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Let me ask a couple of questions:

If (potential) customers sends an e-mail to your company, do they want to receive an answer?
If you, in return, e-mail your customer, do you exp

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

ect that your e-mail is delivered to the customer?

Well, in my case, I answered "YES" on both questions. After all, the customer asks for an answer, so it's normal to expect that when yo

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

Examples of combination products may in

u send an e-mail in return, that the customer receives it.

Unfortunately, this is no longer the case.

It is highly important that you get this point, so let me rephrase that:

If you send an e

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

-mail to a customer that the customer wants and expects, it may be that (s)he never receives it!

I've investigated this issue, and the cause of this is the filtering of e-mail by the ISP of the

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

customer, to prevent unwanted SPAM (unsollicited e-mail) to make its way into their mailbox. But not only genuine SPAM is filtered out. Even e-mail that the customer wants (and often expects) t

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

Combination pro

o receive, may be caught up in this filter. It's happening so often, there's even a term for it: "false positives".

Sometimes this stays unnoticed, because the customer doesn't get a mail telli

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

ng her that it was filtered out. Or you don't get a reply from the ISP/filter that your mail didn't pass.

Your "dolphin" e-mail can essentially be caught in SPAM filter "tuna nets".

This can i

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

mpact businesses on many levels:

Potential customers do not convert into real customers, because they never "heard from you".
Unhappy customers as they "never get an answer on th

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

eir support requests".

Unhappy Customers that don't get the info / product they paid for (download instructions for digital products are often delivered by e-mail)

When this happens

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 customer usually points the finger to the business...

...YOUR business was not responsive;

...YOUR business didn't resolve the customer's issues;

...YOUR business did not delive

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

r!

But, of course, you are not to blame. You responded! You resolved! you delivered! It's the customer's ISP that didn't deliver. An e-mail your customer wanted, and expected.

Mistakes do happ

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

Following aspects would a

en. But sometimes, ISP's and mail service businesses have no interest in righting what went wrong. And since they are not blamed, they get away with doing nothing. But in the mean time, your and

dd to the challenges in developing combination products:

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

my business is hurt by this.

So, it is time to point customers in the right direction. If more and more customers know where to complain if they do not get the e-mail they wanted, chances are

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

that the ISP and/or mail service are forced into action.

There's a lot an ISP or mail service can do. Customers should have the possibility to "whitelist" you. A "whitelist" is a list of e-mail

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

addresses or domains from which the customer allows mail to continue, even when the filter thinks it's "junk". One option that's not an option is to ask customers to switch off the filter. SPAM

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

is just too big a problem for this.

Another company that have taken the heat for filtered mail is SiteSell. They're blamed for not delivering as promissed, because their e-mail was filtered ou

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

Professional from academic institutions, pharmaceutical industries, health care indust

t. And they hit a wall of unresponsiveness when they tried to right this. Or was it that their requests were filtered out? ;-)

As they understood how this is hurting their business, and many ot

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

her businesses around the globe, they decided to take action, and point customers in the right direction when wanted e-mail doesn't make it into their mailboxes. So they created the "Deliver my

.

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

mail!" initiative, which I fully support.

I invite you to join them and me. Read more about "Deliver my Mail!" on: http://de

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

Companies that provide selfless information through particip

liver-my-mail.sitesell.com/sls.html

Let's take a stand, and educate customers on what to do if they do not receive e-mail they really wanted to get. Let customers demand:

"DELIVER MY MAIL!

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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