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Do you hesitate to bring up tough issues, because you aren’t sure how to resolve them? Do you dread talking with your boss or co-workers about controversial topics, because you know the result won’t be good? Do you get stressed out just thinking about a difficult conversation you need to have? Is your organization 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

uffering, because managers and employees don’t know how to talk about challenging issues without ending up in arguments that have unsatisfactory outcomes?

Difficult or “Critical” Conversations can make the difference between success or possible failure for your business or for you as a manager. Poor communicati

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

Examples of combination products may in

on is at the core of 70% of stress experienced at work and consistently creates obstacles for the accomplishment of your major business or career goals. Two things can create the opportunity for managing this personal and interpersonal challenge. Awareness of habitual responses that have sabotaged your communications i

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

s the first step and then practicing certain skills will offer you the ability to break out of old, negative patterns enabling you to succeed more easily where you may have struggled in the past.

Let’s start with creating awareness that will help you to break out of your negative, self-defeating patterns. At the very

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

ore, is understanding how you habitually respond to difficult communications. Do you get so stressed out that you stop problem solving and just create “knee jerk” responses that can make difficult situations worse? When we get stressed we often react with two primitive survival responses: Fear or Anger. Neither of thes

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

Combination pro

e will promote positive outcomes. Controlling, or at least managing, your stress response is one of the first things you can do to promote better outcomes. Since everyone responds in their own unique and habitual way to stress, then you must begin the process with going “internal” to observe, understand, and control yo

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

ur own stress response pattern. (I have written other articles, in fact, books on this topic. See Guide to Stress Reduction for more information.) But in case you do not have the time to study up, start by taking a deep, slow breath. Pause after you inhale and then exhale slowly and completely. Relax your jaw! Relax yo

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

r neck/shoulders. Smooth your forehead. Slow down and become more fully present. Repeat these slow breaths two or three more times until you can begin to feel yourself starting to “let go.” This will take practiced repetition but can be used as you plan and then enter into critical conversations.

Be aware of what you

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

really want from this interaction. Plan and then visualize the most positive outcome. Practice seeing it happen (if you have the time.) If you are confronted and do not have time to plan, then take charge by saying that you are not prepared to have this interaction at this moment, and then schedule it at a more appropr

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

iate time. At the very least, do not get “sucked in to the drama” by reacting. Use your breathing technique to slow things down and to keep from falling into old negative patterns. Know what your ideal outcome would look like and expect this to happen (do not dwell on the potential disasters.)

If possible, study or kn

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

w the “intentions” of your communication partner. If you are unclear, start by controlling the conversation. “Back up” and ask the questions that will allow your communication partner to reveal their “agenda” (including their fears and their expectations.) You do not have to “cave in” to their emotional or personal nee

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

Following aspects would a

ds, but it may be helpful to really feel their position. As an exercise, understand how you or your position may have contributed to their concern (or their issues.) Look to the future, knowing your attitude toward your partner and the situation, and then do not fall into the trap of trying to defend yourself or past s

dd to the challenges in developing combination products:

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

hared experiences. Treat this interaction as an entirely new event that can have the most positive outcome for all concerned. You may not be able to achieve this to everyone’s complete satisfaction, but you can be flexible with your responses, demonstrating respect and better understanding of their position. If you hav

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

e contributed to the obstacles to positive resolution, find a way to acknowledge this situation and then move in a more appropriate direction for finding a workable solution. “Digging in your heals” may not offer the best long term answers or give you the best chance of finding the most appropriate final answers.

The

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

oncept of demonstrating respect for your communication partner’s position does not mean that you accept it. It means that you understand their stance on this issue and will honor that they may have an opinion that is contrary to the position that you may have. There is no “absolutely” right way or only one solution to

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

an issue. There may be group problem solving that will involve some appropriate compromises that allow for contributions from all of the people concerned…The negotiation necessary for a successful outcome at work depends on respect, professionalism, and managed emotions. Get input from all concerned participants and ex

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

Professional from academic institutions, pharmaceutical industries, health care indust

haust all alternatives before agreeing upon a solution.

Finally, it is best to create a realistic quantifiable result that all of the participants agree upon and will be accountable for achieving. Set reasonable and agreed upon timelines. Establish methods for ongoing communication, and checkins, for moving to the agr

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

ed upon, desired result.

So let’s review some of these main tips:
Control/manage your levels of stress (and your emotional responses)
Be aware, and not a victim, to your habitual response pattern
Be clear on what you would like from the critical conversation and see a positive outcome
Respect othe

.

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

r people’s position even if you do not agree
Understand what role you may have played in past negative outcomes
Look for input and viable compromise
Develop a measurable result that all participants agree upon and are accountable for producing

These are some of the basic steps in a program which will le

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

Companies that provide selfless information through particip

ad you to managing your habitual responses and getting results in “Critical Conversation.”

If you are looking for more information regarding critical communication coaching, please investigate the Communication for Success Training Program

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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