Contract Development and Manufacturing


Contract Manufacturing

A World Leader in Medical Devices and Diagnostics


Complete, Single Source Partner | Committed to Quality | Manufacturing Qualifications | Technical Firsts
Strategic Alliances | Capabilities | Engineering and Scientific Expertise

Nova Biomedical is a world leader in the development and manufacturing of state-of-the-art medical devices, patient self-testing and hospital-based diagnostics. We employ over 1000 people, including more than 125 scientists and engineers, and have manufacturing facilities in Waltham and Billerica Massachusetts and Taipei, Taiwan.

Our client list includes many of the world’s largest healthcare companies, including six of the seven largest diagnostic firms. We are also development or manufacturing partners for more than a dozen emerging companies.

Over the past 35 years, we have built a strong reputation based on leadership in diagnostic technology, engineering excellence, cost-effective manufacturing, and integrity. Significantly, in our entire history, we have never had an FDA mandated product recall.


Complete, Single Source Partner


From product development to manufacturing, distribution and field service, Nova can provide either the entire package or individual functions to supplement a client’s internal capabilities. We work with our partners to develop custom strategies, yet maintain the flexibility to respond quickly to changes in their business needs.

We believe it takes more than just developing and manufacturing good products to promote truly successful long-term partnerships. The success of each project is ultimately based on our ability to fulfill total client expectations. While most elements of a program are planned or anticipated, something often occurs that is not expected. The breadth and depth of Nova’s engineering, manufacturing, and operating resources provide us with the ability to solve these unexpected situations.

OEM Chart

Firsthand Knowledge and Experience

Founded in 1976, Nova Biomedical is a technology-driven organization focusing exclusively on medical and biomedical instrumentation. Nova has evolved its proprietary technologies into a leadership position in the design, manufacture, sales, and service of critical care blood gas/electrolyte/chemistry analyzers that we market directly to hospitals worldwide.

Because of our continuing, firsthand knowledge of the entire medical commercialization process – from concept to production to sales and field service – we know the truly important issues that determine product success or product failure. The direct feedback we receive from customers on instrument design, reliability, cost, and service issues has sharpened our skills at the critical interface between the instrument and the end user.

Dedicated Resources

No matter how large or small your project may be, Nova can dedicate scientific
development and/or manufacturing engineering teams to focus their efforts on meeting your requirements. Our focused team concept dedicates staff, equipment, and facilities to ensure the customized service and rapid response demanded in today’s dynamic business environment. This team can integrate as many or as few members of the client’s staff as desired.
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Commitment to Quality

  • We have over 35 years of experience developing and manufacturing high technology medical analyzers and medical devices
  • We have more than twenty client OEM partners
  • We have launched over 90 new instruments for Nova or our partners and have received more than 87 FDA 510(k) clearances
  • Characteristics are high quality, low cost, and focus on customer deadlines

Much of Nova’s success can be attributed to an aggressive quality philosophy which includes the goal of manufacturing products that surpass the stated specifications. To meet this goal, Nova has established an innovative Product Line Quality Committee (PLQC) process for each client. This process establishes a cross functional quality team that includes the client. For each product we manufacture, the teams proactively address quality, operational, and cost issues. To develop truly successful long-term partnerships, we know it takes more than just designing and manufacturing good products. The PLQC is one aspect of Nova’s commitment to total customer service.

Raw Data PLQC
Monthly
(Product line Quality Committee)
Management Review
Semi Annually
Customer Complaint Data Manufacturing Quality Data

Failure Analysis Data

Members:

  • Technical Program Manager or Development Program Manager (Chairperson)
  • Manufacturing Manager
  • Technical Services Manager
  • Quality Assurance Representative
  • Engineering Representative
  • Strategic Partner

Charter:

  • Identify Top Problems Impacting Field Performance
  • Propose and Qualify Solutions
  • Manage Field Implementation of Solutions
  • Set Annual Quality Improvement Goals
Members:

  • President, V.P’s of R&D, Manufacturing, & Technical Support

Updated On:

  • PLQC Activities
  • Progress Against Top Problems
  • Progress Against Quality Goals

Charter:

  • Resource Allocation

Regulatory Compliance

Nova is an FDA-registered manufacturer of medical products and we have never needed to conduct an FDA mandated product recall. All design processes and manufacturing procedures comply with FDA Quality System Regulations (QSR), ISO 13485:2003, and ISO 9001:2008 requirements.

