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Qmed Directory Latest Whitepapers.
Updated: 19 min 3 sec ago

Six Benefits of Selecting an EMS Provider with Product Design Capability

Sat, 13/07/2019 - 3:01am
Product design engineering resources are shrinking at many companies. This often creates challenges for the team that remains. While a standalone product development firm or a contract engineering resource may seem the best option to address an engineering resource shortage, it can often result in a siloed ap
Categories: DOCU Whitepapers

The Clock Is Ticking: Will Notified Body Capacity for the EU MDR Affect You?

Tue, 09/07/2019 - 3:01am
We are less than one year away from the full implementation of the European Union Medical Device Regulation (MDR) (May 2020) and three years away from the full implementation of the In Vitro Device Regulation (IVDR) (May 2022).
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Actionable Steps to Eliminate Small-Bore Connector Misconnection

Tue, 09/07/2019 - 3:01am
Adopting ISO 80369
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Advancements in Clear High Barrier Packaging Materials

Tue, 02/07/2019 - 3:01am

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

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Protecting Healthcare Software

Fri, 28/06/2019 - 3:01am

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.

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How to Avoid Part Warpage

Thu, 27/06/2019 - 3:01am
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!
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Crescent Doubles Production Capacity While Cutting Production Costs by 18%

Thu, 27/06/2019 - 3:01am
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
Categories: DOCU Whitepapers

What is Design of Experiment for Injection Molding

Thu, 27/06/2019 - 3:01am

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.

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Myths for Purchasing Injection Molds and Injection Molded Parts

Thu, 27/06/2019 - 3:01am

Many companies think the purchasing of an injection mold is the tooling necessary to produce a plastic part, while this is correct there are some considerations that need to be made before your purchase.

Categories: DOCU Whitepapers

Challenges with MEMS Pressure Sensor Integration in Medical Devices

Wed, 26/06/2019 - 3:01am
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
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Finding Balanced Solutions for Medical-Grade Materials

Tue, 25/06/2019 - 3:01am

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

Categories: DOCU Whitepapers

New Catheter Based Devices and Procedures Driving Hemostasis Valve Innovation

Wed, 19/06/2019 - 3:01am

The viability of new interventions dependent on more robust componentry

Today's hemostasis valves are a vexingly difficult engineering challenge. Beyond the minimum requirements per ISO 11070 and ISO 10555 for pressure and vacuum decay, emergent invasive catheter therapies are demanding muc
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Case Study: Overcoming Barriers of Adopting ISO 80369

Tue, 11/06/2019 - 3:01am
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,
Categories: DOCU Whitepapers

Benefits of ZPower's Silver-Zinc Rechargeable Batteries

Tue, 11/06/2019 - 3:01am
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
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ZPower FAQ with Electronic Design

Fri, 07/06/2019 - 3:01am
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.
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Sanavita Spinal Case Study

Fri, 07/06/2019 - 3:01am
SanaVita Medical manages reverse-engineering, reduces time to clinical evaluation for spinal tether implant.
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Validating Medical Device Assembly, Packaging, & Sterilization

Tue, 04/06/2019 - 3:01am
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
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Leveraging Human Factors Testing to Develop a Better MedTech Product

Tue, 04/06/2019 - 3:01am

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

Categories: DOCU Whitepapers

What Can the Medical Device Industry Learn from the Boeing 737 MAX 8 Crashes?

Tue, 04/06/2019 - 3:01am
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.
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Die Attach Adhesives Impact Product Quality Well Beyond Manufacturing

Tue, 04/06/2019 - 3:01am
Die attach adhesives serve a vital role in semi-conductor assembly, manufacturing and throughout the product life cycle. In this white paper, learn how they facilitate assembly and about the application process. Find out why thin bond lines are so important for product life cycle. Bond strength is only one, a
Categories: DOCU Whitepapers