HealthBlawg

David Harlow's Health Care Law Blog

    • Twitter
    • Facebook
    • LinkedIn
    • RSS
    • Email
  • About
  • Archives
  • Podcast
  • Press
  • Awards/Reviews
  • HIPAA
  • HCSM

Disruptive Innovation or "Woo"?

December 11, 2014

Is it the best thing since sliced bread? Is it really a better mousetrap? Does it really have that special sauce?

The term "disruptive innovation" gets bandied about quite a bit, and in recent weeks and months, it has been applied to the designs of Patrick Soon-Shiong and Elizabeth Holmes on changing medicine and health care. The former is focused on cancer diagnostics and treatments, the latter, on blood tests. Each has been the subject of paeans in the press, but questions have been raised — less broadly — about the claims they are making. Setting aside for the moment the question of whether talk of disruptive innovation is in itself "woo," let's take a look at these two entrepreneurs and their current projects.

Buried in Ken Auletta's New Yorker profile of Holmes and her company, Theranos — which is working secretively on developing the technology to perform a full range of blood tests on just a pinprick's worth of blood (she's always hated needles, and figures the high percentage of folks who never get blood tests that are ordered by their docs is driven in part by the same basic issue) — is the question of whether the company's lab test methodologies and accuracy have ever been the subject of regulatory or peer review. The company apparently doesn't say much on the question of peer review, though it has submitted its tests for FDA review. But guess what: the FDA doesn't review lab tests. (Sounds like surgical techniques not being subject to any particular review mechanism. Yes, I'm a recovering regulator, but even I recognize that you can't regulate everything. Some things will get used more widely if they become more accepted in the relevant comunity due to testing and peer review. If Theranos wants to grow, it will ultimately have to open the kimono, at least just a bit.) So for now, Theranos is valued in the billions based on a technology that has not been publicly vetted.

Also instructive is Matthew Herper's recent Forbes blog post on Soon-Shiong. It's titled: "Here Is What '60 Minutes' Didn't Tell You About The Billionaire Who Is Trying To Disrupt Cancer Care." Among other things, other folks are actually already doing gene sequencing and personalized cancer therapies — the stuff he plans to do in the future (though he may have the resources to do it on a larger scale) — and Herper calls out 60 Minutes for not pressing Soon-Shiong on some of the hard questions — and some of the easy questions. He wants proof. He wants more clarity, less hype, in marketing. He also calls 60 Minutes to task for basically airing a promo for a company that will soon be taking a piece of itself public. (Read the whole post. And Herper's Forbes cover story on Soon-Shiong, linked to from the post. You should read Auletta's piece, too, but, I know, I already told you it's in the New Yorker, and you're thinking, man, I don't have a week to spend on this …. Just do it. Among other things, you'll love reading about board member Henry Kissinger's realpolitik advice to the college dropout CEO.)

Where science and business collide we have the intersection of the open, peer-reviewed model of knowledge development and dissemination, and the for-profit stealth model, where market advantage includes not only having a good idea, but playing one's cards close to the vest and being first to market. Throw health care into the mix and we have an added layer of concerns regarding safety and efficacy, as well as broader cost, quality and access questions. Some of us look to Big Government for oversight on these matters. Some of us balk at the very idea. Some of us are somewhere in the middle.

As we collectively try to rationalize the health care nonsystem, and get a handle on runaway costs and move quality levels that are not where we'd like to see them, it is natural to hail the disruptive innovators, because they promise great things. It should be just as natural to stop and ask: Really? Can you show me how that works? Or can you at least share with me some non-anonymous external validation form a trusted source? A big chunk of the nearly $3 trillion US health care economy is paid for by federal and state government. A growing chunk of the balance is paid out of pocket by individuals, and much of the remainder is paid by self-insured employers, who are spending money on behalf of individuals. The point is: accountability matters. As an FDA official quoted by Auletta noted, what we're talking about here is not an iPhone, it's "more consequential than a consumer product." We need to find a better balance between competing interests when it comes to ensuring that these innovations don't disrupt all over you and me.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Filed Under: Digital Health, Health care policy, Health Law

you might also like:

  1. Is American Well the disruptive innovation to unseat retail based health clinics?

  2. Disruptive physicians and medical apologies

  3. Digital Health Innovation: The Beat Goes On

« Down, Down, Down: Avoidable Errors, Uninsurance, Cost Inflation
Farzad Mostashari on the Proposed ACO Regulation: The future of the Medicare Shared Savings Program examined in an interview with David Harlow »

Follow me on Twitter

David Harlow 💉😷 Follow 43,243 17,535

Mastodon @healthblawg@c.im #HealthCare #MedDevice #Compliance #Privacy @MyOmnipod #HIPAA #digitalhealth #HarlowOnHC #pinksocks Tweets are tweets No more no less

healthblawg
healthblawg avatar; David Harlow 💉😷 @healthblawg ·
3h 1641080431243042816

The latest Harlow On Health Care Daily #HarlowOnHC #digitalhealth #healthcare #innovation #privacy #hcldr Thx: @joyclee @ClimaxBetty @_timos_ #digitalhealth #healthtech

Image for twitter card

What satisfied EHR users do differently

healthcareitnews.com A new Arch Collaborative user's guide dives into what 3,000 highly satisfied electronic health reco...

paper.li

Reply on Twitter 1641080431243042816 Retweet on Twitter 1641080431243042816 0 Like on Twitter 1641080431243042816 0 Twitter 1641080431243042816
healthblawg avatar; David Harlow 💉😷 @healthblawg ·
7h 1641015055335432193

ICYMI> Paul Schrimpf, at Prophet Consulting, Driving Health Care Transformation — Harlow on Healthcare https://healthblawg.com/2022/12/paul-schrimpf-prophet-consulting.html?utm_source=twitter&utm_medium=social&utm_campaign=ReviveOldPost #digitalhealth #hcldr #hitsm

Image for the Tweet beginning: ICYMI>  Paul Schrimpf, at Twitter feed image.
Reply on Twitter 1641015055335432193 Retweet on Twitter 1641015055335432193 1 Like on Twitter 1641015055335432193 0 Twitter 1641015055335432193
healthblawg avatar; David Harlow 💉😷 @healthblawg ·
14h 1640909216356487173

ICYMI> Frank McGillin, CEO, The Clinic by Cleveland Clinic — Harlow on Healthcare #digitalhealth #hcldr #hitsm

Image for twitter card

Frank McGillin, CEO, The Clinic by Cleveland Clinic

Harlow on Healthcare: Conversations with Healthcare Innovation Leaders

healthblawg.com

Reply on Twitter 1640909216356487173 Retweet on Twitter 1640909216356487173 0 Like on Twitter 1640909216356487173 0 Twitter 1640909216356487173
Load More
Follow me on Mastodon

HIPAAtools

Hipaatools

The HIPAA Compliance Toolkit

The Walking Gallery

The Walking Gallery

Quick Links

  • Home
  • Categories
  • Archives
  • Podcast Interviews
  • HIPAAtools
  • HIPAA Compliance
  • Health Care Social Media
  • Speaking
  • In the Press
  • Blogroll

David Harlow

David Harlow

HealthcareNOW Radio

Connect with David

  • Twitter
  • Facebook
  • LinkedIn
  • RSS
  • Email
  • Subscribe
  • Contact
  • Book Me: Speaking
  • About
  • The Harlow Group LLC
Copyright © 2006–2023
HealthBlawg is a publication of The Harlow Group LLC. See Copyright notice and disclaimer.
Fair use with attribution and a link is encouraged. Click for more on David Harlow.
[footer_backtotop text="Back to top" href="#"]