Medical Device and Pharmaceutical Product Development and Compliance

At Cognition, the success of our customers is key. That’s why our latest product, Compass MED, was designed with 3 key priorities in mind: Improve efficiencies, incorporate quality by design, and enhance risk management and compliance.

How can medical device manufacturers successfully balance the significant pressures of today’s market? On the one hand, they need to bring new devices to market quickly. On the other hand, devices are becoming much more complex, while at the same time, industry standards and regulations are continuing to evolve. During our recent webinar, three panelists—Nathan Brown, R&D Fellow at Boston Scientific; Mike Casper, System Engineer Manager at Smith & Nephew; and Eric Maas, a former Medtronic executive and founder of Six Sigma Experts—shared their perspectives on how medical device manufacturers can achieve speed to market, safely.

A Q&A With Gerald Wesel, Cognition Chairman and CEO Gerald Wesel, Cognition’s Chairman and CEO, is responsible for setting the company’s strategic direction. He is known for propelling innovative, disruptive technology companies to next level success, and has previously served in leadership roles at seven startups and four large enterprises. In this Q&A, he provides his take on how medical device development is evolving—and the persistent and emerging challenges that device companies are facing as a result. He also shares some key strategies that device company leaders should be employing to help their organizations adapt and thrive.

Giving customers more time to focus on developing great products. If you are part of a product development team, you know how tedious and time-consuming documentation can be to manage in various word or excel files. We set out to solve that problem over 10 years ago when we launched our solution, Cockpit. Our goal was to provide a unified and scalable environment to enable companies to structure data and automate processes for more efficient and accurate product development.

Commonly issued after an FDA inspection, a Form 483 informs a company of observations requiring corrective actions. The Form 483 is often referred to as “Inspectional Observations” as it is a list of conditions or practices that indicate a potential violation of FDA requirements. The form is compiled in order of importance and is considered a snapshot of potential issues; it should not be considered all-encompassing.

There are many immediate short-term benefits a compliance software tool can provide to your life science organization: improved documentation, streamlined day-to-day compliance activities, project data unification, and other advantages. But there are many important long-term benefits that may get overlooked. When deciding to adopt these software tools, it’s important to understand how they can promote growth and innovation at your company.

The market for digital health products is rapidly expanding. Reports from Global Market Insights, Inc. project the value of this marketplace to expand to $504.4 billion by 2025. Many life science organizations have seen the opportunity these technologies can provide and are jumping at it. However, this boom in the industry has not gone unnoticed; in recent years, FDA has been rapidly transforming their policies and organization to handle the necessary regulatory work these digital health products bring to the table.

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.

FDA Form 483 Inspectional Observations are one of the many tools the agency uses to verify medical device products do not expose users and patients to undue risk. Many of the commonly cited observations involve some aspect of design controls regulations, which is of particular concern for development teams and manufacturers. Of the 438 inspectional observations in FY2017, FDA cited three design controls regulations more commonly than all others: