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Leaders and Managers often ask us, ‘What do you do when you have tried to coach and counsel an employee about a performance concern, and the employee has no

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 responded?

Unfortunately, we see far too many cases where the leader hasn’t, in good faith, tried to coach the employee or to put the leader’s concerns i

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

Examples of combination products may in

to words. Often, leaders look for a quick fix alternative to what is perceived as a difficult and painful confrontation.

We have also learned from first-h

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

nd experience that management coaching is not a one-shot effort. It takes re

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

ular ongoing discussions and experiences to achieve the level of support and cooperation needed. When you have truly exhausted all your good-faith efforts

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

Combination pro

o coach an employee into change, you have the right to move to the next best alternative, a coaching based solution.

In certain situations, employees have

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

rown accustomed to and dependent on heavy authority in the workplace, or they just don’t feel attached to the job or organization. We are not advocating th

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

t the leader wait for someone to pass out a permission slip to try a different approach; rather, the leader should tell the employee that the management coa

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

hing approach hasn’t worked and it is time to take a different path. Probably the best thing a leader can do is literally call a time-out, pull back, and r

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

examine the entire interpersonal/working contract or agreement with the employee. The leader needs to reconsider the basic assumptions and understanding ab

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

ut the employee’s role and terms of employment in the organization. This is a major renegotiation effort.

It is very possible that the job demands or pers

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

Following aspects would a

onal expectations and objectives of the employee or leader have changed sufficiently that a real pressure point has been created in the leader/employee rela

dd to the challenges in developing combination products:

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

ionship. Remember, a social contract between a leader and employee works as long as there is “mutual consent and valid consideration” for both parties. If

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

a new agreement and shared vision of common goals can be reached, then a new state of leader/employee stability and equilibrium will be achieved. If not, t

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

e leader and employee should begin to explore and plan a way to separate effectively.

Some leaders say they can’t get along without the employee. No probl

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

m – you simply need to look for creative ways to restructure the employee’s job or reassign or retrain the employee to cut your losses and limit your exposu

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

Professional from academic institutions, pharmaceutical industries, health care indust

e. You may consider “down-sizing” the employee’s role to fit the needs of the situation.

Another strategy is to pursue a path or formal disciplinary or pr

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

bationary action. Obviously this is riskier; it may be a path of no return in the sense that cultivating a healthy relationship in a climate of hostility 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

d possible resentment, anger, and embarrassment over disciplinary action is difficult. You may be forced to pursue this path to the unpleasant end of a sep

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

Companies that provide selfless information through particip

ration, the ultimate challenge for any leader.

The other thing you may consider is to take two aspirin, grin and bear it, and go on lots of short vacations

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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