7 min reading time

Guest author Mark Proulx has seen a lot of head-shaking choices from prospective clients. I say “prospective” because, after conversations like the one below, he stayed clear of their impending disaster.

Do yourself a favor: Don’t say this to your auditor.

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Mark: Tell me about your product.

Client: It’s a device designed to tell you how fast you recover. It gives you an indication of whether you might have potential health problems.

Mark: Okay, have the outputs been validated?

Client: Why do we need to validate the outputs?

Mark: (groan) What medical device regulations are you following?

Client: We don’t know. That’s why we’re talking to you.

Mark: (groan) What class device is this?

Client: How would we find that out?

Mark: Have you spoken to the FDA at all about this device to find out what you have to do to get this on the market?

Client: Oh no! We don’t want to raise questions by talking to them. This is just a wellness device. We don’t have to go through the FDA.

Mark: (groan) Who told you this?

Client: Executive management told us we didn’t have to.

Mark: (slaps forehead) Good luck.

Client: Wait… What?

That’s when I knew we “weren’t going to be a good fit.”

Allow me to explain.

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The 3-Phase Design Process: Feasibility

The unfortunate company’s first problem?

First, they had executives without regulatory backgrounds think it would be acceptable to manufacture a physiological diagnostic that outputs health data not require FDA oversight. No, based on your intended use, this is a “screening” device. It is a medical device.

Second, management didn’t consult quality or regulatory people to determine which quality system to use in the product’s definition and design.

It’s impossible to determine a regulatory pathway without knowing the device type. Is it:

• Class 1 Exempt (not likely);

• Class II 510(k) (costing hundreds of thousands of dollars and many man-hours putting together the design dossier, design history file, quality system process, and all verification and validation testing to prove it works the same as predicate devices); or,

• Class II PMA because the device is the first of its kind (meaning possibly costing millions of dollars, clinical trials, large stacks of documentation, etc.)

Third, I question if the product can deliver. Without validating outputs, how do you know if the thing works? And if you don’t know how you’ll measure a condition, you might use the wrong components.

It goes downhill from there: improper results, improper treatment, liability for lawsuits, fines, recalls, and a business-ruining reputation.

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The 3-Phase Design Process: Manufacturing

Take a product you don’t know how it works, the outputs, or what the outputs mean. Yet you manufacture anyway?

Sure, okay. ¯\_(ツ)_/¯

Rather than produce in-house, you contract out to an engineering house or contract manufacturing organization (CMO) because they “seem to know what they’re doing.”

You contract to build the specs, the drawings, and testing to know it “works.”

Congratulations! You own a great-looking device you can’t commercialize without regulatory documentation or proof of efficacy.

By the way, how much did that prototype cost?

Now let’s talk liability. The CMO is liable, you say? Oh no, my friend. They are the hands, you are the head.

You own all the liability for the quality system, device design, the testing, the registration and approval – and responsibility for patient harm, even in cases of unnecessary treatment.

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The 3-Phase Design Process: Sales/Distribution

You push your uncleared/unapproved medical device onto the market. Well done!

Your regulatory oversight clock is ticking. It’s just a matter of time before your mistakes catch up with you.

But let’s set that aside for a moment.

Your sales force is raring to go, declaring wonderful things to medical professionals to get their buy-in.

Beware: That story they’re telling? This is your “intended use” in the absence of your intended use statement. Yes, whatever your people – paid to promote – say about the device (whether true or not), becomes part of the “labeling” of the device.

You are liable for everything they said. You know, the “Anything you say, can and will be used against you in a court of law” thing?

Yeah, that.

The device is yours. You own the design. You own how it works. You own the problems with using it. YOU. OWN. THE. LAWSUITS.

Meanwhile, a problem with the device surfaces.

“Oh that’s easily addressed,” you think, and direct your engineers to come up with a fix that field engineers can use to modify in-use devices. In so doing, you’ve essentially changed the design.

Now your design is changed. Has the output data been affected? Who knows?

You had no real proof the device worked as intended before! Now, you have even less confidence the device yields useful data.

