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)

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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

Problem Solution

5

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 22 Copyright eClinical Forum 2014

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?


challenges and recommendations when implementing new esystems

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