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.
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.
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.
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.
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.
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.
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.More Content Collections