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DOCU Whitepapers

Is Your Contract Manufacturer's Product Design Team Constrained by Production Capability Limits?

DOCU Whitepapers - Thu, 12/09/2019 - 3:01am
One of the key benefits of using a contract manufacturer for both design and manufacturing is the ability to work with a product design team that is experienced with manufacturing. This can eliminate design errors that could otherwise increase tooling costs and secondary processing costs. However, this op
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The Benefits of Vertical Integration in Supply Chain Selection

DOCU Whitepapers - Thu, 12/09/2019 - 3:01am
Outsourcing single use medical device manufacturing with the right supplier can add expertise, cut development time and lower total costs while maintaining superior quality. The question becomes: “what capabilities should that supplier have in-house vs. manage through third parties?” Many suppliers have o
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Can Use of Sequential Injection Molding Reduce Production Costs on Your Project?

DOCU Whitepapers - Thu, 12/09/2019 - 3:01am
Tooling design can be critical to achieving commercialization goals. Tool design has a direct impact on product cosmetics, cost and scalability. Sequential injection molding offers both cosmetic and throughput benefits, but in its traditional form has required a bulky mold and use of larger tonnage machin
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Five Issues Your Contract Manufacturer Should Address in Tool Design

DOCU Whitepapers - Thu, 12/09/2019 - 3:01am
From a medical device manufacturer's standpoint, tooling is often the least focused upon element in a product development process. Yet, tool design often has significant impact on product quality and cost; production scalability; and on-time delivery. A contract manufacturer's ability to educate its custo
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Case Study: Teaming with Your Contract Manufacturer to Reduce Product Introduction Expense

DOCU Whitepapers - Thu, 12/09/2019 - 3:01am
Developing new products can be a costly proposition for start-up medical product companies, especially if they lack established distribution channels. Teaming with a contract manufacturer experienced in similar applications can reduce product development time and open the door to options for lowering product
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Top 5 Common Mistakes Engineers Make When Designing For ePTFE

DOCU Whitepapers - Wed, 11/09/2019 - 3:01am

ePTFE is extremely versatile, perfect for many industries & applications, and offers exceptional physical & chemical properties. It can be strong, rigid, thick, thin, flexible, or permeable (depending on the ultimate use). It is a highly flexible, lubricious, chemically inert, hydrophobic plastic. With all

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High-Performance Micro-Porous Fluoropolymer Plastics for Critical Applications

DOCU Whitepapers - Wed, 11/09/2019 - 3:01am
ePTFE, a non-woven, open pore Fluoropolymer plastic, is suitable for the critical demands of medical applications and other industries.
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Getting the Most from Your Extrusion Tooling

DOCU Whitepapers - Mon, 09/09/2019 - 3:01am
Tooling maintenance improves extrusion efficiency, enhances quality and boosts overall productivity for our medical tubing applications
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Fluid Management Materials Improve Infection Control

DOCU Whitepapers - Thu, 05/09/2019 - 3:01am
Our long history of innovation in porous plastics design, materials selection, and proprietary manufacturing processes provides cost-savings, enhanced performance, and convenience for a wide range of medical device applications.
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How to Improve Resiliency in the Medical Device Supply Chain

DOCU Whitepapers - Thu, 29/08/2019 - 3:01am
Supply chain breakdowns in product quality, delivery or availability are a major disruption in the medical device supply industry. In addition to adding time and cost to the device procurement process, insufficient supply of accurately performing parts could endanger patients' health. There are options for se
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Delving Deeper into FDA Warning Letters

DOCU Whitepapers - Mon, 26/08/2019 - 3:01am
FDA Update
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Foreign Companies Beware – The FDA is on the Warpath

DOCU Whitepapers - Mon, 26/08/2019 - 3:01am
FDA compliance has been much more difficult to deal with.
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Understanding The EU Medical Device Regulation For Device Companies

DOCU Whitepapers - Thu, 22/08/2019 - 3:01am

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

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Success Story - Rapid Design to Commercial Manufacturing of a Specialty Balloon Catheter

DOCU Whitepapers - Thu, 22/08/2019 - 3:01am
Learn how Freudenberg Medical took a specialty balloon catheter from design concept to market-ready product in just 18 months, rapidly bringing the customer to market and helping them establish a commanding market position.
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The Right SAP Solution for Your Midsized Company

DOCU Whitepapers - Tue, 20/08/2019 - 3:01am
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
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Addressing the Challenges of Medium Volume Medical Box Build

DOCU Whitepapers - Mon, 19/08/2019 - 3:01am
Medical device manufacturers face two significant challenges when outsourcing. Their products must meet the requirements of a complex regulatory environment and the pressure to reduce cost continues to grow. The complex regulatory environment limits product redesign for cost reduction options and increases da
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Selecting & Justifying Sample Sizes: Where to Begin?

DOCU Whitepapers - Thu, 15/08/2019 - 3:01am
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.
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Choosing Colorants for Medical Devices

DOCU Whitepapers - Thu, 15/08/2019 - 3:01am
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
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EO Residue Levels in Medical Devices

DOCU Whitepapers - Thu, 15/08/2019 - 3:01am
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
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Current Regulatory Landscape for EO Residue Levels in Medical Devices: What Manufacturers Need To Know Now and What May Be on the Horizon

DOCU Whitepapers - Thu, 15/08/2019 - 3:01am

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

Categories: DOCU Whitepapers