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.

Blog Feature

Thought Leadership

Applying Design Thinking to Risk Management in Life Sciences

By: Nick Schofield
September 25th, 2018

Have you considered using design thinking for risk management?

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Blog Feature

Thought Leadership

7 Stakeholders to Consider While Developing Your Life Science Product

By: Nick Schofield
September 19th, 2018

Developing design inputs for your life science product requires understanding the needs of your stakeholders. You can build this understanding by leveraging design thinking tools such as stakeholder mapping. But who are the stakeholders you need to keep in mind in the design of your product?

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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

3 Key Benefits of the Business Model Canvas in Life Science Product Innovation

By: Nick Schofield
September 13th, 2018

Can looking at your life science organization’s business model really spur advances? The answer’s a bit complicated, but it is possible to work with your business model in coming up with new products and services. However, you need the right tools for the job. The business model canvas, a strategic management template, is one of those tools, offering three key benefits for your life science organization’s early-stage innovation and development.

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Thought Leadership

FDA’s Quality in 510(k) Review Program Pilot—A New Approach to Premarket Notification?

By: Nick Schofield
September 11th, 2018

Once you go through the work to generate the design data of your medical device and establish the case for its safety and effectiveness, all that data needs to be compiled into submission deliverables for regulatory bodies. Making sure those deliverables are thorough and meet the reviewers’ requirements for submissions can be a long process. FDA has implemented some tools to help with this process over the years, but these have been limited. In September 2018, however, they announced the launch of a new program that would expand the reach of these tools and support from the agency: the Quality in 510(k) “Quik” Review Program Pilot.

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Thought Leadership | Industry Updates

FDA Pulse Check: August 2018

By: Nick Schofield
September 4th, 2018

August has been a busy month for FDA. Here are just a few FDA updates worth keeping an eye on as we move toward the end of summer.

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Thought Leadership | Cognition News

Process Validation in Life Sciences is Important—Here are 3 Reasons Why

By: Nick Schofield
August 30th, 2018

It can sometimes seem, in life science product development, that everything needs to be validated. From the design of your product to the computer systems you utilize in your design controls and risk management activities, regulatory bodies ask for validation. And processes have no exception from validation requirements.

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Thought Leadership

3 Overlooked Risk Areas in Your Life Science Product’s Lifecycle

By: Nick Schofield
August 28th, 2018

More often than not, when your development teams are working through risk management activities for your life science products, their primary focus is on the design. Yet multiple risk elements such as design errors, use errors, hazards, harms, and failure modes need to be identified and controlled to ensure safety and effectiveness. This work is absolutely critical in getting your product to market.

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Cognition News

Cockpit®, Systems Engineering, and the Mahola Project: Developing Healthcare Systems in Cameroon

By: Nick Schofield
August 23rd, 2018

Our Cockpit platform is powerful guided compliance software, and at its heart is a deep focus on systems engineering. Many of Cockpit’s features, while aligned to regulations and standards for design controls and risk management, also allow our customers to develop and manage the complex designs of a product’s systems throughout its lifecycle. The systems engineering tools built into Cockpit have been repurposed for a manner of other projects beyond life science product development.

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Thought Leadership

3 Key Compliance Aspects of Your Medical Device’s Use Specification

By: Nick Schofield
August 16th, 2018

Developing a use specification for your medical device is important—not just for your human factors/usability engineering exercises, but for compliance as well. Because the use specification summarizes characteristics related to the context of device use, it helps narrow the scope of your product and can help you align its intended use to its device type within FDA regulations.

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