Have you heard the expression, “I don’t know what I don’t know?”

I was talking with group members Matts Bell and Mike Coon. Both are in business development.

Matts Bell works for Argos Global, a complaint handling company. He said, “In 2013, 75 percent of all device warning letters were complaint-related. Many could have been avoided by using dedicated complaint handling service providers.” See ‘3 Years of Warning Letters’ at http://medgroup.biz/complaints

Mike Coon works for NSF Health Sciences, an extractables & leachables (E&L) testing supplier for meddevice developers. He said, “Often my clients find me because of problems with the materials in their products. They didn’t know about changes to raw materials, interactions of plastics, etc.” See ‘Meeting 510(k) Requirements’ at http://medgroup.biz/material-toxicology

What do your Medical Devices Group colleagues need to know?

Share a comment and save a fellow group member some heartache. It can be in any medical device discipline that sometimes gets overlooked.

Or share what you learned the hard way – and what you had to do to fix a situation.

Thanks for building this resource for the group!

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Christianna Finnern has a few horror stories of her own.

Legal counsel for the Medical Devices Group Advisory Board, Christianna’s seen her share of clients who didn’t know the rules before they ran afoul of:
• Affordable Care Act and Sunshine Act compliance
• Stark Laws and anti-kickback statutes compliance
• Fraud and abuse investigations and other health law-related internal audits
• Corporate formation and organization, and
• Employment issues

Christianna will present “Sunshine and Scrutiny: Managing Compliance with the ACA’s Sunshine Act” at 10x. See http://www.medgroup.biz/Sunshine-Act

You can send her a private note at http://medgroup.biz/legal with questions.

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Great conversations this week. See:

Will Google’s Contact Lens for Diabetics will make it to market? (53 comments already)
http://linkd.in/can-you-see-me-now

A Perfect Technology Space for Start-Ups?
http://linkd.in/this-is-just-perfect

How do you launch a new product into a market when it is B2B and retail model?
http://linkd.in/B2B-and-retail-meddev

How useful are national GPO (ie. Medassets) contracts for surgeon-driven products?
http://linkd.in/medassets-or-medliabilities

How much cost is associated with finding a good healthcare products distributor?
http://linkd.in/hc-distribution

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Medgadget wrote an article about the group: http://medgroup.biz/medgadget

Mike Coon
Associate Director – Lab Sciences at Charles River Laboratories
“Bull’s eyes” being tossed here for sure! The exact reason for the original post. Awareness of these “hidden” issues create temporary hurdles to overcome in terms of new testing to verify changes made still allow development to move forward. And these hurdles are much easier to overcome than the analytical/regulatory “mountains” placed in front of one who didn’t pay attention to the issues earlier in the process!

Joaquin Kurz
Sr Director, Complaint Management and Post Market Surveillance at Johnson & Johnson
I agree with some of the comments in this post. Poor supplier controls can spell disaster for medical device manufacturers. Obviously manufacturers should not apply boilerplate quality agreements to supplier and must carefully consider control points in order to manage risk.

As Regina noted, this is why it is especially important to hire competent service providers and consultants. These are a unique type of supplier because they are often providing expertise in an area that the manufacturer is not familiar with. That makes it very difficult for manufacturers to tightly control the quality of their output. Everyone understands that the responsibility for compliance ultimately lies with the manufacturer.

Joe’s original comments explain that specialized complaint handling companies can help avoid issues with competent authorities. I would agree. My experience has been that it can be particularly difficult for a smaller manufacturer to keep up to date on the reporting requirements of different regions (e.g. Brazil; Columbia). Companies that specialize in medical device complaint handling are familiar with worldwide regulations and can help avoid costly mistakes. In general, I have had a positive experience with this type of service provider. This is a great example of where it makes sense to apply outside expertise.

Matt Lowe
Executive Vice President | Growth Accelerator
The issues John cites regarding suppliers are right in the crosshairs of FDA. The public discussions I have heard over the past couple of years (really since the Heparin situation) have indicated a greater focus on the supply chain and a manufacturer’s ability to control it. With more and more companies outsourcing significant parts of their business, I believe we will see greater regulatory scrutiny several levels deep in the supply chain, particularly in the contract manufacturing arena. This does provide opportunity for contract manufacturers that are sensitive to the requirements of their device customers and are able to respond to thos needs.

