For medical device professionals, there are the “knowers” and the “doers.” One group is knowledgeable about quality best practices and product realization needs, but may not know how, or have the desire, to act upon it. The other group puts that knowledge into action by doing the best practices that are needed to realize the product needs and [seize all] opportunities.

In this episode of the Global Medical Device Podcast, Jon Speer talks to John Kapitan, CEO at Kapstone Medical, about the difference between knowing and doing as medical device professionals and how to do what’s right for the success of your medical device.

• People view quality differently and need to overcome pessimistic and negative perceptions. Quality is a mindset and helps companies solve business problems.
• Quality is knowing the right thing to do versus doing it. Some people are ignorant because quality is not their role and do not necessarily know best practices. 
• Other people are outwardly antagonistic who know the right thing to do, but choose not to do it for a variety of reasons.  
• Apathetic people have an idea of what to do or have been told what to do and want to do the right thing by the patients, regulatory bodies, and investors. 
• Quality is common sense that focuses on best practices, documentation, and performance. Rather than caring about traditional technical quality related areas, a quality system is one of the last things some companies/investors consider.
• Pre-revenue and pre-commercialization companies don’t need to build a quality system that has all the bells and whistles. Start with the core and add-on as needs arise.
• There is a right and wrong way to implement quality in any organization. Take an efficient, effective, and pragmatic approach to understand compliance and the must-haves, not the nice-to-haves. 
• Make sure to have someone on your team to discuss and champion quality, and implement a quality system that runs the company, not the company running it. 

“I want to do the right thing. I know I can learn because I don’t know everything and there’s probably better ways to do this. More efficient ways, more effective ways to do this.”

“If quality is not your role, you’re not necessarily going to be on top of what good practice is, what best practice is for quality, and what quality requirements are from FDA or overseas. You may be ignorant of just what to do and how to do it. ”

“Quality is common sense. It’s not procedures, it’s common sense. It’s how would you do this if you were going to have this device put in your own body or your family members?”

“There is a right way and a wrong way to implement quality in any organization.”

“It’s always about prioritizing what we spend time thinking about, what we talk about, and what we invest in.”

John Kapitan on LinkedIn

Kapstone Medical

FDA - Design Controls

ISO 13485 - Medical Devices 

Premarket Notification 510(k)

Premarket Approval (PMA)

Investigational Device Exemption (IDE)

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

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