Challenges and Recommendations When Implementing New eSystems

Challenges and
Recommendations
When Implementing
New eSystems
Jules T. Mitchel, MBA, PhD
President, Target Health Inc.
Cambridge, MA
October 2014

How to Innovate!
Avoiding Resistance and
Inefficiencies When There Are New
Ideas and New Opportunities
Experience From the Real World
2 Copyright eClinical Forum 2014

A Touch of Philosophy
Every truth passes through three stages
before it is recognized:
In the first it is ridiculed
In the second it is opposed
In the third it is regarded as self-evident
(Arthur Schopenhauer)
3

A Touch of Philosophy
What a person hears he/she may doubt
What he/she sees, he/she may possibly doubt
But what he/she does, cannot be doubted
 (Adapted from Seaman Knapp: American Agriculturist and Educator)
4

WHAT IT IS ALL ABOUT
1. REALTIONSHIPS AND TRUST
2. GOOD AND NOVEL IDEAS
3. FUNDING
4. EXECUTION

PROPOSAL TO MANAGEMENT 20
YEARS AGO
Remote Data Entry
Overall Goal:
1. To decrease the time it takes to have accurate
field data available for analysis and to reduce
NDA submission time.
2. One of the alternatives being considered is the
entering of data at the study site (Remote Data
Entry, RDE).

PROPOSAL TO MANAGEMENT
How to Achieve
The use of RDE, if it is to be an effective tool in clinical
research, must be approached in a step wise manner.
Since quality and accuracy of the data are paramount,
the first step is to deal with the system with the goal of
maximizing accuracy within the most efficient time
span. It will be necessary to have a simplified data
entry system.

How to Achieve
To allow the initial test to be independent of the
investigator, Ayerst personnel could enter the data in
the field and verify the data through error checks and
discussions with study personnel. In this manner the
system can be tested without involving the investigator
and his/her personnel at the initial stages of testing.

How to Achieve
This may require an additional Ayerst person on each
monitoring trip. If an investigator already has an
existing data entry system with adequately trained
personnel, his performance could be compared with
that of other sites where data are entered by Ayerst
personnel.

How to Achieve
CRFs could also be sent to N.Y. according to existing
procedures and the quality and timeliness of data
entered in the field could be then compared to these
standard procedures. Error rates, time to enter
corrections, general quality, and time to enter into the
main frame can be assessed without affecting study
performance.

RESPONSE FROM MANAGEMENT
SINCE THE SOFTWARE IS NOT
COMING FROM IBM
GO AWAY!!!!!!!

THE PROBLEM STATEMENT
“IF IT AIN’T BROKE WHY FIX IT”

THE SOLUTION IS ALL ABOUT
VISION, LEADERSHIP and RISK
TAKING

WHERE DO IDEAS COME FROM?
1. Think tanks?
2. The boss?
3. Consultants?
4. Employees?
5. Other sources?

POST-IT NOTE STORY
There were two accidents that led to the invention of
the Post-It note. The first was by Spencer Silver.
According to the former Vice President of Technical
Operations for 3M Geoff Nicholson, in 1968, Silver
was working at 3M trying to create super strong
adhesives for use in the aerospace industry in building
planes. Instead of a super strong adhesive, though,
he accidentally managed to create an incredibly weak,
pressure sensitive adhesive agent called Acrylate
Copolymer Microspheres.

POST-IT NOTE STORY
This adhesive did not interest 3M management as it
was seen as too weak to be useful. It did have two
interesting features, though. The first was that, when
stuck to a surface, it could be peeled away without
leaving any residue. Specifically, the acrylic spheres
only stuck well to surfaces where they were tangent to
the surface, thus allowing weak enough adhesion to
be able to be peeled easily.

POST-IT NOTE STORY
The second big feature was that the adhesive was re-
usable, thanks to the fact that the spheres were
incredibly strong and resist breaking, dissolving, or
melting. Despite these two notable features, no one,
not even Silver himself, could think up a good
marketable use for it. Thus, even with Silver
promoting it for five years straight to various 3M
employees, the adhesive was more or less shelved.

POST-IT NOTE STORY
Finally, in 1973, when Geoff Nicholson was made products
laboratory manager at 3M, Silver approached him
immediately with the adhesive and gave him samples to
play with.
Silver also suggested what he saw as his best idea for
what to use the adhesive for, making a bulletin board with
the adhesive sprayed on it. One could then stick pieces of
paper to the bulletin board without tacks, tape, or the
like. The paper could subsequently be easily removed
without any residue being left on the sheets.
While this was a decent idea, it wasn’t seen as potentially
profitable enough as annual bulletin board sales were
fairly low.

POST-IT NOTE STORY
Interestingly, because management at 3M still didn’t think
the product would be commercially successful, they more
or less shelved it for three years, even though the Post-It
notes were extremely popular internally at 3M labs during
that span.
Finally, in 1977, 3M began running test sale runs of the
Post-It note, then called “Press ‘n Peel”, in certain areas in
four different cities to see if people would buy and use the
product. It turned out, no one much did, which confirmed
in the minds of the executives that it wasn’t a good
commercial product.

POST-IT NOTE STORY
So after 5 years of constant rejection for the adhesive
and another seven years in development and initial
rejection, Post-It notes were finally a hit and have
since become a mainstay in offices the world over,
today being one of the top five best selling office
supply products in the world.

WHAT ARE SOME OF THE ISSUES THAT
PREVENT CHANGE?
1. There are no incentives to risk-taking
2. What is in it for me?
3. FDA will beat us up and issue a 483
When FDA issues a 483
The hammer comes down, that’s the end of me.
We’re out of business, I lose my job
Get me outta this mess, I pray to God
4. Risk avoidance
5. Will I lose my job if I fail?
6. I am retiring soon

HOW DO WE IMPLEMENT CHANGE
1. Have a Culture That Supports Risk-taking Within
an Organization Separate From Current
Operations
2. Identify Needs
3. Identify the Barriers
4. Convince Management to Experiment
5. Do Not Be Afraid to Fail

HOW DO WE IMPLEMENT CHANGE
1. Leadership has to come from the top
2. However, ideas often come from the bottom/middle
3. Do exploratory work on your own time
4. Talk is cheap, so do a demo

APPROACHES TO INNOVATION
1. INNOVATION 4A
a) All Individuals
2. INNOVATION 4B
a) Businesses
3. INNOVATION 4C
a) Countries
© Target Health Inc.

INNOVATION 4B
Is there a culture in my organization that supports
innovation? If YES:
1. How did it happen?
2. Is it separate from current operations?
3. Can it run a project?
4. Does it have it’s own budget?
5. Can you give an example?
6. Was it successful?
a. If yes, why?
b. If no, why?

INNOVATION 4B
Is there a culture in my organization that supports
innovation? If NO:
1. Why not?
2. Have you tried to implement a project?
a. If yes, what happened?
b. If no, why the fear?
3. What would be needed to support innovation?

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