MEDICAL FROM TO FINISH. Product Design Capabilities

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1 MEDICAL FROM THOUGHT TO FINISH Product Design Capabilities

2 About Sparton Corporation Sparton has become the partner of choice for companies that want to design and manufacture the most complex electronic and electromechanical devices. We have proven ourselves to be engineering and production experts, as well as responsive, client-focused partners. Our services include everything from next generation product enhancements to complex system assembly, at facilities worldwide. The unparalleled experience and expertise we have amassed over the years ensures that we consistently meet and exceed our customers expectations. INDUSTRIES Medical and Biotechnology Military and Aerospace Industrial and Commercial EXPERIENCE Founded in 1900 GLOBAL ORGANIZATION Over 1,700 Employees Worldwide LOCATIONS 13 Locations (12 in North America and 1 in Viet Nam) PUBLICLY TRADED Listed on NYSE since 1929, ticker symbol SPA 2

3 Product Design Specialists Whether on a napkin, or in a documented presentation package, our product design engineers can transform your concept into a tangible, fully-functional, marketable reality. With experienced engineers schooled in software, mechanical, electrical and systems design, we are capable of bringing almost any concept into existence. In addition to complete programs, we also have the fl exibility to apply our expertise at any point in the project. 3

4 The Sparton Advantage We maintain a nearly 90% retention rate with our design customers primarily due to our history of completing projects on-time and within budget. Our ability to minimize risk, improve capital effi ciency, and reduce time to market are further reasons that our customers return so frequently. Couple those attributes with our direct ties to manufacturing, regulatory knowledge, and depth of experience and we re confi dent that we can be the perfect partner for any situation. So if you re a Fortune 500 company or just placed your idea on a crowdfunding site, we ve got the capabilities to meet your challenging and complex design needs. Product Design by the Numbers 100+ Design engineers 25+ Patents 7 Design awards 4

5 Engineering Capabilities Software & Firmware Engineering Sparton offers comprehensive software design, architecture, coding, development, documentation, verifi cation, and validation services to ensure that your software and fi rmware fulfi ls the specifi ed requirements, complies with FDA (including IEC 62304) and international safety regulations. Development can follow the waterfall methodology or take an agile approach providing short sprints of demonstrable functionality. From requirements and comprehensive test plans to hazard analysis, code reviews, automated testing, compliance audits, and documentation for the design history fi le, we can help you get your product to market. Embedded Software and Firmware Development PCs, microprocessors, micro-controllers and multiprocessing systems Generic I/O Drivers: SPI, I 2 C, UART, CAN, etc. Real-time operating systems Closed-loop control systems Bluetooth, Wi-Fi, RF communications Sensor interfaces Consumables management Application Software Development C/C++/C#, Java, Python, JavaScript, HTML Windows.NET, Linux, Qt Graphical user interfaces Databases Web applications Cloud services Systems interconnectivity Remote device management Mobile Application Software Development ios Android Software Quality Assurance Regulatory & standards compliance Technical writing, design artifacts and documentation Software verifi cation and validation Requirements management and traceability Hazard analysis and risk management Code reviews Test plan development and test case execution Unit test Compliant SOP implementation Design history fi le (DHF) gap analysis and remediation Regulatory submission support 5

6 Electrical Engineering Sparton s comprehensive electronics hardware design capabilities include: digital and analog circuit design, PCB layout/design and programmable logic (FPGA/CPLD) implementation. Proven experience in various technological areas including: Accurate and stable digital RF power control Analog and digital design Closed-loop control systems analysis and synthesis Fluid metering Microcontroller, microprocessor and DSP architectures Various glue logic, buffers and transceivers Motor/Motion control Optics integration Power supplies and battery management systems Pneumatic control Pump control RF power generators for surgery and therapy Robotics Signal conditioning of low-level signals from transducers, and sensors Schematic and Printed Circuit Board Design Sparton utilizes the latest technologies including: Altium Cadence Allegro, Orcad Mentor Graphics Logic, DxDesigner and PADs Valor We are equipped to work with the most challenging layout issues, including: high layer counts, advanced materials, blind, buried, stacked vias as well as 2 mil space and 2 mil trace technologies. Our highly skilled PCB layout team utilizes feedback from our assembly and test operations to ensure that every printed circuit board is a product of real world manufacturing experience. Our PCB layout services consist of: Schematic design PCB layout Design for manufacture Design for test Obsolescence review/resolution Manufacturing process development 6

7 Mechanical Engineering Sparton provides mechanical engineering capabilities for concept exploration, detailed design, and rapid prototyping. We also offer support tooling and packaging design, reliability and life testing, and design for sterilization. System Concept & Design Precision Fluidic Systems Microfl uidic Interfaces Positioning Systems & Robotics Optics Integration Thermal Control Systems Consumables Design Prototyping & Pilot Build Staying on the Cutting Edge Sparton is dedicated to staying ahead of the curve in all disciplines of medical device design. In order to continually produce state of the art products, it is vital that we further enhance our capabilities to include new and emerging technologies. We continue to innovate and provide our clients solutions for today s problems including cloud connectivity, remote device management and the ability to collect data while maintaining patient data and device security. Certifications and Quality Systems ISO ISO 9001 FDA Registered Design of FDA Class I, II and III Devices Apple MFi Microsoft Certifi ed Partner LabVIEW Alliance Partner 7

