Main Subject - Business

"We're just so busy and have too much on our plates, but we know we have to find time to measure performance - it's too important not to."

Sound familiar? I've been hearing complaints like this

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

more and more frequently over the last year or two. And you don't have to look too far to see the nasty consequences of trying to do too many things: half-baked strategic direction, most projec

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

Examples of combination products may in

ts under-resourced, staff accumulating too much annual leave, flurries of activities and no-one knows which are working and which are a waste.

Performance measures are even more important when

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

things are busy and chaotic. Well designed measures make priorities clear, give specific and definite direction to activity, and provide feedback so you can avoid wasting time.

The first tip fo

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

r finding time to measure performance is about reducing the rest of your workload: what is one thing you are doing now, that is less important than getting more control over your workload and yo

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

Combination pro

ur performance?

* Is it a project that you've lost passion for, that just isn't getting the results you need or that you feel compelled to finish just because you started it?

* Are you still d

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

oing administrative work that you can easily delegate to an assistant, like typing and formatting documents, basic internet research, sorting and sending emails, organising meetings and workshop

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

s, conducting simple surveys or consultations?

* How many hours a day do you give to distractions like chatting over the photocopier, answering the phone any time it rings, checking your email

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

every 15 minutes, starting new tasks that you didn't even plan to do?

* Are you driven by your priorities, or the priorities of other people? Which tasks are you doing that really are not your

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

responsibility, that are dragging you off the path to your most important goals?

Once you identify just one thing less important than having meaningful performance measures, stop doing it (yes,

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

that can be hard and will take a real serve of discipline).

Then, allocate the freed up time to designing and bringing to life performance measures for the results that really do matter most.

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

Following aspects would a

It will help if you treat this as a project of its own, and plan it properly and resource it sensibly and schedule it in your diary with at least as much importance as anything other appointment

dd to the challenges in developing combination products:

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

you have made.

The second strategy for finding time to measure performance is about reducing the measurement workload itself: how can you save time in designing and bringing to life your measu

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

res right now, so you get some runs on the board, so you can start making it a natural part of your work?

* Of all the results you want to measure, which are the 3 most important results to mea

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

sure now? Just measure these. Leave the rest on the back-burner until you have the first 3 up and running smoothly.

* Can you use a smaller team to draft the measures, and then consult more wid

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

ely afterwards? Who are the 2 or 3 other people that can help you most in measuring the 3 most important results to you? How can you make it easy for them to help you now?

* Does the data need

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

Professional from academic institutions, pharmaceutical industries, health care indust

to be 100% accurate, or is a reliable indication of trends really all you need? What data can you already access or very easily collect to provide your most important measures?

* Where are you

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

collecting data from entire populations when random samples could work well enough?

* Do you really need to put all that effort into an electronic reporting dashboard when some Excel charts in

.

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

a Word document report will do the job for now?

Focus more on building your momentum for measuring performance, and worry about perfection on your second or third iteration through the performa

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

Companies that provide selfless information through particip

nce measurement process. Starting small and deliberately will lay a solid foundation to build more and better measures upon, as you get faster and more skillful at doing performance measurement.

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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