Advice You - Business

You’ve undoubtedly witnessed (or participated in) conversations such as the following:

Perry Noid: “Why aren’t those estimates ready for the budget report yet? I told you yesterday that I needed

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

them by 2:00. Thanks to you, I’ll be here half the night getting this ready.”

Vic Tom: “This place doesn’t revolve around you, you know. I had customers to tend to. Without them, you wouldn’t have a budget

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

Examples of combination products may in

to worry about.”

Perry: “That may be, but you could have at least had the decency to let me know you were going to be late.”

Vic: “If you were ever available, I would have told you what was happening.”

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

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Hardly constructive, these exchanges resemble debates or ping-pong games and serve only to inflame emotions and entrench the participants. How do normally intelligent and articulate people fall i

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 such unproductive patterns? And what can be done about it? The answers to both questions lie in the roles we instinctively and sometimes unconsciously adopt when confronted by conflict.

In conflict, ever

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

Combination pro

yone has a story or at least their side of the story. To better understand these stories, try prefacing them with the words “Once upon a time.” People’s conflict stories feature the same three types of cha

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

racters as do the fairy tales of our youth: the innocent, helpless victim; the evil, controlling villain, and the brave, righteous hero. We encounter these same character types on the front page of our newsp

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

apers, in our favourite television shows and on movie screens everywhere.

When we perceive ourselves as attacked or threatened by another, we usually see ourselves as the victim—innocent and powerless. We m

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

y quickly shift to playing the hero and stand up to our attacker. And if we don’t manage our angry impulses, we may even slip into the role of the villain and personally attack the other person. Each role li

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

mits our understanding of situation; together they form a “drama triangle” that traps us in confrontation. This explains why people in conflict refer to feeling “stuck”.

In the example above, Perry felt let

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

down (the victim) when he didn’t receive the budget figures he needed and blamed Vic (the villain). Conversely, Vic felt unfairly blamed (the victim) when Perry (the villain) criticized him for responding t

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

Following aspects would a

o customer demands. Each saw himself as justified in attempting to right the wrong (the hero) by defending themselves and attacking the other (the villain) in their place. Soon the questions of the budget fi

dd to the challenges in developing combination products:

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

ures and communication were forgotten in the wake of the ensuing verbal jousting that caused each person to become angrier and more entrenched. This “drama triangle” traps us in confrontation and damages rel

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

ationships.

Once we become aware of this pattern and our role in it, we can choose more constructive approaches. When we shift our judgement to curiosity, we open ourselves to understand the other person in

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

stead of attributing evil motives to them. Curiosity leads us to ask questions, listen, and understand why the other person might feel like a victim in the situation. When the other person feels heard instea

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

d of attacked, they become more willing to hear our side of the story – we win ourselves a hearing. We can take advantage of that hearing by asserting our perspective in a way that doesn’t label the other pe

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

Professional from academic institutions, pharmaceutical industries, health care indust

son as the villain.

Consider the example above. Instead of discounting Perry’s concerns, Vic could have responded “Perry, I get that you’re up against it with the budget. And you’re right – I didn’t get you

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

those estimates yesterday. Something came up for me with a key customer and I had trouble tracking you down to let you know. I’d like to sit down for five minutes, get this back on track and figure out how

.

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

to handle it better in the future.” No victims, no villains – just two people working to solve a problem.

Some people view conflict as negative and destructive, as it well can be. But when we bring genuine

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

Companies that provide selfless information through particip

curiosity, respect and compassion to our conflict conversations, we build bridges, deepen relationships and solve problems. We move beyond the drama of confrontation to resolution.

Copywrite 2005 Gary Harpe

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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Advice You - Conflict Stories: From Confrontation to Collaboration

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