Google health shuts down and the FDA approves a device in 30 days

Google Health is apparently shutting down, too soon, we're just getting ramped up in fact.  Although they didn't seem to embrace the key to making their system widespread and more popular, user input, not just physician input, the two would be easy to separate.  The aps are already out there, they just need to be linked to health records, blood pressure, workout data, smoking, drinking, drugs, diet, etc.  The whole state of California would love to upload their workout history to their health record, with the user invested in their health record, the health record becomes more useful and valuable.  Someone will put this together and it will be awesome.

Anyway, enough on that, I did say that I had something good to say about the FDA a post or so ago, from Mass Device: "The system was submitted for Food & Drug Administration 510(k) review in mid-May and is available for sale in the U.S. just one month later."  They managed a 30 day 510(k) review, which is probably nothing impressive for a blood pressure device, but it is on the iPhone which is probably somewhat more difficult to show that it wouldn't be corrupted, do you apply for the Ap from Apple or for approval from the FDA first?  So, good work.

New product turn over

MedCity News has an article on J&J exiting the coronary drug eluding stent business:  End of J&J stent business carries lessons for medical device innovators.  It is very surprising to me that they are just leaving the market, surely with $400 million revenue this year they could make something happen.  I know they were getting their clock cleaned, but what kind of signal does this send to their R&D organization as a whole?  We're not afraid to throw in the towel?  Obviously J&J has a lot of smart people and I've never run a Fortune 500 company.

The take away message from the article is you need to keep innovating...  I have no idea why you wouldn't, you need to turn over your devices regularly to stay competitive, plus each time you do it you can raise prices and increase margin.  Plus you're paying those engineers anyway (hopefully)- don't let them get distracted on non value added side projects.  How often you turn over your devices with new models depends on the devices, guide wires and catheters, every 1-2 years you should have a new model or at least a respectable line extension.  Other devices can take longer depending on their complexity and regulatory approval time, obviously for drug eluding stents you need a more significant investment. 

That being said, don't do it just for the sake of having something new, if the device isn't actually improved a reasonable amount they customer will notice.  I was part of one launch with really good immediate sales, then a huge fall off because the customer realized this new product didn't meet any need the old one didn't, in fact it was worse (from their point of view, from the company point of view it was cheaper.)  After the initial buys, the customers didn't reorder, they saw right through it despite the best efforts of marketing.  If you're investing in a medical device company this is one thing you want to look for, are they launching new products at a reasonable rate, or are they just sitting back and letting things happen?

Anyway, congratulations to Abbot, Boston Scientific, and Medtronic enjoy your extra sales. 

How to help

From a recent FDA press release:

The FDA is helping advance the development of an artificial pancreas system...

I think they should be more clear.  What they are really doing is releasing a new guidance document which "will help provide clarity for manufacturers, investigators and reviewers in the development of the artificial pancreas system. It proposes safety and effectiveness goals that the FDA may require researchers and industry to meet when developing a type of artificial pancreas system".  Some other things are listed (like a workshop...), but they aren't actually advancing the science.

It is quite a stretch to say this actually helps to advance the development of anything, it just sets expectations, which is great, but lets call it like it is.  To advance the development, you need to be working on the device itself, not what you may require as the regulatory pathway. This is probably oversimplifying, but if we were to say all cars must get 50 mpg meeting a defined criteria, I don't anyone would claim that we were helping to advance the development of high mileage cars.  (I have some FDA praise slated for a future post, so don't feel bad for them)

Not that this is limited to government.  This is a fairly common response when a project team runs into an issue.  The project manager calls a meeting to help resolve the issue and the theory is we all pitch in and solve it.  In reality there is one guy doing 90% of the work on this problem and it takes too long to really bring another person up to speed on all the required details and anyway they have their own stuff to do.  The meeting (or workshop...) just serves to piss the person doing all the work off by either suggesting common sense things he's already done or doing, giving him unnecessary work, or suggesting unnecessary work that he has to fend off.  If he is your subject matter expert, trust him, who else is going to solve the problem, the Sr. Director?

If you're the project manager- one on one the guy doing the work, figure out what he wants.  Also know his weaknesses and compensate.  If he's great at solving the problem, but can't write a report or presentation that passes management muster, then get your ace report writer primed and ready to take over. If he doesn't have the attention span to stand around in the lab for 14 hours straight and supervise testing, make sure the lab guys know what is expected and fill in to keep them running.

I've seen projects delayed for months because everyone was too busy solving the problem with meetings (Why don't we look at this... How about a build that does this.... Did you write that PO yet...) to get hands on time to actually solve the problem.  If you're not working on the device, on the manufacturing floor, in the test lab, you're not advancing the development of the device.

Update 1: If you'd like to read more on the FDA and company responses on the artificial pancreas, try here or here.

