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FEATURED EDITORIAL

Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications

While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. Such risks are foremost about injury to the patient and to the user. Other associated risks may be to the environment or with any data collected. It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk posed by these devices.

The Impact Of Market Restrictions On The U.S. Stem Cell Biomaterials Market

Biomaterials are biomedical materials that can be safely implanted or injected into the body and are, more often than not, a form of biologically active tissue themselves. This article examines stem cell research and the market of cell-based products for orthopedic biomaterials.
Medical Device Commercialization: Traits For You To Be Successful, Part 1

There are virtuous ways to “BE” when you’re working hard to move your promising medtech innovation further along the pathway to commercialization, success, and prosperity. This article shares insights from a Med Tech Gurus podcast episode and shares 5 traits for you to pave the way to commercialization success.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk

In Part 1 of this 2-part series, the authors presented a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. This method can be applied to any medical therapy, and this article (Part 2) provides a very relevant and contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.

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INDUSTRY INSIGHTS

How To Avoid Pharma’s Top 5 FDA Form 483 Triggers
Read about most commonly cited conditions that led to the issuance of Form 483s to drug companies last year (as summarized by the FDA in the most recent 12-month inspection period on record) and practical tips for avoiding them.

EIA MLCC Case Sizes: Past And Future

Standards are a form of technical infrastructure, and their influence is felt throughout the electronics industry. For example, formed in 1924, the Electronic Industries Alliance (EIA) was an American standards organization that established an alliance of trade associations in the United States electronics manufacturing industry.

Vital Signs Of The Medical Device Industry

The medical device industry emerged from 2020 a little beat up and bruised, but those that were able to adapt successfully will act as models for 2021 and beyond. As the medtech ecosystem and medical device regulations continue to evolve in conjunction with the continued pressure to meet demand while adhering to quality expectations, medical device companies must embrace digital transformation and shifts in mindset to remain competitive.

5 Medical Device Best Practices For Managing Risk To Users, Patients, And The Environment

Medical device companies of all sizes are often concerned about speed-to-market, new device clearance overhead costs to maintain compliance, and lack of certainty about what is needed to maintain compliance, and fear of non-compliance consequences. We explain how to meet these compliance standards by following these best practices to bring new medical devices to market with success.

Cybersecurity In Medical Device Development

Security now needs a seat at the medical device design table, accompanied by its own list of requirements. Here are resources to identify specific areas to focus cybersecurity efforts throughout the product’s life cycle.

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SOLUTIONS

21 CFR Part 11 Data Integrity Software for Container Closure Integrity Testing Systems

PTI has developed a new standard for protecting, storing and presenting data generated from its line of non-destructive leak testers in the form of a software package called PTI Ethos.

Rapid Tooling And Medical Device Prototyping

Whether you need a few pieces or a few thousand, Donatelle's highly specialized team can produce parts with near-production tolerances in as little as a few days. As part of their integrated services, they work closely with your design team to select the best polymers and metals to bring accuracy and consistency to your molded components. You can also rely on their expertise with hundreds of exotic materials, including high-temperature, implantable-grade and silicone.

Pressure Relief Valves (For Plastic)

The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.

Low Volume Molding

PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

Adhesive Films Coatings And Sealants Technology

DSM Biomedical delivers a versatile and tunable hydrophilic polymer technology designed for adhesive applications. This technology mimics the proteins of marine mussels when they bond to underwater surfaces.

Linear Ultra Sonic Motors

Canon's new ultra sonic piezo motor offers great features such as compact, quiet and accuracy for linear positioning applications. Canon has been using this technology for driving focus lens in camera product.

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FEATURED SUPPLIERS

MasterControl, Inc.

MasterControl's software solutions enable medical device manufacturers to increase compliance while reducing the time needed to get their products to market. Our software is designed for the medical device industry by industry professionals. MasterControl MD™, the premier software solution for the medical device manufacturer, includes rich functionality for document management and control, quality event management, training management, bills of materials, supplier quality management, design history file (DHF) management, project management, device history record automation, and much more.

PTI - Packaging Technologies & Inspection, Inspection Technologies

PTI Packaging and Inspection Systems

Packaging Technologies & Inspection (PTI) is a leading manufacturer of inspection technologies for the pharmaceutical industry that are non-destructive, non-invasive and require no sample preparation.

MED DEVICE ONLINE CONTENT COLLECTIONS

Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.

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