ISO 13485 and ISO 9001, TUV Certified World Class Quality

Nova has been awarded ISO 13485:2003 and ISO 9001 international quality certifications, quality standards recognized by over 90 countries. As a natural evolution of Nova’s world class quality philosophy, ISO standards require that a company develop, document, and effectively implement comprehensive quality systems from research and development to manufacturing, delivery, and customer support.

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Manufacturing Qualifications


Nova’s Manufacturing Group consists of the personnel and infrastructure to support manufacturing engineering, materials management, quality control/assurance, 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
  • Final system assembly and test
  • Full in-house plastics molding and machine shop (over 170 molds produced)
  • State-of-the-art information systems (paperless factory)

Intensive Quality Philosophy

At Nova, quality begins before the raw materials ever enter our factory. Our Supplier Quality Engineering (SQE) program assures that each of the suppliers we select is certified to meet stringent product quality standards. Moreover, periodic evaluations are conducted to assure that these standards are constantly maintained.

During a development or manufacturing program, our innovative quality control program establishes cross-functional quality teams including members of our clients’ staffs to proactively address quality and operational issues throughout the project duration. This intensive philosophy results in an internal level of quality that deliberately surpasses our clients’ requirements.

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; each PLQC is comprised of Nova and client participants. The PLQC is an oversight group that proactively addresses a wide range of quality and operational issues before they could reach a problem stage.

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.

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 and management throughout the manufacturing process.

Range of Manufacturing Capabilities

Among the capabilities that separates Nova from other manufacturers is our ability to accommodate a broad spectrum of projects from simple to complex, low to high volume, including reagents and/or instrumentation.
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Nova Biosensor Technical Firsts


sensors

  • 1978: First biosensor for Ionized Calcium
  • 1980: First biosensor to measure Chloride in blood
  • 1984: First biosensor to measure Total Calcium
  • 1985: First biosensor to measure Hematocrit by ISE/Conductivity
  • 1987: First biosensor to directly measure whole blood Glucose
  • 1988: First biosensor to measure Lithium
  • 1990: First biosensor to measure BUN (urea)
  • 1992: First biosensor to directly measure whole blood Lactate
  • 1994: First biosensor to measure Ionized Magnesium
  • 1996: First biosensor to measure Creatinine
  • 1996: First biosensor to measure Total CO2 in whole blood
  • 1997: First muti-wavelength fiber optic SO2% assay
  • 1998: First fiber optic Hemoglobin assay
  • 1998: First Ammonium biosensor
  • 1999: First non-diluting direct Glutamine biosensor
  • 2001: First Acetate biosensor
  • 2006: First Hematocrit corrected Glucose test strip
  • 2007: First Calibration-free Glucose test strip
  • 2007: First calibration free Glucose strip
  • 2007: First Creatinine strip and meter
  • 2009: First calibration free Ketone strip
  • 2009: First IgG assay on a biotechnology analyzer
  • 2011: First Hematocrit corrected hospital Lactate meter and strip

More Tests, More Technology, More Experience

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Successful History with Strategic Alliances


A development/manufacturing partner must satisfy two fundamental requirements. It must share your core values and must be able to scale resources and operations to meet your needs. Although we cannot guarantee a fit with every partner, we enjoy very successful partnerships with companies ranging from the smallest emerging companies to the largest healthcare companies in the world. The following partial list of Nova’s partners represents the great diversity of size, resources, and needs that we have been able to satisfy. The only similarity is that all demanded world class quality at the most economical costs.

