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Digg It - Get Your Team Moving: Get Your Business Moving
How Familiar are these situations to you?
An organisation adopted a new strategy. While paying lip-service to the change, key staff were still resisting the new direction, complaining and hoping that things would go back to the way they wer
An organisation adopted a new strategy. While paying lip-service to the change, key staff were still resisting the new direction, complaining and hoping that things would go back to the way they wer
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
e before
A team regarded itself as a group of individuals who ‘happened’ to report to the same person – though they were each doing their own job effectively, the synergies, economies of scale and innovation that it was hoped would come from bringing them t
A team regarded itself as a group of individuals who ‘happened’ to report to the same person – though they were each doing their own job effectively, the synergies, economies of scale and innovation that it was hoped would come from bringing them t
; 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
gether were not happening
A layer of management was taken out of an organisation to empower the next level of managers to make quicker decisions, interface directly with their own customers and produce enhanced results. However, they weren’t stepping up to
A layer of management was taken out of an organisation to empower the next level of managers to make quicker decisions, interface directly with their own customers and produce enhanced results. However, they weren’t stepping up to
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
he new challenge, and were waiting for direction and seeking permission, just as they had done in the old structure
Two functional heads whose roles required that they work together closely, clashed to the extent that they did their best to avoid each other
Two functional heads whose roles required that they work together closely, clashed to the extent that they did their best to avoid each other
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
When they did have to work together there was friction, resulting in inefficiency and poor outcomes
Conflict and ‘fingerpointing’ were arising because team members were not clear on the exact boundaries of their roles, and tended either to ‘tread on each o
Conflict and ‘fingerpointing’ were arising because team members were not clear on the exact boundaries of their roles, and tended either to ‘tread on each o
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ther’s toes’, or to miss targets and deadlines altogether because it was not clear who was accountable for their achievement
Sound Familiar?
Do you see similar issues in your own business? They cost hassle and sleepless nights. But have yo
Sound Familiar?
Do you see similar issues in your own business? They cost hassle and sleepless nights. But have yo
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
ever stopped to calculate what they are really costing you? The real cost is a brake on business results which, if not tackled head-on, becomes permanent because it becomes the norm - ‘just the way things are round here’.
Typically, the knee-jerk
Typically, the knee-jerk
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
eaction is to fire people, move them ‘sideways’, re-structure, tell ‘them’ to get their act together, hope it gets better by complaining enough, put them on ‘special measures’ at appraisal time, or call a ‘cards on the table’ meeting – all expensive, risky a
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
d ultimately ineffective.
What does not usually happen is that all the people concerned with the issue get together and surface it fully in a series of face-to-face conversations in which they explore in depth how things got to be this way, and agr
What does not usually happen is that all the people concerned with the issue get together and surface it fully in a series of face-to-face conversations in which they explore in depth how things got to be this way, and agr
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
ee new actions and behaviours which permanently prevent the issues from arising again. This approach to creating great, results-producing teams, in contrast to the knee-jerk response, is inexpensive, very fast, and if done properly always produces o
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
tstanding long-term results.
Why does the Approach Work?
The approach works because it creates a necessary forum, managed by a facilitator, to identify and surface issues that have not been expressed before. If the platform for doing this
Why does the Approach Work?
The approach works because it creates a necessary forum, managed by a facilitator, to identify and surface issues that have not been expressed before. If the platform for doing this
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
ad existed before, organisational issues would have been resolved already, or would probably never have become problems in the first place! A valuable outcome of this approach is the creation of a long-term organisational process for dealing with team issues
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
whenever they arise in the future - ‘just the way we do things round here’!
The second reason the approach works is that it is based on consistent research findings showing that, with very few exceptions, individuals are always capable of producing
The second reason the approach works is that it is based on consistent research findings showing that, with very few exceptions, individuals are always capable of producing
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
outstanding results given the right skills and mindset. If individuals don’t have the necessary skills, organisations are very familiar with the process of identifying and addressing skill gaps through training. However, people quite frequently
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
still don’t produce the results they are capable of. This is because what gets in the way is not just their level of skill, but equally importantly their mindset and th
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
groupthink in the team – this approach tackles these head on.
What Is the Key to Success?
The key to the approach’s success is the toughest bit: telling
What Is the Key to Success?
The key to the approach’s success is the toughest bit: telling
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
the truth. The experienced facilitator encourages participants to uncover and face up to key, relevant truths that will unstick the team and enable it to move on. They might otherwise shy away from these issues, leaving them forever buried from view, but cau
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
sing unacknowledged blocks to progress. The team cannot do this without the impetus from an outside facilitator; it would be like doing brain surgery on yourself!
You may or may not have the ‘right’ strategy, the ‘right’ product, the ‘right’ appointment, th
You may or may not have the ‘right’ strategy, the ‘right’ product, the ‘right’ appointment, th
.
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
‘right’ new computer system, but as a business leader, whatever you give your team to work with, you need their full, unconditional commitment. The process we outline uncovers very quickly any barriers in the way of every member of the team providing this,
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
em>and leaves the team with a new ability to surface and resolve issues quickly and permanently in future.
==> For more information view the original newsletter article here <=
==> For more information view the original newsletter article here <=
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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