Four Key Dynamics Driving Effective Outsourcing Decision-Making for Lab Automation OEMs
Lab automation OEMs need to maintain flexible outsourcing strategies—enabling them to better accommodate and respond to new operating and market needs. This white paper explores the four factors that can impact and change outsourcing strategies: economic rationales, accelerating innovations, supply chain v

The Value of ISO 13485 in a Design Centric, Medical Product Development Firm
This article explores the value that ISO 13485 Certification brings to both the medical design and development firms that maintain certification and to the clients that benefit from them. Common misconceptions about a Certified QMS include that it adds expense to the project and that it is

Five Areas to Audit when Utilizing a Low Cost Medical Contract Manufacturer
Medical device manufacturers face a significant challenge in the market-driven need to reduce cost without sacrificing quality. This has driven sourcing teams to seek suppliers in lower cost labor regions. The lowest cost regions may lack suppliers with quality systems, procedures and production infrastru

Less is More: How Lean Processes can Bolster Profits and Sustainability
Medical device manufacturers are just like every other business regarding their desire to maximize profits and sustainability by reducing waste and losses. However, unlike most businesses, medical device manufacturers don’t use specific, proven methodologies to achieve these goals.

Going (Well) Beyond Product Safety Standards
Medical manufacturer GCX outlines safety tests that every hospital or medical device manufacturer should conduct before a solution is put into production.

Endocrine Disruptors in Medical Devices: An Integrated Approach for Compliance with Regulatory Requirements
The goal of the present paper is to propose a systematic, standard workflow for the safety assessment of endocrine disruptors through the understanding of what EDCs are, where they are found and how to mitigate their exposure via the performance of the biological evaluation of MDs, followed by the evaluat

How to Select a DC Motor: Coreless and Iron Core Brushed DC Motors
Considering a coreless DC motor for your next application? Can’t decide between brush and brushless? Despite their simplicity, selecting a small DC motor for an application can still be a daunting task. There are many other variables to take into account including dimensions, load, duty cycle, etc. This white

Calculations & Formulas for Brush DC Motors
When selecting a brush DC motor for an application or developing a powered prototype, there are several basic motor physics principles which must be considered to produce a safe, well-functioning, sufficiently-powered precision drive system. This guide includes important methods, formulas & calculation detail

The Role of Virtual Prototyping in Product Development
When performed at the right stages of medical device development, virtual prototyping can provide certainty that speeds up the process. This white paper looks at the three stages of product development and the role of virtual prototyping including useful tools for each phase.

Building the Engineering Team You Need
Finding the right resources to meet your company's engineering needs can be challenging. In this white paper, Kent Kallsen, Vice President of Engineering at Delve, outlines the various types of work that engineers perform and how to effectively hire internal staff and team-source contract resources to keep pr

Surgical Robotics: The Market Landscape Today and Tomorrow
A look back at the history of robotic-assisted surgery offers a glimpse into the future of surgical robots.

Case Study: DC Dexcom
Dexcom is a leader in continuous glucose monitoring (CGM) systems for people with Type 1 and 2 diabetes. Rather than the “snapshot in time” reading that a traditional glucose meter provides, CGM continuously tracks glucose levels so that users can see trends and patterns to help better manage their diabe

Top 100 Medical Device Companies of 2019
See which companies lead the pack in the medtech industry with our free 2019 ranking of the top 100 public medical device and diagnostics companies by sales. Information in the report includes the following: Company name Exchange ticker Exchange 2019 revenue

Surgical Robotics: The Market Landscape Today and Tomorrow
Robotic surgery has been a reality since Intuitive Surgical came to market in 2000, but recent innovations are transforming the landscape significantly. Both startups and traditional medical device companies have introduced robotic approaches for a range of surgical procedures, while Intuitive has already

Outsourcing in Mexico: Is This Location the Best Fit for Your Project?
The last few years have challenged every supply chain manager’s ability to craft a successful outsourcing strategy as perceived advantages have shifted due to tariffs, changes in tax policies, new trade agreements and unanticipated supply chain disruptions.There are some universal truths releva

Motor Type Selection
Parameters that define a motor type are the mechanical output power, the shaft bearing system, the commutation systemused, and the possible combinations with gearheads and sensors. The most important criteria include the speed andtorque requirements, and the commutation system.

