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Over the past several years, Growthink has had the opportunity to assess the successes and failures of numerous entrepre

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

neurs. In doing so, several lessons have become apparent that can often make the difference between success and failure

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

Examples of combination products may in

n entrepreneurial ventures. Here is a review of the top four lessons.

Focus, focus, focus, focus, focus. The word “focu

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

s” simply cannot be said enough. When launching and growing a venture, tons of opportunities and obstacles arise. Entrep

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

eneurs that succeed are typically the ones that see the forest from the trees. They remain focused on the prize. They co

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

Combination pro

sider new opportunities, but also note that pursuing them often takes them away from accomplishing what they set out to

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

do.

Hire smart. Companies succeed based on the people that comprise them. Virtually all people in a small, growing entr

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

preneurial company make key decisions and take actions that can significantly impact the success of the venture. As such

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

, the people that are hired must be hired with care. They must be intelligent, responsible, and equally importantly, hav

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

the enthusiasm to succeed and the ability to work in a fast-paced, rapidly changing entrepreneurial environment.

Commu

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

icate. So, you’ve followed the first two lessons. You have set company goals and remain focused on achieving them. You h

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

Following aspects would a

ave hired great people. Now, it is important to effectively communicate. The laser-sharp focus and goals must be communi

dd to the challenges in developing combination products:

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

ated to the great team. Management must share information, instill company values and vision, discuss each employee’s pe

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

rformance with them, and make employees feel that they are the company and that the company is them.

Win. Entrepreneurs

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

ip, like basketball or football, is a game. There are winners and losers. There are narrow victories and landslides. The

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

e are Davids and Goliaths. Competition should be hard work, but it should also be fun. The company should be instilled w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ith competitive spirit and be committed to winning. Winning may take many forms, such as hitting sales goals or turning

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

profit by a set date. Regardless of how winning is defined, it should be clearly articulated and everyone in the compan

.

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

y should have a competitive, winner spirit instilled within them.

The above four lessons can help entrepreneurial ventu

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

Companies that provide selfless information through particip

es edge out their competition and enjoy the financial and emotional success that such ventures are capable of generating

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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