Digg It - Business

Is your organization driven by a clear vision and strategy that is understood and supported by every person at every level?

A few year ago during an all employee meeting, t

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

he following question was asked of the audience, "What would you do if you knew you could not fail?"

Distinctly different answers emerged, which proved divisive and formed

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

Examples of combination products may in

two groups: "Glass-half-full" and "Glass-half-empty."

Glass-half-full: The first group developed this view: we're free to explore, free to make mistakes, fre

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

to learn, and encouraged to grow.

Glass-half-empty: The second group misread the question's intent and came of with this negative view: we must do as we’re told, ou

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 work has to be perfect, we must stick to what we know, and no matter what, "we must not fail."

Until we figured out how the message had been misinterpreted, we

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

Combination pro

hought the second group of employees had lost their minds. Later, however, we discovered the source of the issue was the innocent but misread question asked during the all-employee

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

meeting. Quickly, the leadership team reinforced the correct message. Then, we tested for "buy-in."

Buy-in is the result of a clear consensus, which fosters a bond to work toward

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

the fulfillment of a common objective. Employees are still free to express their opinions, even if that means discussing different paths to accomplish their common goal.

With buy

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

in, the diversity of the group works toward the common good. Vince Lombardi said, "Build for your team a feeling of oneness, of dependence upon one another and of strengt

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

h to be derived by unity."

Once buy-in has been established, differing opinions are welcomed by other team members because such input offers multiple opportunities to find the

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

best solution: one that offers consistent and sustainable results that fulfill the common goal.

How do we encourage buy-in within a fast paced environment? One of th

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

Following aspects would a

e key opportunities to generate buy-in occurs during the planning process. A workshop format is used to develop a consensus of the issues facing the organization, which produces tw

dd to the challenges in developing combination products:

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

o benefits: (1) it helps all employees to understand the challenges; and (2) it encourages all employees to own the issues and to personally contribute their best efforts toward fi

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

ding solutions.

For example, the workshop included in LMI's Organizational Strategic Analysis (OSA) encourages employee participation. The workshop develops a consensus of

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

the issues and generates potential ways to solve the challenges.

After the analysis phase, the potential solutions are refined. Then, the selected solutions are built into the

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

rganizational Plan of Action (OPA). Once completed, the strategic plan will enjoy greater support because of the buy-in developed during the OSA workshop.

Leadership teams can

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

Professional from academic institutions, pharmaceutical industries, health care indust

also benefit from learning the techniques and practicing the skills used to foster buy-in in everyday situations, such as projects and group meetings. For example, LMI's Effect

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

ive Communication program and Teleometric's Communication (Modual 3) will help supervisors and managers to develop consensus-building skills.

Picture what could happ

.

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

n when the potential locked away in every employee is released to overcome the challenges facing your organization. Buy-in can channel their collective potential toward the fulfill

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

Companies that provide selfless information through particip

ment of the organizational vision and strategy.

If each employee clearly understood the vision and strategy, how much further would that buy-in propel your organization?

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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Digg It - Effective Communication: Planning Buy-in

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