Catheter recall - tip detachment due to embrittled material

Boston Scientific is getting a bit of attention for an IVUS catheter Class I recall, to be honest a smaller company probably wouldn't get the same attention.  What I thought was interesting was that they published a rate for the catheter tip detachment, from Cardiovascular Business:

The corrective action, announced May 27, is being taken due to eight confirmed cases of catheter tip detachments caused by the embrittlement of catheter material. The Natick, Mass.-based company confirmed a rate of 0.027 percent of catheter tip detachments in the U.S. and Puerto Rico from April 1, 2010, to May 10, 2011.

I don't think I've seen a rate published before and a quick search didn't turn up anything.  Presumably this is their complaint rate, of 0.027% or about 1 in 3700, so their recall of 30,000 devices prevented 8 tip detachments.  No more details are available, so we don't know if it is a design issue or a manufacturing issue, although an "embrittlement of catheter material" sounds like a design issue- but it is not impossible to imagine something done incorrectly in manufacturing that could cause this.  That being said, storage conditions or sterilization effects (if it is not EtO) would be where I would start.

From a risk point of view, if there is one thing you don't want to happen is for parts of a catheter to fall off inside of someone, the severity is obviously high.  Tip detachment is generally detectable at least when you remove the catheter from the body, if not sooner, depending if the part detaching is radiopaque or if the catheter stops functioning when the tip detaches.  In this case the bar has been set, a rate of 0.027% is too high, which I would agree with, especially for a large company and this type of diagnostic device with suitable alternate diagnostic methods available.  Boston Scientific is doing the right thing with the recall and hopefully they are able to address the issue and move on.

SonoChief predicts the costs of the recall:

Boston Scientific’s voluntary recall of the iCross Coronary Imaging Catheters will be disruptive to their ultrasound division. With an average street price of  [private]$800 dollars a recall of nearly 30,0000 catheters equates to a loss of 2.4 million inventory.
...
Boston Scientific customers are being told all iCross Coronary Imaging Catheters are being replaced with Atlantis SR Pro Coronary Imaging Catheters, which will operate with Boston Scientific’s IVUS imaging consoles and are immediately available.  The Company does not expect this recall to have a material financial impact.

Which is actually $24 million (incorrectly multiplied above), if you use street value, but presumably Boston has a margin of 60% or more, and no one buys list price, which would put the cost closer to $4 million.  Although the recall is being expanded beyond the original 30,000 catheters.  The cost to their reputation as competitors gain is obviously significantly higher.

I'm not sure what the take away from this is other than do a thorough job on your verification testing, Boston Scientific surely documented and tested for the tip detachment risks and thought they were acceptable, but the rate came out higher than predicted.  I would like to know the material and conditions that lead to the issue, I have a few guesses, but its doubtful we'll ever see that level of detail.

Lean Product Development

I've been working on lean product development lately, but haven't made much progress.  For the most part we're able to turn over prototypes quickly enough, the addition of a simulated sterilization cycle would help, but we don't have the equipment for decently controlled humidity.  The two areas we seam to have the most problem is fixing very minor product problems and document control. 

The minor problems are usually software bugs or nagging fit or packaging problems that we can make work, but we wouldn't release with.  No one is really excited about tackling these because they have the tendency to turn into a lot of work.  Someone just needs to grind them out before we get to verification.

The document control delays are the delays that really get under my skin.  I've worked with both paper and electronic systems now and I by far prefer electronic- especially if the team is split geographically.  By electronic I don't mean the team signs a paper and scans it in and someone compiles it, I mean an approved online signature method.  The problem almost always turns into we all agree on everything when we're talking, but putting it down on paper makes people weird, especially if you have a bad system where it is all or nothing and no one read anything ahead of time so you end up with several restarts.  Now if you have a change you want to make that is 100% fine-by-me just do it in a timely manner and we're square.  Try to avoid being one of the following types:

1. Double-dipper - bring up everything you want changed the FIRST time through, don't keep coming up with new issues.  Second rounds of comments should be very rare.
2. Nit-picker - does adding that re-formatting really add value?
3. Delayer - doesn't read anything until its past due then has to find some issues to make the delay seem appropriate
4. 2 center - can't let anything go without adding more work no matter what, 90% of the time adds no value.  You want a hold order on this engineering product even though it is labeled "Not for Human Use" and the part number isn't active in the distribution or customer service systems so there is no possible way it could ship on an order?

Not that I'm perfect, but I try to come back to value added when making comments.  Most of the time it is quicker and better for relationships to just suck it up and put up with whatever to get to the next step, but that doesn't really create a culture of improvement.  Every cycle through the documentation system probably costs $500 when you have a bunch of Californians involved.  For now I've decided to gently nudge people in what I consider the right direction, hoping to change the culture over the long run.  If we can just focus on what is important maybe we don't have to work so many late nights, etc.  I don't really know of another way to approach it.

BTW, there are a ton of great lean blogs out there, here are a few:

Evolving Excellence
The Lean Thinker
gemba panta rei
Gemba Tales