Main Subject - Business

One of the most dangerous and damaging practices of business owners is MICROMANAGING their business. And this practice is entirely too prevalent in today’s business world and it wastes valuable resources of time, talen

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

t and financial assets. It is particularly prevalent in entrepreneurial businesses. And the reason behind that may be rooted in the fact that entrepreneurs are motivated to start their businesses so they could be their

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

Examples of combination products may in

own boss, make more money and gain more freedom.

So, with that being said, I need to ask those of you out there who are entrepreneurial business owners a couple of questions. My first question is: If you had to leav

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 your business for an extended period of time, let us say a couple of months, would you come back to a business that is still running smoothly and profitably? My second question is: What would your answer be if we cha

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

nged the time frame of your absence to two weeks? Let me say that if your answer was anything other than yes, then you probably don’t really own a business, you own a job.

Well guess what? The good news is that you ar

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

Combination pro

e not alone. It is well known that small business owners are among the hardest working people in the world. However, it cannot be said that they are among the smartest working people in the world. To be successful in

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

today’s business world, it is imperative you adopt and develop a strategic thinking mind-set. As a strategic thinking business coach, I emphasize repeatedly to my clients that a major goal for them is to develop a self-

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

managing and systems-oriented business that still runs predictably and profitably while they are not there. And this enables them to “work on the business” instead of having them only “work in the business.”

The first

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

commitment a business owner must make is to stop acting like an employee and start thinking land acting like a CEO. A transition is necessary for the business owner to think and behave more strategically and less tacti

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

cally in their role as owner. The business owner must stop micromanaging and delegate. The business owner must start reducing the amount of time they spend involved in the daily transactions of their business.

Michael

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

Gerber implores business owners to implement systems and procedures into their business that ensure daily tasks are completed correctly. In any well run business, all current systems and procedures need to be evaluated

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

Following aspects would a

based upon results and updated as needed. In addition, documentation for all procedures, policies and systems need to be created to have a reference for employees and new trainees. Another good proactive and strategic

dd to the challenges in developing combination products:

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

business practice is to cross-train your employees before the need arises, not after the panic has set in.

Please read this very carefully - Trust your employees. One of the common major issues I hear from employees i

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

n my business coaching practice is that they are not trusted by the owner(s) of the business. What a sad commentary that is on business today. If you cannot trust your employees to complete the daily tasks and act in

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

the best interest of the company, then maybe they shouldn't be employees. In the long run, the more hands-off you can be, the more time you will have to work on the strategic issues and the larger vision for the busines

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

s, which is what a business owner needs to do.

Boiling all this down to a single thought: you should run your business; it should not run you, your family or your life. You need to have a systems-dependent business, n

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

Professional from academic institutions, pharmaceutical industries, health care indust

ot an owner-dependent business. Many of these concepts are very challenging for owners. And some owners will never “get it” and will continue in a vicious cycle of turnover in their business and failure to achieve full

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

potential in their business. Other owners will recognize the error of their ways and transition into a new way of thinking and managing. The owners that understand this will survive and thrive, while those who refuse

.

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

to let go of the “micromanaging mentality” will experience turnover of employees, less than optimal performance of employees, continual dysfunctional behavior and decision-making in their business and therefore be dest

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

Companies that provide selfless information through particip

ined to be under –achievers and failures in the long run.

The Dangerous Consequences of Micromanaging Your Business By: J. Glenn Ebersole, Jr., Chief Executive of J. G. Ebersole Associates and The Renaissance Group ™

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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This second article in a series discusses what has become an epidemic: ads and websites that simply don't communicate because they assume the reader knows as much about their business as they do. Result: ad dollars down the drain.

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