MEDICAL THE LIFEBLOOD OF YOUR DEVICE. Software Design Capabilities

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1 MEDICAL THE LIFEBLOOD OF YOUR DEVICE Software Design Capabilities

2 Holistic, Flexible Software Engineering Services Every project is different, but our mindset is consistent. Our experienced project managers and software engineers take a comprehensive, customer-centric approach to get your product to market quickly and efficiently. Our flexible process allows us to partner from initial prototyping to completed product for manufacturing, or target our expertise to key areas of your development life cycle. Our regulatory knowledge in specialized industries, such as medical and military/aerospace, enable us to effectively create solutions that meet regulatory requirements and bring your project to life. Whether you re a sizable OEM looking to extend the life of an existing product or a new business ready to bring the next innovation to the world, Sparton has the software development and testing capabilities to meet your needs. Phase Model DEFINITION & FEASIBILTY DEVELOPMENT & PROTOTYPING VERIFICATION & VALIDATION TRANSITION TO MANUFACTURING Quality Underlies our Execution Use of a Software Development Life Cycle (SDLC) model that fits the project (e.g., waterfall, iterative, agile). Development processes refined using industry standards, best practices and decades of experience with a variety of customers. Project management and tracking throughout the project execution. Develop the product for ease of maintainability, a long product life, and potentially support future product direction. Verification activities performed throughout the development life cycle. Use of automated testing to augment the manual testing both of which are fully documented. Generation of appropriate and compliant design outputs to document activities. 2

3 Software Development Life Cycle (SDLC) Model Early Mockup Regulatory Strategy Technical Feasibility Models Increased Functionality Release Parts Obsolescence Release Customer Feedback Release Remote Management Release Cybersecurity Monitoring Project Plans Initial User Interface Product & Software Requirements Software Release Manufacturing Acceptance Test Risk Mitigation Integrated System Initial Prototypes Performance Parameters Verification Reports Validation Reports User Manuals Eliminate Software Design Challenges Electromechanical devices are often the most challenging to design and manufacture with those challenges growing as component capability increases. With our proven record of developing complex electromechanical devices, diverse depth of software skills and strong customer relationships, Sparton can accelerate achieving your product goals. A myriad of tough challenges can compromise product viability and quality right out of the gate. Leveraging our 35+ years of software development and testing experience across more than 36 applications and domains, Sparton s Software Center of Excellence provides endto-end services, applying mature processes that clear away the complexity and challenges. Our engineers immerse themselves in your vision, plan their activities, work as a multidisciplinary team, and apply their expertise with the latest functional components (e.g., sensors, motors, fluidics, lasers, optics) and latest software technology (e.g., frameworks, algorithms, imaging, remote management, IoT, robotics, cybersecurity) to achieve your product commercialization. 3

4 Sparton Software Design Technology In today s marketplace, communication between devices and platforms is essential. Depending on the products composition, the software may reside within the device itself or include a smartphone app, the cloud, or interaction with other systems to perform its intended function covering the Internet of Things (IoT). Sparton is proficient and flexible enough to develop software for any connectivity modality including integral cybersecurity concerns. Web App FPGA Cloud Embedded Firmware Smartphone App Other Systems Depth of Experience Across the Medical Device Industry In Vitro Diagnostic Analyzer Cancer Diagnostics Medical Imaging Ophthalmic Device Sterilization System Dialysis Treatment Ultrasound-guided Biopsy Home Medication Dispenser Infusion Pump Patient Monitoring System RF Ablation Device Botox Injection Fetal Monitor Urinary Incontinence Diagnosis Cognitive Assessment Clinical Trials System Glucose Monitoring Device Surgical Sponge Management Asthma Management System Sound Therapy Platform Point-of-Care Cell Therapy Dosimetry and QA System Blood Gas and Electrolyte Analyzer Cell Isolation System The expertise we have developed over years of creating medical device software translates to other industries using similar technologies including: Military, Aerospace, Industrial, and Commercial. The above is a sampling of our capabilities, contact your local sales representative to discuss your specific project requirements. 4

