Medical Device and Pharmaceutical Product Development and Compliance

Cognition Blog

Our blog navigates product development and compliance for the life science industry. Our solutions save time and money, delivering products with less risk.

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Medical Device | Product Development | Risk Management | Design | Process | Documentation

Cultivating Risk Focused Design Instincts

By: Sally Carter
September 29th, 2022

How a risk-based design approach provides safer and ultimately better quality products to market. Product designs are stronger when risk is inherently considered. Not everyone has the experience and instincts to naturally consider the critical factors required in a comprehensive approach. A solid process ensures risk is addressed consistently throughout product development by all of the stakeholders. It is not enough to intuitively consider risk when designing a product; decisions need to be articulated and documented - this documentation is used to support the design choices throughout the product's life.

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Medical Device | Product Development | Risk Management | Webinar

Webinar On Demand: Why Flexibility and Support Matter for Effective Risk Management

By: David M. Cronin
September 9th, 2022

Medical device development is a complex process, with a critical element focusing on risk management. The consequences of not managing risk properly can be catastrophic.

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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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design controls | Product Development

Space and Time. Are You Considering the 4th Dimension in Product Development Data?

By: Ansgar Liening
June 15th, 2022

An introduction to how smart data utilizes information and actionable context to support business-critical decisions.

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Medical Device | Product Development | Risk | Risk Management

Three Key Questions for Assessing Medical Device Risk Management Tools

By: David M. Cronin
September 28th, 2021

In the highly regulated world of medical device manufacturing, the relentless requirement to minimize and mitigate risk places a huge onus on design, development, and manufacturing teams. That’s why companies, large and small, are looking for software solutions to help ensure consistency and objectivity in the creation, auditing, and monitoring of critical risk management processes.

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Medical Device | Product Development | reusability

Reusability: Data Duplication to Accelerate Medical Device Development

By: Bradley Sylvestre
September 14th, 2021

Key takeaway: The ability to reuse product data can dramatically reduce the time taken to design, gain regulatory approvals, and ultimately bring new medical devices to market. Time equates to money in any business, and in the world of medical device design and manufacturing, that can mean BIG numbers! Depending on the route taken, following FDA regulations, the average cost to bring a medical device to market through the Premarket Approval pathway is $94 million. The less intensive 510(k) process averages out at $31 million.

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design controls | Medical Device | Product Development | Risk | Risk Management

Beyond Excel, Managing Risk in Medical Device Development

By: David M. Cronin
August 17th, 2021

Using unstructured tools such as Word and Excel when doing risk management for medical devices could result in harm to a patient. Why? Because many medical devices are complex, with hundreds to thousands of inter-related design inputs/outputs, testing, and risk management data. Managing that amount of data manually is nearly impossible when using tools like Word and Excel...

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Medical Device | Product Development

Accelerate Medical Device Development with Systems Engineering

By: David M. Cronin
October 16th, 2020

Systems engineering should be used more often in medical device product development. This may be a strong statement, but it can be transformative for device development through decreased development costs, streamlining of interactions with the FDA, and reduced time-to-market. We would like to address this through a series of articles on systems engineering role in Medical Device Product Development of which this is the first.

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Medical Device | Product Development | Compass

Only a Comprehensive Process Can Deliver True Quality in Medical Device Development

By: Ansgar Liening
August 27th, 2020

Often in medical device product development, functions exist in silos. Risk, requirements, and test management functions often exist separately, on their own - different systems, different teams, different objectives. Yet, the data related to these functions are both continuously changing and highly dependent on one another. Some type of process is needed to (1) manage the effect of changes across all three systems and (2) provide evidence of a process for notified bodies if and when needed.

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Product Development | Thought Leadership | Risk Management

How Engaging Patients Benefits Life Science Product Development

By: Cognition Corporation
November 19th, 2019

Your product’s intended patients have a wealth of experience and information that can be valuable to your development process. Whether it’s the day-to-day realities of the condition, the symptoms they feel need the most attention, or things they might be missing in their current treatment regimens, this data cannot be elicited from doctors and engineers alone.

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