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We have all heard the old adage, "Never Assume," but, of course, we do it anyway. We run our lives on assumptions. When we drive to work we assume people on the other side of the road will stay there. We assume the paycheck will come on the expe

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

cted day. We assume others will do their job or do what they say. We are always assuming. What "Never assume" really means is that we need to be aware of our assumptions and often, test them. This is of great importance to any organization that

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

Examples of combination products may in

considers itself a learning organization.

Some assumptions are purely our own, and others are shared. In organizations where customers are truly valued, it is assumed that their needs are seen as important. This assumption comes from a consiste

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

tly held and communicated expectation from the leadership that customers are the primary focus. It comes from consistently addressing customer needs in a timely and effective manner. In this manner we want to build certain shared assumptions rig

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

t into the mindset of our organization.

Leaders often become frustrated with others when they don't perform to expectations. Our frustration comes from our assumption that the others "should" perform well. We move from frustration to anger wh

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

Combination pro

en we assume that the reason performance wasn't as we expected was because:

a. They didn't care.
b. They are incompetent.
c. They have their own priorities and agendas.
d. They are stubborn.
e. They didn't prepare.

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

f. They should have known what to do; so they were either lazy or stupid.

These are all blaming assumptions. The real problem with assumptions in organizations is that we do not share them. In other words, I make certain assumptions about you,

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

but I don't tell you about them. For example, I ask you to complete a project by four p.m. You say that it will be done. I have certain assumptions about what "done" means. Are they the same as yours? We need to make sure we agree on what "done"

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

means. Will all signatures be on the document? Will the envelope be addressed and ready to go?

As a leader I may tell my employees to offer great customer service. What does that look like? What do I assume that means? I need to share my assump

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

tions about customer service with examples, specifics, and parameters. You can walk into any retail store or restaurant and tell if a manager has shared his assumptions about service. When I receive poor service I know it is a failure of leaders

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

ip to provide clear expectations.

How do leaders make their assumptions visible? Constant repetition helps. Constantly saying what is expected, constantly modeling it, and constantly having conversations to find out what others assume makes our

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

Following aspects would a

assumptions visible.

Conversations have to be two way. Leaders need to be in touch with what people are assuming. What do they assume you want? What do they assume is their role in relation to customers, each other, and you? Ask them how they

dd to the challenges in developing combination products:

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

ame to that assumption. Was it something you said? Was it something they learned somewhere else?

Most people live in their heads. They don't converse in a spirit of inquiry, wanting to know about the needs, concerns, and motives of others. When

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

we see others act, we determine needs and motives by making it up in our heads. In other words, we assume with no real basis or proof.

Today's leader needs to be a conversationalist. I don't mean lots of small talk. I mean the kind of conversa

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

ion that gets at people's needs, concerns, and motives. It is the kind of conversation that builds a shared understanding. A leader can never assume that the people will do a great job unless that expectation is shared, in great detail, and disc

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

ssed. Leaders sometimes say: "I don't have time to be doing all that talking with others. I'm too busy." Often they are too busy putting out fires that could have been prevented by having precise and inquiring conversations.

If we want people

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

Professional from academic institutions, pharmaceutical industries, health care indust

o perform well we need to take the guess work out of what they are doing. In my corporate life years ago, I worked for a leader who always told me how the job should have been done after I did it. He made certain assumptions about the results t

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

hat he never shared with me. It became my job to ask him precisely what results he wanted. I asked him to share his assumptions and expectations. Often I disagreed with his assumptions which helped us to work out more details before the work was

.

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.

We all make assumptions. As leaders we need to test those assumptions by asking others for their view. We need to share our assumptions so that others know what we mean. We need to offer the opportunity for others to question our assumpt

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

Companies that provide selfless information through particip

ons. One assumption we can safely make is that no one person knows everything. If we are to create learning organizations we must recognize that we learn by sharing, testing, and challenging our assumptions about work, customers, and each other

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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