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The last 3 of the 6 most common worries about setting targets for performance measures are:

* challenge 4: Anticipating the consequences of achieving and not achieving t

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

he target.

* challenge 5: Finding the courage to go beyond your comfort zone.

* challenge 6: Having the wherewithal to change whatever must change for the target to be

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

Examples of combination products may in

accomplished.

Here are my ideas and learnings about overcoming them.

idea #4: keep one eye on the target, and one eye on the bigger picture

Even if you had enough fore

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

sight to explore the unintended consequences of achieving your target before you locked it into your plan, the world will still change later on. I once heard a story abou

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

t a rail organisation that placed more importance on on-time running of trains than any other performance outcome. So much so, that one day, due to pressure risking the t

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

Combination pro

ain running late, the driver omitted an important safety check to save time. The train derailed because of a braking problem that the safety check would have easily picke

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

d up.

Every now and then, ask your self "is this target still a good idea?" and "if we miss it, what's likely to happen?" and "if we achieve it, what's likely to happen?

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

". It's okay to change a target that is no longer going to serve its original purpose. Is this check a part of your regular performance review process?

idea #7: give you

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

rself (and your staff) permission to learn by not achieving targets

You are not supposed to achieve every goal or target you ever set. And if you do, then it's probably

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

because you aren't challenging yourself enough. You're staying inside your comfort zone, inside of what you know works, what you know you can accomplish. That's not what

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

mprovement is about. There is no learning without failing, no improvement without learning.

If you want to jump over a creek without landing in the water and getting you

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

Following aspects would a

r shoes all wet, then don't aim for the far bank of the creek. Aim for a metre or so beyond it. Set the target further than you think you can achieve. That way, you'll be

dd to the challenges in developing combination products:

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

less likely to land in the water, and more likely to land even further than you thought possible. Somehow, our strides are longer when our eyes focus further ahead.

ide

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

a #6: do some preliminary scoping of "how-to" before locking in the target

If you and your team do not yet possess the target setting and achieving prowess of an Olympic

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

athlete, then avoid setting any kind of target without first exploring a range of ideas of how you might go about achieving it. A very innovative manager I know has for

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

ears used simulation software to model his business processes (freight). The model simulates the steps in the process, the variability in the time each step takes, the va

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

Professional from academic institutions, pharmaceutical industries, health care indust

riability in market demand, resource constraints, and much more. He can then make changes in the model to simulate changes like investing in more equipment, or changing a

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

step, or removing a constraint (like a policy). So before he spends a single dollar, he can get a good idea about which strategies are going to work best to reach his ta

.

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

rgets.

What's wrong with taking an iterative approach to finding the right target? Scope a little and set the first target value. Explore what it might take to achieve t

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

Companies that provide selfless information through particip

hat, then revise that value if necessary. Start the more detailed action planning to get a stronger idea of resource implications, and revise the value again if necessary

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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Branding is not what you say about your company and products; it's about your customers' perception of your company and products. A memorable and trustworthy brand reinforces customer loyalty. It helps them remember that your business provides the perfect solution to their problems.

It is amazing the lack of knowledge of economics and free markets that state franchise regulation states have in America. Worse when you try to explain the reality of things to them, they pull the liberal debate line of reasoning that class action and personal injury trial lawyers are so keen too.

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