Examples of Business Partners and Products

  • Abbott Laboratories – Chemistry analyzer
  • Abiomed – Cardiac assist products
  • Baxter Clintec – Pharmaceutical compounder
  • Baxter Fenwal – Viral inactivator for donated blood
  • Baxter Renal – Peritoneal dialyzer and urea monitor for hemodialysis
  • Becton Dickinson – Blood glucose self-test meter/strips
  • BioStar (Thermo Electron) – Immunoassay by ellipsometry for physician offices
  • Boston Medical Technology – Cardiac and respiratory sufficiency monitor
  • Chromatics Color Sciences – Noninvasive bilirubin analyzer
  • Dade Behring – Chemistry diagnostic products
  • DakoCytomation – Automated immunohistological slide stainer
  • Euclid – Corneal topographer
  • Gambro – Hemodialyzer components
  • GMP Genetics – Sample processing laboratory converting diploid DNA to haploid
  • GMP Thromboflex – POC coagulation analyzer for new glycoprotein inhibitors
  • Haemonetics – Blood salvaging for orthopedic procedures
  • Immunetics – Automated Western Blot for Lyme, HIV
  • Johnson & Johnson LifeScan – FastTake electrochemical glucose meter
  • Johnson & Johnson Sterilization – Chlorine dioxide sterilization system
  • Medtronic – Wireless consumer glucose meter
  • Menarini – Consumer Glucose Meter
  • NeuroMetrix – Carpal tunnel neural diagnosis
  • Nipro – Hospital POC Glucose Meter
  • Roche – Chemistry diagnostic module
  • Sanvita – NovaMax Consumer Glucose Meter
  • Smith & Nephew – Tissue regeneration system to promote bone healing

Partner logos
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Capabilities


Nova’s resources include over 800 employees and 300,000 square-feet of R&D and manufacturing facilities in Waltham, Massachusetts. Our state-of-the-art R&D and manufacturing departments utilize advanced product development procedures and manufacturing equipment to provide the highest quality products on schedule and at the agreed price. Engineering and R&D employ over 120 scientists and engineers.

Manufacturing

Dedicated facilities and personnel organized in focused factories for clients
Precision electromechanical assembly
Biosensor fabrication
Fully equipped machine shop
Injection molding
Surface mount and through hole PC board fabrication
Ongoing product quality improvement / cost reduction programs
Reagent production
Packaging for medical devices, supplies and reagents

Engineering

Precision small volume fluid handling systems and pneumatic control
Computer-based electronics
Electromechanical systems
Optical and electrochemical sensor development
Chemistry and reagent formulations
Motion control
State-of-the-art digital, analog and ASIC electronics
Thermal control and refrigeration

Software Development

Real-time control
Multi-tasking operation
Custom embedded systems software
Communications
User interface

Product Prototypes and Pilots

Component, subsystem, and product prototyping via a parametric solid modeling
CAD/CAM system
Prototype model shop
Product design, development, and manufacturing

Product Distribution

Fully automated distribution center
Flagship Federal Express partnership
Real-time inventory control

Product Support

On-site field engineering / technical support options
Depot repair or field service capabilities

Extensive Experience

Nova has extensive experience in the development of complex medical products, with broad-based expertise in blood-based chemistry diagnostics including electrochemistry, immunochemistry, optical assays and flow cytometry.

Open Book Pricing

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

Worldwide Service Organization

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


3d modeling
Nova’s engineering and product development expertise begins 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. 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, subsystem, and complete product prototyping via a state-of-the-art parametric solids model CAD/CAM system and prototype shop.

Our engineering and scientific expertise encompasses the following disciplines:computer aided design/drafting

  • Mechanical Engineering
  • Electrical Engineering
  • Software Engineering
  • Plastics Engineering
  • Packaging
  • System Integration
  • Connectivity/Integrated Data Solutions
  • Analytical Chemistry Methodologies
    • Electrochemistry
    • Spectrophotometry
    • Flow Cytometry
    • Optics
    • Reagent Formulation
prototypes

Proven Development/Methodology

This process flow diagram is Nova’s proven methodology for the development and manufacturing of more than 85 products over a 35 year period. Nova has secured approximately 87 FDA 510(k) clearances for itself and its clients.

Proven Development Methodology graph
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