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Compassion is one of five principles of the Skilled Facilitator approach. (It's also one of the four core values of the approach.) I have already written about the other four principl

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

es: curiosity, commitment, accountability, and transparency.

Compassion means temporarily suspending judgment so that you can appreciate others' perspectives or situations when they

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

Examples of combination products may in

re different from your own. To be compassionate you need to be genuinely concerned about the other person or people's needs. You need to think about and feel it from their perspective

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

Here's a simple example. When I'm teaching facilitators to work with groups, sometimes they get really frustrated by the group. The group members don't stay on task or they don't ke

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

p commitments. When the facilitators get frustrated they wonder why I can seem so "patient." My answer is that I have compassion for the group. The team members are trying to change (

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

Combination pro

hich is why we're working with them) and they don't always change at the pace we would like them to. Getting angry at the team for not changing fast enough doesn't help them or me.

I

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

you're working with someone who is feeling overwhelmed by his workload and you don't think he has that much work to do, being compassionate means temporarily saying to yourself, "Thi

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

sounds really difficult for him. Let me understand how he's thinking and feeling about it. I may be missing things that he sees." It's easy to be compassionate when you agree with th

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

other person's situation; it's more difficult - and more meaningful - when you're compassionate with others who see things very differently from you.

Sometimes people think that com

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

assion means feeling sorry for people and taking care of them in a way that rescues them. Not in our approach. Our definition of compassion means appreciating their situation and hold

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

ng them accountable. It means sharing all the relevant information with someone even if she may feel bad hearing it. Sometimes a client will tell me, "I don't want to give a coworker

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

Following aspects would a

negative feedback because it would hurt her feelings." But when you withhold feedback that can help someone change and improve, you take away the chance to change. I think that's crue

dd to the challenges in developing combination products:

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

, not compassionate.

When I introduced compassion to my work a number of years ago, I was concerned that my clients (some of whom work in scientifically-based organizations) would se

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

it as "touchy-feely." To my surprise and relief, they immediately understood the value of compassion - often because it was missing in their own workplace.

It's hard to have compass

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

on for others if you don't have compassion for yourself. As a recovering perfectionist, I know this well. As long as I demanded perfection of myself, I would take myself to task when

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

didn't meet my own standards. And I did the same with others. If you are always judging yourself unfairly; you will do the same to others.

Compassion makes it easier to use the othe

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

Professional from academic institutions, pharmaceutical industries, health care indust

principles I've discussed in earlier columns. When you have compassion, it's natural to be curious about what leads people to do what they do and it's easier to be transparent about

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

hat you're thinking. That's because the questions you ask and the points of view you share stem from your interest in learning rather than simply judging. When you have compassion, it

.

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

s easier to maintain accountability because accountability is in the service of development rather than punishment. And when you have compassion, you are more likely to surface everyo

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

Companies that provide selfless information through particip

e's underlying needs; that makes it easier to generate commitment.

What do you think? Share your thoughts with me and others at the Mutual Learning Action Group.

© 2005 Roger Schwar

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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