AN INTRODUCTION TO MPE

1978Tom Dambach founded Midwest Products & Engineering (MPE) as a precision metal fabricator for the medical and electronic industry from his home basement

2011Pfingsten Partners

LLCpurchase MPE

1985MPE was purchased by a group of investors, which included Dennis Wenger who led the company for the next 27 years

1997Expanded facility to 120,000 Sq. Ft.

2002MPE De Mexico established in Monterrey, Mexico to support a medical OEM

MPE De Mexico operations is sold

2014

OUR HISTORY

+ +

ISO 13485:2003 Certification

20151999ISO 9001:2008

Certification

1986Moved to our location today, a 40,000 Sq. Ft. facility. Later that year MPE added 10,000 Sq. Ft. and paint/coating capabilities

Expanded Milwaukee facility assembly area to 160,000 Sq. Ft.

2008MPE Moved to a

2,000 Sq. Ft. facility in Brown Deer

1983 2014Hank Kohl announced

as CEO / President

160,000 sq. ft. Facility (14865 sq. m)Office, Engineering + Manufacturing OperationsISO 13485:2003ISO 9001:2008FDA Registered Class I exemptRegistration No. 3003500271

Our Facility

10597 W. Glenbrook Ct.Milwaukee, WI 53224

+1.414.355.0310www.mpe-inc.com

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HANK KOHLChief Executive Officer, President

JACK KOEPKEDirector of Supply Chain Management

PAUL ELLSWORTHDirector of Business Development

DAVID BONGARDVice President of Engineering

GEOFF LEFEBERDirector of Operations

JIM GARTZKEDirector of Quality

TOM GROBLEChief Financial Officer

OUR LEADERSHIP TEAM

DAWN KUBIAKDirector of Human Resources

INDUSTRIAL DESIGN

PROJECTMANAGEMENT

SOLUTIONENGAGEMENT

ENGINEERING

SUPPLY CHAINMANAGEMENT

MANUFACTURING

ASSEMBLY

QUALITYMANAGEMENT

INVENTORYMANAGEMENT

+ Retain ownership of your product accessing our core competencies in order to move quickly, lower risk, avoid costs and maintain your core focus of business.

+ MPE-Inc’s experience and breadth delivers cradle to grave product lifecycle management.

+ It’s not about who we are; it’s about our approach, our process and our experience.

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vWith an established and knowledgeable team it is easy to trust MPE to approach each project instrumentally, with focus, to find and answer difficult questions.

Through observation, identifying opportunities and outlining problem triggers, feel confident that MPE will aggressively produce market success.

THE FRONT-END PROCESS

IDENTIFY PROJECTSOur team’s expertise starts with attention to detail in the project process. Guided by our Project Manager, kick-off starts with a multi-disciplinary team to develop project specifications, map out the timeline and define a program to ensure success.

EXPERTISE

COMMUNICATION

PLANNING

ATTENTION TO DETAIL

Strategizing Principles: Key to Project SuccessSOLUTION ENGAGEMENT

STAGE 1

STAGE 2

STAGE 3

STAGE 4

DEFINITION & CONCEPT feasibility

DESIGN & PROCESS DEVELOPMENT with project planning

PRODUCT & PROCESS verification

REVIEW & FOLLOW UP for closure

PRODUCT QUALIFICATION &

preparation

Stage-Gate Product Development CyclePROJECT MANAGEMENT

Using the Stage-Gate Product Development Cycle our PMP Certified Project Management team combines expertise, communication, planning and attention to detail to take the workload off your hands and deliver your product to market.

STAGE 1 STAGE 2 STAGE 3 STAGE 4

STAGE 5

Planning for Success

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PROJECT MANAGEMENT

Product IntentProduct RealizationEmpathetic DesignDesign for Manufacture (DFM)Stakeholder ObservationUser Interface / ExperienceBenchmarking

Connect

Get it right the first time. Avoid costly pitfalls and benefit from our expert experience. Our in-house Industrial Design (ID) Department collaborates and works along-side the Engineers to design products with intent, function and aesthetics. Design for Manufacture (DFM) considerations are established and assessed at the conception of the project ensuring budgets, timing and costs are within the project requirements.

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Hyper Focused on Human-InteractionINDUSTRIAL DESIGN

Observation, Integration & User-Centered DesignHUMAN FACTORS

Engaged in field observation and analysis our team identifies customer needs, uncovers insights and establish target opportunities.

Behavior psychology, design empathy and ergonomics critically influence market acceptance and distinguishes product competition. We pick out what is important to target and integrate solutions within our design.

Every stage of the product development stage requires continuous consideration of ergonomics and consideration of the manufacturing process to ensure Design for Manufacture (DFM).