Jessica Alexander
Vice President, Quality & Operations at Idem Translations, Inc.
Many of our medical device colleagues may be surprised to learn that some device manufacturers today, especially smaller companies still in the start-up mentality, still don’t set themselves up for translation success, even while planning to sell their product in OUS markets. Any software, labeling or other documentation that may be needed in foreign languages down the line can and should be created with future translation in mind. Such internationalization (i18n) efforts cost next to nothing while documentation is still English-only, but the problems incurred by the translation of non-internationalized documents can become very expensive to correct. We recommend that manufacturers planning to eventually market abroad identify and vet an appropriate translation services provider as early as possible in their product development and seek their guidance on the creation of any software and labeling documentation. Simple conversations with a translation provider about the handling of dates, units of measurement, and even cross-reference content can save a manufacturer serious pain when regulatory submissions or shipment deadlines are looming…

Matts Bell
Account Manager at PierianDx
Thanks Joe. It’s true there can be challenges in working with specialty service providers, but one of the primary advantages is being able to leverage their expertise. Complaint regulations are complex, they can vary by geography and they are constantly changing. Working with a service provider who is solely dedicated to medical device complaint handling can not only increase the compliance and cost-efficiency of a complaint system, but also help the manufacturer focus on their core competencies.

Ed D.
QA/CAPA Manager/Design Engineer
There are known knowns, known unknowns, unknown knowns and unknown unknowns…..(Dick Chaney!)

John E. Lincoln
Medical Devices / Regulatory Consultant; also pharma and dietary supplements
I’ve mandated “extractables and leachables” testing for clients for combination devices, fluid storage bags / containers, cleaning effectiveness. And could add, “residuals” testing, required by the FDA for 510(k) submissions using EO sterilization.

Rick Stockton
Product Design (Medical, Scientific, Consumer)
John has an excellent point. As an example, undesirable inferior polymer material substitutions are made easy (and even likely) by design specs that lack detail. These can create real problems. A polymer material substitution may result in a large cost reduction. Unfortunately, the cost reduction is all on paper, as the new material requires a second $100,000 curing oven, and is still unreliably completed, resulting in the eventual shutdown and replacement of an entire production line. I am confident that examples of this type of misjudgment could turn a blog into a book.

As an engineer, I would encourage thorough review of material changes. Strangely, the answer cannot lie solely in the comprehensiveness of the material spec. Often, technological advances in materials and processing can create new and unanticipated properties. If you propose a change, you should also review the way in which the material is specified. Are there new properties that are now relevant? Has a new additive necessitated a new test? Has a new formulation made an old property value irrelevant, or even misleading? Are the old specs still relevant? Still sufficient?

Effective pursuit of real change requires a certain morality and integrity made most visible in its absence.

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Thanks, John. In the spirit of this piece, I had no idea about any of this.

When I first spoke with Mike, I told him ‘extractables and leachables’ sounds like a medieval treatment. I’d never heard of it.

John E. Lincoln
Medical Devices / Regulatory Consultant; also pharma and dietary supplements
Joe, here’s a couple more: A vendor’s production employee’s bringing in their own “manufacturing materials” to clean the product equipment; or a vendor using an cleaner identified as a carcinogin to clean medical device parts that were incontact with the fluid path. Hence the FDA’s increased emphasis on supplier controls, site audits.

John E. Lincoln
Medical Devices / Regulatory Consultant; also pharma and dietary supplements
My response was to your comment on Mike Coon and “changes in raw materials…”. I have seen many problems when med device companies have to buy RM / components from the larger marketplace, where the vendors’ could care less about FDA issues, and the client companies didn’t set up compensatory IQC testing/verification. Or when the vendor was the “cheapest” as a result of a not-so-rigorous QMS. The problem a year or so ago that bit some major pharma companies when a provider of wood pallets changed their wood preservative treatment / chemical and caused problems with the subsequent contents stored on those pallets comes to mind. And the list goes on …

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
John, would you explain further? I don’t completely follow you.

Regina Fullin
Director of GxP Consulting at Compliance Team, Inc.
This is the reason why company management needs to hire PROFESSIONALS, who are able to identify the rules, and incorporate systems capable of ensuring compliance. Ignorance of the law is not considered a legal defense for failure to meet the requirements. Management (and not undertrained/inexperienced employees) is ultimately held responsible.

John E. Lincoln
Medical Devices / Regulatory Consultant; also pharma and dietary supplements
A point above strikes at a major problem in use of vendors / outsourcing — unknown changes. Companies use contractural agreements and PO boiler plate “continuing guarantees, but, unless a vendor knows the seriousness of informing regulated customers of pending changes, has a strong change control system, and acts on it consistently, a customer company’s product, validations, COAs/COCs, et al, can all be compromised.