Digg It - Business

Don’t you love the medical dramas on TV…

You know - the ones where doctor’s dash around telling nurses to do “tox screens” and get the “blood gas” and the patients are connected to th

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

e latest in plasma screened computers which show their “vital signs”? Isn’t medical technology wonderful? They can measure all sorts of aspects of a person’s condition and carry out all kinds of tes

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

Examples of combination products may in

s to determine how well the patient is doing.

But you know it all still comes down to the fact that if someone has a dangerously high fever, if their breathing is irregular and if their puls

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

is weak then they have some fairly serious problems. If the paramedics, the ER staff and the surgeons don’t keep an eye on these indicators the patient will get worse, not better. And the “tools” n

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

eded to measure those things aren’t particularly complicated or sophisticated.

Same thing applies to a business. There are all sorts of systems – computerized and otherwise - which measure p

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

Combination pro

oductivity in the plant, or efficiency in the warehouse or tell us who buys how many of what. We use tools to help us purchase better, forecast our sales more accurately (sometimes at least!), recor

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 the information we picked up on the last sales call, send out email blasts and do all sorts of marvelous things.

But we can be focusing on all of that while the business is slipping away from

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. If we don’t know how much cash is in the Bank, or what the outstanding order situation looks like the company can become very sick, very quickly. We take our eyes off these things at our peri

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

– particularly when the business is growing. And they’re not hard to measure.

Every business has some key indicators which directly address the health of the company – do we have enough cas

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

for the next 90 days, is the order backlog increasing or decreasing, are Receivables coming in on time, is Inventory increasing and/or getting stale, are we close to capacity in the plant or should

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

we be thinking of asking people to take voluntary time off? Figure out what the most important 3 or 4 are for your Company. Stay on top of them and you’ll stay out of trouble.

Your financial sta

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

Following aspects would a

tements – income statement, balance sheet and cash flow statement - are undoubtedly the most important source of information about your company’s state of health. Given the variety of software p

dd to the challenges in developing combination products:

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

ckages which run on even the smallest computers there’s really no excuse for not being able to get those statements monthly. However, challenge yourself and your team; insist you have them early in

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

he month. Getting the previous month’s statements after the fifteenth of the current month should be unacceptable. (I know someone who says it’s better to be pretty accurate and early rather than ve

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

y accurate and too late.)

While those financials are accurate, they’re also historical. They tell you the facts – about a period that’s already gone. So, think also about the things that wil

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

give you advance warning of trouble – in the company and in the industry - and pinpoint the top 3 or 4 of those too.

Then have someone collect the data on those 6 or 8 important indicators and

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

Professional from academic institutions, pharmaceutical industries, health care indust

give it to you regularly. I’d suggest you look at them at least once a week. When I had what my wife refers to at cocktail parties as “regular jobs”, I used to look at them every day – particula

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

ly when there was a lot of change going on in the industry and in the company.

Watching the vital signs in your industry and in your company is one way to ensure that you perform well. Harol

.

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

S. Geneen, who had his faults but who built ITT into a global powerhouse said “It is an immutable law in business that words are words, explanations are explanations, promises are promises, but onl

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

Companies that provide selfless information through particip

performance is reality.” Performance is one of the key elements of the 5”P” Process. To learn more go to www.profitpath.ca/services

© Copyright ProfitPATH, a division of JDS & Associates Inc., 200

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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