Human Factors

V

Industrial Design Support

Mechanical Design Engineers

Industrial Process Engineers

Manufacturing Engineering

Experience Matters

The StructureENGINEERING

CREO · SOLIDWORKS · FEA SIMULATION

A collaborative approach to engineering. With no boundaries between our departments we build your design hand in hand and ready to move fast. Using MPE’s ID for support we design within the software package you require and maintain your design.

Design Verification – IEC60601-1 & Reliability Testing ENGINEERING

SUPPLY CHAIN MANAGEMENT

Supplier ConsolidationCost Reduction Lead Time ReductionLeveraging the Economies of Scale

Over 437 Qualified Suppliers Managed through 1 Contact

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With an established and knowledgeable team it is easy to trust MPE to approach each project instrumentally, with focus, to find and answer difficult questions.

Through observation, identifying opportunities and outlining problem triggers, feel confident that MPE will aggressively produce market success.

THE BACK-END PROCESS

Full Range of Precision Fabrication CapabilitiesCUSTOM FABRICATION

Full Offline ProgrammingComputer Aided-Manufacturing Methods (CAMM)Factory Integrated Enterprise Resource Planning (ERP)

Rapid ChangeoverQuick Response Manufacturing (QRM)Medium Volume SpecialistsLean/Flexible Factory Focus with Low – Medium Volume Requirements

Full Range of Welding & Metal FinishingWELDING & FINISHING

Extensive Experience in High Cosmetic Requirements Certified Welders

TIG / MIG CapabilitiesRobotic and Manual WeldingSpot Welding Metal Finishing of Various MaterialsIncluding Steel, Aluminum and Stainless Steel

POWDER COATING & SILK-SCREENING

Over 130 Medical-Grade Powders in Use Complete Automated Powder Coat Line with 5 Stage Washer System and Curing Period (Iron Phosphate & Non-Chrome Sealer)No Use of Reclaimed PowderComplete In-House Silk-ScreeningClass 1 FDA & EPA Compliant

Product Serialization and TraceabilityCustomized PackagingImplementation of Lean Manufacturing Principles including 5SOrganization Focus on Efficiency & Lean PrinciplesHigh Priority on Ergonomics

Managing Over 250 High-Level AssembliesFlow Line ProcessMinimal to Zero Set Up TimeElectrostatic Discharge Area (ESD)Laser Jet Part Marking

ASSEMBLY40,000+ Sq. Ft. (3716 sq. m.) Assembly Area

ASSEMBLY & TEST AREAMechanical Assembly with Electrical Integration

Electrostatic Discharge Area (ESD)Hipot & Continuity TestingPneumatic Testing

Supplier Quality Management System (SQM)ISO-13485:2003ISO-9001: 2008FDA Registered, Class I exemptUDI Compliance

QUALITYQuality Management Control

Process Qualification CapabilitiesFull PPAP SubmissionsAdvanced MetrologyMaterial & Product Traceability Systems

KanbanCustom Packaging Development Direct Shipment to You or Your Customers Customer Inventory ManagementInternational Shipment

INVENTORY MANAGEMENTManaging All of the Details

CUSTOMER SERVICECommitment to Responsiveness

Integrated with your businessHyper-focused Team to Ensure Your Focus Remains on DevelopmentGuide you to avoid pitfalls in emerging marketsLogistics

Customer Response Time:+ 3 Hour acknowledgment+ 24 Hour Commitment

CONTINUOUS IMPROVEMENTDedication to Serving

Continuous Improvement (CI) Team leaders that come from a cross-section of the company: Manufacturing, Engineering, Quality and Human Resources

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More projects are targeted for completion by the end of the year 17

2016 Projects to date with focus on manufacturing, customer responsiveness, and improving our internal auditing process22

The largest cross-functional CI initiative this year has been the Sales Order Process Improvement Plan (Reset)+

5 CI teams closed out projects in 2015 with primary focus on manufacturing improvements and 5S initiatives

PORTFOLIO TECHNOLOGY ENERGY

MEDICAL

Driven by the passion to enhance patient outcomes, a team of physician-scientists developed the technology for an energy based, minimally-invasive soft-tissue ablation system. They engaged MPE at an early stage of the design and engineering process. With focus on providing an intuitive and ergonomic workflow, the Industrial Design team identified critical needs for clinicians through research and observation. We proposed solutions focused on implementing features within the aesthetics that assisted in positioning the unique technology. In parallel, the team of Design Engineers approached the configuration of a structural chassis that would allow the thermal regulation required of the state-of-the-art technology. Several rounds of rigorous proof-of-concept modeling, prototyping and testing of concepts and integral features transformed the result-focused, energy-based technology into its final form. The launch of the powerful, physician-focused device harnessed features to maximize ergonomics and procedure efficiency. The synergistic development approach resulted in launching a stylish, sleek and intuitive system and a brand which has grown to be recognized for its reputation for revolutionizing patient care.

Synchronized Energy DeliveryMICROWAVE ABLATION

Microwave AblationCASE STUDY

The Challenge: Redesign a successful flagship system in order to satisfy physicians’ demand for technological enhancements.

