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Around the world's coffee machines, talk about the culture of an organisation and its impact on performance wastes thousands of hours a day. We talk about the results that would

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

be possible if the culture were just right; we complain where we see issues of organisational culture impacting performance.

Talking is one thing; what’s rare, however, is real r

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

cognition of the fact that great leaders explicitly manage the culture of their organisation. They understand that results are not only linked to culture, results are the

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

i>expression of an organisation's culture.

Results are the Expression of Culture

Results are tangible, measurable, and objective. Results in business always include

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

rofit and cash. Results in other organisations may be different, but every credible organisation will have a set of tangible results to produce.

The state of the results of an o

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ganisation displays the prevalent culture. We're not just talking about the long-term results; we're talking about results in every period - including this one! We're talking ab

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

ut the results that need to be produced this week, and even today. Where there is a shortfall in results, there is always a shortfall in culture. If you look for the cultural sh

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

ortfall and resolve it, your required results will be easier to produce.

A client recently was off track in producing agreed cost savings. They had a target of ?50k to find in o

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

e week. It was Thursday and they hadn’t properly identified any savings. They called us up and said that they wouldn’t meet the target - they had had a very busy week. They fel

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

it would be OK, because they had a lot of ideas “in the pipeline”, and were confident they could recover later. Ordinarily, this would have been accepted, but we had them confro

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

t the culture that was being expressed: “It’s OK not to deliver on commitments; we’re busy and we’ll catch up later”.

They decided to challenge this, and instead to build and dev

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

lop a culture of: “We deliver on our commitments, regardless of the circumstances”. The result was that they identified ?50k of cost savings by the deadline on Friday.

Cultur

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

Change hasn’t happened until the Results are produced

Some groups are very diligent in addressing cultural issues. In these groups we often see the same issue from the othe

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

perspective. Often people celebrate a wonderful “breakthrough” in culture. Relationships are repaired and teams are built – hooray! Surely, breakthrough results are on the way

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

? Don’t count on it.

Unless the breakthrough that has been achieved is demonstrated in tangible, measurable, and objective results, it has not been effective and will fade into

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

emory. The time and resources that have been spent on the culture change will have been a waste of money. While there might be a new possibility of a culture shift, and a lot of

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

excitement, the reality is that the organisation’s results still reflect the former culture, and what typically happens is that early attempts to alter results are met with resist

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

nce in some way - either cultural or structural - and the enthusiasm for change is blunted or killed entirely.

Until the point when the important results have changed to reflect

.

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

he new culture, and it has been demonstrated that the new level of performance can be consistently and sustainably delivered, the hard work of organisation change is not complete!

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

==> to find out how to quantify the impact of culture on performance see the original newsletter 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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The cost of presenteeism has now surpassed the cost of absenteeism. Presenteeism, which refers to sick employees who come to work instead of staying at home, now surpasses $180 billion annually. Absenteeism, where the employee does not report to work, costs $118 billion annually and medical expenses and lost productivity.

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