Health & Life Science Product Design and Manufacturing

Sigma Design Company designs, refines, and manufactures products, analytical tools, and test systems for the healthcare and life sciences sectors. As a trusted design and manufacturing partner, we make our customers’ visions a reality by inventing ground-breaking medical devices, improving existing products, and designing test systems that improve people’s lives. The products we’ve created include medical devices, surgical tools, blood centrifuges, equipment for diagnostic and analytical laboratories, tools for drug delivery, and more.

Healthcare & Life Sciences Product Design, Engineering, and Manufacturing

Sigma Design’s technical team transforms your ideas into practical product solutions by utilizing the most cutting-edge design, engineering, and manufacturing technologies. The experts at Sigma Design have years of experience in:

Concept design
Complex geometry and specialty mechanisms
Developing manufacturing methods and drawings
Defining and testing separation technologies
Advanced engineering analyses, including FEA and CFD stress, as well as flow and heat transfer analysis

As regulatory requirements in the healthcare and life science sectors continue developing, Sigma Design can help you navigate these changes while shortening your time to market. We have experience designing and developing products in compliance with various FDA regulations and Class I, II, and III device specifications.

We fully adhere to the following specifications for the development and production of healthcare devices:

ISO 9001
ISO 13485
ANVISA
NMPA
ISO 14001
CE Mark
EN 46001
21 CFR Part 820
JGMP

Medical Equipment Manufacturing

Medical product manufacturing is vital to improving and saving people’s lives. These products range from at-home monitors to advanced handheld devices to therapeutic technologies. Whatever the requirements are for developing and manufacturing your equipment, our medical device designers have the capabilities and expertise necessary to bring your products to market—to the people who need them the most.

Our medical device contract manufacturing services have produced these products:

Surgical tools
Knee and hip replacement parts
Wheelchair design
Cell homogenizer
Vaccine prep & devices
BFE testing system
PPE face mask

Project Snapshot: Assisting Drug Discovery

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One of our past projects is the Behavioral Spectrometer, a humane tool that records every action a research mouse takes without the need for researchers to watch and analyze hours of film. This “mouse house” was designed, tested, and produced by Sigma in our New Product Manufacturing Center. We used our advanced engineering analysis capabilities to include LED lights, isolation dampers, and vibration sensors in the device. With advanced vibration and video analysis, it can record the most thorough descriptions of mouse activity.

This product has seen tremendous success in the research and pharmaceutical industries, notably at Rutgers University’s Department of Neuroscience and Cell Biology, Pfizer, and other international R&D facilities that create new medications. Units were also recently supplied to an Austrian R&D laboratory.

Life Sciences Product Development

It takes a lot of effort to transform an idea into an effective life science instrument. Without the right partner, it can be difficult to gather the expertise and resources needed to turn the idea into a practical, scalable product.

The team at Sigma Design specializes in the life sciences, with a track record of incorporating sophisticated technologies like yours into fully compliant products. We will help you achieve your idea’s full potential and solidify your position as a leader in the field.

Examples of life science products we helped produce include:

Blood centrifuges
Analytical and diagnostic laboratory equipment
Drug administration tools

Project Snapshot: Sigma Design Responds to the COVID-19 Pandemic

As a result of an increase in requests due to the COVID-19 pandemic, a testing facility contacted Sigma to design and manufacture a Bacterial Filtration Efficiency (B.F.E.) test stand to assess how well face masks remove virus particulates from the air.

Sigma designed and constructed an automatic test stand based on two standards: ASTM F2101-19 and EN 14683:2019+AC. The device included a control panel, filter equipment, HMI, and test stand base, where a lab hood from a commercial supplier was mounted. With our customer’s expertise, we sourced and produced specialized components with a high level of laboratory cleanliness to create the testing device.

Partner With the Right Medical Device Development Company

Since 1999, Sigma Design Company has built a clientele that includes hundreds of international manufacturing companies and well-known brands from various industries. We have transformed more than 1,000 design and design/build projects into profitable products and specialized machinery used worldwide.

As a life science and medical device design company, Sigma Design can work with you on your new product’s design and manufacture. Contact us today to get started.