What Can the Medical Device Industry Learn from the Boeing 737 MAX 8 Crashes?
In this paper, we will focus on only one very small aspect of this investigation revealed in several articles, which has relevance to the medical device risk management process of both the hardware and the software system, as it relates to cases the author has encountered in the medical device industry.

Case Study: Overcoming Barriers of Adopting ISO 80369
The high stress of an emergency room or ICU creates an environment in which the probability of human error spikes dramatically, adding a layer of risk to an already-tense situation. Asking medical professionals to make rapid diagnoses and decisions in that stress-filled state can lead to device misconnection,

Delving Deeper into FDA Warning Letters
FDA Update

Foreign Companies Beware – The FDA is on the Warpath
FDA compliance has been much more difficult to deal with.

Understanding The EU Medical Device Regulation For Device Companies
Europe’s new Medical Device Regulation (MDR) will have a big impact on product-development timelines. Companies must be planning now for stricter biocompatibility testing requirements, which will go into effect in May 2020. This white paper, Understanding the EU Medical Device Regulation for Device Com

The Right SAP Solution for Your Midsized Company
Trying to understand SAP and their product line can be a bit like trying to learn a new language. This eBook compares and contrasts SAP’s three ERP product offerings for small and mid-sized businesses – SAP Business One, SAP Business byDesign and SAP S/4 HANA in the public cloud. You’ll find an objective appr

A "Particle" of Prevention Is Worth a Pound of Cure
The Significant Benefits of Premarket & Postmarket Particulate Testing of Cardiovascular Devices

Current Regulatory Landscape for EO Residue Levels in Medical Devices: What Manufacturers Need To Know Now and What May Be on the Horizon
The goal for medical device manufacturers that use EO sterilization to minimize patient exposure to EO residues and (and EO derivatives) from their devices and ensure that the levels of residual EO, ethylene chlorohydrin (ECH), and ethylene glycol (EG) pose the least amount of risk possible to the patient

Choosing Colorants for Medical Devices
Colorants are often added to the substrates and material components of medical devices with the primary intent of improving the usability of the devices. For instance, color coding can assist users in matching devices or sizes together when multiple options are available. Colorants can also be used to brand m

Selecting & Justifying Sample Sizes: Where to Begin?
Within our industry, we have seen several approaches to selecting samples sizes; this paper will not cover all of the approaches, but it is a guide to give medical device manufacturers and pharmaceutical companies a good starting point for determining their own ideal sample size.

EO Residue Levels in Medical Devices
Sterilizing medical devices via ethylene oxide gas is an effective and common practice within the industry. EO gas is active at a relatively low temperature compared to other methods, such as steam, and it is compatible with plastics, polymers, and many products that are not compat¬ible with other sterilizati

Establishing Bioburden Alert and Action Levels
Most national and international standards regarding bioburden, sterilization, or environmental testing refer to establishing alert and action levels to assist in demonstrating continued control over a process or product. The standards sometime include guidance on evaluating the data but seldom go any furth

Sterilization & Biocompatibility of 3D-Printed Orthopedic Devices
Download this whitepaper to learn about the various biocompatibility and sterilization considerations surrounding 3D-printed orthopedic devices. 3D-printed orthopedic medical devices are gaining attention and popularity due to their potential for enhanced biocompatibility, customizability, and cost-effectiven

Considerations for Third-Party Reprocessing of Single-Use Medical Devices
Reusing single-use devices that have been safely reprocessed by a third-party reprocessor can enable healthcare providers to maintain high-quality patient care while saving on costs and reducing medical waste. Validated functionality testing must be paired with validated cleaning, disinfection, and steriliza

3D Printed Medical Devices and Biocompatibility
The use of three-dimensional (3D) printing techniques to address challenging fabrication problems has become mainstream over the past decade. While this rich resource has extended fabrication of personalized medical devices to the limit of our imagination, the myriad materials and morphologies available pr

