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.

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Thought Leadership

5 User Needs Driving the Future of Medical Devices

By: Nick Schofield
November 13th, 2018

Our lives are rapidly evolving, thanks in part to the technological revolution of our current age. As our way of life changes, so too does the healthcare required to support it. This is forcing a massive disruption in the medical device industry. The user needs of the past are giving way to new ones, and planning for the changes now helps your organization prepare for the future of medical devices.

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Thought Leadership

5 Auditing Features You Want in Your Life Science Product Development Software

By: Nick Schofield
November 8th, 2018

Auditing is often a four-letter word in life science product development; even if you’re conducting one internally, audits can be a dreaded experience. However, they don’t have to be—especially if you’re using the right software. Here are five features of product development software you should be looking for when it comes to auditing activities.

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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

6 Best Practices for Implementing Compliance Software Tools in Your Life Science Organization

By: Nick Schofield
November 6th, 2018

So, you’ve decided to adopt a compliance software tool for your life science organization. Congratulations! However, you’re only at the start of a big implementation process—one that has a lot of moving parts and work attached. How do you make the start of using compliance software the best process it can be?

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Thought Leadership

Risk-Benefit Analyses: The Importance of Context and Iteration

By: Nick Schofield
November 1st, 2018

Risk management is crucial in life science product development, but, like any other activity, it can become burdensome. It can also complicate your product’s design past the point of feasibility for both production and use. Too much risk management and your teams are stuck with piles of mitigations and controls to manage; too little, and your product may face rejection during the premarket notification process or force CAPAs in postmarket environments. Neither of these options is ideal, but how do you find that “Goldilocks” zone?

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Thought Leadership | Industry Updates

FDA Pulse Check: October 2018

By: Nick Schofield
October 30th, 2018

We’re getting close to the end of the year, and FDA is still working at a solid pace. Here are some of the interesting updates in October 2018 we think are worth checking out.

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Thought Leadership

What Industry 4.0 Means for Medical Device Manufacturing

By: Nick Schofield
October 25th, 2018

The price of industrial robotics continues to fall, and advances in computing—AI, deep learning, software automation, etc.—are accelerating. As a result, we’re moving towards a new era of mass production and manufacturing known as Industry 4.0. But what does this new age of industry look like, and what does it mean for medical device manufacturing?

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Thought Leadership

Evaluating the Cybersecurity Risks of Your Medical Device

By: Nick Schofield
October 23rd, 2018

Cybersecurity is a growing concern for FDA and other regulatory bodies when conducting reviews for medical devices. As instances such as the WannaCry cyberattack have shown, there are real, persistent threats to global health systems, and interconnected devices with cybersecurity vulnerabilities can exacerbate these attacks. Therefore, it’s critical to identify these vulnerabilities and control their risks.

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Thought Leadership

5 User Needs Considerations in Life Science Risk Management

By: Nick Schofield
October 18th, 2018

Developing user needs for your life science product: is it just about capturing input from your stakeholders and translating it into requirements?

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Thought Leadership

4 Benefits of Industrial Robotics in Medical Device Manufacturing

By: Nick Schofield
October 16th, 2018

Across industries, robots are more prevalent in the manufacturing process than ever before. Skilled labor is steadily being replaced as labor costs rise and technology prices fall. As a result, we are moving toward a world where machines—not humans—are the primary workers on the production line. But what impact can this shift have on your medical device manufacturing processes?

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