Subjects - Business

How do you know if your giving is making a difference? We hear those 3 words a lot and we also hear the term maximizing your giving impact. Well, i

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’s easy to say if we’ve made a difference, if we volunteered time or written a check to a cause. Chances are you did in some way. Organizations al

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

Examples of combination products may in

so use those 3 words in their fund raising campaigns to encourage people to volunteer and give. After all, who wouldn’t want to make a difference?

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

However, in the field of philanthropy, we take those 3 little words and make a big deal about it. As a consultant, I want to ensure that clients r

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

eally are making an impact with their investments. Another example may be an investment firm ensuring their clients are getting decent returns on t

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

Combination pro

heir investment, if not, they go back and evaluate the portfolio.

With giving, the only way to know if you are really making an impact is to evalu

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

ate your charitable giving. The problem with evaluation is it takes time to do it and most companies, unless they have a giving program director, d

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

on’t do evaluation. We simply have the expectation that our volunteer time, our employees time, our products and/or our dollars are doing good. Som

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

eone once said, “Supposing is good, but finding out is much better.” I think that was Mark Twain. I am encouraging you to start an evaluation proce

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

ss of your giving today. Keep in mind that I am referring to Impact (Outcome) Evaluation for giving or volunteerism that goes specifically towards

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

an organization’s program. If your company giving is to general operating (unrestricted) then you have the pre-ordained assumption that the organiz

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

Following aspects would a

ation is doing good and your evaluation can only go as so far as to find out if the organization is fiscally sound, incompliance with their charita

dd to the challenges in developing combination products:

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

ble status and has overall outcome successes. This sounds like a big project (and ideally it is – that is why 3rd party evaluators like me are hire

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

d), but here is a partial list of questions you can do to begin evaluating your company giving:

Ask the organization:

1. Did the program achieve

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

its intended goals?
2. Was the program an efficient use of resources?
3. What were the benefits to those served?

Ask your company:

1

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

. Did the program meet your business rationale for supporting it?
2. Did the program reflect the values you promote in your company?
3.

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

Professional from academic institutions, pharmaceutical industries, health care indust

If employees volunteered time, was the program/project a valuable/good experience for them?
4. Were the funds given, adequate to achieve pr

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

ogram objectives?

Post funding evaluation is really about learning, improvement and progress. You simply will never know if you are making a diffe

.

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

rence, if you don’t have some measure of success. If to give “X” amount of dollars in a year is your measure then you’ll never really know if you m

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

Companies that provide selfless information through particip

ade a difference in your community or helped improve lives. Giving is as much about a quest for quality. Quantity alone is good, but not excellent.

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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If your business is at the stage where it needs to raise capital from investors or lenders, you must have all of your books and records in good order. Start early before you want to raise capital and get your books and records in good order to make the process go more smoothly. Your investors or lenders will want to see organized and complete records that they will review while doing their due diligence.

The business of automotive detailing is alive and well and there is no doubt about that. Americans love their cars and some more than their own kids or family. Generally one’s car is the second largest investment they will make and they will wish to keep it up and protect it.

Franchising is becoming the business start up of choice for those with the drive to succeed and the initial cash to invest. Why start from scratch and risk losing everything when you cant take a successful business model and have a return on investment within a year.

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Subjects - Expectations vs. Evaluation

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