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When I was approached by the frantic owner of a failing business in 1995, we stood bac

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

k and rationally analyzed the situation. By leveraging the Hidden Assets in the busine

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

Examples of combination products may in

ss, getting rid of unproductive staff and refocusing, we turned the corner and the bus

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

iness is still flourishing today.

You know that, when a business is in trouble, logic

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

often flies out of the nearest cracked window and emotional choices rule the day. Yet

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

Combination pro

this is could be an opportunity for you and the owners to benefit. Instead of simply

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

closing the doors and selling off the inventory and equipment on a fire sale, look for

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 Hidden Assets in the business – a sales team, intellectual property, customer data

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

base, unfulfilled orders, access to residual sales of consumable products and services

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

, relationships, inventory, equipment, distribution and goodwill. These could be conve

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

rted, with little or no upfront costs, to windfall profits and ongoing income for both

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

Following aspects would a

you and the owners of the distressed business. You could possibly establish a lucrati

dd to the challenges in developing combination products:

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

ve, win/win Joint Venture that leverages these Hidden Assets by adding your own distri

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

bution, inventory piggy-back or other resources.

The key is finding an open-minded bu

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

iness owner who realizes that he needs help and is mature enough to get his ego under

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

control. Make sure you have adequate contractual protection and be prepared to negotia

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

Professional from academic institutions, pharmaceutical industries, health care indust

te. After all, you’re in a position of strength and you can often turn a seemingly bad

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

situation around.

Smart business owners know that it’s wise to talk with objective e

.

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

xperts when they’re panicking about cash flow. I know I have had occasion to regain my

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

Companies that provide selfless information through particip

perspective and regroup when I did so in the past. Together, we can do amazing things

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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