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Advice You - How to Avoid Implementation Failure
Failure to implement the recommendations of an investigation into what ails an organisation is a norm for most organisations.
For some organisations it is a serial norm. As a consultant arriving to complete the analysis of a perceived problem or to determine the problem behind some prevalent symptoms, one of our first requests is to have
For some organisations it is a serial norm. As a consultant arriving to complete the analysis of a perceived problem or to determine the problem behind some prevalent symptoms, one of our first requests is to have
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
delivered to us previous reports into the problem.
It is normal to have delivered to us ten or more reports consisting of internal and external audit reports, previous consultant reports, incident reports, strategy documents and planning documents. The documents have two things in common.
The first common element is that problem areas
It is normal to have delivered to us ten or more reports consisting of internal and external audit reports, previous consultant reports, incident reports, strategy documents and planning documents. The documents have two things in common.
The first common element is that problem areas
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
re repeatedly identified and acknowledged in the documents which may cover over five years of elapsed time.
The second common element is that all of the documents are heavy on analysis and light on implementation. Classic consultant reports give two to five pages on why the consultancy was set up, three to five pages on method and any nu
The second common element is that all of the documents are heavy on analysis and light on implementation. Classic consultant reports give two to five pages on why the consultancy was set up, three to five pages on method and any nu
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ber like, fifty or one hundred pages, on analysis and recommendations.
Implementation, if considered at all, scores two or three pages on a high level implementation plan which does not take into account the operating environment, resource requirements and availability, likely support and opposition to the changes recommended and the tim
Implementation, if considered at all, scores two or three pages on a high level implementation plan which does not take into account the operating environment, resource requirements and availability, likely support and opposition to the changes recommended and the tim
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ing interrelationship between the recommendations.
To avoid the apparent paralysis by analysis syndrome, an approach with six simple elements has, in my experience, met with more success than failure.
Plan the implementation
When, as a leader of an organisation, you receive a report which consists of ninety-five percen
To avoid the apparent paralysis by analysis syndrome, an approach with six simple elements has, in my experience, met with more success than failure.
Plan the implementation
When, as a leader of an organisation, you receive a report which consists of ninety-five percen
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
analysis of the problem and five percent implementation of the solution, reject it. Better still, when setting the scope of the investigation and the charter for the team, insist that the final report has as much to say about implementation as it does about the problem and its causes.
Insist further that the implementation plan take int
Insist further that the implementation plan take int
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
consideration the resource requirements and availability, relationships with other projects and day-to-day business and whether a pilot programme is required to understand all the implementation issues.
Challenge the analysis
An aspect which is common to failed implementations is a lingering disbelief in the analysis b
Challenge the analysis
An aspect which is common to failed implementations is a lingering disbelief in the analysis b
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
y influential stakeholders. During the presentation of the analysis these stakeholders may say a few words in opposition and are often seen as a "negative" influence on change. Others say very little in the room and wait until they get to the corridor before they voice their concerns. Even a well planned implementation will fail if the ba
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
is on which it was planned is not believed.
Presentations of analysis should be set up so that it is mandatory to challenge the analysis. Don't be afraid of opposition to analysis, welcome it. It is the means by which organisations can do two things.
One is to get all of the intellectual and practical understanding of what makes an orga
Presentations of analysis should be set up so that it is mandatory to challenge the analysis. Don't be afraid of opposition to analysis, welcome it. It is the means by which organisations can do two things.
One is to get all of the intellectual and practical understanding of what makes an orga
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
isation tick out on the table. Counter-arguments to perceptions embedded in the analysis will ensure the analysis is robust.
The other is that those with opposing views will be able to rationally debate what the correct analysis is and if the session(s) is facilitated well, will come to a level of agreement that will not hinder the imple
The other is that those with opposing views will be able to rationally debate what the correct analysis is and if the session(s) is facilitated well, will come to a level of agreement that will not hinder the imple
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
entation of the recommendations.
Challenge the Recommendations
For each set of analyses about a problem's origin, there are not only multiple solutions, there must be found multiple solutions to make implementation stick. Implementation set on a path of a group of singular solutions has a high risk of failure. Life neve
Challenge the Recommendations
For each set of analyses about a problem's origin, there are not only multiple solutions, there must be found multiple solutions to make implementation stick. Implementation set on a path of a group of singular solutions has a high risk of failure. Life neve
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
r quite turns out as we expect it. External and internal influences occur which cannot be predicted. Some occur which are predicted but were thought to be low probability.
An implementation plan needs flexibility in building solutions to problems. Challenge the recommendations to find them. Whilst settling on a preferred solution, having
An implementation plan needs flexibility in building solutions to problems. Challenge the recommendations to find them. Whilst settling on a preferred solution, having
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
alternate solutions known particularly for low probability and high impact scenarios is simply just good risk management.
Challenge the Implementation Plan
As well as challenging the "what" (recommendations), challenge the "how" (implementation plan). Challenge the use of resources, challenge the need for detailed desig
Challenge the Implementation Plan
As well as challenging the "what" (recommendations), challenge the "how" (implementation plan). Challenge the use of resources, challenge the need for detailed desig
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
versus a pilot approach and challenge the timeline. Challenge everything about the implementation plan. If it is robust, it will survive the challenge and there will be some robust alternatives which have been thought through should circumstances change.
By welcoming challenge and making it a formal part of the process at each stage, th
By welcoming challenge and making it a formal part of the process at each stage, th
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
e likelihood of having something robust to execute is greatly enhanced. More than this, the sense of ownership by the leaders of the organisation grows with a shift from, "This is being done to me" to "I own this".
Clear the Decks
Give the implementation plan room to breathe. Most organisations need to do less to get mo
Clear the Decks
Give the implementation plan room to breathe. Most organisations need to do less to get mo
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
e done. If you are executing more than four strategic platforms and the implementation of the recommendations effectively creates a fifth strategic platform, decide which one to quit or postpone. If each function is coping with more than three tactics which are new rather than being part of business-as-usual, stop at least one of them.
I
I
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
people with the appropriate skills knowledge and behaviour to make the implementation work are involved in other projects or business-as-usual, free up their time, give them authority and the resources to do the job. Don't add it on as an extra responsibility.
Lead and measure
Make sure everyone in the organisation kno
Lead and measure
Make sure everyone in the organisation kno
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ws how important implementing the recommendations are to the organisation, its key stakeholders and to you personally. What wavering support there is left for implementation will usually be galvanised by a "call to arms" if there has been the opportunity to be part of the process, to actively challenge the analysis, recommendations and im
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
lementation plan.
Make sure that implementation progress is measured and reported on against key milestones identified. Do not accept failure to meet milestones lightly. Tolerance of missing milestones (that is, tasks on the critical path) quickly creates an atmosphere where failure to implement is almost a given.
Implementing recommend
Make sure that implementation progress is measured and reported on against key milestones identified. Do not accept failure to meet milestones lightly. Tolerance of missing milestones (that is, tasks on the critical path) quickly creates an atmosphere where failure to implement is almost a given.
Implementing recommend
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
tions should be the norm in organisations rather than the exception. Otherwise, either the need to review or the analysis itself was flawed. Following a few simple principles and making challenge a formal part of the process will increase your rate of implementation and save significant costs of repeated analysis or implementation failure
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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