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When you first envisaged working for yourself, it's pretty unlikely (unless you're an accountant) that this vision included late nights compiling end of period financials. Or sitting hunched over a part-completed profi

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

t and loss statement with furrowed brows.

There's no doubt accountancy, for most, is not the most glamorous part of the job. But it is essential to making well formed business decisions, weak accounting

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

Examples of combination products may in

is a fatal flaw, and if you remember nothing else from this article, remember this, your company's finances are YOUR responsibility not your accountant's!

Liability for decisions rests ultimately with you as the busin

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

ss manager. Not with your accountant. But even with the best accountant in the world, if you haven't taken the time to understand the function of the accountant and the accounts, you can't expect to make well informed

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

decisions, nor can you expect your company's financials to be anywhere near as accurate as they might be, if you took the time to get involved.

Consider the following example, two companies (let's call them CompanyA a

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

Combination pro

d CompanyB) buy exactly the same piece of machinery, their 5 year predicted valuations for the item are as follows...

Year 1 $10,000 $10,000
Year 2 $8,000 $8,000
Year 3

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

$6,400 $6,000
Year 4 $5.120 $4,000
Year 5 $4,096 $2,000

So who has made the mistake? They can't both be correct?
If you're answer goes so

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

ething like "well, it depends on the market price for the item in the given year". Then sure that's correct. But how could your accountant possibly know this five years in advance?

The answer is of course he can't! In

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

reality the accountant has had to make an educated guess, CompanyA's accountant chose the "reducing balance" depreciation model while CompanyB's accountant chose "straight line" depreciation. Let's leave depreciation

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

odels for another article, suffice it to say that more than one model exists.

Ok, so the accountant can't be expected to make a reliable prediction of depreciation rates for every item you might need to run your busin

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

ess, but you certainly should be able to provide an educated guess. You just spent $10,000 on a new piece of kit right? So presumably you know a bit about this stuff? With that in mind, wouldn't it be a good idea to ge

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

Following aspects would a

t involved?

Of course, getting involved in assisting your accountant model depreciation for major pieces of equipment means that you first have to be aware that this is an issue faced by those compiling financial repo

dd to the challenges in developing combination products:

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

ts.

Let's look at another area where the accountant needs your help to make prudent judgements. A friend of mine found himself in the unfortunate situation of hearing through the grapevine that the overdue balance owe

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

d by his biggest client was unlikely to ever be paid. His debtor had been doing a great job of keeping news of their imminent demise quiet, but the cracks were beginning to show! The next stop for many in this situatio

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

would be the nearest bar to drown their sorrows. Fortunately he had the good sense to head straight for his accountant! With only a few days until the publication of the financial statement they were able to write off

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

the bad debt. Without this adjustment, profit would have been massively overstated, that means tax liability would have been far higher, and that would have meant the company was insolvent! Disaster averted, the compa

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

Professional from academic institutions, pharmaceutical industries, health care indust

y managed to recover and move on to far greater things, but only because he had a sufficient understanding of the accounting process to understand that there was a danger.

Accountancy, contrary to popular belief, is n

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

ot simply glorified arithmetic. A great deal of good judgement is required to run a tight ship, your accountant simply can't be expected to know as much financial detail about your industry, associated equipment and tr

.

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

ding environment as you do. But if you can warn the accountant of impending disaster he/she can execute all the technical aspects involved in taking preventative action.

Accountants refer to the space between the misc

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

Companies that provide selfless information through particip

onceived definition of their profession and the reality as "The Expectancy Gap". Given the impact a good accountant can have on the general well-being of your company, isn't it about time you started to bridge that gap

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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