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Do you sometimes feel that all your time is focused on dealing with problem employees? It seems that when you're not addressing perfor

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

mance or discipline issues, you're creating new policies, procedures, and work rules that are geared to correct the bottom 10% of your

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

Examples of combination products may in

workforce. In all my years in consulting, working with large organizations and small, I regularly hear this from executives who are to

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

ally exasperated by both employee issues and the inability to focus on anything else.

But how do you know when enough is enough? What

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

barometers can you use to determine whether you’ve hit a wall and need to get some expert help? Here’s a quick quiz:

1. When recruit

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

Combination pro

ing, are you finding that the people coming through the door are not qualified to do the job?

2. When a new hire starts working, do yo

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

sometimes wonder: “Is this the same person I interviewed for the job?”

3. Are your employees not learning the job as fast as you need

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

them to?

4. Are your supervisors ill equipped to manage their employees?

5. Are you losing top performers because you haven’t been a

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

ble to provide them enough challenge?

6. Do you often wonder what the heck your employees are thinking?

7. Do you find that increases

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

in wages do not result in any increase in productivity?

8. Do conducting performance appraisals seem to create more problems than they

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

’re worth?

9. Do injured workers seem to stay out of work longer than you think they should?

10. Do you often wonder if some employee

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

Following aspects would a

s are even going to show up for work?

11. Does it seem like your turning over people at a faster rate than you can replace them?

12.

dd to the challenges in developing combination products:

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

s it sometimes easier to do the job yourself rather than try to train someone to do it?

13. Do you often hear “it’s not my job”?

14.

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

Do you struggle to get projects done on time and within budget?

15. Are you unsure of your obligations under the law?

16. Do you find

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

yourself so focused on problem solving that you have no time to think about innovation?

17. Do you sense that your employees are not

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

ocused on the customer?

18. When dealing with employees, do you constantly worry that you might get sued?

19. Is soliciting ideas and

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

Professional from academic institutions, pharmaceutical industries, health care indust

suggestions from your employees like pulling teeth?

20. Do you sometimes feel that things just aren’t working?

If you answered “yes”

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

to more than 2 or 3 of these, you’ve got problems. Things need to change—and need to change now. Get some professional help. If you

.

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

are to survive and prosper, you need to start doing things differently. Successful organizations depend on well trained, engaged emplo

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

Companies that provide selfless information through particip

yees. When your workforce is operating effectively, you will find that you are in better control and problems with employees disappear

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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