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How much time and money does your organization lose because people are not able to have the tough conversations?

The important conversations that can have the most impact are the ones that people avoid. They may know the conversation needs to happen but hope that somebody else will initiate it or fe

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

el it’s not my job, or want to wait until the time is right. They make an attempt to have the conversation but sidestep the important issues. The question is; how much talking is happening in your organization? The talking that creates synergy builds relationships and inspires results. These c

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

Examples of combination products may in

nversations that never happen become the elephant in the room that everyone is trying to avoid. That elephant gets more powerful with every communication that doesn’t happen or with every failed conversation. With every open and honest conversation the elephant gets smaller, putting the power not in

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

the middle of the room but in the people. Personal power is built one conversation at a time.

What blocks the real conversations from occurring?

What people often are not aware of is that all conversations occur within themselves first. Another words, you may think you are seeing people as they ar

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

but in truth you are seeing people as you are. It means that powerful conversations cannot occur until we challenge the perceptions we hold about ourselves and other people. Perceptions are the lens or filters that we see the world through and every person has a different set of lens that they oper

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

Combination pro

te out of. Real powerful conversations cannot occur until a person has some degree of awareness of who they are, their strengths, weaknesses, values and beliefs because that is what shapes their perceptions. We often assume that people think the same way we do or see things the same way but that is

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

ever the case, every person is different and until we challenge our assumptions important conversations cannot fully occur.

When people are afraid to tell the truth because of a potential negative reaction or not wanting to hurt someone’s feelings they are stopping the important conversation from occ

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

rring. When we don’t tell the truth people often know it. They feel the incompleteness and they see the same elephant in the room but don’t know how to confront it. Important conversations require preparation, they should not be done on the fly or without self-reflection, only then can we look the el

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

phant square in the eye and know how to approach it. Here are some things to keep in mind as you prepare for your next important conversation:

· Why does the conversation need to happen?
· What would happen if we didn’t have the conversation?
· What’s the cost of not having the conversa

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

ion?
· What do I want for the other person?
· What do I want for me?
· What are my feelings, opinions, and concerns about this particular issue?
· What are my feelings about this conversation?

Answering these questions gives us perspective and allows us to view the issue and t

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

e elephant from a different vantage point and have a conversation from the heart.

What Creates Powerful Conversations?

A powerful conversation involves a give and take not a one-way dialogue or lecture. The word conveys flow and equal exchange. Powerful conversations can only occur when people are

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

Following aspects would a

exchanging equally. Real listening is what can create a powerful conversation, listening not just for the words that are being used but what’s not being said, awareness of body language and expressions. When we are able to fully listen we are able to understand and see things through a different se

dd to the challenges in developing combination products:

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

of lenses. Listening to understand builds bridges and values the other person.

Powerful conversations can occur in all situations. A supervisor giving a subordinate feedback on their behavior is a wonderful opportunity for a powerful conversation. Providing an opportunity to share their perceptio

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

with no blame or faultfinding. Powerful conversations involve speaking the truth from the heart; they are direct and caring. When we are indirect in our communication we are not having a powerful conversation we are finding ways to skirt the issues and giving the elephant in the room more power. T

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

e only way around an issue is to face it directly with compassion and understanding.

The Elements of a Powerful Conversation

· Speak the truth with understanding.
· Challenge your perceptions and the perceptions of those around you.
· Demonstrate personal responsibility and create op

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

nness for mutual responsibility.
· Speak with feeling, be vulnerable, and maintain your personal power and center.
. Know what you want from the conversation and from the relationship.
· Ask questions
· Change buts to ands

What’s Important?

Real conversations are a process t

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

Professional from academic institutions, pharmaceutical industries, health care indust

ey are not an event, Issues are not left hanging they are completed. That completion will often mean several conversations with mutual commitment from each person. Real communication cannot fully occur with only one dialogue, Powerful conversations require commitment, commitment to the relationship

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

s well as oneself. Building the skills necessary for a powerful conversation don’t happen over-night and must continually be nurtured.

It can be easy to ignore the important issues or find reasons to procrastinate on having the important conversations but the big issues will never go away by themselv

.

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. When we decide to give power to the elephant in the room things don’t get better, it is only when we claim our own power and have the conversations that change happens. Change sometimes isn’t easy and human nature will pull us back to the easy and safe way. The safe way involves staying where we

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

Companies that provide selfless information through particip

are and avoiding the real important issues. We must be guardians of that and take charge, reclaim our power from the elephant in the room and have those important conversations. Whether they be with a boss, subordinate, co-worker, spouse or child let us all step up to the plate and make a difference

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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