8 Case Studies Remendium Labs Leva System Remendium Labs is a US-based company that is leading the way in treatment and prevention of pelvic dysfunction. Their mission is to end the epidemic of pelvic dysfunction. Sparton s Services The design center team from Sparton was engaged by Remendium Labs to design a home healthcare device (compliant to ) to map out the female anatomy giving users feedback of their pelvic fl oor position as kegels are performed. The Sparton team provided full system design including electronics, software, mechanical, industrial design, and rapid prototyping from feasibility to production as well as regulatory submissions. Full System Design App interface that can be used with an iphone or ipod Touch Wireless Bluetooth communication between device and Apple products Electronics embedded in USP class VI silicone Secure, HIPAA compliant web database Position and scoring algorithm Key Challenges FDA medical device requiring regulatory approval Expertise in compact electronics and app integration Proven experience in developing compact electronics-based systems for home health usage End Result Sparton s knowledge and expertise in compact electronics and app integration proved to be a winning combination for Remendium Labs. Additionally, Sparton s capabilities all the way through to full scale manufacturing was an attractive fi t for Remendium Labs to continue with one organization that can support them into full commercialization. This device has recently obtained 510(k) clearance. Remendium Labs Treats pelvic dysfunction. 8

9 BioMarker Strategies SnapPath System BioMarker Strategies is a tissue-based cancer diagnostics company that is developing the SnapPath live tumor cell testing system to improve the treatment of cancer. Supported with funding from the National Cancer Institute, the SnapPath system enables the generation of PathMap Functional Signaling Profi les which help guide targeted drug development and treatment selection, including drug combinations. SnapPath units are being utilized in human clinical and preclinical studies for advanced melanoma and other solid tumors. Sparton s Services Biomarker Strategies partnered with the Sparton design and manufacturing teams to develop a system that would standardize and automate biopsy sample preparation and live cell molecular analysis. In addition, the detailed services provided by Sparton include: Full System Design Electronics design Software design Mechanical engineering Fluidics system design Thermal management design Systems engineering Disposable development (partnership) Prototype builds Key Challenges Proven expertise in complex fl uidics Experience in interfacing the disposable with the instrumentation Deep understanding of the FDA regulatory environment Specifi c knowledge in working with in vitro diagnostics devices End Result The SnapPath System has been recognized by various industry experts for its novel technology. In one report, SnapPath is ranked as 1 of 6 promising technologies that will change cancer testing. Sparton is proud to have played a key role in the development of this emerging technology. Product Awards BIOMARKER SnapPath TM Standardizes and automates biopsy samples. 9

10 Neuronetics NeuroStar Neuronetics, Inc. is a privately held medical device company focused on developing non-invasive therapies for psychiatric and neurological disorders using MRI-strength magnetic fi eld pulses. NeuroStar TMS Therapy is an FDA-cleared safe and effective treatment for patients with depression who have not benefi ted from prior antidepressant medication. It works by stimulating areas of the brain that are underactive in patients with severe depression. Sparton s Services Neuronetics partnered with Sparton s design and manufacturing teams to provide comprehensive services to bring the Neurostar product to realization and commercialization. The detailed services provided by Sparton include: Full System Design Electronics design Software design Mechanical engineering Prototype builds Testing Developed full system testing protocols Full scale production Key Challenges FDA Class II medical device requiring regulatory approval Expertise in compact electronics and intuitive software design Proven experience in developing compact electronics-based systems End Result Sparton s design and manufacturing teams provided the right solutions and performed seamless hand-off from design into full scale manufacturing for the NeuroStar product. Sparton s proven expertise across several design and engineering disciplines resulted in a successful device launch for the Neuronetics organization. The NeuroStar has received several industry accolades and continues to grow in use by physicians around the globe. Product Awards NEUROSTAR Helps treat chronic depression. 10

11 In Vitro Diagnostics Instrumentation Sparton has developed software for virtually all of the elements of a highly complex IVD device from precision sample metering, mechanical motion, and instrumentation, to user interfaces, connectivity, and remote diagnostics. Our expertise in in vitro diagnostics, combined with our capabilities in diagnostic imaging, means that we are well positioned to help our clients realize the full range of opportunities associated with targeted medicine and the trend toward providing a complete diagnostic picture. Our broad experience enables us to provide solutions that address the needs of both clinical and radiology labs. Examples of our In Vitro Diagnostics expertise: Integration of new user interface with fl at panel display while increasing time-to-fi rst-result improvement increase of 12%. Developed the operational software for a new multiple-assay clinical laboratory analyzer. Provided software validation and verifi cation for a project that combined two current products into one integrated system, providing both clinical chemistry and multiple immunoassay testing on one platform. Architected a next-generation remote diagnostics system. Produced an Assay Protocol Verifi cation Utility that compares the assay protocols used by several instrument models to the data created when assays are run. Implemented software support for a direct high-density lipoprotein (HDL) chemistry on two of its analyzer platforms. Performed complex analysis of analyzer movements and provided all the software that communicated with a LAS. IN VITRO DIAGNOSTICS Multiple-assay clinical laboratory analyzer 11

12 CORPORATE OFFICE 425 N. Martingale Road, Suite 1000 Schaumburg, IL DESIGN FACILITIES 2602 McGaw Avenue Irvine, CA Milmont Drive Milpitas, CA Offi ce Park Way Pittsford, NY Lunn Road Strongsville, OH th Avenue N, Suite 500 Plymouth, MN MDS-BRO-Design-SCH