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Have you ever finished listening to an explanation from a purported subject matter expert only to wonder what it was they just said? It has been my experience tha

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 the more vague, general or ambiguous an explanation, the less command of the subject matter the person doing the explaining likely possesses. It is one thing to

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

Examples of combination products may in

toss around the latest buzz-words, but it is quite another thing to actually know what they mean and have the ability to correctly apply them. In today’s blog pos

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

I’m going to reveal the tricks of those who practice what I call “the black art of confusion.”

Those of you that know me have come to understand that I prefer t

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

cut to the chase and get to the root of an issue as quickly as possible. While I appreciate the great oratory skills of those who communicate using wonderful wor

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

Combination pro

pictures or the academics that can wax eloquent always using best form of prose, I prefer my business communication to be quick and dirty…In the immortal words o

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

Jack Webb: “The facts ma’am..just the facts.” Don’t get me wrong, I’m not word bashing as I enjoy and appreciate anyone who has command of a great vocabulary (se

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

an earlier post entitled “Vocabulary…It does Matter“), but I don’t have time for a 30 minute explanation of something that could have been, and should have been

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

ommunicated in 2 minutes…Ahh, the lost art of brevity, but I digress.

What all of us need to remain on guard against are the people (notice I didn’t say professi

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

nals) that always seem to speak at the 30,000 foot level…A high-level overview is fine as a summary, but certainly nothing beyond that. Vocabulary should be a too

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

for communicating expertise and not masking a lack thereof…Let’s define what I call the black-art practices of confusion:

1. Job security by confusion: H

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

Following aspects would a

ve you ever had an employee in a particular business unit or practice area paint the picture that things are soooo complex that only they can solve your problem?

dd to the challenges in developing combination products:

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

othing is too complex to be explained or understood, and no single individual is invaluable…

2. Sales by confusion: Have you ever been party to a sales pr

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

sentation that was so sophisticated and technical that you arrived at the conclusion that surely “these guys really know their stuff” and ended-up purchasing some

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

hing that wasn’t at all what you thought it would be? Remember, if someone can’t tell explain the benefits to you in plain English the benefits probably don’t exi

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

t.

3. Intimidation by confusion: We’ve probably all had someone attempt to steamroll us at some point in our careers…multi-syllable techno jargon used in

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

Professional from academic institutions, pharmaceutical industries, health care indust

ircular conversational patterns with an authoritative posture doesn’t mean someone knows what they’re talking about, rather it usually means they are attempting t

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

dazzle you with feigned brilliance in an attempt to intimidate.

So, what is the best way to deal with the black art of confusion? Force people to justify their

.

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

ositions by being specific…Make these wizards’ of confusion give you examples of relevant experience or have them explain their business logic in understandable t

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

Companies that provide selfless information through particip

rms. Make sure that your client’s, vendors, suppliers, partners, investors and employees all know that you value clear, concise, lucid and accurate communications

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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