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There are few things in life that effect our relationships, our ecounters and our interactions with other people as much as expectations.

Every time we move in a new experience of any kind we conciously or

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

unconciously create different sets of hopes about what it will be like, what will happen and so on. Often we also create fears, things we do not wish to happen. Meaning we create a set of expectations. These

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

Examples of combination products may in

can be a powerful ally and they can also be a pit fall that can mess things up in the most well meant interactions.

Imagine the following scenario; a Thursday meeting has been called at Department C3. On t

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 agenda that has been sent out well in advance there is the item “Purchase of new computers”. Charlie goes to the meeting filled with a feeling of “finally it is time to get new computers” and looks forwar

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

to a quick decision that leads to buying and even better starting to use the new computers. On his way to the same meeting is Brian. He looks forward to meeting his collegues again and having time to discus

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

Combination pro

s things that will lead to improvements in the workplace and of the company. He thinks “it is a great thing that a meeting has been called so we together can really find the best alternative for new computer

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

s”. Charlie arrives at the meeting looking forward to a fast and powerful decision, Brian arrives inspired by the thought of thorough discussion that leads to a well thought through decision.

About fifteen

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

inutes later Charlie and Brian have collided head on. Either in a verbal flow of words or in wordless communication in the form of sighs and frustrated body language. Charlie is highly annoyed perceiving Bri

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

an as a slow thinking snail and Brian feels that Charlie is a high-speed bulldozer that just wants to run people over. This image of each other, is not spoken of though, instead they hit it out by being extr

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

emely not in agreement on the size of RAM-memory in the new computers.

It is clearly possible that there are other aspects of Charlies and Brians relationship that need to be dialogued, but if they had star

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

ed the meeting with airing their expectations on meeting, they could have spent their energy talking about what their differences were really about, i.e. different expectations. Not on playing a mental and v

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

Following aspects would a

erbal tennis game around what is was really not about, i.e. the number of mega bytes in the RAM.

The advice to you is a simple as it is powerful, make it a habit to start all your meetings with a round-up o

dd to the challenges in developing combination products:

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

f the expectations on the meeting. If somebody expects a five-minute quick meeting and somebody else a one-hour thorough meeting it is of great value to get this out in to the open. Another example is if som

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

ebody wants a fact-filled decision meeting versus somebody else who feels it is important to spend time on discussing the relationships in the group, then that needs to be adressed also.

Great is the number

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

of relationships and conversations that have dug a hole for themselves due to unspoken expectations both in private life and at work. There is an expression that goes “assume makes an ASS out of U and ME”. T

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

here are many conflicts that I have encountered during my years of work in organizations and with people that could have been prevented and resolved in their early stages if the people involved would have be

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

Professional from academic institutions, pharmaceutical industries, health care indust

en able to speak to each other about their mutual expectations on each other and the doings ahead. What were your expectations when you started reading this text? Did you hope for something that would give

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

he answer to all your questions, something that solves your present problem or were you hoping for something that would stimulate your own thinking and give you tools to create your own solution to your prob

.

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

lems? Regardless of which was true for you these different expectations will have effected how you feel now at the end of the text.

I wish for you excellent, rewarding and productive interactions with other

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

Companies that provide selfless information through particip

people. It is my sincere hope that the above be helpful to you. If you haven’t already start practicing the question “what do you expect from this/me?” and put your listening ears on.

Markus Eriksson

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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Just Other Articles - Everything Your Parents Did Not Tell You About Expectations

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