N O VA B I O M E D I C A L

Medical Product Designand Manufacturing

Nova Biomedical is a world leader in the development and manufacturing of advanced technology blood testing analyzers and diagnostic products. As the second largest privately held in vitro diagnostic company in the United States, we employ over 1,000 people, including over 125 scientists and engineers, and have sales and service subsidiaries in 7 countries and distributors in over 90 other countries. Nova also has 420,000 square feet of development and manufacturing space in facilities in Waltham and Billerica, Massachusetts, Bello Horizonte, Brazil, and Taipei, Taiwan.

Over the past 35 years, we have built a strong reputation based on leadership in diagnostic technology, engineering excellence, cost-effective manufacturing, and integrity. In our entire history, we have never had a mandated product recall from the U.S. Food and Drug Administration (FDA).

Complete, Single Source PartnerFrom product development to manufacturing, distribution, to field support, and from refurbishment to spare parts management, Nova can provide the entire package or individual functions to supplement a client’s own internal capabilities. We work with our clients to develop customized strategies, yet maintain the flexibility to respond quickly to changing business needs. Nova’s comprehensive staff of design, manufacturing, and test engineers; global supply chain experts; and quality and regulatory specialists can handle almost any client need.

A World Leader in Medical Devices and Diagnostics

Peritoneal Dialysis System

Immunohistological Slide Stainer

Glucose/Ketone Meter

Immunoassay Analyzer

POC Glucose Meter

Manufacturing EngineeringNova uses Manufacturing Engineering as the key constant in all projects. Manufacturing Engineering is assigned to the product development project on day one and stays with the project for the life of the product. There is no handoff from development to manufacturing. There is no redesign for manufacturing effectiveness. There is a seamless transition that is managed by Manufacturing Engineering, who assures that the product is a reliable, and cost effective manufacturing design.

Dedicated ResourcesNova will appoint a dedicated development and manufacturing team to your project. Manufacturing will be done through a “focused factory” concept where dedicated staff, space and equipment are permanently assigned to your project.

Urea Measuring System/Hemodialysis

Viral Inactivator for Donated Blood

Blood Salvaging System

Ventricular Assist Device

Manufacturing QualificationsNova’s manufacturing group consists of the personnel and infrastructure to support our manufacturing engineering, materials management, quality control/assurance (QA), purchasing, scheduling, and production functions. Our state-of-the-art production facilities incorporate sophisticated manufacturing equipment to provide high quality, reliable products at an agreed upon schedule and price. Key areas of expertise include:

• Full printed circuit board capability — both surface mount and through hole boards

• Automated reagent mixing, filling, and sealing

• Mechanical assembly

• Final system assembly and test

• Full in-house plastics molding and machine shop

• State-of-the-art information systems

• Automated manufacturing and packaging of high volume disposables

Intensive Quality Philosophy During a development or manufacturing program, our innovative quality control program establishes cross-functional quality teams, including members of our clients’ staff, to proactively address quality and operational improvements throughout the duration of each project. This intensive philosophy results in a level of quality that consistently surpasses our clients’ expectations.

Continuous Quality Monitoring Our standard quality procedures include organization and training, incoming QA, in-process inspection, full system functional testing, and statistical analysis. Importantly, we also form a Product Line Quality Committee (PLQC) for each product that is comprised of Nova and client participants. The PLQC is an oversight group that proactively addresses a wide range of quality and operational issues.

Continuous Product Improvement With a goal to improve the quality of each product and reduce its manufacturing cost, Nova provides cost reduction and manufacturing engineering support to each client on an ongoing basis at no additional charge.

Direct End User ExperienceNova is unique among medical equipment contract manufacturers because we have direct sales and service experience with end users of Nova brand products. Our experience is not limited to building products to a contract specification and shipping those products to a warehouse. Since 1978, we have been selling and servicing our own line of critical care blood analyzers, chemistry analyzers for biotechnology, and handheld point-of-care analyzers directly to hospitals worldwide. We know firsthand the importance of manufacturing, quality, speed, and cost to the commercial success of medical products. We can share the lessons learned from our 35 years of direct sales and service experience with you, as we develop and manufacture your product.

