Minnetronix Medical

Category: Minnetronix Medical

  • Formal System Testing for Medical Devices – Part 2

    Health care researchers working in medical science technology research in a laboratory

    Verification is critical for medical device testing, which is why we recommend reading part one if you haven’t already. In part one of this series, we examined the need for medical testing and briefly covered the first few aspects of device verification. In this article, we’ll cover the verification dry run and the formal verification process that makes new medical products a reality. 

    The Verification Dry Run 

    Once initial prototypes are available, the protocols for medical devices may be run. This dry run is a rehearsal of the verification testing, which evaluates how well the test protocol performs. Dry run testing can also make an initial evaluation of whether medical device requirements have been implemented correctly.

    Dry runs identify issues with the test protocol (i.e., steps that cannot be completed as described) or problems with the design (i.e., features which have not been implemented as described). Identifying and addressing these issues before a formal verification is crucial because correcting them later in the project is more challenging and expensive.

    After completing dry run testing, the protocols are updated with the new findings in mind. The updated verification protocols are reviewed with the appropriate stakeholders before beginning formal verification.

    Minnetronix strongly advocates for dry run testing within a project’s schedule. The additional investment is well worth it because dry runs identify issues before design completion.

    Executing Formal Verification

    Formal verification testing can begin once the verification protocols are written, reviewed, released—and a final prototype is available. If the test protocols were comprehensively dry run before formal testing, little new information should surface. However, it is always possible that further issues may arise. These issues can be addressed in various ways, utilizing your team’s expertise.

    Any design changes that occur after formal verification (including changes made to address test failures) may require regression testing. Regression tests evaluate design changes and assess their impact throughout the requirements, design, and verification stages. These design changes may be limited in scope—requiring only a handful of tests to be redone. As an alternative, they may impact enough of the design that it is necessary to re-execute the entire suite of tests.

    The outcome of the verification phase is a set of documents outlining the final version of the requirements, along with reports showing that either the requirements were met or not met. If some requirements are not met, the documents will include rationales. These rationales explain why some conditions weren’t met and why the failure to meet those conditions is acceptable. 

    The Medical Device Development Process

    Verification is an essential phase in the medical device development process because it can positively impact the project and provide necessary information for regulatory submission.

    Minnetronix seamlessly integrates quality assurance into the medical device development process. Although this can increase the upfront investment, the overall project cost decreases. Factoring in each stage of the process from the beginning helps ensure issues are identified and addressed early rather than at the last minute. This careful practice ultimately saves the customer time and money.

    Our experience in managing formal verification efforts can help ensure a smooth testing effort, resulting in more predictable project costs and timelines. When you need help accelerating your next breakthrough, contact the team at Minnetronix.

  • Formal System Testing for Medical Devices – Part 1

    A health care researcher working in a laboratory

    The medical device development process relies on ‘requirements.’ Every device relies on requirements to dictate its function, but in a partnership between designers and medical device developers, both parties must agree on your device’s prerequisites. This agreement is critical because requirements can drastically impact your product’s schedule, budget, and quality output. After deciding upon the requirements for a medical device, the rest of the development process can begin.  

    The Need for Medical Device Testing

    Medical device testing is crucial at the end of a project to ensure your device meets each requirement adequately. But how do medical device development companies test these requirements at the end of the line? A medical device development company will rely on formal system testing to accomplish this task.

    There are two aspects of medical device testing: verification and validation. Minnetronix focuses on verification—often deferring validation to their customers because they have easier access to system users. In this two-part blog, we’ll cover every aspect of device verification, so you can know how development companies will verify your invention at the end of production.

    What is Device Verification?

    Verification is the process of guaranteeing the design was implemented correctly. This process ensures that the system and subsystem requirements have been met in the design. Verification simply asks the question, “Was the product developed correctly?”

    Properly executed verification can positively impact the project outcome and provide necessary information for regulatory submissions. Before this aspect of the medical device testing process can begin, preparation must occur.

    Preparation for Verification

    Verification test preparation should begin early in the development process, with test engineers at the table throughout the development process. Ensuring the project is testable, verifiable, and that the protocol is appropriately designed is vital. There are a plethora of reasons for each of those characteristics.

    • Testability – As requirements are documented, a quick check for testability involves asking, ‘How will this requirement be tested?’ This check helps to refine the criteria and makes them easier to understand. 
    • Verifiable – One characteristic of adequate requirements is that they are verifiable. This term means requirements can be quantitatively evaluated for implementation. The test protocols provide the step-by-step instructions to complete this quantitative evaluation and the acceptance criteria, which show if the requirement is met.
    • Protocol Design – Each protocol may verify more than one requirement. It generally makes sense to group related requirements in the same protocol. Effective protocol design also relies on traceability. Test protocols should be traced from the requirements which they verify. Setting up traceability early can track the impact of requirements changes.

