How 'bout that new law suit ladies

Oddly enough Joe Kiani is a vocal proponent of misaligned incentives in healthcare, frequently preaching on the need to eliminate misaligned incentives:

Kiani on "eliminating misaligned incentives"...
peds2040.chocchildrens.org/safety-pediatric-patient-joe-kiani-ceo/

Kiani on "fixing misaligned incentives"...
http://www.forbes.com/sites/robertszczerba/2014/03/13/re-engineering-healthcare-to-eliminate-preventable-deaths/

Kiani on "correcting misaligned incentives"...
http://patientsafetymovement.org/speakers-panelists/joe-kiani/

If only he'd practice his own advice, he'd be an expert on the subject by now. Instead, he's that other thing that preaches what he doesn't practice.

 

Key to joker's success tip #6 (from earlier post) has application here...

"If you ever stand accused of exhibiting an undesired behavior, i.e. based a decision on misaligned incentives, you must act fast. In some official, public way go on record as a radical opponent of the very (undesired) behavior you stand accused of. This shadowy maneuver is completely legal and may help "soften up" the perception of your guilt among the naysayers."

 

But shouldn't the threat of personal injury or death be the ultimate incentive to properly investigate a reported device malfunction? If those potential outcomes don't get people at MASI jumping around fixing things, then what will? Not FDA regulations either apparently.

 

"According to the specifications of the device, an alarm would alert medical personnel of any sudden changes in the vital signs of the patient. In one case where a patient died, the question arose as to whether the device emitted the warning signal prior to his or her death." According to the FDA Warni g. Letter, Masimo failed to adequately investigate even this complaint, which involved the death of a patient.

That concerns me. And so does this...

"These [Masimo Pronto-7 SpHb] devices are used in hospitals and surgical theaters across the country, and medical personnel rely on their accuracy and ability to identify abnormalities in vital signs. However, if there is only the slightest possibility that a device may malfunction, it poses a threat to the well-being of all patients on whom the devices are used. This may lead to misdiagnoses or a doctor's failure to diagnose a condition. After an inspection, the FDA found that the complaints and reports totaled many dozens, but the company failed to satisfactorily investigate the issues and provide the FDA with its findings."

 

I know what I'd do if I was running Philips

 

All that glitters

 

Next wed (10/29) is MASI's Q3 earnings call (see link below) Masi needs to provide an update on the Federal Grand Jury Subpoena they've been facing since May, and FDA warning letter this time? It will be very concerning if Masi avoids any discussion about either of these on our call.

"Masimo to Report Third Quarter 2014 Financial Results After Market Close on Wednesday, October 29th, 2014.
http://online.wsj.com/article/PR-CO-20141017-907720.html
Nasdaq predicted another dismal StatStrip GLU

I hope MASI's EPS doesn't take another hit--to 0.25 as Nasdaq predicts it will.

 

My palm reader said there will be an update on the much anticipated GE/Philips deal on Masimo's Q3 earnings call next Wednesday. But unfortunately she said it will be the same basic update we've heard on every earnings call since 2011. She said there will be no commitments made by either CEO Joe Kiani or CFO Mark de Raad to specific dates or months or even quarters by which we can expect to have a signed contract... But, there will be some optimistic banter between the two executives on the subject and a general reference to the near future.

 

Signed contracts or not they will still need FDA's re-blessing before use on pts as OEM. could be the hold up, considering FDA approvals are less predictable now on Masimo products--branded or OEM--until warning letter demands r met.

Joe Kiani explains to SEC in Aug:
"The failure of our OEM partners to obtain required FDA clearances or approvals for products that incorporate our technologies could have a negative impact on our revenue.
Our OEM partners will be required to obtain their own FDA clearances for products incorporating Masimo SET® and licensed rainbow® technology to market these products in the U.S. We cannot guarantee that the FDA clearances we have obtained will make it easier for our OEM partners to obtain clearances of products incorporating these technologies, or that the FDA will ever grant clearances on a timely basis, if at all, for any future product incorporating Masimo SET® and licensed rainbow® technology that our OEM partners propose to market."
http://www.sec.gov/Archives/edgar/data/937556/000093755614000112/masi-20140628x10qx.htm

 

If only an analyst would step up and demand answers to tough questions, like the turmoil going on at Masimo that is evident by recent SEC filings, federal investigations, court documents and the swelling press coverage on events involving both the company and it's Founder Joe Kiani.

Based on the questions we heard last time, I'm not holding my breath for a neutral. Do we know if it will be same four joker had last time?

William R. Quirk - Piper Jaffray Companies, Research Division
Matthew J. Dodds - Citigroup Inc, Research Division
Brian Weinstein - William Blair & Company L.L.C., Research Division
Tao Levy - Wedbush Securities Inc., Research Division
m.seekingalpha.com/article/2398855

 

Oh really Masimo???? Are you actually suggesting Sphb measurements have fewer outliers than a Roche Cobas series blood gas analyzer? Oh and a smaller bias and similar sensitivity and sample-to-sample trending accuracy, compared to the Roche instrument?!?

Readers...take extreme caution before believing in such unfounded claims. Folks, the Roche Cobas B221 is a straight up commercial lab analyzer. Countless hospital laboratories around the world rely exclusively on this instrument as the principal reference analyzer for measured Hb/Hct, ABG's, Bilirubin, Co-Ox and other analytes.

I don't know anyone who considers the Cobas B221 a POC device in the first place, when it's classified as a highly-complex whole blood lab analyzer. I call BS on any "clinical study" that could somehow show comparable results in any performance category between the two instruments, i.e. precision, accuracy, correlation, linearity, bias, sensitivity, specificity, total allow. error, etc For all practical purposes the Radical-7 sphb pt monitor and the Roche Cobas are in no meaningful way comparable - not in their clinical application, nor in level of performance. I challenge anyone to find a laboratorian or healthcare provider who disagrees, and can back it up.

 

You know what that means..Soon we'll be marketing sphb as the gold standard in Hb measurement. You'll see

 

Masimo doesn't belong in the same paragraph w/ Roche.
What an insult. They look so desparate and ridiculous in that articles at a left

 

One of the main purposes of quarterly earnings calls for a public company is to report significant factors that could impact the stability or value of the organization.
From a financial standpoint the grand jury subpoena & FDA warning letter are two of Masimo's greatest threats. An unfavorable outcome of either, not to mention both, could have devastating effects on the company.

If the call Wed is mysteriously void of discussions about grand jury subpoena and FDA warning letter....it would be very telling of the controlled environment joker thrives in.

 

It's as though the analysts are on Masimo's payroll
Is that possible or would it be illegal

 

I hear the next new parameter is a non-invasive Ebola screen.
Sign me up!
I'm sure it's every bit as accurate as the lab.

 

Of course they will be discussed because...
transparency is king at Masimo

 

It will be as accurate as joker tells congress it is.

 

+/- 3 grams of hogshit a la pj du jour

 

Will be acknowledged in MASI's 10-Q statement to SEC on the 30th regardless