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Most nonprofit organizations that I know run in a very efficient and business like manner, so I hesitate to criticize the

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

hardworking folks in this sector. But there is a tendency in many non-profit organizations to look for quick, short-term r

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

Examples of combination products may in

sults rather than develop and stick to a strategic plan. Some search results I ran across support this observation.

Accor

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

ing to Overture, there were about 25,000 searches last month for the term “fundraising idea” and another 5000 or so search

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

s for related terms like “school fundraising idea” or “sports fundraising idea”. On the other hand, the term “fundraising

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

Combination pro

plan” was searched only about 350 times, with another 100 or so searches for related terms.

Compare this to searches made

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

by business or people interested in business. The term “business plan” was searched 66,000 times and the term “business id

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

a” was only searched 11,000 times. Based on these numbers it would appear that far more people in business are interested

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

in a plan more than just an idea. People in nonprofit organizations or charities seem to be more interested in ideas than

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

lans.

One can’t draw too many conclusions from a single observation and to be fair, there are lots of small nonprofit org

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

nizations that just need an idea for an event or something to make a few bucks. But I think this observation should also m

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

Following aspects would a

ke managers of nonprofit organizations ask themselves how much time their staff, volunteers and board members spend trying

dd to the challenges in developing combination products:

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

to come up with or imitate the latest great idea, and how much time they spend in strategic planning.

Strategic planning

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

or a nonprofit organization can be complicated. There may be historical reasons, traditions and values of the founders to

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

onsider when making fundraising decisions that may preclude some options. The reaction of the community and relationships

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

ith government and major donors like the United Way may need to be taken into consideration. A few strong willed voluntee

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

Professional from academic institutions, pharmaceutical industries, health care indust

s may exert undo influence on the organization. The priorities of the CEO may not include fund development.

In spite of t

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

ese complexities, a nonprofit organization should still be able to determine a long-term vision for what it wants to accom

.

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

lish as an organization, the resources it has at hand to start it down that road, and a fair assessment of its strengths a

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

Companies that provide selfless information through particip

d weaknesses. Too many organizations try to be all things to all people and should focus on achievable, quantifiable goals

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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