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.

Question: Is there a software system that you recommend to track CAPA, bugs, etc.? How about for coding software?

Answer: There are a lot of solutions that can work, but I have two pieces of advice before you attempt to automate your Quality System processes with software. First, make sure you fully understand the requirements of electronic documentation in 21 CFR Part 11. Second, make sure you are automating an efficient and effective process. Make the process work well on paper, and then automate the process. Otherwise, you will simply be doing stupid things faster.

Question: What do you think will happen as companies try to use data from outside the U.S. for premarket approval?

Answer: I believe the first company to successfully use 100% European data for a U.S. PMA submission was a spinal company. The key to any data submission is having a well-designed trial and meeting all the requirements for clinical trials. Historically the device companies were very weak in this area, but this is changing as the device industry becomes more sophisticated and as clinical study requirements (ISO 14155) have evolved. Even after the proposed EU regulations are implemented, we should still expect orthopaedic companies to launch high-risk products in Europe first in order to gather clinical data for U.S. PMA submissions. The change I expect to see is an expansion beyond using EU data. More clinical data will be used from Canada, and eventually the clinical trial regulations in Southeast Asia and Latin America will be sufficient to use data from these regions, as well.

Question: When should a company approach FDA for an IDE meeting?

Answer: Companies should go to FDA as soon as they have a preliminary clinical study plan. FDA can’t tell you what studies to do, but they can give you feedback on a plan. This early communication will also help build a relationship with division reviewers.

Question: When do we decide to hire a regulatory person?

Answer: Most companies wait until after they have verification and validation data before they hire a regulatory person. However, when this is done, it is too late for the regulatory person to have input on which studies and testing should be done. Instead, the person will spend most of her time writing justifications for why testing wasn’t done that should have been. A company should establish a detailed regulatory pathway for each product during the initial concept development—prior to developing the device. This plan should include the most likely deliverables for verification and validation. This plan should also reference the harmonized standards that will be applicable. This activity is best performed by a consultant, because once you have a good plan, you don’t need much help from regulatory until you are actually gathering verification and validation data. If the company is a startup, the time to hire the regulatory person is probably at design freeze or approval of the design outputs. Hiring a QA person and expecting them to also do regulatory is increasingly unsuccessful because the regulations are too sophisticated for someone to keep track of part time. A full-time regulatory person is needed.

Question: What are your thoughts on CMS reimbursement and regulatory approval decisions being combined?

Answer: I don’t support the concept of those two processes being combined by a regulatory body. The parties involved are dissimilar and I expect turf wars that slow down both processes. Companies that are seeking regulatory approval need to have fully-developed reimbursement strategies early in the product development process—ideally during the concept development phase. These processes should run in parallel and any pilot launches or clinical studies should be designed specifically to provide the data needed for reimbursement. There are plenty of other economic drivers that are forcing companies to use this strategy, and I see no need to combine the decision processes.

Rob Packard loves to teach. Come to OMTEC 2014 and benefit from his ability to do so. You can also contact Rob directly at rob@13485cert.com.

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