generation device program.