    Minnetronix creates the design and test protocols in a highly collaborative environment. The Minnetronix verification team is involved in requirements reviews to ensure they are testable and verifiable from the beginning. The group begins to write test protocols once appropriate stakeholders have agreed to the requirements and an initial architecture has been defined.

    The design team and the quality engineers work closely during the development effort to ensure appropriate testability. By starting work on the protocols as soon as possible, issues such as holes, conflicts, and redundancies of requirements can be easily identified and addressed early. Correcting problems as early as possible lessens the impact of project costs and timelines.

    Minnetronix works with you to set requirements and facilitate the device verification process. In part two, we’ll cover the initial dry run and the formal verification process of your medical device. Find out how we accelerate breakthroughs by visiting our page. Contact us to bring your product to fruition and help clinicians and their patients. 

  • Minnetronix Medical Quality Leader Awarded Prestigious Technology Recognition

    SAINT PAUL, MINN. (November 17, 2021) – Minnetronix Medical, Inc. a leading medical technology and operations partner to global medical device companies, today announced that Rachael Kuntz has been recognized with a 2021 TEKNE Rising Star Award. The TEKNE is presented by the Minnesota Technology Association (MnTech) and recognizes the top technology companies, products, and leaders in Minnesota.

    Kuntz is senior quality assurance manager at Minnetronix, where she leads a team of 23 professionals. Under her leadership, Kuntz has taken a transformative approach to quality systems at Minnetronix, integrating multiple quality departments into one unified team. Kuntz is a hands-on and forward-thinking leader, investing in her team’s development and serving as a model for the company’s future leaders.

    “This award, for Rising Stars, is truly fitting for Rachael,” said Jeremy Maniak, CEO of Minnetronix Medical. “She’s an excellent example of the type of leader who is driving our extraordinary growth, as she is deeply committed to adding value for our customers.”

    “I am honored to receive this award, and I’d like to thank my team for being such an integral part of this achievement,” said Kuntz.

    About Minnetronix Medical
    Since 1996, Minnetronix Medical has accelerated medical device breakthroughs as a design, development and manufacturing partner to leading device companies around the world. Today, through life-cycle efficiency, opportunity realization, and increased utility, the organization is creating value in key technology segments, including RF energy, fluid and gas management, optical systems, and stimulation and active wearables. From design and manufacturing services to whole product solutions, Minnetronix brings expansive industry insight and intentional technical acumen, delivering better medical devices to market, faster. Minnetronix is based in St. Paul, Minnesota. More information can be found on the Minnetronix website, by calling 651-917-4060 or emailing info@minnetronixneuro.com.

  • The Pitfalls of Medical Device Design: Beginning and End, but No Middle

    Technical professionals assemble part to repair computer motherboard and processor. Top view.

     

    The task of creating safe and reliable medical devices is the primary responsibility of medical device designers. Using good judgment to assess technology, evaluate consumer needs, and execute the design and development of the device is critical throughout the lifecycle of production.

     

    Integrating usability throughout the design life cycle can greatly facilitate a favorable result, leading to a safer device and better patient outcomes. Throughout this series of articles, we have discussed the most common pitfalls of medical product design, including design follow-through and late-stage design changes. In the last installment of this series, we will discuss the often-overlooked period of production: the middle.

     

    While usability is considered and thoroughly tested at the development and launch of a new product, a common mishap of some medical device developers is to consider the beginning and the end of production, but not the middle.

    Medical device usability pitfalls: neglecting the middle stages of production

    The usability of a new medical device is thoroughly considered during the device’s early conception, then rigorously tested after final validation. However, the middle of the device’s development is where mistakes might take place.

    Occasionally, one firm is hired for the device’s initial design while a separate firm is engaged toward the end for usability testing. When this is the case, a well-coordinated hand-off does not always occur between the two firms. The testers are forced to re-accumulate background knowledge and potentially repeat work. Both the designers and testers may even be required to start from scratch, leading to wasted effort on both accounts.

    Another common scenario, particularly for smaller firms, is when usability is involved throughout, but it is being performed by a separate contract design firm. The outside vendor may not be fully integrated into internal requirements, FMECA, or other verification techniques. This disconnect often results in reduced efficiency and higher overall costs.

    The benefits of an integrated approach

    To help reduce or eliminate project neglect once the beginning stages are complete, Minnetronix Medical chooses to adopt an integrated approach to device development. The pursuit of such an integrated, user-centered design approach throughout all phases of the design life cycle has many valuable benefits, including:

    • Improved product functionality and patient safety: Errors and field failures can be minimized due to careful testing of the designs.
    • Improved efficiency: Necessary changes are made during the life cycle at the appropriate time.
    • Reduced costs: Numerous expenses can be avoided, including the costs of lost productivity, ill-timed design changes, implementation challenges, etc.
    • Smoother regulatory pathways: Regulatory agencies can see the clear path from user needs to testing.
    • Increased speed to market: The use of an integrative rather than a piecemeal process can expedite successful project completion and product commercialization.
    • Higher user satisfaction and market acceptance: Customers are provided with well-designed, easy-to-use, safe products.