Engineering and Scientific ExpertiseNova’s engineering and product development expertise begin with world-class experience in both optical and electrochemical diagnostic technologies for blood chemistry and immunoassay applications. To this we add strong project management with computer-based electronic and electromechanical systems experience. We place particular emphasis on designing for reliability, value, and manufacturing readiness. Key mechanical skills include optics, precision fluid handling, heat transfer mechanisms, plastics, packaging, and industrial design. Electronics skills include both analog and digital circuitry, embedded microprocessors, ESD, and power supplies. Nova’s software engineers are proficient in real-time control, multi-tasking operation, and custom embedded systems software. All products are designed for worldwide sales and marketing, with appropriate regulatory certifications. Nova offers component, sub-system, and complete product prototyping via a state-of-the-art parametric solids model CAD/CAM system, a prototype shop, and 3-D printers. Our engineering and scientific expertise encompass the following disciplines:

• Mechanical engineering

• Electrical engineering

• Software engineering

• Digital imaging

• Plastics engineering

• Packaging

• Test engineering

• System integration

• Connectivity/integrated data solutions

• Analytical chemistry methodologies – Electrochemistry – Spectrophotometry – Flow cytometry – Immunofluorescence – Immunoagglutination – Ellipsometry – Optics – Reagent formulation

Product Development

Conceptual Drawing

Computer AidedDesign/Drafting

Prototypes

Circuit Board Design

Final Product

Solid Modeling

Products Developed and ManufacturedThe following is a partial list of products developed and/or manufactured by Nova for our clients:

Proven Development/MethodologyThis process flow diagram illustrates Nova’s proven methodology for the development and manufacturing of more than 100 products over the past 35 years. Nova has secured more than 100 FDA 510(k) approvals for our products and clients.

Product Development

Production/Product SupportPilot ProductionPrototypeBreadboardConcept

Phase

Finished Product"Works-like,""Looks-like,""Made-like"

model

"Works-like,""Looks-like"

model

"Works-like"unit which proves

technology

Detailed SystemSpecifications

Marketing Requirements

PreliminarySpecifications

Program Plan

Output

Manufactureand Sell

DemonstrateManufacturability

Demonstrate Technology in

Final Packaging

DemonstrateTechnology

Develop Product PlanObjectives

• Electrolyte/Chemistry module for a laboratory analyzer

• Peritoneal dialysis system

• Viral Inactivator for transfused blood

• Pharmaceutical compounder

• Cardiac and respiratory sufficiency monitor

• Blood gas analyzer

• Immunoassay analyzer (Ellipsometry) for physician offices

• Immunoassay analyzer (Flow Cytometry) for hospital laboratories

• Noninvasive bilirubin analyzer

• Automated immunohistological slide stainer

• Urea monitor module for hemodialysis

• Blood saver for orthopedic procedures

• Corneal topographer

• Hospital IV pump

• Hemodialyzer components

• POC coagulation analyzer

• Automated Western Blot analyzer for lyme, HIV

• Electrochemical glucose meter for diabetes self-testing

• Chlorine dioxide sterilization system

• Carpal tunnel diagnosis

• Portable home IV pump

• Erythrocyte sedimentation rate analyzer

• Bone healing device

• Bacterial detection

• Tissue regeneration system

• Wireless glucose meter

Manufacturing QualificationsNova’s manufacturing group consists of the personnel and infrastructure to support our manufacturing engineering, materials management, quality control/assurance (QA), purchasing, scheduling, and production functions. Our state-of-the-art production facilities incorporate sophisticated manufacturing equipment to provide high quality, reliable products at an agreed upon schedule and price. Key areas of expertise include:

• Full printed circuit board capability — both surface mount and through hole boards

• Automated reagent mixing, filling, and sealing

• Mechanical assembly

• Final system assembly and test

• Full in-house plastics molding and machine shop

• State-of-the-art information systems

• Automated manufacturing and packaging of high volume disposables

Intensive Quality Philosophy During a development or manufacturing program, our innovative quality control program establishes cross-functional quality teams, including members of our clients’ staff, to proactively address quality and operational improvements throughout the duration of each project. This intensive philosophy results in a level of quality that consistently surpasses our clients’ expectations.

Continuous Quality Monitoring Our standard quality procedures include organization and training, incoming QA, in-process inspection, full system functional testing, and statistical analysis. Importantly, we also form a Product Line Quality Committee (PLQC) for each product that is comprised of Nova and client participants. The PLQC is an oversight group that proactively addresses a wide range of quality and operational issues.

Continuous Product Improvement With a goal to improve the quality of each product and reduce its manufacturing cost, Nova provides cost reduction and manufacturing engineering support to each client on an ongoing basis at no additional charge.

Contract Manufacturing

High Volume Consumables

Packaging

Circuit Board Assembly

Reagent Filling

Mechanical Assembly

A World Leader in Medical Devices and Diagnostics Focused Factories

In contrast to many contract manufacturers, Nova does not “time share” its production resources. Instead, Nova dedicates manufacturing personnel as well as space and inventory resources to each individual project. This focused factory approach clearly identifies responsibility and promotes the most effective operation throughout the manufacturing process including: manufacturing management, technical support, production control and planning, quality control, production supervision, and inventory warehouse.

