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M E D I C A L

Product Design Capabilities

THOUGHTTHOUGHTTO FINISH

FROM

LOCATIONS

13 Locations (12 in North America

and 1 in Viet Nam)

PUBLICLY TRADED

Listed on NYSE since

1929, ticker symbol SPA

INDUSTRIES

Medical and Biotechnology

Military and Aerospace

Industrial and Commercial

GLOBAL ORGANIZATION

Over 1,700 Employees Worldwide

EXPERIENCE

Founded in 1900

About Sparton CorporationAbout Sparton CorporationSparton 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.

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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.

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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 Product Design by the Numbers

100+100+Design engineers

25+25+Patents

77Design awards

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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, I2C, 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

Engineering CapabilitiesSoftware & Firmware Engineering

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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

Electrical Engineering

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Mechanical Engineering

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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.

Certifi cations and Quality Systems• ISO 13485• ISO 9001• FDA Registered • Design of FDA Class I, II and III Devices• Apple MFi• Microsoft Certifi ed Partner• LabVIEW Alliance Partner

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 60601-1-11) 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 ResultSparton’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 Leva System

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

Remendium LabsTreats pelvic dysfunction.

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Case StudiesCase Studies

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 ResultThe 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 Strategies SnapPath® System

•• Specifi c knowledge in working with in vitro diagnostics devices

End ResultEnd ResultThe SnapPathexperts for its novel technology. In one report, SnapPathas 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 AwardsProduct Awards

BIOMARKER SnapPathTM

Standardizes and automates biopsy samples. 9

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 ResultSparton’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

Neuronetics NeuroStar

Proven experience in developing compact electronics-based systems Proven experience in developing compact electronics-based systems

NEUROSTARHelps treat

chronic depression.

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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 Instrumentation

IN VITRO DIAGNOSTICSMultiple-assay clinical laboratory analyzer

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CORPORATE OFFICE

425 N. Martingale Road, Suite 1000 Schaumburg, IL 60173 800.772.7866www.sparton.com

2602 McGaw AvenueIrvine, CA 92614949.581.0188

1940 Milmont DriveMilpitas, CA 95035408.957.1300

16305 36th Avenue N, Suite 500 Plymouth, MN 55446605.886.2519

160 Offi ce Park WayPittsford, NY 14534585.383.1290

22740 Lunn RoadStrongsville, OH 44149440.878.4630

DESIGN FACILITIES

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