The Medical Device Supply Chain: At What Stage of a Product’s Lifecycle Should You Bring in a CM Partner?
Your contract manufacturing partner can have a dramatic effect on the success (or failure) of your project. While an end-to-end CM can come in at any point of your production cycle, bringing them in at exactly the right time enables you to reap the greatest rewards

Providence Buyers Guide
SATISFACTION GUARANTEED: A Step-by-Step Guide to Identifying Your Perfect Fit Contract Manufacturing Partner

The Many Hats of an Integrated Contract Manufacturer and How Each One Fortifies Your Medical Device Supply Chain
In its 2020 report, Risk, Resilience and Rebalancing in Global Value Chains, McKinsey Global Institute includes a graph plotting different types of ‘shocks’ and their potential to disrupt value chains around the world. It includes everything from trade disputes to man-made disasters to changes in regulat...

Causes, Costs and Cures for Unplanned Downtime: Insights for Medical Device Manufacturers
Some causes of unplanned downtime are as old as manufacturing itself, while others are very recent. Some of these causes impact highly regulated industries, such as medical device manufacturing, more so than other areas of manufacturing. Whatever the cause, the damage is considerable. The very nature of...

GREAT COMMUNICATORS: How CM-Enabled Transparency Reduces Risk and Improves Your Medical Device Supply Chain
Communication plays a critical role in any partnership. As you consider the conversations with your contract manufacturing (CM) partner, how can you ensure the best communication strategy to exceed your expectations? At the very least, you need to tell them your product specs and they need to let you kn...

WINNING THE SPEEDTOMARKET RACE: Ten ‘Must-Haves’ for Medical Device Manufacturers
Worth nearly $450 billion in 2019, the global medical device market is expected to break the $670 billion mark by 2027. In spite of such healthy growth, those who want to capture a decent share of the market need to start early and hit the ground running.

The Makings of a Successful Medical Device Design: 10 Dimensions of Excellence
While far more than just trendy jargon, “Design for Excellence” (DfX) fulfils two common buzzword criteria: • A lot of people have heard it, but only a fraction of these really understand what it means. • The concept behind it is actually pretty straightforward and based on sound business s...

A SPECTRUM OF POSSIBILITIES: Medical and Cosmetic Applications of Light Therapy
For millennia, sunlight was revered for promoting good health. Then, it was discovered that too much sun drastically aged skin and increased the risk of skin cancer. New wisdom advised people to stay out of the sun…until it was found that more health issues around the world were caused by underexposure ...

NETWORKING WONDERS - 5 Things Engineers Need to Know about IoMT
The future of healthcare is proactive, marking a shift in focus from treating illnesses to preventing them. Medical self-monitoring is a booming trend and the networks that connect patients to machines to practitioners are increasingly complex, enabling multidirectional flows of information. Patients ar...

When To Use a Fast Cure Adhesive
To reduce assembly costs, why not consider a fast cure adhesive? But one caveat might be to question the need for speed when selecting the appropriate adhesive for an application. In this white paper, you’ll find an overview of the different types of fast cure adhesives, including one and two part epoxies,...

Innovative Medical Adhesives Simplify and Improve Fastening in Medical Devices
Modern adhesives offer medical device engineers a leg up with new options to simplify fastening and improve performance as medical devices and materials continue to advance. When faced with often hostile environments of human bodies and hospitals, modern, well-designed structural medical adhesive compounds...

Case Study - UV15: For Fabrication of Polymer Optical Waveguides
With its outstanding light transmission properties and optical clarity, Master Bond UV15 is widely used for a variety of bonding, coating and sealing applications in the optical, electronic and optoelectronic industries. In fact, it has been effectively used by RMIT University, the University of Texas at A...

Epoxies Safeguard Medical Electronic Devices
The combination of increasingly complex assemblies and exacting quality requirements is compelling design engineers to be extremely diligent when selecting materials for the assembly of medical electronic devices. In this white paper, we explore various polymer chemistries and what the different families o...

Sterilization of Medical Equipment
Sterilization plays a major role in the use of both reusable and disposable medical devices. Download this white paper to learn about the different types of sterilization methods and their effects on materials used in medical devices. Also included is The Spaulding Classification System and recommended pro...

Implementation of Redundancy in Miniature Stepper Motors
Some of the recent research in the area of electric motor drives for critical applications (such as aerospace and nuclear power plants) are focused on various fault tolerant motor and drive topologies. This paper focuses on a miniature PM stepper motor design which falls in this fault-tolerant category by ...

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 wh...

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 det...

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 supp...

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 produc...

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 eval...

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.

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