Range of Manufacturing CapabilitiesAmong the capabilities that separate Nova from other manufacturers is our ability to accommodate a broad range of projects from simple to complex, and low to high volume, including reagents, instrumentation, and disposables.

Our production capabilities range from high volume, low cost products to low volume, high cost products. We have structured our “focused factories” to accommodate this range of product mix.

Open-Book PricingOur unique “open-book” pricing model identifies costs for materials, overhead, labor, and profit associated with the project. This full disclosure policy keeps each client fully appraised of the financial status of a project every step of the way.

Regulatory ComplianceNova is an FDA-registered manufacturer of medical products. All design processes and manufacturing procedures comply with FDA Quality System Regulations, ISO 13485:2012, and ISO 9001:2008 requirements.

TÜV Certified World-Class Quality Nova has been awarded ISO 9001 and ISO 13485 international quality certification — quality standards recognized by more than 160 countries. A natural evolution of Nova’s world-class quality philosophy, ISO 9001 and ISO 13485 require that a company develop, document, and effectively implement comprehensive quality systems from research and development to manufacturing, delivery, and customer support.

Worldwide Service Organization Nova’s U.S. service organization consists of more than 40 field engineers. We also have direct service organizations in Austria, Brazil, Canada, France, Germany, Japan and the United Kingdom.

Machine Shop

Dust Free/Clean Room

Production Work Cell

200 Prospect Street, Waltham, MA 02454 U.S.A. • Toll Free: 800-458-5813 • Tel: 781-894-0800 • Fax: 781-894-5915 www.novabiomedical.com

For more information, please contact: Manager OEM Products • Email: info@novabio.com

We’re Known by the Company We Keep Nova’s clients include some of the world’s best-known healthcare companies, as well as some of the most innovative newcomers.

No. 77A V15 EN 4/28/15

TP

TMg

Creat

IgG

tHb

Gly

SO2%

PO4

tHb

O2Hb

RHb

COHb

MetHb

sHb

SO2%

Hb

Influ A

Influ B

Herpes

Cell Density

CellViability

Potentiometric (whole blood or plasma)

O2 membrane, O2 reduction by cathode

Glucose oxidase immobilized enzyme

Lactate oxidase immobilized enzyme

Immobilized three enzyme system

Immobilized two enzyme system

Glutamate oxidase immobilized enzyme

Beta-hydroxybutyrate immobilized enzyme

Electrical resistance, Na+ corrected

Immunofluorescence

Immunoagglutination

Amperometric (whole blood/plasma, or cell culture media)

Conductivity (whole blood)

Hydrogen ion selective glass membrane

pH electrode with CO2 gas permeable membrane

pH electrode, CO2 membrane, acidified sample

Calcium ionophore in polyvinyl chloride (PVC)

Calcium electrode with acidified sample

Valinomycin in PVC

Chloride anion ionophore in PVC

Magnesium ionophore in PVC

Sodium ion selective glass membrane or sodium ionophore in PVC

Urease enzyme membrane and ammonium ion selective electrode (ISE)

Ammonium ISE ionophore

Lithium ionophore in PVC

pH electrode with acetate permeable membrane

pH

PCO2

TCO2

Ca++

TCa

K+

Cl -

Mg++

Na+

Urea

NH4+

Li+

Ace

PO2

Gluc

Lac

Creat

Gln

Glu

Ket

Hct

Spectrophotometric (plasma and cell culture media)

Photometric (lysed whole blood)

Ellipsometry (saliva/urine)

Imaging (cell culture)

Biuret, absorbance, end point

Methylthymol blue, absorbance, end point

Modified Jaffe, alkaline picrate, rate absorbance

Affinity binding assay, absorbance

Cyanmethemoglobin absorbance

Glycerol absorbance endpoint

Multi-wavelength spectral scanning of hemolyzed red blood cell (RBC)

Absorbance endpoint

Multi-wavelength spectral scanning of hemolyzed RBC

Multi-wavelength spectral scanning of hemolyzed RBC

Multi-wavelength spectral scanning of hemolyzed RBC

Multi-wavelength spectral scanning of hemolyzed RBC

Multi-wavelength spectral scanning of hemolyzed RBC

Multi-wavelength spectral scanning of hemolyzed RBC

Multi-wavelength fiber optic reflectance (oximetry)

Multi-wavelength fiber optic reflectance plus conductivity, sodium correction

Light reflectance

Light reflectance

Light reflectance

Cell staining followed by digital imaging

Cell staining followed by digital imagingImmunochemistry (whole blood or plasma)

Measurement Technologies Used by Nova