Improving Injection Molding Processability Using Transparent Medical ABS Resin
This White Paper presents processing and injection molding details for TOYOLAC® ABS transparent medical resin providing significant cost-advantages when injection molding TOYOLAC® due to lower operating temperatures and lower pressure requirements compared to polycarbonate.

Biological Evaluation of Medical Devices as an Essential Part of Risk Management Process: Updates and Challenges of ISO 10993-1:2018
In August 2018, a new version of ISO 10993-1 was published, which highlighted the importance of gaining deeper knowledge of the device. In the new version of the standard, not all biological effects should be assessed by biological testing. Some tests can now be waived if there is a sound rationale to support

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)

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

Insights into in-vitro Hemocompatibility testing according to ISO 10993-4
Hemocompatibility testing of blood-contacting medical devices is one of the most important criteria for successful clinical application.

Singapore: Innovative Medtech Hub Combined with World Class Contract Manufacturing
In the medical industry, hubs of innovation aren’t created overnight. They are cultivated over time, when policymakers, institutions, medical device makers and suppliers collaborate to create an environment with the right infrastructure to support innovation. If you study areas of the world with a high co

Case Study - Seal Coupler
Delivering on LSR market demands for critical cardiac component

Case Study - Implantable Micro Component
Leading cardiovascular company leverages vertically integrated capabilities for intricate implantable component

Case Study - Limits of Micro Manufacturing
Pushing the limits of micro manufacturing, Donatelle helps OEM create implantable grade component to improve cardiovascular device

Case Study - Race Against Time
In a race against time, startup takes advantage of Donatelle’s pure medical expertise and vertical integration for novel Class III device

Case Study - Critical Launch
Accelerated time-to-market keeps critical launch on track

Case Study - Development to Deployment
From development to deployment in six months flat

Case Study - Full Product Line
Full product line, tight timeline

Case Study - High Stakes
Tall order, high stakes

Case Study - Vertical Integration
Vertical integration adds value – and viability

Molding Bioresorbable Materials for Medical Devices and Components
Taking full advantage of bioresorbable materials in medtech requires an understanding of each material’s strengths, production challenges, and ideal applications.

How to Establish High-Quality, Sustainable Dock-to-Stock Programs
Effective dock-to-stock programs ensure optimal outcomes by identifying risks up front, setting clear timelines, and assigning unambiguous responsibilities to all shareholders.

Toray TOYOLAC MEDICAL TRANSPARENT ABS 909 MG1 White Paper
The Effects Of Electron Beam And Gamma Sterilization On Transparent Resin Used In Medical Devices

Toray RAYTELA® Polymer Optical Fiber White Paper
RAYTELA® Polymer Optical Fiber Is Ideal For Minimally Invasive Surgery

Before You Outsource: 10 Strategic Considerations for Partnering with a CMO for Biochemical Reagents and Formulations
Should you outsource production of biochemical reagents and formulations to a contract manufacturing organization (CMO), or invest in in-house capabilities? This is a foundational business decision that requires careful consideration of capacity, capabilities, and resources. This list of 10 strategic consider

4 Challenges Custom Cables Solve and When to Consider Them
Custom cables aren’t needed for every application, but sometimes off-the-shelf cables can’t meet specific requirements for medical/healthcare; industrial; automation; and government applications. If you have cases where cables slow your installations, cause repeated problems, or don’t fit/work just right, dow

Test Strategy: Balancing Cost and Coverage
In a world where keeping product cost low is seen as integral to maintaining competitiveness, it can be difficult to justify the cost of test. After all, if there is a superior quality manufacturing process with appropriate inspection steps and control limits, why is testing necessary? The reality is that

Improving Project Transition: Four Areas to Focus On
One of the most challenging aspects of the outsourcing process can be project transition: moving an existing project from one facility to another. In some cases, this is a move from the OEM customer’s facility and in other cases it may be a move from one contract manufacturer to another. S

Field Oriented Control (FOC) - A Deep Dive
DC Brush, Brushless DC (BLDC) and step motors are the three most commonly used motor types for positioning and velocity motion control applications. Of these, Brushless DC and step motors are 'multi-phase', meaning they require some type of external coil excitation to keep the motor moving. This de

CMS Coverage Playbook: How to Secure IDE Clinical Trial Reimbursement
Requesting CMS reimbursement for investigational device exemption (IDE) clinical trials is nothing if not complicated. Sponsors that succeed, however, can offset routine healthcare and device costs accrued during the clinical trial. Download Avania's latest white paper to find out how to apply for coverage an

Outsourcing Partnerships: Four Success Stories
One of the phrases used in describing successful outsourcing relationships is that the electronics manufacturing services (EMS) provider becomes an extension of its customers’ manufacturing operations. While that represents the most common sign that the outsourcing relationship is aligned in ways that pro

Supply Chain Challenges: How Resilient is Your Contract Manufacturer’s Supply Chain Management Process?
Supply chain management (SCM) is one of the most critical services an electronics manufacturing services (EMS) provider offers. In a perfect world, the combination of good systems, good supply chain partners and internal expertise creates an efficient flow of material into a production system flexible eno

The Engineering Equation: Why Product Development and Manufacturing Teams Should Work in Tandem
Originally, the basic premise of outsourcing was that manufacturing was a commodity activity and that divesting it would free up OEM resources and cash for R&D and marketing. While that works in a business school case study, the reality is that truly leveraging the benefits of outsourcing requires that pr

The Cost Benefits of a Lean Six Sigma-Based Continuous Improvement Approach
The COVID-19 pandemic has created far more than just a health crisis. The impact of government-mandated shutdowns, restricted travel and unpredictable demand has increased costs and created imbalance among supply chains and their end markets. This impact is particularly significant in medical manufacturin

Learn Why & How to Profit from the New Hub for Contract Manufacturing: Vietnam
Vietnam has emerged as a leader for outsourced manufacturing among southeast Asian nations due to its exceptional cost competitiveness and consistent high quality. Vietnam’s location — adjacent to established supply chains across the border it shares with China — provides original equipment manufacturers (