Industry Perspectives
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Human Factors Engineering Considerations For Medical Device Packaging
2/27/2023
As an integral component of product design, human factors engineering should be applied at the onset of a product-design initiative and carried out throughout the complete development process. This article shares key regulatory considerations and usability considerations for medical device packaging.
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New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices
2/15/2023
The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.
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What's Behind The ASTM E3263 Standard Revision?
1/17/2023
ASTM has published the revision of ASTM E3263 Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues. This article, written by the ASTM revision team, explains the reasons behind the revision and delves into the key updates.
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6 Key Inbound Value Chain Considerations For Medical Device Companies
1/13/2023
Medical device companies were hit especially hard during the pandemic. In 2023, key inbound considerations for medical device value chains will need to include sourcing strategies that enable dependable supply and rapid innovation, sophistication in balancing cost and risk, and agility and transparency in managing uncertainty.
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What’s Wrong With The Medtech R&D Department?
11/22/2022
Executives, staff members, and investors of medical device companies commonly ask, “What’s wrong with the R&D department? What’s taking so long?" This article discusses five common culprits and the common thread solution that could solve all of them.
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Wearable Electro-Patches: 4 Development Considerations
10/26/2022
When developing wearable sensor patches capable of providing medical-grade monitoring, we must begin by appreciating that creating a fully functional system involves some essential building blocks, all of which must work together.
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Autonomous Supply Chain Planning Is Within Reach
10/19/2022
In a fast-paced industry constantly innovating — from personalized medicine to health wearables — life sciences companies must be prepared to adopt transformative technologies that can help them meet the demands of the future of medicine. Autonomous supply chain planning is not science fiction; it's here, and it's now. Building a practical road map will help.
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You Have A Medical Device Proof Of Concept. Now What?
10/5/2022
No matter what the medical device in development, the first major milestone is usually proof of concept. How do you go from a build-of-one device to something you can manufacture reliably and at scale? This article shares key considerations in engineering and design, quality systems, and more.
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Human Factors Methodology In Medical Device Design For FDA Approval
10/3/2022
Human factors engineering processes are a critical component that should be considered throughout the full medical device development continuum rather than as a final requirement to check off at the end. This article shares tips for methodologies to enable FDA approval of your device.
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3 Steps For A Smarter Medtech Supply Chain
9/21/2022
Our medtech industry has a huge opportunity to make our supply chains “smarter" by making the most of digital technologies and data. But we need to work in an agile manner to adopt and scale technology. This article shares three main steps to take.