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The end of the year in an organization is often a time of reflection and evaluation. As I look back over the decisions I have made over the past 12 months, I evaluate them to

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

see how they have affected our company and what I might do differently. As I reflect, I am paying attention to that voice in my head that is tempted to blame our failures on ot

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

Examples of combination products may in

her people (or organizations) while taking complete credit for our successes. If I want my team to work together effectively, I have to resist this impulse to assign blame or c

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

redit.

I recall an incident that occurred in my life several years ago that is emblematic of this tendency to blame other people for the unfortunate events that happen in our

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

ives. I was in my car at a green light waiting for a pedestrian to pass so that I could turn right at a street corner. Suddenly a truck hit the back of my car. It was a US Post

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

Combination pro

Office truck driven by an employee who proceeded to back up and drive away from the scene of the accident. Given that those trucks have a large identifying number on the back,

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

this was not such a great idea. I wrote that number down and followed him straight to the post office where I told a supervisor what happened. The supervisor left to get the o

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

ficial paperwork. As the two of us stood looking at the back end of my car, he actually said to me in a accusing tone of voice: "Well, I hope you're happy. You just made me los

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

e my job."

I remember that situation and his comment whenever I am tempted to blame someone else for the consequences of my own actions. To avoid that, I find it useful to ask

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

myself: How have I contributed to this outcome? What would I do differently if I could do this over? The next time I face this problem what will I do?

When we lead teams, we

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

an help them develop this habit of taking personal responsibility for their part in a difficult outcome. The trick is to do it without blaming them or ourselves. We can lay the

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

Following aspects would a

foundation by talking through the issue or challenge with phrases such as:

As I think about what happened, I can see that I contributed by....
We all share

dd to the challenges in developing combination products:

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

responsibility for this outcome. For instance, I wish that I had....

The next time we handle this challenge, I plan to....

And we can also help our employ

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

ees and co-workers take ownership of their part by asking questions such as:

Looking back, how do you think you played a part in this?
If you could do it ove

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

again, what would you do differently?

What steps do you plan to take the next time you face this situation?

When people make clear statements that demonst

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

rate that they are taking at least partial ownership of a challenging situation, we can reinforce their positive behavior by making statements such as:

I really apprec

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

Professional from academic institutions, pharmaceutical industries, health care indust

iate your ability to look at this challenge objectively.

I think your assessment of this situation is right on target.

I trust that you will succeed next ti

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

e. These are great ideas.

Thank you for talking this problem through so that we can work together to get better results.

As we model taking ownership and r

.

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

esponsibility and as we recognize this same level of personal responsibility demonstrated by others, we reinforce a positive cycle that paves the way to healthy, collaborative

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

Companies that provide selfless information through particip

teamwork.

So what will it be? A team that is at the mercy of lunkheads in other departments? Or a team that is confident in its ability to meet any challenge? It's your choice

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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