Advice You - Business

The small, fast-growing, quite profitable three-person company had reached a plateau. Sales for the past c

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

ouple years were essentially flat in a rapidly growing industry. The owner was concerned that this might 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

e the beginning of a downward trend and wanted to bolster the sales and marketing effort yet none of the th

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

ee people had expertise in this area. Worse, the owner hated the sales process.

Through various contacts,

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

the owner met a person who is a VP of Sales and Marketing for a major corporation who wanted, for personal

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

Combination pro

reasons, to relocate to the community where the business is located. In a couple of lengthy conversations

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

they discussed compatibility, opportunities, and business values. The owner then asked the VP for an asses

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

sment of the company’s current reality and how, with his help, prospects for significant growth could be re

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

alized.

The VP presented an accurate assessment of the business and his thoughts on what he could do to in

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

rease sales and profitability. But he used language that is foreign to the business owner. I think the la

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

nguage is known as “CorporateSpeak.” Some examples: “Increase throughput of existing systems to maximize

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

Following aspects would a

the current investment,” “consolidate & streamline the value chain to maximize total return,” and “…the con

dd to the challenges in developing combination products:

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

ept of developing a customer driven product planning portfolio.” Those phrases might be easily defined in

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

a corporate boardroom, but to the owner of a small business, they are suspect. The owner doesn’t know what

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

they mean and, more importantly, doesn’t know if the VP knows what they mean so negotiations have bogged d

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

wn.

When negotiating or making a presentation, it is best if everyone is speaking the same language, using

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

Professional from academic institutions, pharmaceutical industries, health care indust

the same terms, so each is confident they understand the conversation. The goal is to be clearly understo

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

od, not to sound impressive. If the VP had considered the owners background, experience, education, and de

.

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

ree of sophistication when choosing his words he would have better defined the terms he used and the decisi

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

Companies that provide selfless information through particip

ons based on the presentations would have been made long ago. In simple words don’t obfuscate, speak plain

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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Advice You - Plain Talk Vs Obfuscation

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