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In a recent article in the Performance Improvement journal, William Liccione presents a model that estimates a person's motivation to accomplish their assigned goals based on

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

the relationship between factors like goal commitment, instrumentality to attain the goal, expectancy of receiving compensation, the value of the compensation and the fairness

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

Examples of combination products may in

relative to compensation given to others.

This article inspired me to think about the relationship of motivation to accountability, a word that is bandied around a lot in wor

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

places today, without much practical discussion about exactly what it means nor exactly how to get it. In essence, it's the pointy end of responsibility - that when you are 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

ponsible for getting something done, you will need to show account (show a count?) of having gotten it done, or bear the consequences of not.

So if we want more accountabilit

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

Combination pro

, what are the things we need to pay attention to?

Ingredient #1: Clear, clear, clear goals

What exactly is the person accountable for? How similar is the vision in your hea

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

to the vision in their head about what it looks like when their goals are attained? Get rid of ambiguity, inert language, all-encompassing broadness and keep the number of go

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

als manageable (e.g. 3 to 7 priority goals per person).

Ingredient #2: Personal interest in pursuing those goals

Does the person care about the goals? What's in it for them?

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

You know how hard it is to apply yourself to a task you just don't want to do - like vacuuming under the rug, cleaning out leaves from the roof gutters, giving high pressure s

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

les presentations to disinterested audiences. Craft goals with the person, not for them. And help them explore the most ways they can contribute the best of themselves to thei

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

work.

Ingredient #3: Belief that the goals are attainable

Has the person got (or will they get) all the resources and time and knowledge and skill to pursue and attain thei

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

Following aspects would a

goals? Do they believe they will have these things? How much fear do they have about not attaining the goals? When you are choosing and designing goals, it helps to draft the

dd to the challenges in developing combination products:

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

action plan at the same time to both check that the goals are attainable and to pace the person through their objections and concerns about their ability to achieve them.

Ing

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

edient #4: Belief that attaining the goal is worth their effort

Do they want to attain the goal enough that they are willing to pay the price to achieve it? Is the size of th

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

e reward for them large enough to compensate the extra mile they'll need to go to attain the goal? Discuss and agree the rewards up front, and contrast the having of those rew

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

rds against the time, effort, frustration, fear and whatever other price the person must pay to take on the goals.

Ingredient #5: Buy-in to objective measures that will track

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

Professional from academic institutions, pharmaceutical industries, health care indust

the goal

Are they confident that the measures chosen to monitor progress toward the goal - and evidence its attainment - are fair and useful measures? Do they believe that th

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

measures are a true reflection of their progress and that, through their constructive goal-pursuing actions, they can affect the trends of these measures? Design the measures

.

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

collaboratively at same time you design the goals.

I've written here about accountability of individual people, but I wonder how different the ingredients list would be for o

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

Companies that provide selfless information through particip

ganisational accountability?

References

A Framework for Compensation Plans With Incentive Value, by William Liccione, published in Performance Improvement Volume 46 Number 2

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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