In IDE program, Applied Spine Technologies credits MCRA in moving device to next level

Polina Hanin – an analyst at Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) - talks to Tom Wood, Founder, CEO and President of Applied Spine Technologies, Inc., of New Haven, CT.

PH: Can you tell me about your business and your need for an experienced regulatory consultant?

Tom Wood: We’re developing a dynamic stabilization device for use in the lumbar spine and have been working on a regulatory project – an IDE - for the last 2 years. We use regulatory consultants who are terrific but when the FDA came back to us with questions on our submission, we wanted specific high level expertise to add to the team.  That led me to contact MCRA’s Glenn Stiegman and Justin Eggleton.

We have a very strong scientific story and they helped us craft it for our response to the FDA letter. When the FDA came back with another set of questions, the dialogue was narrowed to finer points. Glenn’s and Justin’s knowledge of the nuances of the FDA and their grasp of the issues saved us months of back and forth – there’s no doubt in my mind.

PH: How time consuming was the IDE project? Especially answering the FDA questions?

TW: We had all the science nailed down, but the FDA’s questions indicated that we didn’t satisfy them on some key issues despite our pre-IDE meetings. MCRA was able to help us provide answers to the questions in less than 30 days, instead of maybe twice that time. Then the FDA came back with more questions, and those were answered in less than 30 days, as well. Without MCRA’s help it would have certainly been longer.

At that point, MCRA’s understanding of FDA protocols got us quickly to the start of the trial when we could have still been dealing with more questions. MCRA probably saved us 3 months or maybe more.

PH: Was saving time critical to you in terms of getting your device to market?

TW: Yes, less time to market but ultimately, less time to begin the trial. When you’re ready to begin the trial, your burn rate is ramping up. That reduction of a few months is a lot of money.

PH: How much money would say that MCRA has saved you?

TW: In time saved, hundreds of thousands of dollars.

PH: How much of a commitment was required of your staff in working with  MCRA?  

TW: Our staff was deeply involved on the technical side but they didn’t have MCRA’s experience in working with the FDA.  My team’s knowledge of the device and what the FDA requires, combined with MCRA’s experience in dealing with the agency, is what made this a successful team effort.

PH: How did MCRA work with your team?

TW: MCRA actually became an integral part of the team by being easily available and highly responsive. When we had a question or needed a conference call, we would get one set up within hours, never days. They took the time to work with us to understand who we really were and what we were in context of the FDA’s questions.

PH: Has MCRA done other work for you besides having to answer those FDA questions?

TW: Not yet – and I mean, yet.
  
PH: Did MCRA deliver all their commitments?

TW: 100%

PH: Is there anything else you would like to add?

TW: With MCRA, what Glenn and Justin brought to the table was more then just knowledge, it was a tempo and a visceral commitment to our mission. They got it right from the start. After we got our FDA letter they called and asked “How did you do?” They demonstrated to me that they are not like those consultants who do exactly what they’re asked, but much more proactive.  

Would we continue working with MCRA? Absolutely. Would we seek other opportunities, would we like to better understand the scope of what MCRA does so they could do more for us? Absolutely. Would I recommend MCRA to another company? Absolutely – no qualifiers.

PH: Thanks, Tom.  Good luck with the device and look forward to seeing you again soon.