5 IoT Medical Device Development Case Study Medical Device Startup Services Provided: Developed entire system including sensors, embedded firmware, mobile application, and cloud development Leveraged REST API and web services in development Created secure, HIPAA-compliant database to save and view patient training records Developed novel positioning and scoring algorithm Key Challenges: Product was for the home healthcare market requiring ease of use and product robustness A small compact size was required for all electronics FDA 510(k) approval for mobile application before the agency provided guidance on medical applications. End Result: Sparton s knowledge and expertise in compact electronics and app integration proved to be a winning combination for the customer. Additionally, Sparton s design to manufacturing services provided a complete turnkey solution from a single vendor. Sustaining engineering services are being provided along with manufacturing. Fully Automated Diagnostic Device Case Study POC Diagnostic Manufacturer Services Provided: Full system development for a point-of-care hand-held diagnostic device Developed FPGA Verilog code for Xilinx SoC Developed real-time software for multi-core ARM processor using OTS embedded operating system Created core control and safety functions for product Supported custom, on-demand assay script development Key Challenges: Complex challenges in system design, compact electronics and app integration Requirements for wireless WiFi and Bluetooth connectivity End Result: Sparton helped the customer conquer complexity by using innovation in development, through a deep understanding of their needs and from expertise in complex electro-mechanical systems with FPGA and embedded software. Additionally, Sparton s capabilities from design into full-scale manufacturing provided a long-term success. 5

6 Partner with Sparton and Capture the Market At Sparton, we go beyond producing functional, reliable software by working with your team to create a competitive advantage for your product. New Product Launch Support Our skill-set supports your new product launch by reducing time to market while mitigating risk. By eliminating design challenges and reducing complexity we enable a quicker product launch. Our regulatory process knowledge and experience streamlines the development process and generates compliant documentation that facilitates attaining regulatory approval. In today s market, interfacing other devices/systems is essential. Our knowledge of communication standards accelerates the development timeline. Outsourcing your software development allows you to focus on your core intellectual property (IP) and other product launch needs. Use of highly skilled engineers and team-size scaling allows you to operate with a leaner, more efficient organization. We ll perform a compliance gap analysis to uncover any potential pitfalls, avoiding regulatory concerns and costly rework. 6

7 New Product Launch Case Study Cognitive Assessment Device Manufacturer Services Provided: Developed commercialized product software for computerized office-based cognitive assessment Completed product verification and provided guidance for product validation Created and continually updated the Design History File (DHF) during development Provided regulatory strategy and guidance during the FDA submission process Key Challenges: No predicate device existed for 510(k) submission leading to de novo 510(k) submission Confirmation of product results to match current paper-based standardized tests Refinement of algorithms for increased correlation to a broader set of patients Create the complete DHF as no historical information from initial prototyping effort was available at project start End Result: Sparton s design team provided the design controls, product software, and regulatory guidance to take an initial prototype to a commercial product. This product was the first computerized cognitive assessment device presented to the FDA. After numerous exchanges about the safety and effectiveness of the product, the FDA signed into law a new regulatory class titled Computerized Cognitive Assessment Aid ( ). Going forward, future cognitive products will have a much easier means to gain FDA approval. 7

8 Mitigate Risks Sparton s Design Center of Excellence aids in reducing the uncertainty that every product on the market faces through the following attributes By use of our established ISO certified and FDA compliant QMS processes and best practices developed from our broad product experience. Development of a scalable, modular architecture to support unforeseen changes, future needs, and potentially a family of products. Our exceptional project management team completes projects on-time and on-budget providing regular communication to keep you informed. Adherence to regulatory guidelines, ISO, safety, and related standards to streamline submission, approval, and future auditing needs. Being part of a manufacturing organization with a proven track record enables us to take a holistic approach to your software development needs from concept to final product. Standards and Regulatory Guidance Experience Process Technical Safety ISO 9001 HIPAA IEC ISO HL7 IEC ISO DICOM Device Classification IEC NCCLS LIS1, LIS2 Software Safety Classification 21 CFR Part 11 CLSI POCT 21 CFR Part 820 (QSR) CLSI AUTO IEEE

