Advice Pool - Self Improvement

How often do you engage in the kind of conversation that stimulates others to change their performance? First, reflect on the following: How many conversations do you have during an average day? 30, 50, 100? How many of these 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

imply function as social lubricants, helping you slide through the day without having to address the real and important issues you face? How many of these conversations really matter?

Now, reflect on the significant conversati

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

Examples of combination products may in

ons you had over the last week. Consider the following: at the end of the conversation did you feel complete? Did you say everything that needed to be said? Did you feel good about the interaction? If so, notice why. If not, co

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

nsider what was missing. Notice if there was something else you wish you had said or done. Did you feel that you held back in the conversation? Did you find yourself later having the conversation you wish you had had with anoth

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

r co-worker, friend or perhaps your spouse? Maybe you just have the conversation with yourself. If so, you are not alone. These are very typical reactions when we avoid the important conversation.

Leaders at all organizational

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

Combination pro

levels are being asked to be more coach-like with their

team members, colleagues, and even their customers. Unfortunately, many who lead organizations find themselves ill-equipped to provide such coaching. It’s not that we la

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

ck the requisite interpersonal and leadership competencies, but that coaching requires more. Coaching challenges us to engage in a different kind of conversation; one that confronts real topics of performance discrepancies, asp

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

rations, values, disappointments, and passions –topics that are often uncertain, uncomfortable and emotionally charged.

We call these Dangerous Conversations. Not dangerous because someone will be hurt (quite the contrary), bu

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

t dangerous because they always explore new, uncharted territory with all the accompanying risks that range from defensiveness to vulnerability, from anger to euphoria.

Coaching requires us to engage in the Dangerous Conversat

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. It is dangerous because it confronts questions that need to be asked: “Are you doing your very best work right now?”, “How are you getting in your own way?” and “What would happen if you really took your foot off the brake

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

” It is dangerous because it raises issues that are uncomfortable for even the most experienced managers: “You are better than this”, “This sounds like an old, tired story” and “I think you are afraid to try.”

Walk Away Empty

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

Following aspects would a

When we engage in a dangerous conversation we walk away empty; everything that needed to said was said directly and honestly to the person who needed to hear it. We know immediately when we have done this because we feel a rel

dd to the challenges in developing combination products:

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

ease. The burden we carried is transformed into a wonderful gift for another. Even if the message is very difficult for the other person to hear, if it is delivered with the other person interests at heart, we can take comfor

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

t in knowing our work is done. We did not hold back in our communication; we respected the other person enough to tell him the truth. We cared enough about his success to take the risk and to be uncomfortable for his benefit.

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

e also know immediately when we haven’t given everything to a conversation. We held back, not wanting to hurt, challenge or even affirm the other person, arrogantly believing that our words would be too much for him to handle.

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

We lacked the courage to share our unvarnished perspective. As a result, we leave the interaction feeling unsettled, still filled with our real concerns and all the thoughts we censored, left to ruminate on them indefinitely. S

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

Professional from academic institutions, pharmaceutical industries, health care indust

ometimes we even seek out a third party with whom to finally speak our truth; the conversation that we didn’t have the courage to share more directly. Communication experts call this process “triangulation,” but to most of us,

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

t is simply gossip.

Are you a Leader Coach? Are you known to be able to have the Dangerous Conversation? Would others call you a coach?

Try This: Think of someone you have complained about recently. Also, think about someon

.

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

e whom you believe is very talented but underachieving. Then ask yourself, “What is the dangerous conversation I need to have with these people?” Make a promise to have those conversations today.

After the conversation, notic

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

Companies that provide selfless information through particip

e how you feel. Do you feel empty? Did you say everything you needed to say to the person at that time? If you felt you held back, notice what you held back and why. Develop the habit of having Dangerous Conversations every day

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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