Advice You - Business

One of the problems we have when we interact with professionals, whether they’re architects, doctors, lawyers, or accountants, is the fact that we never quite know enough to know w

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

hen THEY don’t know enough.

We can spin our wheels, wasting time and money, and suffer even worse outcomes if we deal with the WRONG professionals.

Divorces and dissolutions of b

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

Examples of combination products may in

usiness partnerships can go on for years instead of months.

Our medical maladies can be misdiagnosed, and what was curable, or at least manageable, could rage out of control with

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

the passage of time due to wrong or incomplete treatment.

Important deadlines can be missed because some professionals have substance abuse, financial, or family issues of their o

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

wn that are hopelessly distracting them.

That architect who had his structural engineer assess your property for sturdiness might have miscalculated, and when the next earthquake

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

Combination pro

or windstorm comes along, you’ll learn just how devastating his error was.

That accountant, or CPA who attends a one-day seminar, suddenly decides to bill himself as a “Wealth Con

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

sultant,” when most of his friends, neighbors, and family members know something you don’t.

He couldn’t pick a winning stock or investment if his life depended on it.

So, how can

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

the rest of us get a clue that a professional is way out of his depth, that he or she is incompetent?

Remember these six tip-offs:

(1) Don’t trust smooth talk; trust results. If

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

he hasn’t been delivering the goods, put his feet to the fire. When my ear infection wasn’t cleared-up by the EYE MEDICINE my ear specialist prescribed, I was on his case right aw

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

ay, expressing displeasure. At first, the nurse tried to put off my next appointment, and I insisted I couldn’t hear—get me in, now! She did, he blasted my ear with a powder that t

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

asted lousy, but it worked.

(2) Don’t blame yourself if their advice or techniques fail. Generally, if you did exactly what they instructed you to do, and you didn’t get the inten

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

Following aspects would a

ded result, IT'S THEIR FAULT. Don’t let them off the hook. Get them to re-do it, as mentioned above, or to refund your money. If you suffered a large loss as a result of their inco

dd to the challenges in developing combination products:

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

mpetence, seek the help of a competent attorney.

(3) Get another opinion, but don’t expect the next practitioner to be a panacea, or even competent. He could be just as bad, and y

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

ou could be encountering SERIAL MALPRACTITIONERS. Call it dumb luck, but you can win the booby price twice in a row. Best advice: Cut your losses again, and find a better practitio

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

ner.

(4) Don’t let price or fees fool you. Some of the greatest charlatans charge plenty, while competent folks might require more modest fees. Price isn’t value.

(5) Do your res

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

earch. Contact professional societies and search the web for negative comments. You’d be surprised at what you’ll find that fills public records. One physician I researched was sue

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

Professional from academic institutions, pharmaceutical industries, health care indust

d successfully for malpractice. Everybody can make a mistake, but why risk your health by placing it in hands that have already been court-certified to be incompetent?

(6) Finally

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

, trust your gut. You may not have a smoking gun, a definitive knowledge of exactly how they’re incompetent, but if you feel it is so, it may well be. One of the satisfactions of d

.

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

ealing with true professionals is the fact that many of them put you at ease. If someone causes the opposite to happen, making you nervous or suspicious, make a change.

Sooner or

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

Companies that provide selfless information through particip

later almost every one of us encounters an incompetent professional, though it may never become apparent. If you do, take action, and get the treatment and satisfaction you deserve

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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