But you persevere. You place units. You make money. You earn favorable reviews in prominent magazines and social media.

Someone from FDA sees them and decides to pay a visit.

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The FDA Arrives

Our titular auditor rings your doorbell. Ding, dong!

How did your device get to market? What is its intended use?

You explain management said you didn’t need to run this by the FDA. You have no design controls processes. Your design requirements are whatever the CMO gave you. You have no quality management system (QMS), no quality unit to approve product releases, no clinical proof.

You explain you have units all over the country. You regularly made changes with no controls, vetting, testing, or validation.

You never processed complaints; never recorded non-conformances.

But it’s okay, you reassure him. No one ever complained.

The auditor makes a phone call.

The auditor returns to request copies of all documentation you have. The auditor will need to speak to your supervisor and will return tomorrow, leaving without another word.

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The Next Day

The auditor returns and states:

• You will cease all operations and stop producing all devices.

• You will list all devices and all customers, contact every customer, and recall devices sold from day one and at your expense.

• You will receive Warning and Cease and Desist of Operations letters.

• You will be investigated further.

• You will follow these instructions or Federal marshals will return to lock your doors until you comply.

Now you tell every salesperson to stop selling (and earning) but please retrieve every device.

Your costs accumulate: Reimburse customers (or not, never to see them again), pay for shipping, pay for the storage (quarantining them, preventing them from ever being used again).

You breach your CMO supplier agreement to avoid paying for the order balance.

And if you ever want to do business again?

Well, it’s likely FDA will determine you put an unapproved medical device on the market and will require your company to establish entire quality management systems from scratch which, by the way, you have no experience with. So you’ll hire experts to come in and spend months – possibly years – establishing systems and processes from the start.

You’ll sell zero devices throughout this ordeal. That one executive management directive killed all business, increased expenses exponentially, and exposed you to any and all lawsuits customers may file to recoup losses.

Then – if you’re lucky – no one was harmed by your device and you may escape being sued. But everyone’s out of work and management futilely attempts to sell the intellectual property but can’t get past due diligence.

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Yes, This Really Happened

Hey, it’s Joe again. I was skeptical the first time I read Mark’s story. Surely, he exaggerated to make a point.

Nope! He assured me. “This is a 100 percent accurate account of what happened to a company who thought they could put a device on the market ‘because it was a good idea’ and because management wanted ‘to generate revenue right away,'” he told me.

Mark concluded with this. “Design controls and regulations are in place for a reason. If you think the rules don’t apply to you, or if you don’t have a healthy respect for quality and regulatory, do us – and you – a favor.

Go into another business. Please.”

Mark Proulx has led his quality and regulatory consultancy since 2004 and has worked with medical device and pharmaceutical companies to re-mediate issues 25+ years, serving regulated organizations from multi-billion multi-nationals to small startups. He welcomes new connections on LinkedIn. (Tell him Joe sent you!) 😊

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This Could Be You!

It’s always surprised me how few ask me to feature them in our weekly message.

That nice article Mark wrote? You could do that!

Similarly, relatively few apply to speak at the 10x Medical Device Conference. You could do that, too(!), with a simple Call for Speakers application.

The point is… I may push the publish button, but this is Your Community. If you can educate the group, I’m too happy to feature you.

Please, email me for details.

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Okay, last 10x movie clip for a while!

As you likely know, I sprinkle in movie clips between 10x speakers to keep things fun. Well, 10x is next Tuesday, so here’s one last clip to enjoy!

From your click-through rates, it seems you enjoy these little diversions. Maybe I’ll think up a replacement in coming weeks. 😀

Best line, Buddy Hackett to Ethel Merman, “Except you, Lady. May you just drop dead!”

🤣🤣🤣

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Thank you for being part of our Medical Devices Group community!

Make it a great week.

Joe Hage
Founding Principal, Medical Devices Advisory Group

P.S. Please  this post if your customers would value it.

P.P.S. Shafi has a question about point five in the IVDR Annexure. Help him out? Thank you!