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I once worked for someone who would periodically stroll into my office and say, “Can I give you some feedback?” Obviously, I wasn’t likely to say no to my boss, s

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

o I’d nod and swallow, knowing what was coming. It was always--and I mean always--a criticism about a project, one of my staff, or of me. After several such inst

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

Examples of combination products may in

nces, I noticed myself beginning to take a defensive posture before he'd even spoken and realized I needed to change this dynamic. When he was done with his “feed

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

ack” one day, I seized the opportunity to ask him, “Now may I give you some feedback?” A bit surprised, he said yes. “Feedback,” I said, “is not the same as criti

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

cism.”

Feedback Is Not the Same as Criticism

I recall a poster I once saw that distinguished feedback from criticism in a very visual way. One drawing sh

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

Combination pro

wed a hand with scissors, with the scissor points aimed toward another person’s hand. This was criticism. The second drawing showed a hand holding the scissor bl

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

des and the handles facing toward the other person’s hand. This was feedback. While perhaps a bit simplistic, it's a helpful image.

When you criticize, you enti

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

ce the other person into defensive mode, much like a person might defend against scissor points coming toward him. This not only reduces the chance that they will

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

ake in and do something constructive with your information, but also creates a potentially difficult dynamic in the long run.

When you share real feedback, you re

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

uce the implied threat and the defensive response, and invite the other person into a discussion about potential and opportunity. Giving feedback is an intimate h

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

man exchange that can strengthen relationships and create an opportunity for everyone’s growth.

A Mediator’s Guide to Effective Feedback

Provide

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

Following aspects would a

positive feedback at least as frequently as negative. People grow not just by doing less of what isn’t working, but also by doing more of what is working. <

dd to the challenges in developing combination products:

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

i>Be curious. When sharing difficult feedback, don’t think of it as “telling.” Reframe it in your mind as the act of entering a learning conversation about someth

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

ng that doesn’t seem to be working as well as it might. What do you want to understand?

Don’t use the “sandwich” approach, putting the tough news between

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

two positive pieces of feedback. Sandwiching diminishes the positive feedback, which the receiver perceives you used only to soften the blow.

Don't pre

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

ume you know what the person intended by her actions or words. Instead, discuss the impact on you, your work or your department.

Avoid generalized, swee

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing statements. Give specific examples and make them behavioral (name the behavior, not the personality trait you think caused it).

Feedback does not ne

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

ed to include suggestions. It’s more important to describe the behavior that’s problematic or positive and assist the other person with reflecting on what might b

.

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

done differently.

Feedback is more effective when provided regularly. Providing feedback only during evaluation periods has limited impact on performan

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

Companies that provide selfless information through particip

And perhaps most importantly, be humble. At the end of the day, we’re all imperfect beings struggling to live our lives with a little grace.

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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