Kid-Sized Medical Devices

Bad-Medical-Devices Blog asks Are Financial Incentives to Encourage Kid-Sized Medical Devices a Good Idea? I believe the answer for that is yes. The company I work at initially thought we would submit our device and a smaller one for pediatrics. The boss called the FDA and they indicated it would undergo extra scrutiny, so we nixed the smaller device and left any reference to pediatrics out of the initial filing, we don't need to go looking for more trouble initially.

Getting approval for pediatric use is now somewhere off in the future, probably forgotten for a few years. The development work required is pretty minimal- the design wouldn't take long at all and the validations would basically be repeats of what has already been done. But a pediatric device was never projected to be a big market to begin with, so other projects will get priority.

I think the blog article completely misses the point when it says:

The government should be offering financial incentives to device corporations who promise to increase scrutiny over manufacturing practices

We already have plenty of incentive to manufacture quality products, the regulations ensure that, I promise you, no medical device company wants a recall. What we don't have is incentive to go through lengthy approvals to chase small markets.

Biocompatibility testing on a formerly radioactive medical device

Patrick in the comments asked a while ago:

We have a radioactive device, and the act of charging with radiation has an impact on the surface chemistry, so we need to conduct biocompat tests. Now, our device has a very rapid decay rate, and with a month or so it is effectively not radioactive any more...but testing house are not willing to test it because of the stigma of having once been radioactive. Any idea how these types of devices should be tested?

I don't understand the device and when exactly it would be used clinically, but I think you'll probably have to find some way to test to ISO 10993. Assuming the device is used clinically after the radiation has dissipated, I'd write up a nice summary report saying as much with relevant radiation references and call every testing lab I could with it. Talk and offer incentives to as many people as possible at each lab until I got a definite no from management, you might be able to get a smaller lab to do it, or even offer to do the extractions yourself or under their supervision at your facility if you have a local lab, non-GLP would be better than nothing. You could try hiring a consultant with good contacts at a testing lab as well, they might be able to persuade the testing lab better than you can. Other than that depending on what device category you fall under maybe you could do the testing yourself, although I admit this is not ideal. I don't have any other ideas beyond those, good luck.

The Medical Device Quality Plan

I got stuck with writing a quality plan for our products, here is what the FDA says in CFR 21 820.20 (part d):

Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.

If you're trying to please the FDA, you should probably keep the quality plan separate from the quality policy (part a) for clarity. I'm not sure why, but our documentation requires one quality plan per product, this makes it easy for me anyway. MD&DI's take:

As formulated in the new regulation, the requirements for quality planning are intended to apply to activities that are conducted during the production phase of a product's life cycle, and should refer to the company's design and development plan. In practice, the content of a company's quality plan will most often be provided by the outline of quality system documentation (820.20(e)) and by the device master record, and the plan itself may refer to sections of those documents where key activities are detailed. Guidance for establishing a quality plan can be found in ISO 9004-5.⁷

Seems simple enough, the quality plan should reference quality system procedures (part e) and design and development plan or validation and verification (V&V) activities. My example quality plan:

PURPOSE - Establish a quality plan that meets CFR 21 820.20.
SCOPE - This plan applies to product X.
QUALITY PLAN
~INSPECTIONS - sampling requirements, component receiving, in-process and final assembly inspection references (DMR reference if it includes inspection points)
~PACKAGING V&V - sterility, packaging, and shelf life V&V references
~DESIGN V&V - design V&V references including biocompatibility
REFERENCES - includes all documents listed above

Sorry, but I can't master formatting in blogger. It'll be fun updating the quality plan every time someone comes up with a new V or V protocol. Let me know if I'm missing something.

Book Reviews

I spent a couple days in the Hoosier state and read some business/workplace related books while traveling and thought I'd review them.

Less Is More: How Great Companies Use Productivity As a Competitive Tool in Business by Jason Jennings

The best book of the three, it was good from start to finish, even though the basic message is simple: have a clear goal, stop screwing around and get to it. Anyone halfway intelligent knows the difference between productive and non-productive work. Both the vision and culture have to be pushed and maintained by management (or CEO) taking a long term view. The book does recommend being polite to a point, but doesn't adhere to the rule as strictly as the next two books.

What Got You Here Won't Get You There: How Successful People Become Even More Successful by Marshall Goldsmith

This book details 20 character flaws that can hold you back in your career such as:

• Withholding information to maintain an advantage over others
• Passing the buck
• Telling the world how smart we are
• Passing judgment
• Adding too much value, the overwhelming desire to add our two cents to every discussion

etc., you get the idea. The books generally describes how to be nice and why being nice is good for your career. I liked the first half of the book, but after a while it seemed a bit repetitive. Most of this stuff is common sense, but the book does a decent job of making you think about it in new ways and gives good success story examples. I bought this book for $1 + shipping on EBay and it was completely worth it.

The No Asshole Rule: Building a Civilized Workplace and Surviving One That Isn't by Robert I Sutton

Since this is a family blog, I'll use the term jerk instead. This book shows how persistent workplace jerks lower everyone's productivity. Common bad actions:

• Personal Insults
• Invading one's "personal territory"
• Uninvited physical contact
• Threats and intimidation, both verbal and nonverbal
• Jokes and teasing used as insult delivery systems
• Withering email flames
• Status slaps intended to humiliate
• Public shaming rituals
• Rude interruptions
• Two-faced attacks
• Dirty looks
• Treating people as if they are invisible

I better watch the jokes and teasing one, although I generally think I'm too nice and put up with more crap than I should despite the passive aggressive blog. Anyway, I thought this book was not as useful or interesting as the other two and wouldn't recommend it. It is about 200 pages that could have been fit into a decent magazine article.

2008 RAPS Horizons Conference

The 2008 Regulatory Affairs Professionals Society (RAPS) Horizons Conference just concluded, I would have gone if I'd known about it, at least for the Navigating Product Development Process and Defining Research Ends and Design Control begins presentations. This link has many of their presentations available online, readers might find something interesting.