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Everybody seeks advice and opinions from others from time to time, even those in the medical device industry. What are the pros and cons when it comes to hiring consultants?

Today’s guest is Isabella Schmitt, regulatory affairs consultant at Proxima Clinical Research. Listen to this episode as Jon Speer and Isabella discuss good and bad practices when identifying and selecting advisors for your early stage or established medical device company.

 

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Some highlights of this episode include:

  • Who are advisors? Consultants, board members, thought leaders, accelerators, and others that offer opinions on the course and direction of your company.
  • Who can you trust? Avoid advisors that are posturing, egotistical, always have to be right, and don’t listen to other opinions. A level of humility can gain your trust. 
  • Startup vs. Established Company: Consider pass/fail criteria for advisors based on strategic approach, assessed risks, experience, cost, and connections. 
  • Regulatory Affairs/Quality Assurance: If you ask three different advisors the same question and get three different answers, which do you choose? It depends.
  • Due Diligence: Review résumés of advisors with similar values from different perspectives. Determine if they can build a healthy, helpful, and appropriate relationship with you, your company, and products.
  • Be Careful: Choose advisors that guide and pivot you through challenges, obstacles, hurdles, and pitfalls—not create them for you and your company.

 

Links:

Isabella Schmitt

Proxima CRO

De Novo

Pre-market Notification 510(k)

Pre-Market Approval (PMA)

FDA - Medical Devices

International Organization for Standardization (ISO)

MedTech True Quality Stories Podcast

Greenlight Guru True Quality Roadshow

Greenlight Guru

 

Memorable Quotes by Isabella Schmitt:

“Nobody actually retires. They still want to dabble a bit.” 

“Companies should always sort of vett whatever anyone’s telling them. Get a second opinion. Do some research on their own. Really think about it.”

“I wouldn’t just take what anyone says on face value.” 

“Ultimately, the company is the one that is going to be most affected by whatever decision is made.”


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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.