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Device Company Questions Answered

OMTEC 2014 registration is open! Check out the educational line-up at www.OMTECexpo.com right now, and get your team thinking about which sessions you’ll each attend.

Here are a few questions that Rob Packard fielded on the exhibit hall floor last year from people just like you. He’s coming back in 2014. Get your questions ready.

Attendees Asked…

  1. How do you go about qualifying suppliers before you get “engaged”? How do you pre-screen suppliers on the front-end to narrow down to a list that you can really qualify?
  2. What do you do look at for mitigating risk when selecting suppliers?
  3. What are the ethics and propriety of asking a supplier if you can see another company’s audit report of them?
  4. When setting up a quality system, do you recommend compliance with the QSR and ISO 13485 at the same time, or one at a time?
  5. Is there a software system that you recommend to track CAPA, bugs, etc.? How about for coding software?
  6. What do you think will happen as companies try to use data from outside the U.S. for premarket approval?
  7. When should a company approach FDA for an IDE meeting?
  8. When do we decide to hire a regulatory person?
  9. What are your thoughts on CMS reimbursement and regulatory approval decisions being combined?

Rob Answered…

Question: How do you go about qualifying suppliers before you get “engaged”? How do you pre-screen suppliers on the front-end to narrow down to a list that you can really qualify?

Answer: Here are six suggestions.
Size: Big enough for capacity, but not so big they don’t care about you.
Technology: You want a company that is investing in new technology to keep costs down, and so you can learn from them.
Location: Depends heavily on volume, but the location should be closer if the volume is low.
Referrals: I built a 5,000+ contact database for a reason. Ask non-competitors that might have a referral for you, too. Look at the ORTHOWORLD Supplier Directory and the list of OMTEC exhibitors.
Here’s a tip from one of your fellow OMTEC attendees: “Before you date (that is, audit) your supplier, you might ask to see their internal performance report for Quality and On-Time Delivery.”

Question: What do you do look at for mitigating risk when you are selecting suppliers?

Answer: First, use the term control instead of mitigate. Mitigate means to eliminate, and was removed from the 2007 version of the ISO 14971 Risk Management Standard because it is not possible to eliminate risks. Instead, companies do their best to reduce risks by monitoring and measuring key process variables.The key is to monitor your suppliers. If there is no way to monitor and measure the supplier and their process, then that concerns me. Recently I did a supplier audit and the customer’s top priority was to get a validation report. The problem is that the material variation from lot to lot is greater than process variation. Therefore, an SPC run chart would be more helpful to monitor that supplier. For example, a wide variation in hardness could dramatically affect your feeds and speeds for machining.

Question: What are the ethics and propriety of asking a supplier if you can see another company’s audit report of them?

Answer: If it’s a third-party audit report, then the report should be redacted to eliminate proprietary information. Whole findings should not be redacted. Asking for a competitor’s supplier audit report (i.e., second party) is unethical, and sometimes the supplier doesn’t even get the report. You could have three OEMs request a joint report, but all parties must agree and the auditor must omit proprietary information. This requires that all parties agree on the scope. This saves money and the supplier might be audited far less frequently. I can’t be hired by the supplier to do an audit and have that serve as a supplier audit, because the supplier is the client—not the OEM.

Question: When setting up a quality system, do you recommend compliance with the QSR and ISO 13485 at the same time, or one at a time?

Answer: If you have the right person who really knows the requirements, and you use the right cross-reference table to help identify the minor differences, then it’s quite easy to comply with multiple regulations at the same time. The only time I recommend that clients limit their ambitions to just one regulation is when the goal is to achieve certification in under three months. If you have a year, there’s no reason to limit the number of regulations. If you have ten weeks, you need to cut out everything that is not absolutely essential.

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