Useful Advices - Business

Even though I am no longer an official, card-carrying member of the corporate workforce, I remain close to it through my executive wife. My

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

business partner and I must clearly communicate with each other and others in order to meet the goals we have set. We talk often and use a

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

Examples of combination products may in

web-based planner to get on or stay on the same page, literally.

My wife and I have an on-going conversation about “current events” in her

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

workplace. I appreciate her inclusion of me as it helps me stay sharp and feel involved. Furthermore, I know many of the people from my ow

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

n employment there, so it is an easy conversation.

Time and time again, a main theme continues to emerge in those conversations. Well, the

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

Combination pro

e’s several, but I’m going to talk about clear communication in the workplace.

For-profit businesses are results-driven. Whether the compa

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

ny is public or private, conducting business that produces revenue is the goal. Then, managing the operating expenses in order to turn a pr

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

fit is ‘the name of the game’. Now, work it backwards.

What I mean is what is the first step? The very first step for management to take

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

is clear communication. It is vital to the morale-flow of the employees for the management team to be direct and concise regarding their in

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

tructions of revenue-generation. For example, if a manager wants a task done, the question s/he must answer beforehand is, “Do I care how i

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

t is done?”

Very little is more annoying to a capable employee than to receive a directive from a manager, complete the directive with qual

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

Following aspects would a

ity and by the deadline, only to hear criticism from the manager as to how the directive was completed. So, if the manager is particular as

dd to the challenges in developing combination products:

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

to how a directive is completed, s/he must take the time to clearly explain the process. Herein lies another problem.

Many managers are, i

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

n effect, lazy. It is almost as if they expect the employee to “just know what I mean.” Have you ever heard anything like this? The other

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

part of the manager’s failure to clearly communicate is the time it takes to do it. Often, the manager cares how the directive is completed

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

, but takes for granted that the employee knows what s/he knows. The manager fails to communicate how the directive is to be completed. In

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

Professional from academic institutions, pharmaceutical industries, health care indust

the manager’s defense, s/he must reasonably be able to assume that the employee has the knowledge or skills to accomplish the directive with

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

out a crash course. Invariably, the employee completes the task to the chagrin of the manager. Every circumstance is slightly different; n

.

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

vertheless, the manager is ultimately accountable for the performance of the team and must know the team well to be safe in making assumptio

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

Companies that provide selfless information through particip

ns.

The most effective managers are the ones who clearly communicate. Thus, they avoid morale pitfalls that steal synergy from their teams

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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