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Fred, a manager, needs to teach Grant, his employee, that there would be consequences for poor performance. Let's use a three-month project that Grant had failed to start as an example of

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

how to go back and fix a problem that Fred inadvertently caused.

Step One: Delegate clearly. This was the step Fred did do pretty well. He specified the results he was looking for

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

Examples of combination products may in

, by when, and what costs.

Step Two: Set a benchmark for partial completion. In the future, Fred needs to establish benchmark dates when sequential pieces of the project must be a

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

complished to insure completion before the drop dead date his management is expecting. He also needs to check for understanding and ask Grant if he needs help.

To insure Grant will get the

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

new process, Fred must specify when he wants Grant to get back to him with the first part of the project done. . . in this case, choice of a vendor and preliminary budget figures. Because

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

Combination pro

this is now a rehab project, Fred can't allow too long a time before the first deadline. He also can't miss checking in on the agreed upon date.

Step Three: Deliver consequences for le

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

s than stellar performance. If, by this first deadline date, Grant hasn't found a vendor and started to put together the costs, it's time for Fred to apply pressure to move Grant to a

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

ction. Fred needs to use the first indication of lack of performance to reinforce his new expectations for changes in Grant's behavior.

Fred needs to ask Grant, "What do you need from

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

me to make this happen now?" If the answer is anything but nothing, it's time for Fred to have a coaching conversation with Grant: What have you done? What steps have you already ta

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

en? What's your process? What additional resources do you need?

This is a conversation, a dialogue, not a monologue, with the stated expectation that Grant will do what needs to be don

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

e. Ask for clarity, understanding, and agreement on date and time for completion. Fred is looking for commitment from Grant that the task will be done. This is the accountability c

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

Following aspects would a

onversation, closing all the escape doors. At the end of the conversation they will both know what will be done by the drop dead date.

If Grant's answer is nothing, then it's time for

dd to the challenges in developing combination products:

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

red to restate his expectations, deliver a close in due date, and ask for agreement that the job will be done by then.

With Step Three, Fred is going for accountability and commitment, an

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

assurance by Grant that he will do what he needs to do to get the job done by the deadline. Fred needs to go for this commitment now to teach Grant that Fred really does expect him to do

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

his work on time.

Step Four: Drop Dead Date Compliance. Fred's most important task this day is to ask for the deliverable. If he doesn't ask, all the hard work of teaching Grant a n

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

w lesson will be lost. Grant will have had one more chance to learn that Fred doesn't care if work that is promised is really delivered.

If Grant delivers, great. Fred can take the next s

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

Professional from academic institutions, pharmaceutical industries, health care indust

tep, set expectations for what the next part of the project is and when it is to be delivered.

If Grant doesn't deliver what was expected, time for a counseling conversation.

What is

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

the difference between coaching conversations and counseling conversations? Coaching is when the person hasn't delivered but says they want to. It is a slip between what is attempted and w

.

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

at is accomplished.

Counseling is needed when people won't deliver what they have promised.

What you have been inadvertently teaching your employees? Have you been undermining the pro

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

Companies that provide selfless information through particip

ductivity you say you want by rewarding bad behavior?

See the articles that discuss this further:

Teaching Employees to Underperform, Coaching Conversations, and Counseling Conversations a

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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