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

Eldon James shelf-life determination for products produced with Flint Hills Resources 13R9A polypropylene random copolymer and tubing produced with FX polymer.
DENVER, COLORADO  – August 12, 2016 – Eldon James Corporation – a leading, U.S. based manufacturer of plastic tubing and fittings – announced the successful results of accelerated aging test results for their polypropylene fittings and FX polymer tubing.

Rapid Sterility Testing: A New Solution for Short Shelf Life Products
All drug products undergo sterility testing to comply with Good Manufacturing Practices (GMP). Parenteral drug products go through especially rigorous testing to ensure sterility and safety, otherwise risking contamination, which can lead to expensive reputation-damaging recalls and illness. Until recently

Developing Cost Effect Refurbishment/Remanufacturing Solutions to Extend the Life of Legacy Products
While the wealthier nations of the world want the latest technology in their medical products and have the budgets to pay for it, developing nations are often happier with the price points of older technology, provided it has been refurbished and meets appropriate quality standards. In a perfect world, thi

Is Made in Seychelles a Solution for Lowest Cost Entry into African Markets?
While medical technology can make a big difference in the overall health of developing nations, these nations have the smallest budgets for that technology. Medical device manufacturers often address this with lower cost, more basic product versions manufactured through contract manufacturers or joint ven

Production Inefficiency: Can A Specialized Medical Contract Manufacturer Be a Solution?
Most sourcing teams and many production managers have run into a common issue: manufacturing projects whose lower volumes, near end-of-life status or specialized manufacturing processes make them outliers in the overall sourcing or manufacturing strategy. When forced on contract manufacturers as part of ov

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 infrastruc

Safety in medical electrical equipment starts with the power input
Electrical equipment used in medical technology must not place patients or medical staff in danger. This, in turn, requires that designing safe equipment starts at the point where the power is supplied. Power connectors and power entry modules with or without a power-line filter must fulfill the requiremen

Offshore, Nearshore or Onshore: What Makes Best Sense for Your Project?
SigmaTron International's latest whitepaper looks at manufacturing sourcing strategy and the factors that influence whether offshore, nearshore or onshore represents the best option based on different product characteristics.

Medtech Mergers & Acquisitions of 2019
Mergers and acquisitions (M&As) continued to change the landscape in the medical device and diagnostics industry in 2019. See which companies were bought, sold, or spun-off last year with our comprehensive list of 2019 medtech M&As. Information in the report includes the following: Buyers

The Relationship Between Product Development Support and Smooth Outsourcing Transitions
Outsourcing manufacturing provides a number of benefits including reduction in inventories and capital requirements, the ability to leverage shared production resources, and the ability to consolidate supply chain management activities. However, one of the largest and often untapped benefits is the abilit

Self-Monitoring
As Demand for Self-Monitoring Devices Surges Custom Converters Need Release Liner Experts

Is Singapore a Good Option for Your Medical Product Development Strategy?
While an innovative, market differentiating approach is critical to achieving competitive advantage and dominant market share, it isn’t the only critical element in new product development. Market timing, quality and cost are also in the mix. The question becomes: “what is the right strategy to achieve op

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

The Quality Equation: Four Areas Your Contract Manufacturer Should Support
While outsourcing manufacturing helps original equipment manufacturers (OEMs) allocate more internal resources to core competencies in product development and marketing, it also outsources much of the responsibility for quality to a contract manufacturer. In effect, the contract manufacturer is not

What Causes Wrinkles in Heat-Sealed Pouches?
Wrinkles in the seal area can cause a package to be rejected. Let's look at somethings that can be done to avoid packaging failures.

Is Heatsealing Art or Science?
The evolution of heat sealing perfection from hot bars, to impulse to VRC TOSS Technology. Today's heat sealers provide much more than just sealing the pouches.  Advanced security, information downloading, recipe storage, easy validation.....  

The Real Story About Controlled Impulse Heat Sealing of Polymeric Materials
Toss VRC Technology is an improved method of impulse heat sealing that overcomes the limitations of simplistic convention methods. It brings advantages to the fabrication and packaging requirements of the Medical/Pharmaceutical/Healthcare and Biotech Industries. Advantages that are not available with oth

Avoid Pouch Sealing Disasters - The 9-Steps to Heat Sealing Perfection
Step 1 Heat Sealing Configuration. Determine what is expected from the seal. What does one expect from a heat seal? Wide, narrow, shaped, or just seal or seal and cut? Before a satisfactory sealing system can be designed it is necessary to decide what seal configuration is desired. Step 2 Heatseal Ban

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

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.