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What does an ideal new direct mail donor look like? How can you spot one in a crowd? Or in a list of pote

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

ntial donors? Look for the 3 Cs.

Capacity

The most important measure is a potential donor’s capaci

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

Examples of combination products may in

y to give. Some development officers trip here, concentrating their energy on wealthy donors. But in dire

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

t mail fundraising, the majority of gifts are small. Donors don’t have to be wealthy, just willing. That’

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 beauty of appealing for funds through the mail.

So look for people who are able to give the size of

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

Combination pro

gift you want. Some apparently wealthy people have zero disposable income. And some apparently poor peopl

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

(and some actually poor people) have disposable income. So the first criteria to look for is not how muc

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

money a potential donor has, but whether the person is able to give away what they have, preferably to y

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

u, of course.

Connection

The second criteria to look for in potential donors is their level of con

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

ection with your organization. Every potential donor fits in here somewhere on a scale of 1 to 10. At the

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

high end you have the nice folks who sit on your board of directors. They are 10s. At the other end of th

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

Following aspects would a

scale you have the strangers who know nothing about who you are or what you do or who you help or where

dd to the challenges in developing combination products:

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

ou operate. They are 1s. In the middle you have clients (the people you serve), volunteers and vendors.

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

Commitment

Finally, you measure all potential supporters by their level of commitment to your caus

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

. You can measure commitment by the amount of money that potential donors give to similar organizations.

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

r the length of time they have supported similar initiatives. Or the frequency of their donations (assumi

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

Professional from academic institutions, pharmaceutical industries, health care indust

g you can discover such things). Or their level or length of volunteer service.

An ideal new direct mail

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

donor will be able to give, have a strong connection with your organization, and feel committed to suppor

.

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

ing you. Some potential donors have the capacity to give but don’t know you. Others know you but are not

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

Companies that provide selfless information through particip

ommitted. Whenever you can find people who meet all three criteria, you will be blessed. And so will they

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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There is an ongoing debate on the Superfactory web forum concerning SMED (Single Minute Exchange of Die) as developed by Shigeo Shingo, and in particular about Shingo’s influence on Toyota. As someone who had the privilege of meeting Shingo a few times before his death in 1991 and who has taught SMED for 15 years, I would like to give my view on the importance of the SMED process.

Are you shopping for a company to help with your direct mail marketing program? If so, there are certain things you should know about a direct mail fulfillment. This guide will help you understand the process of direct mail fulfillment and choose a provider accordingly.

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