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Episode 67  |  37:55 min

How to Think About Quality and Regulatory as Your Company Scales

Episode 67  |  37:55 min  |  11.07.2019

How to Think About Quality and Regulatory as Your Company Scales

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This is a podcast episode titled, How to Think About Quality and Regulatory as Your Company Scales. The summary for this episode is: As companies transition from being a start-up or small company to a more established business and bring new medical devices to market, they tend to not put a lot of thought into their processes, systems, and approaches for regulatory strategies and quality systems. Regardless of the shape and size of your company, these factors are foundational to the growth and success of your business. Host Jon Speer and Mike Drues of Vascular Sciences discuss key tips on what to think about regarding regulatory and quality during a transition. It is about doing the right thing - prudent engineering. SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE: -Theoretically, regulatory agencies have an independent approach, no matter the nature of the company they are working with. -When starting to work with agencies, it is like a first date - and first impressions make a difference. Pre-submission process is a great place to start. -FDA is now much more interested in building collaborations with medical device companies, but it still has a responsibility to uphold regulations. -Cleaning up after someone else’s mess and doing damage control; bumps in the road with FDA, but let’s start with a clean slate. -Eyes glaze over when small companies are told to have a quality management system (QMS). Right size your QMS: There are things you can do now. -Evaluate your company’s regulatory strategy and QMS to make sure they can be integrated in a minimally burdensome way. -Focus on content/information and intent behind what you are doing. -----Forms and procedures are important, but focus on what matters most. -Companies measure efficacy of a device, but how often is the efficacy of systems and processes measured? Implement failures/errors to measure efficacy.
As companies transition from being a start-up or small company to a more established business and bring new medical devices to market, they tend to not put a lot of thought into their processes, systems, and approaches for regulatory strategies and quality systems. Regardless of the shape and size of your company, these factors are foundational to the growth and success of your business. Host Jon Speer and Mike Drues of Vascular Sciences discuss key tips on what to think about regarding regulatory and quality during a transition. It is about doing the right thing - prudent engineering. SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE: -Theoretically, regulatory agencies have an independent approach, no matter the nature of the company they are working with. -When starting to work with agencies, it is like a first date - and first impressions make a difference. Pre-submission process is a great place to start. -FDA is now much more interested in building collaborations with medical device companies, but it still has a responsibility to uphold regulations. -Cleaning up after someone else’s mess and doing damage control; bumps in the road with FDA, but let’s start with a clean slate. -Eyes glaze over when small companies are told to have a quality management system (QMS). Right size your QMS: There are things you can do now. -Evaluate your company’s regulatory strategy and QMS to make sure they can be integrated in a minimally burdensome way. -Focus on content/information and intent behind what you are doing. -----Forms and procedures are important, but focus on what matters most. -Companies measure efficacy of a device, but how often is the efficacy of systems and processes measured? Implement failures/errors to measure efficacy.

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