FEATURED EDITORIAL
The Role Of Trust And Communication In Successful Medical Device Teams
Why do we experience teams that seem to start out well, then stumble throughout the project, resulting in delayed launches, product defects, and poor sales? How do they differ from teams that start out similarly yet appear to breeze through the project development stages to launch a successful product? This article also examines each team member's role in improving trust and communication.
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![iStock-1226943453]( "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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![New-Business-Technology-iStock-1220938772]( "4 Strategies for Medtech Compliance With FDA’s Upcoming Computer Software Assurance Guidance")
As the FDA finalizes and publishes the Computer Software Assurance (CSA) guidance later this year, companies that have not already started the transformation process to CSA should get started now. Here are 4 strategies to be successful.
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![iStock-178895760]( "A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I")
This article introduces a novel model of benefit-risk by taking a bottom-up approach using the _risk of the therapy_ and comparing it to _risk of no therapy_ to quantify risk and benefit with the same scale. This overview is relevant not only to the pharmaceutical and biotech industries, but also the medical device industry.
INDUSTRY INSIGHTS
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![Sales business meeting]( "How To Avoid Pharma’s Top 5 FDA Form 483 Triggers")
How To Avoid Pharma’s Top 5 FDA Form 483 TriggersRead 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.
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.
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.
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.
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.
SOLUTIONS
At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.
The margin for error when it comes to critical components for medical device manufacturing is zero. That's why Accumold ensures robust production processes, extremely tight requirements, and part-to-part consistency.
Cardinal Health’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.
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.
MasterControl's supplier management solution automates supplier management processes and ensures supplier quality and compliance.
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.
FEATURED SUPPLIERS
The Lee Company is a leading supplier of miniature, precision fluid control products to a wide range of industries including medical devices and scientific equipment.
Carclo Technical Plastics is an international engineering based company led by engineers coupling industry standards with a Six Sigma culture. We specialize in injection molding and contract manufacturing services for medical devices, medical equipment, optics, and electronics applications.
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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