The Process: MPE’s design and development team was engaged early in the design process. Empathetic to the sensitive needs and critical nature of its use, MPE’s strategy focused on identifying and mitigating risks within the wide array of design for manufacture, integration, commercialization, and the complex end-user constraints.

The Outcome: With the combined expertise of the team, MPE developed a user-focused, two-piece surgical navigation system. The solution included a unique docking system which simplified the transportation of the system as a whole while requiring a minimal footprint within operating rooms (OR)s.

4th PlatformSince 1999The Evolution of Neurosurgery

SURGICAL NAVIGATION SYSTEM

Surgical NavigationCASE STUDY

Efficiency and reliability are just two of the vital needs of the equipment used when dealing with lifesaving ambulatory care of an infant. That pressure increases with need for air transport. In order to seamlessly interface existing trolleys and maintain a high level of configuration to critical devices and accessories, MPE’s multi-disciplinary team approached the comprehensive design process with calculation. With the wide-ranging list of product constraints and harsh environmental conditions that the mobile neonatal intensive care system would be exposed to the team conducted in-depth research to develop the structure design. Prototyping was used to further perform structural analysis of the designs and in the vetting of materials. The data lead the team to develop new manufacturing processes for the framework that guaranteed reliability and durability under the extreme conditions of both ground and air ambulatory transportation care. Rigorous FEA and physical testing proved the device to meet and/or exceed the following air and ground requirements: EN 1789:2007, EN ISO 10993-1:20096, Federal Aviation Regulations (FAR) and Canadian Air Regulations (CAR) – FAR 23/CAR 523 and FAR 29/CAR 529.

Ground and Air Life Support

MOBILE NEONATAL INTENSIVE CARE TRANSPORT SYSTEM

Mobile Neonatal Intensive Care Transport System

CASE STUDY

Reduced Exposure to Radiation PET Infusion System

Charged to redesign the next generation of a Positron Emission Tomography (PET) Infusion System which aids in the administration of Fluorodeoxyglucose(FDG) for patient care, the Industrial Design and Design Engineering team at MPE began by establishing feedback directly from users at established cancer care centers.

The Voice of Customer (VOC) loudly identified the targets which needed to be resolved in the redesign – the overall size and the mobility of the unit. A lead-lined chamber at the core of the system protects technicians from exposure to the radioactive isotope stored within the compartment, however the weight associated with it is significant and disadvantageous.

MPE’s team utilized a powered drive motor and introduced ergonomic enhancements that increased transportability of the system. The solution addressed the end-user’s desire for increased mobility and retained the brand’s competitive-edge, maintaining the integrity of what it means to protect the technician.

Reduced Exposure to Radiation PET Infusion System

Self-Guided CPR Skills Training PlatformCASE STUDY

Hands-on training is essential in the education and certification of lifesaving techniques. Cardiopulmonary Resuscitation (CPR) skills and recertification can be required as often as every six months for healthcare practitioners adding another task to an already overwhelming list. The use of simulated, self-guided training and aptitude testing on the CPR Skill Station allows practitioners to maintain their certifications with ease.

Facilitating the development of a skill station redesign, the multi-disciplinary Industrial Design and Design Engineering team at MPE dove into research, observing and gauging the differences between facilitated training and self-instructed training. Observations informed designers of key issues and opportunities to address. The rigorous, short, bursts of pressure required in CPR compressions generated instability, amplified by the use of and placement of the casters.

Driven by human factors and ergonomics MPE exponentially enhanced the platform to withstand the demands of weight distribution. The end product combines elegance within a functional, performance based architectural form. Moving quickly from concept to prototype and moving into commercialization, MPE was able to maintain the integrity of the human-centered design.

Self-Guided CPR Skills Training PlatformCASE STUDY

STRENGTHSEXPERIENCE OUR

01 Reduce Cost & Time to Market

02 Market Understanding & Experience

03 Product Value & Competiveness

04 Reduce Operating Costs

05 Intimate Business Alignment

06 World Class Manufacturing Operations

07 Supplier Consolidation

08 Member of the PfingstenPartners Portfolio

Flush out and set milestones, list required qualifications and establish validations.

Determine How will your new product be announced and where will it exhibit?

Identify Move Budget

Identify Time Budget

Layout project initiatives, identify pain points and brainstorm challenges and needs to anticipate.

Activity List common pitfalls and areas of stress from past projects.

Review and analyze the numbers of targeted cost, R & D resources and tooling budget.

Discuss Predict the annual production and first years sales.

LET US SOLVE YOURPROBLEMS

10597 W. Glenbrook Ct., Milwaukee, WI 53224 TF (800) 226.1687 P (414) 355.0310 F (414) 355.5259 E sales@mpe-inc.comwww.mpe-inc.com

MIKE PICKETTBusiness Development Manager, EastP 609.350.9238pickett@mpe-inc.com