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.

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Product Development | Thought Leadership

9 Methods for Improving Your Life Science Product Development Processes

By: Nick Schofield
May 23rd, 2019

Life science product development is all about process: to ensure safety and effectiveness of your product, processes must be in place to maintain high quality in your design and development work. In smaller organizations, these processes and procedures can be fairly easy to control and manage. However, as your business grows, so do the scope and complexity of your development activities. To maintain and improve your life science product development processes, there are a handful of methods your organization can undertake.

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Thought Leadership

8 Benefits of Centralizing Your Product Development Data

By: Nick Schofield
May 21st, 2019

Managing multiple disciplinary teams to generate design data and documents for premarket submission and the actual production, servicing, and overall life cycle of your life science product is a big enough challenge already. When you have to manage that data across multiple, global worksites, the challenge becomes more complex.

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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

Understanding Patient Preferences in Life Science Product Development

By: Nick Schofield
May 14th, 2019

The input of users and patients is vital in life science product development. Yet how these inputs are understood and evaluated differs based on the information being sought out. An interesting subset of patient inputs is what’s known as patient preference. For life science organizations attempting to build innovative, patient-focused products, it’s important to understand what patient preference is, how regulatory bodies view it, and why it matters.

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Thought Leadership

3 Quick Tips for Improving Compliance with Design Controls

By: Nick Schofield
May 9th, 2019

A familiar issue to most life science organizations is compliance—making sure your products and services meet the regulatory requirements necessary for clearance to market. Especially for growing businesses, ensuring compliance with things like design controls can prove to be a real challenge. To improve your teams’ efforts with design controls compliance, here are some quick tips to employ in your organization.

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Thought Leadership

8 Important Facts About FDA’s New Office of Product Evaluation and Quality

By: Nick Schofield
May 7th, 2019

In March 2019, FDA’s Center for Devices and Radiological Health (CDRH) began their reorganization initiative first announced the year before. The Center has taken a major step forward in this process by launching the Office of Product Evaluation and Quality (OPEQ) in May 2019. With this new office, a number of important changes begin taking place at CDRH.

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Thought Leadership | Risk Management

7 Ways to Bolster Your Life Science Risk Management Programs

By: Nick Schofield
May 2nd, 2019

Implementing a robust risk management program into your life science organization requires a solid understanding of your needs, capacities, and goals. Whether to improve alignment with regulatory requirements and standards or adjust your overall risk procedures, identifying what you can do to bolster your current risk management programs is vital to promoting long-term growth. There are many ways out there to improve your risk management, but there are a few worth using as a baseline to build on.

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Thought Leadership | Industry Updates

FDA Pulse Check: April 2019

By: Nick Schofield
April 30th, 2019

Between a redesign of their website and a number of different actions undertaken related to patient safety concerns, FDA had a lot going on April 2019. Here are a few key highlights of this month.

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Thought Leadership

Common Concerns for Developing Life Science Products That Address Mental Health

By: Nick Schofield
April 23rd, 2019

Over the past few years, life science organizations have produced and marketed more products and services intended for mental health treatment. While certainly not a novel effort by the industry, the increased pace reflects cultural, economic, and scientific shifts that are changing the way we view and treat mental illness. For many organizations joining this new wave, the territory is unfamiliar and uncertain. However, there are a few baseline concerns that, once understood, can help development teams push for products meant to treat mental illness.

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Thought Leadership

9 Sources of Design Inputs for Life Science Product Development

By: Nick Schofield
April 18th, 2019

Coming up with the design inputs for your life science product is not an easy task; your teams need to make sure their scope and applicability are appropriate in relation to the needs of your users and patients. But before you get to that point, you have to first generate the ideas and insights that will become those design inputs. Where do you find this data?

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