Medical Device Product Development

Navigating Medical Device Design Control & Risk Management

Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.

Nick Schofield

Nick Schofield is a content creator for Cognition Corporation. A graduate of the University of Massachusetts Lowell, he has written for newspapers, the IT industry, and cybersecurity firms. In his spare time, he is writing, hanging out with his girlfriend and his cats, or geeking out over craft beer. He can be reached at nick.schofield@cognition.us.

Blog Feature

Thought Leadership | Industry Updates

FDA Pulse Check: June 2019

By: Nick Schofield
June 27th, 2019

Things appear to be slowing down at FDA as summer approaches. June 2019 saw less regulatory activity than in previous months, but there are still a handful of important updates worth checking up on.

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Thought Leadership

6 Ways to Make Your Life Science Product Development More Productive

By: Nick Schofield
June 25th, 2019

Product development in life science industries is not always consistent; it naturally ebbs and flows depending on a variety of factors, such as: project reviews, technological breakthroughs, changes in personnel, and so on. However, if your organization is struggling with being productive, some larger issues need to be addressed. To improve productivity at your life science organization, there are six different approaches you can take.

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How to Approach Usability Engineering & Use Error Analysis

Learn how activities like Use Error Analysis can lead to more dynamic, impactful risk management.

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Thought Leadership

4 Factors Influencing User Needs for Younger Patients

By: Nick Schofield
June 20th, 2019

Life science organizations are continuously attempting to handle the ever-changing needs of the marketplace—especially those of users and patients. With the rising number of retiring Baby Boomers set to double Medicare and Medicaid costs by 2020, it is advantageous for organizations to build products and services that meet the needs of this population. However, shifting demographics are causing growing pains that life science organizations need to factor in for long-term stability and growth.

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Thought Leadership | Industry Updates

A Refresher on FDA Form 483s and Inspectional Observations

By: Nick Schofield
June 18th, 2019

FDA Form 483 inspectional observations can be disruptive to life science organizations, causing anything from delays in time to market to lost profit on currently marketed products. However, it’s vital to tackle the disruption to minimize these issues; procrastinating on or ignoring a 483 only makes the situation worse.

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Thought Leadership

7 Ways to Bolster Your Risk Analysis

By: Nick Schofield
June 13th, 2019

Risk analysis is a vital component of life science product development. However, because FDA and other regulatory bodies aren’t specific about how to conduct risk activities that they deem appropriate, some organizations struggle in implementation. For teams dealing with this, there are a handful of ways to bolster your risk analysis.

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Thought Leadership | Drug Stability

What Factors Impact the Quality of Drug Stability Reports?

By: Nick Schofield
June 11th, 2019

Drug stability reporting is an integral part of pharmaceutical product compliance. For both the development of new drug products and the required annual monitoring processes, ensuring stability reports are done thoroughly and in a timely fashion is key. Quality is also important; the fidelity and integrity of all the data generated from drug stability studies and aggregated into your reports can impact your organization’s ability to market your drug products.

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Thought Leadership

How to Write Effective CTQs for Your Life Science Product

By: Nick Schofield
June 6th, 2019

Implementing a critical-to-quality (CTQ) program in your life science organization’s product development process can be a valuable effort. Identifying CTQ requirements and working through both CTQ Flowdown and Flowup activities can lead to more robust, well-made products that meet your user needs.

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Thought Leadership | Industry Updates

FDA Pulse Check: May 2019

By: Nick Schofield
June 4th, 2019

There was a lot happening at FDA during May 2019. As we’ve already discussed on the blog, CDRH’s new Office of Product Evaluation and Quality is now up and running. Besides this big piece of news, there are some other FDA stories worth catching up on this month.

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Thought Leadership

How Can Design Thinking Impact Design Controls?

By: Nick Schofield
May 30th, 2019

Many life science organizations treat design thinking and design controls as separate product development stages. In reality, they can overlap; while this feels counterintuitive to some, it’s actually an important point that teams need to manage. For a more robust product development process, your teams should be thinking about how to use these two aspects of product development together. How  design thinking can impact design controls is valuable to understand and evaluate as part of your organization’s plans for long-term growth.

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