Useful Advices - Business

Tom was working hard to change the culture in his organization. He wanted to create greater collaboration, teamwork and empowerment. He envisioned an organization where people loved coming to work each d

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

ay. He knew that when these things were a part of working life that productivity would sky rocket, and greater business results would flow naturally from this new culture.

Since he really wanted people t

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

Examples of combination products may in

have more ownership in their work and results, he felt he needed to drive more decisions through consensus. He reasoned that if he or other leaders made all the decisions, he’d never achieve the culture

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

e hoped for.

So after he explained that consensus was his goal for most decisions, people tried to reach it. They had longer meetings, more discussion, some frustration, and limited success. They seldom

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

seemed to be reaching the nirvana that consensus was supposed to be.

A bit disillusioned, Tom tried to learn more about consensus and how to achieve it. Here is what he learned . . .

What Consensus

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

Combination pro

s

The dictionary defines consensus as: agreement in the judgment or opinion reached by a group as a whole. This definition is why we all aspire to reaching it – it sounds good and we know that if we

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

each it there will be high levels of commitment to the decision made by the group. But as Tom had learned, while it is a worthy goal, it is sometimes hard to reach. One of the reasons it is hard is that

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

eople don’t have a clear definition of it – one that makes the concept more real than a dictionary definition.

Consensus is reached when everyone involved can honestly make the following three statements:

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

“I believe that you understand my point of view.”

“I believe that I understand your point of view.”

“Whether or not I prefer this decision, I will support it because it was reached openly and fairly.”

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

he two most important words in the statements above are understanding and support. Decisions that are truly reached by consensus are decisions that all parties understand – both the background and the rat

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

onale – and therefore can and will support.

Remember too that support is more than just agreeing in the meeting. Support means actively supporting the decision back in the workplace and always being a pr

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

Following aspects would a

ponent for it.

What Consensus Isn’t

While a consensus decision may be a compromise in some ways, it isn’t negotiated from the perspective of two sides negotiating to get their way. It also isn’t

dd to the challenges in developing combination products:

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

a majority vote. Voting may be a step that helps a group move towards consensus, and there are times when a majority vote is an appropriate decision making approach – just don’t call it a consensus.

Some

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

imes, unfortunately, you don’t know how complete your consensus is right away. If people backtrack or undermine the decision through their words or actions, it is proof that true consensus wasn’t reached.

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

When Do We Go For It?

Consensus decision making is a powerful tool for any group when they are trying to cement the commitment to a decision or course of action. When the stakes of a decision ar

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

high, or a high level of commitment is needed from every involved person, then the time required to reach a consensus is a worthwhile investment.

There are many decisions and situations that don’t requir

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

Professional from academic institutions, pharmaceutical industries, health care indust

that level of commitment or buy-in. There are many times when team members are happy to have input but will support whatever course of action is selected. In this large percentage of situations, investi

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

g the time to reach consensus is not necessary and may actually be counter-productive.

So like any other tool it has its place. There are times when you want to build true consensus and other times when

.

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

our effort and time could be better spent in other ways. When you recognize this fact you’ve taken the most important step towards using consensus decision making most effectively.

There is much more tha

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

Companies that provide selfless information through particip

can be said and written about consensus and consensus decision making. But all of this conversation should come after you have a true understanding of what it is, and when it is appropriate to achieve it

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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