High Efficiency Motors
To understand the concept of high efficiency motors, you must first know how to calculate efficiency and the losses associated with the motor components themselves.

Finding the Optimal Metal Tubing for Medical and Critical Applications
Selecting the best alloy for a tubing application can be a daunting task considering the wide variety of stainless steel and metal alloys available. The chromium in stainless steel forms a coherent passive oxide film and oxygen barrier, which imparts corrosion resistance. All stainless steels contain at least

IP Protection: Four Areas to Audit in Selecting A Contract Manufacturer
Intellectual property (IP) is the core of competitive advantage. When products are outsourced, the contract manufacturer performing the final assembly typically has access to the complete documentation package for the products they build. Where are the checks and balances? How can be certain your c

The Benefits of Outsourcing with A Full Service Contract Manufacturer
Contract manufacturers serving the medical device market typically divide into two distinct segments: electronics contract manufacturing and precision engineering contract manufacturers. Electronics contract manufacturers build both printed circuit board assemblies (PCBAs) and electromechanical systems. Pr

The Tooling Equation: Are You Maximizing Value?
Tooling for molded parts is often an area that many medical device manufacturing sourcing teams see simply as a line item in non-recurring engineering costs. However, anticipated project volumes, complexity of tool, tooling vendor selection and tool maintenance strategy are all issues that can impact prod

Simulation of Radiation Sterilization: Choosing the Best Packing Configuration
For cost reduction, it is beneficial to choose a packing configuration that allows for the highest throughput. Typically, the ideal arrangement is found through experimental trial-and-error. In addition to being expensive and time-consuming, such an approach might miss the packing configuration that finds the

Simulation of Radiation Sterilization: Guiding Product Design
In a typical product design process, testing to ensure that the sterilization regulations are met is only performed after the product has been fully designed, built, tested, and readied for mass production. There is an inherent risk to this approach: a great deal of effort and resources have been invested in

Simulation of Radiation Sterilization: Selection and Optimization of the Right Source
When using radiation sterilization, medical device and pharmaceutical companies are faced with the choiceof gamma, electron-beam, or x-ray sources. But which one to choose? While it may be tempting to go withthe familiar option, each of these techniques has its own benefits that might make it the ideal choice

Sterility Testing of Medical Devices: An Overview
A sterile medical device is one that is free from viable microorganisms. Medical devices produced under standard manufacturing conditions in accordance with the requirements for Quality Management Systems (QMS) may have microorganisms present on and/or within them prior to sterilization (non-sterile products)

Why Lean Manufacturing is Essential to Superior Product Quality
Contract manufacturing is a form of controlled chaos because most facilities have at least 30 different customers with differences in product technologies, preferred vendors, process specifications and demand patterns being manufactured in the same production area. SigmaTron International incorporates Lean ma

Continuous Microbial Air Monitoring in Clean Room Environments
Environmental monitoring is an important part of quality assurance for the production environments of medical devices and sterile pharmaceutical products. Especially for aseptic filling lines where products are filled without a terminal sterilization step it is of utmost importance for product safety and thus

Using Polyisoprene to Differentiate Your Medical Device
3 Key Takeaways for Engineers

Eliminating Adhesives in Medical Tubing Assemblies
EJ BioMed, an Eldon James Company, released information on the successful testing and application of PVC FREE tubing and fittings that do not require adhesives. Working alongside their supplier, Teknor Apex, the assemblies were tested for pull-off force, flow test, and leak test. The EJ BioMed fittings c

Automated Pill Dispenser
An automated pill dispensing system manufacturer required a unique seal coupler design to enhance pill counting and dispensing functions. Minnesota Rubber and Plastics provided a new lip seal design solving the initial problem of seal alignment with a more precise fitting lip configuration at the seal end for