Could Lean Product Development Get You to Market Faster?
Every manufacturing engineer is familiar with The Machine That Changed the World: The Story of Lean Production. First published in 1990, this classic book was the first to detail the Toyota Production System from which the principles of Lean Production were derived. The authors predicted that Lean Producti

Medtech Mergers & Acquisitions of 2018
Mergers and acquisitions (M&As) continued to change the landscape in the medical device and diagnostics industry in 2018. See which companies were bought, sold, or spun-off last year with our comprehensive list of 2018 medtech M&As. Information in the report includes the following: Buyers

Medtech Salary Survey 2018
Is it time to ask for a raise? Each year, we ask medical device and diagnostic industry professionals detailed questions about their compensation and careers. This year, 245 full-time medtech professionals sent in responses. We’ve analyzed the data to reveal the median salary for the industry as well as ga

Advancements in Clear High Barrier Packaging Materials
Clear high-barrier materials are an excellent alternative to traditional aluminum foil. Manufacturers enjoy the ability to easily inspect packaged product through the use of vision systems, metal detectors, and manual visual inspection. As a marketing tool, clear materials allow for product differentiation

Protecting Healthcare Software
The purpose of this white paper is to highlight potential threats in typical modern medical applications in terms of cybersecurity and protection of patients’ medical data, and how to effectively address these threats with Intertrust’s whiteCryption® technology.

Crescent Doubles Production Capacity While Cutting Production Costs by 18%
A global OEM and longtime Crescent Industries customer needed a customized, automated, and high-throughput solution to capitalize on a successful product—and they needed it fast. As demand for its reagent dipstick exploded due to rapidly increasing market share, this OEM struggled to supply hospital labs with

What is Design of Experiment for Injection Molding
When developing a new product using injection molding processes, the customer wants to achieve specific levels of product performance. The manufacturer wants to have a certain level of production efficiency. The end user wants to have reliable performance of the product in the field.

How to Avoid Part Warpage
Successful part designs and material selection are built on an understanding of potential process-related issues such as the potential for warpage – thus, it is very important to understand the causes of warp in order to avoid this defect!

Challenges with MEMS Pressure Sensor Integration in Medical Devices
This white paper discusses the need for pressure sensor integration in medical devices with a focus on applications, different pressure sensing technologies, MEMS sensor options, and considerations during the encapsulation and integration process. It highlights the need for an experienced partner to help stre

Finding Balanced Solutions for Medical-Grade Materials
When medical device and diagnostics manufacturers work through material selection for their products, polymers such as polycarbonate (PC), polyethylene terephthalate (PET), and poly-vinyl chloride (PVC) are commonly used materials that first come to mind. Some of these established grades are used because t

Benefits of ZPower’s Silver-Zinc Rechargeable Batteries
This white paper details the benefits of ZPower’s rechargeable microbatteries for designers and engineers aiming to create new and disruptive products. ZPower’s rechargeable cell is the smallest, high-energy microbattery available to innovators looking to shrink the next generation of consumer & medical produ

ZPower FAQ with Electronic Design
This FAQ covers the major benefits of ZPower’s silver-zinc microbatteries. ZPower batteries are the smallest, safest, highest-energy rechargeable microbatteries available. They are a good choice for designers and engineers aiming to enable new, next-generation smaller and safer consumer and medical products.

Validating Medical Device Assembly, Packaging, & Sterilization
Medical device packaging and sterilization validation are required for FDA 510(k) submissions yet are often causes of delay. Sterile packaging validation is a vastly misunderstood topic in its own right but becomes even more complicated when considering it involves the additional coordination of manufacturing

Leveraging Human Factors Testing to Develop a Better MedTech Product
Historically, human factors risk has taken a back seat to clinical risk. For a product to be viable it needs to clinically work and used as intended in a safe and effective way. By not focusing on mitigating risk on both fronts, there remains a chance that the safety of patients, doctors, nurses

Medtech Incubators and Accelerators
Are you a medtech entrepreneur looking for support and resources to help start or grow your company? Start here, with our free list of dozens of incubators and accelerators serving the medical device, diagnostics, health IT, and digital health fields. The list features incubators and accelerators based acr