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A successful business needs good management. However, without satisfied, dedicated employees, it will fail. Happy employees are optimistic and productive. Their enthusiasm rubs off on both mana

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

gement and customers. There is nothing like going into a business where the employees are happy, enthusiastic and satisfied with their careers and the way the company is run. As a customer, supplier or

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

Examples of combination products may in

even a competitor, it is a pleasure to walk through the door of such a business.

Happy, satisfied employees are the most attentive and helpful to the customers. An employee with a positive attitude 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.

ontagious and can change the attitude of every staff member they are around. However, just as a positive mind set is easily spread, so is a negative one. If a member of the team is unhappy, watch out!

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

His or her negative attitude can become infectious, contaminating coworkers and customers alike. These pessimistic employees can breed an atmosphere of low morale. This will lead to decreased productiv

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

Combination pro

ity, higher than normal turnover and unproductive time spent gossiping and complaining. The expense of training each new employee so they may excel is lost when they leave to work at some other organizat

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

on because the atmosphere is too negative at your organization.

This is where competent management earns their big salary. They must quickly identify the source of discontent and eliminate it as quickly

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 possible. If the cause is some new procedure or policy change, then corrections must be implemented immediately. If the problem is an employee, then that employee must be taken aside and counseled.

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

Part of that counseling should include notification that their employment will be terminated unless they improve their attitude and behavior within a specified time frame. This notification should be ma

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

e in writing. One copy of this notification should be left with the employee and one copy with a signature from the employee acknowledging receipt of the notification should be retained by management and

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

filed on the employee’s personnel file. If improvement doesn’t occur, then the employee must be dismissed from the company. Just like a rotten apple can destroy a whole barrel of fruit, one pessimisti

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

Following aspects would a

c disruptive employee can destroy a company if left to fester away.

To combat negativity in the workplace, management must continually motivate employees by encouraging them to work to the best of their a

dd to the challenges in developing combination products:

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

ilities. Regular management/employee contact is necessary to show that an employee’s contributions are valued. Management should implement a suggestion award program which will allow employees to have

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

input into the running of the company. Compensation should be made for any suggestion that is implemented. Regular scheduled employee/management meeting should be implemented. These meetings should be

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

used to discuss what is working and what isn’t. New policies or procedures should be announced at these meetings along with adequate justification for their implementation. Staff luncheons could be mad

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

part of these scheduled meetings. A free lunch for employees who attend the meeting should ensure good attendance. Also, Employee of the Month recipients can be announced at these meetings.

Another mo

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

Professional from academic institutions, pharmaceutical industries, health care indust

rale booster for employees is a continuing education program. If employees receive free or heavily subsidized education from their employer, they appreciate it. This is especially true when successful

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

completion of the program results in a promotion within the company.

If your organization recognizes that its employees are valuable and deserve to receive praise and recognition, then you will benefit fr

.

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

m increased productivity and employee satisfaction and retention. This will also positively affect customer satisfaction.

The success of your business depends upon creating an environment that is conduci

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

Companies that provide selfless information through particip

ve to employee happiness. If your environment doesn’t do this, then you must make the necessary changes to correct it. REMEMBER, that good management and happy employees result in a successful business

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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