9 Product Verification Case Study Leading Infusion Pump Manufacturer Services Provided: Created software test procedures using current requirements Participated in test procedure review and approvals Executed verification and validation test protocols recording results Supported problem reports, regression testing, engineering discussions and risk assessments Generated and discussed software test summary reports Key Challenges: Over 1,000 small product changes (ECOs) over many years resulted in the product being substantially different than the originally approved device. This resulted in a product stop ship order from the FDA leading to lost revenue until equivalence was demonstrated Current DHF documentation was many years out-of-date and noncompliant to the latest regulatory guidelines Provided sufficient evidence in the updated DHF to the FDA to meet regulatory review/approval resulting in a return to product manufacturing End Result: Sparton s quality and test engineers were able to create sufficient evidence to demonstrate equivalence and confirm product functionality and performance. Their efforts reduced the project timeline by over 3 months, which enabled them to return the product to manufacturing and generate revenue for this product in less than 1 year. 9

10 Extend the Longevity of Your Existing Product Our veteran engineers will design your software with a mindset that supports future product direction and enhances sustainability. Expand your product s geographic reach by enhancing the software user interface and other market preferences. Rework existing designs to add enhancements and functionality that puts you ahead of your competition. Reduce the need for product alterations by proactively addressing parts obsolescence issues as well as efficiently supporting a change when required. Create documentation that conforms to shifting regulatory guidelines and standards. Modify the software to support customer feedback and concerns pertaining to the product. Sustaining Engineering Support Case Study Leading IVD Manufacturer Services Provided: Ongoing sustaining engineering effort to significantly extend the life of product Developed software modifications for component changes due to parts obsolescence Created remote connectivity for 2-way communication and real-time alerts Developed additional languages for the user interface to support other countries and increased product throughput Provided verification and validation activity to confirm product functionality and performance while maintaining regulatory compliance Key Challenges: The product was not originally designed by Sparton, so limited historical information was available resulting in a number of questions about the product. Support client s strong desire to maintain precision and accuracy of product given many component and consumables changes Provide support for off-the-shelf software included in the product. This was necessary as the original manufacturer stopped providing updates and bug fixes to users. Given limited information from customers at the onset, numerous sites needed to be contacted to get sufficient data to address the issues raised End Result: This 10-year old product has been extended for another 20 years resulting in a stable population of units generating ongoing revenue from consumables. This worldwide product is one of the most successful products from a business perspective. The product s Remote Management capability providing improved product uptime and faster field service, which created industry recognition regarding product service that is a strong differentiator against their competition. This has led to stronger brand recognition and customer loyalty. 10

11 Product Modernization Case Study Leading Women s Health Device Manufacturer Services Provided: Updated product software to support hardware changes and functionality additions including availability on a broader set of acceptable computers Created and executed software test procedures to confirm requirements and final product performance of software release Enhanced DICOM communication feeds for improved image classification information to the user Provided support for the latest billing codes within the product for more accurate billing and less manual intervention Supported sale of the product to new customers by addressing their detailed questions regarding networking and security features of the product Enhanced design control documentation after performing a gap analysis on DHF for each product Provide integration services for key users of client s products Key Challenges: The product was not originally designed by Sparton, so limited historical information was available resulting in a number of questions about the product Need to resolve configuration management issues to establish each product s software baseline DHF documentation was missing and current documents did not address the latest regulatory guidelines End Result: Sparton has undertaken the sustaining engineering effort for all products that contain a significant amount of software. Sparton s broader knowledge and experience resulted in an over 1.5 FTE cost savings as well as improved customer service for these products. 11

12 CORPORATE OFFICE 425 N. Martingale Road, Suite 1000 Schaumburg, IL SOFTWARE DESIGN CENTERS OF EXCELLENCE 160 Office Park Way Pittsford, NY Kelvin Ave, Suite 100 Irvine, CA th Avenue N, Suite 500 Plymouth, MN Lunn Road Strongsville, OH ABOUT SPARTON CORPORATION Sparton Corporation is a provider of complex and sophisticated electromechanical devices with capabilities that include concept development, industrial design, design and manufacturing engineering, production, distribution, field service and refurbishment. The primary markets served are Medical & Biotechnology, Military & Aerospace and Industrial & Commercial. Headquartered in Schaumburg, Illinois, Sparton currently has thirteen manufacturing locations and engineering design centers worldwide. MDS-BRO-Software