    By incorporating user-centered design at numerous touchpoints during product development, Minnetronix strives to reduce business and development risk for our clients. Multiple touchpoints also reduce the lag at the center of a project and eliminate duplicate work, delayed delivery, and other costly issues.

    We understand that medical devices are scrutinized by regulatory agencies to levels far beyond consumer products. This adds significant requirements that affect both development efforts and product costs. With increasing healthcare pricing pressures, the need to meet the demand for innovative, higher-tech medical devices becomes even more challenging.

    At Minnetronix, we offer full lifestyle solutions that offer our clients expertise across the lifecycle of a device’s development¬—not just at the beginning and the end. From development through commercialization, our expertise and technology-specific processes get your device to market faster, all without sacrificing quality. Contact Minnetronix Medical to learn more.

  • The Pitfalls of Medical Device Design: Late-Stage Design Changes

    A close-up image of a technician’s hand as they place a processor in CPU socket on the motherboard of a computer or piece of tech

     

    Creating medical devices that are safe and reliable is the primary responsibility of a medical device designer. They must assess technology, customer wants and needs, and the completeness of the execution of designs and processes.

     

    Numerous challenges can arise if usability is not considered throughout the process from early conception to final validation. One common issue that might arise in the production of a medical device is late-stage design changes.

     

    Changes to a device’s design after production begins is another of the most common pitfalls of medical device design. In the first installment of this blog series, we discussed the lack of design follow-through. In this second look, we will take a moment to discuss the late-stage design changes, potential delays and added costs that might develop.

    Roadblocks in medical device design: late-stage design changes

    When developing a new medical device and preparing to bring it to market, companies may not consider users at the beginning of the project. They may find themselves beginning the production with one path in mind, only to attempt to adapt the design in the later phases when alpha or beta prototypes are tested by users.

    This can be one of the most difficult pitfalls to prevent in a design process. Engineering teams often insist early on that they know what users want, only to be proven wrong by user feedback later in the process.

    Increasing expenses as the project progresses
    Identifying a need that requires a design change early in the development process is all but free to the developer and the client. As the project begins, there is no incremental NRE cost because identifying changes and alterations is what those phases are designed to accomplish.

    Identifying that same need later in the project requires re-working elements that have already been established. This represents going backwards, re-spending money and extending the end of the project, which eats into the ROI and the NPV of the overall program.

    Backfilling usability data
    Another issue in identifying potential issues early on is the idea of backfilling usability data. To meet technical standard requirements, companies may try to backfill usability efforts at the end of a project. These last-minute additions are done only to pass product standards and there is no time or intent to make meaningful changes if issues are discovered.

    Sometimes, these efforts are even conducted after the release of the product, when real-world issues have already been identified and have taken place. To prevent late-stage changes and unhelpful backfilling, proper diligence must be adhered to throughout the design and production of a medical device. User research, application analysis, and further testing must continually take place.

    The Minnetronix approach to medical product design

    Minnetronix has developed a robust approach to the integration of usability. At each stage in the design life cycle, a focus on usability is a key component of the evolution of product design. This helps our design team identify adjustments early on and prevent changes later in the development of the product.

    1. User Research: Define our user groups – how, where, and when they will use the device, what tasks they perform, and what their core needs are. Information is gathered from stakeholder knowledge, research into predicate devices, and field observations of users working with similar systems.
    2. Application Specification: User research is compiled into an Application Specification. This includes a description of the users, user environment, and basic workflow. It is also where user needs are defined.
    3. Task Analysis: A Task Analysis document includes a breakdown of user tasks and associated risks which feed into every element of the user interface design and evaluation process.
    4. UFMEA: User needs and task-associated risks from the Application Specification inform the writing of a Use Error FMECA.
    5. Design Concepts and Prototypes: Concepts for the device design are vetted against the knowledge summarized in the application specification. Prototypes of the system are generated to be evaluated by representative users.
    6. Formative Testing: The task analysis is used to generate formative test procedures. Formative testing is performed with representative users on early prototypes or alpha versions of the devices.
    7. Concept Finalization and Design Specifications: As the design is finalized, knowledge gained from formative testing is used to refine the device. Gathered feedback, user needs, task analysis, and the Use Error FMECA inform the writing of usability requirements and a User Interface Design Document.
    8. Summative (Usability Validation) Testing: When finalized devices become available, the last step is summative testing. A protocol is written based on tasks defined in the Task Analysis. The risk associated with various tasks in the use error FMECA determines pass/fail criteria. A submission quality Summative report is generated which describes the entire usability process and the final evaluation.

    During the entire design process, we seek to find opportunities to save steps and take leaps. This helps us prevent issues further down the road, preventing delayed launches and costly setbacks. Our strategic foresight and the proactive approach we apply to each project come from decades of experience in medical device design.

    We can help your company uncover inefficiencies, discover new and bigger potential, and increase the impact of your technology. Contact Minnetronix Medical to learn more.