Medical Product Design and Manufacturing
A World Leader in Medical Devices and Diagnostics
Nova Biomedical is a world leader in the development and manufacturing of advanced technology blood testing analyzers and diagnostic products. As the largest privately held in vitro diagnostic company in the U.S., we employ over 1,000 people, including over 125 scientists and engineers, and have sales and service subsidiaries in seven 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; Belo Horizonte, Brazil; and Taipei, Taiwan.
Nova’s clients include some of the world’s best-known healthcare companies, as well as some of the most innovative newcomers.
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).
Nova 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, which assures that the product is reliable and cost-effective manufacturing design.
Nova appoints a dedicated development and manufacturing team to your project. Manufacturing is done through a “focused factory” concept where dedicated staff, space, and equipment are permanently assigned to your project.
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 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. Electronic 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 encompasses the following disciplines:
- Mechanical engineering
- Electrical engineering
- Software engineering
- Digital imaging
- Plastics engineering
- Test engineering
- System integration
- Connectivity/integrated data solutions
- Analytical chemistry methodologies: Electrochemistry, Flow cytometry, Immunofluorescence, Immunoagglutination, Ellipsometry, Optics, Reagent formulation
- Electrolyte/chemistry module for a laboratory analyzer
- Peritoneal dialysis system
- Viral Inactivator for transfused blood
- Pharmaceutical compounder
- Cardiac and respiratory sufficiency monitor
- 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
- Chlorine dioxide sterilization system
- Portable home IV pump
- Erythrocyte sedimentation rate analyzer
- Bone healing device
- Tissue regeneration system
Products Developed and Manufactured
The following is a partial list of products Nova developed and/or manufactured for our clients:
This process flow diagram illustrates Nova’s proven methodology for 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.
- 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
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.
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.
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 addition charge.
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.
Among 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.
Our 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.
Nova 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.
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.
Nova’s U.S. service organization consists of more than 40 field engineers. We have direct service organizations in Brazil, Canada, France, Germany, Japan, and the United Kingdom.