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Recently I received a support call from a customer who was not receiving mail fro

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

m one of her partners. After some lengthy troubleshooting, we found that the part

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

Examples of combination products may in

ner’s Internet Service Provider (ISP) was listed on some of the public SPAM black

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

ists. This actually came as a shock to us since the ISP is a very large telecommu

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

nications provider in the South.

Since customer service is our focus, we did not

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

Combination pro

leave the issue as someone else’s problem, we attempted to work with the ISP to r

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

esolve their problem. Try to imagine our shock when the ISP told us that they wer

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

e aware of the issue, had no intention of resolving it, and were sorry for the “I

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

convenience”.

I tell this story because it brings to light one of the major prob

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

lems with ISP’s and their free add-on email services, but the story gets better.

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

We decided to use a pay for SMTP email service (SMTP stands for Simple Mail Trans

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

Following aspects would a

mission Protocol and is the electronic language used to move email throughout the

dd to the challenges in developing combination products:

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

Internet). We signed up with the service and configured the email clients to sen

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

mail to the new service. Once again we got shot down. The ISP was blocking all S

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

MTP traffic through their connection that did not go to their server.

We finally

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

resolved the client’s problem with both a short term and a long term solution tha

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

Professional from academic institutions, pharmaceutical industries, health care indust

t did not require them to host their own email server internally.

What this has

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

shown us is that even the biggest ISP’s sometimes take the easy path instead of t

.

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

e right path to solutions and that sometimes free add-on email services are not t

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

Companies that provide selfless information through particip

he right solution for a business that considers email to be a vital business tool

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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A lot of printing companies already offer online printing services. You just need to upload your project on their website, talk to their customer service representatives, talk about the price, and then if they deliver as well, you would only be waiting for that project of yours right at your doorstep. And while all of these might sound very easy, it is not.

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