Industry Perspectives - Design & Development
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Attribute Vs. Variable Testing For Device Functionality: What They Are & When To Use Which
11/24/2021
Testing performed during medical device development serves to (1) demonstrate that the developed manufacturing process can produce good products that meet the established specification reliably and (2) demonstrate with confidence that the device design will consistently meet the established specification. This article discusses the strategic approaches to selecting one over the other.
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Risk-Benefit of Personally Identifiable Information in Extended Reality Medical Applications
11/15/2021
The expanding use of extended reality (XR) in medical applications presents a number of unique opportunities and challenges. Due to the extensive reliance on software and networked data, cybersecurity risks must be addressed during the design, development, and use of XR devices. And, of course, compliance with all regulations concerning privacy and control of PII is essential.
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Collaborative Communities: An Opportunity To Contribute To Medical Device Industry Improvements
11/2/2021
Collaborative communities are a global grassroots effort convened by interested public and private stakeholders who work to solve shared challenges and achieve common goals related to medical devices. These communities do not replace established regulatory mechanisms, are not federal advisory committees, and are not chaired or convened by the FDA, but FDA may participate. Here are the descriptions, goals, and contact information for each of the 12 collaborative communities that have FDA CDRH participation.
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How To Create A Pathway For Diversity In Medtech
10/20/2021
When different perspectives and backgrounds come together, it sparks innovation that can drive significant technological advancement. The most diverse companies are now more likely to outperform their less diverse peers. Beyond company performance, ensuring adequate representation throughout the product development pipeline leads to better outcomes for patients in underserved and underrepresented communities.
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The Role Of Trust And Communication In Successful Medical Device Teams
10/18/2021
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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4 Strategies for Medtech Compliance With FDA’s Upcoming Computer Software Assurance Guidance
10/6/2021
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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COVID-19 Vaccine Benefit-Risk Analysis/Ratio Using Real World Data
10/6/2021
For National Immunization Awareness Month, we're highlighting timely vaccine manufacturing-centric articles such as this one, covering a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. The article provides a relevant, contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.
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Medical Device Biocompatibility Testing: Best Practices & How To Minimize Risks
10/4/2021
In Part 1 of this two-part series, the author discussed strategies to ensure biocompatibility success from an organizational standpoint. In this second article of the series, he discusses some of the ways to ensure biocompatibility study successes and how to minimize risks.
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A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I
10/4/2021
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.
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3 Reasons Why Medtech & Digital Healthcare Companies Should Consider Direct-To-Cloud Connectivity for IoMT
9/29/2021
A critical part of the digital health ecosystem, wireless connectivity is a key enabler for medical devices that can be used by patients at home and on the move. For example, connected drug delivery devices enable pharma companies to offer remote monitoring, while wearable sensors enable continuous remote diagnostics. This article explains 3 reasons why you should consider direct-to-cloud connectivity for your product.