Advice You - Business

This is not the first time I have talked about micromanagement over the years, and I am sure it won't be my last. Recently, I had some business friends complain to me how their employees cannot follow directions. But on the

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

other hand, I also know a lot of people who wonder why management doesn't trust them to do their job properly. You see this not only in the corporate world but in nonprofit organizations as well. Today, managers are spending

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

Examples of combination products may in

more time supervising the work of others as opposed to actually managing them.

Back in the 1960's and 1970's we talked a lot about empowering workers and teamwork, but the pendulum seems to have swung the other way and mic

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

omanagement is now in vogue in today's corporate cultures. I have a theory as to why this has happened:

First, we now live in a litigious society where everyone is paranoid about accepting responsibilities that may result i

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 a lawsuit. As a result, employees come down with an acute case of "The Stupids" and heaps everything on their manager's desk. Such a mindset means there is little, if any, self-initiative by employees.

Second, we overly s

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

Combination pro

ructure the activities of our youth, be it at home, in school, or on the playground. For example, when I was a kid I was always ready for a pickup game of baseball (I think I carried my glove and bat with me just about every

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

where). But the youth of today doesn't think this way anymore. Instead, they need uniforms, equipment, coaches and manicured baseball fields in order to play. Further, they are more inclined to play an electronic game indoor

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

as opposed to interacting with their peers. This is causing our youth to become socially despondent and a legitimate cause for concern in the workplace in the years ahead. And because they are only being given tasks to perf

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

orm around the home, and not responsibilities, there is no sense of initiative being instilled in them. In other words, our youth are being subliminally trained to accept micromanagement. How about delegating some responsibi

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

ities to them instead? We used to call this "chores" in the old days.

Third, We've forgotten how to manage. Regardless if you are in the corporate world or a nonprofit volunteer organization, our leaders are now more driven

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

by ego as opposed to a results orientation. Being a manager is not about having a fancy job title or building an empire, its about producing a quality product or service on time and within budget. And the only way this can

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

Following aspects would a

be accomplished is through people. Consequently, managers need to develop their interpersonal communications and leadership skills. Its not about numbers or technology, its about people.

Managers want workers to show some s

dd to the challenges in developing combination products:

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

lf-initiative and perform their work well, but to do so, you have to train them properly and trust them accordingly. This means building loyalty and investing in the staff. It also means empowering them with responsibility a

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

nd holding them accountable. Employees have to understand what their duties and goals are, and be allowed to try and conquer them. "Empowerment" implicitly means a worker has a right to try. This of course means motivation,

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

raining, and experience.

The three "top-down" primary duties of a manager are:

1. Delegate - prioritize and assign tasks to qualified employees.

2. Control work environment - minimize staff interferences and provide a sui

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

table workplace to operate with the proper tools to perform the work.

3. Review progress - study employee reports and take corrective action where necessary.

In return, the "bottom-up" responsibilities of the workers inclu

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

Professional from academic institutions, pharmaceutical industries, health care indust

e:

1. Participate in the planning process - review work specifications and give feedback; estimate amount of time to perform an assignment, assist in the calculation of work schedules with management.

2. Perform work withi

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

n time and costs constraints.

3. Report activities to management - including the use of time, interferences, possible delays, and anticipated accelerations of schedules.

This "bottom-up" approach to management represents a

.

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

empowerment scenario where the workers are made to realize their voice is important, builds trust, and encourages initiative.

But if you are the type of manager that finds its necessary to supervise the actions of your wor

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

Companies that provide selfless information through particip

kers, than you are part of the problem, not the solution. Remember: "Manage more, supervise less.

"Surround yourself with the best people you can find, delegate authority, and don't interfere." - Ronald Reagan (1986

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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We all have recollections of historical dates of significance. So as you plan out your yearly calendar, have a little fun with what is going on in the outside world. Look for clever dates and innovation memorials that you can use as a marketing tool. Not only can you use these little tidbits to amuse yourself, you can also use them to reconnect with friends, colleagues, associates, bosses, potential employer, and reporters.

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