Advice You - Business

In management seminars I often compare debt to an infection. A reasonable amount of debt will not kill a business, but too much debt will. While mos

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 businesses carry a substantial amount of debt from time to time, it must be maintained in an acceptable relationship to stockholder’s equity.

Infect

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

Examples of combination products may in

ion is also a threat in business relationships. How serious the illness your business’ relationships experience depends on how effective management is

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

at controlling business relationship germs that are spread around in the normal course of doing business.

The following are a few of the relationship

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

germs I’m referring to. Managers must understand them and control them to keep their business relationships healthy.

Belittling your employees. Your

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

Combination pro

company’s best and most productive employees have more options than ever. With so many options, employees have the luxury of demanding respect. So i

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

you observe your managers belittling, putting down or showing disrespect to the people in the organization, corrective action is called for.

Seeing m

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

ore negatives than positives. Is the glass half full or half empty in your organization? When employees break rules, make mistakes or violate company

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

policies, these issues certainly need to be discussed and dealt with. However, when employees do something that you perceive to be over and above the

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

call of duty, they also deserve praise.

In the little management book, The One-Minute Manager by Kenneth H. Johnson, the “one-minute praising” is reco

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

mmended when employees are observed doing something right. To be most effective, “praisings” must occur as soon as possible following the positive beh

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

Following aspects would a

avior and should be as specific as possible.

Failure to provide employee feedback. Employees deserve to know where they stand and in professionally m

dd to the challenges in developing combination products:

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

naged organizations, feedback is typically given via a formal performance review.

What is the employee turnover in your organization? Are your operat

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

ing expenses higher than necessary due to excessive employee churn? Excessive employee turnover is a sign that your people are either not earning a co

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

mpetitive wage or management is not communicating clearly.

Poor customer care behavior. Competitors are highly motivated to begin more aggressive att

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

cks on your customer base. Because so many of your industry’s less professional salespeople will employ low-ball pricing tactics as bait, more attenti

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

Professional from academic institutions, pharmaceutical industries, health care indust

on than ever must be paid to how well your company is treating its customer base.

The owner or general manager should be on a first-name basis with ea

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

ch of the customers that make up the top 80% of your sales. A manager should visit each top customer at least on a quarterly basis, showing genuine an

.

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

sincere interest in their business and asking what the company can do to improve the efficiency of their operations.

Invite customers and prospects o

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

Companies that provide selfless information through particip

nto your turf. Organize customer seminars, hold an open house, invite vendors to conduct new product demonstrations, launch a customer newsletter, etc

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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