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It is worth remembering that the work environment is primarily an unconventional setting for adults. At home we may have responsibilities for bringing up children, paying mortgages, doing DIY and being good neighbours. These are all self-regulating activities and most people manage to

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

do these without too much stress. The workplace however often requires us to leave our adult instincts at the door and adopt a ‘role-play’ approach in order to fit in with the prevailing culture. Such a setting can encourage competition which in itself can encourage the individuals w

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

Examples of combination products may in

ithin it to raise their game and perform better than they may do alone. On the other hand, this competitive ‘system’ can lead to behaviours that seem to conflict with adult best practice. When disagreements arise, the consequences can often be ugly and lead to ongoing stress and low m

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

rale amongst those involved. Below we shall look at how such a situation may arise and how a facilitated discussion might help.

Let us take an example – Joe is in charge of business development for an IT consulting firm. He has successfully negotiated a key contract to develop some s

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

oftware for a hedge fund company. The negotiations were difficult, considering that a competitor was also bidding for the same project. Joe is very pleased to have won the deal. A team is assembled to design and deliver the system. It is estimated to take six months and cost ?200,000.

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

Combination pro

There are financial penalties involved for late delivery. The project seemingly starts well but as it progresses, Kevin, the Project Manager is getting stressed and key deadlines are being overshot. Five months later, it is clear that the project is way behind schedule and the compan

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

looks likely to incur penalties. Whilst Joe had consulted with his analysts before pricing the deal, he had ignored some of their concerns about a particularly complex module of the work. The analysts couldn’t quantify how potentially complex it might be until they started the work.

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

In the end Joe decided to ‘wing it’ by taking the most optimistic scenario, i.e. that the module would be easy to develop.

A meeting has been called by the CEO of the consulting firm to find out what has been going wrong. Joe is blaming the analysts and the project manager for not

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

being efficient in their work. Kevin, the Project Manager is furious that Joe is questioning his ability and his integrity. He tells the CEO that Joe has set the team up for failure by incorrectly pricing the deal in order to get his commission. The CEO meanwhile is furious at the pr

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

spect of his resources being wasted and of having to pay considerable financial penalties. Clearly we have a situation of conflict. Joe is stressed because he feels that Kevin has got him into trouble with the CEO and that his team has let him down by not delivering the project on tim

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

e. Kevin is stressed because he feels Joe was being dishonest in his negotiations and is trying to use him as a scapegoat.

Is this an unsolvable stalemate? Perhaps and perhaps not? It depends on how the individuals handle it from this point forward. In an ideal situation, a good faci

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

Following aspects would a

litator, (in-house or external), would convene a meeting between Kevin and Joe. Open communication is key at this point and it is important to look at the positive intentions behind each person’s behaviour. Kevin would be asked what his positive intentions were in not communicating ea

dd to the challenges in developing combination products:

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

lier that the project was off-track. He might say that he didn’t want to cause any concern or that he didn’t want anyone to think that he was a failure. As for Joe, he might say that he ignored the analysts concerns when pricing the deal because he was desperate to prove that he was a

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

ble to win good business for the company. He was also determined to ‘beat’ his opposite number at the competitor firm, whom he had worked with before and disliked intensely. A deeper analysis would probably reveal more positive intentions for each party. The key thing about this conve

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

rsation is that even though Kevin and Joe are at loggerheads, it is clear that neither of them had any intention to offend or undermine the other. Their intentions were pure given the ‘system’ that they are operating in.

The discussion could then look at the values or ‘drivers’ of ea

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

h employee. If Joe were asked what was important about winning the deal he might list the following: Money, Pride, Recognition, Job Security and Success. These are the ‘drivers’ behind his intentions. Kevin on the other hand might say that it was important to him not to flag the probl

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

Professional from academic institutions, pharmaceutical industries, health care indust

em earlier because he strongly values: Harmony, Determination, Pride and Teamwork. Both parties are ‘driven’ by different things (although the both value ‘Pride’). Since Kevin values Harmony, he didn’t want to cause a fuss by indicating that there might be a problem. Since Joe is driv

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

en by Money, he may do whatever it legally takes to secure it. In this type of dialogue the facilitator would encourage both parties to see how the methods they have used to meet their values might have caused collateral damage to other people. They could then explore new ways of meet

.

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

ng their values that may be better for the other party and the company in general.

The type of facilitated discussion outlined above is entirely realistic, even when there is animosity or conflict. It broadens the participant’s awareness of how other people have good intentions and a

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

Companies that provide selfless information through particip

dmirable values irrespective of the outcomes of their actions. The participants can also come away with a better understanding of how they themselves think and operate. Building this type of awareness is an excellent way to foster understanding and future cooperation amongst employees

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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Medical labs minimize waste from this practice by making parts interchangeable. For example, only a scalpel blade is tossed, while the handle is kept for a new blade. The remainder of hospital lab equipment is larger machines

I finally found a way to move forward in network marketing without hype and promises. I grew my business and kept my friends and family.

Before you conclude it's impossible to make that deal, consider seven crucial things, says Dr. Gary S. Goodman, best-selling author, keynote speaker, and President of Customersatisfaction.com.

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