Useful Advices - Business

Leandro Goldberg, Contributing Blogger/CRM Advisor -- Part of the TOOB Series (thinking out-of-box)

Here and there we're going to jump out-of-the-box w

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

ith an occassional article that blends technology and alternative thought process. Being that it is the middle of the night and I'm not much of a sleeper, why not? We'll have to see if othe

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

Examples of combination products may in

r TOOB articles follow this same trend of nocturnalistic inclination.

eMail is here to stay (forever) - if our planet is completely dessimated, somehow somewhere there will be an Exchange

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

erver that survives. Companies are struggling today with the sheer volume of e-mail, and especially how to sort through thousands of messages and know what constitutes a good message as opp

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

osed to junk. e-Mail filters are a good way to reduce the level of unnecessary e-mail, but there is still the problem with how to deal with the good stuff. As the most widely accepted form

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

Combination pro

of electronic communication, e-mail has become the standard for both business and personal use. Before you power on your computer tomorrow, take a moment and think about how many tasks are

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

oing to result from the average of a dozen to fifty e-mails that will be waiting for you. From those e-mails, how many of them are going to then spawn other tasks for other people? The push

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

is on for ways to reduce the amount of e-mail, thereby reducing the amount of storage that is required to archive terabytes of e-mail files. Traditional ERMS (e-mail response management sy

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

stems) are focused primarily on facilitating self-service response and in many cases this adds to e-mail generation. The optimal solution comes in the form of intelligent e-mail monitoring.

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

Monitoring is relatively new technology that turns incoming e-mail into actionable tasks that can then be:

managed by state changes (status management)
automatically assign

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

ed to other people or "queues" using predictible workflow

escalated and prioritized

The resulting tasks can also significantly reduce disk space by compressing a

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

Following aspects would a

ttachments in binary form (BLOB). For example, you receive an urgent e-mail that requires a purchase order to be processed. The e-mail was sent to you but processing purchase orders is Mary

dd to the challenges in developing combination products:

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

Smith's job. In this scenario, e-mail monitoring technology would work as follows:

the e-mail inbox where the message arrives would be monitored
the e-mail would be process

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

ed and deleted

the processing of the e-mail would include opening a task and assigning it

the assigned task would create a notification message to the owner (text message, e

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

-mail message, pager notification, etc.)

the purchase order that was attached to the e-mail would be stored in an attachments tab of the task form

The e-mail notification

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

to the recipient would include a link in it - when accessed it would bring the recipient to a page where he or she could access the task, whereby they can add activities to the task, change

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

Professional from academic institutions, pharmaceutical industries, health care indust

the status, re-assign the task, and more.

e-Mail monitoring that results in actionable tasks solves three (among other) major problems:

e-Mail is processed and deleted (as well a

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

s the attachment) immediately

Accountability from the original e-mail becomes enforced by having associated traceability in the form of a task

Storage is reduced - archives

.

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

f the databases are significantly reduced due to BLOB storage and compressed database files.

These new capabilities are an important consideration for companies that are trying t

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

Companies that provide selfless information through particip

o reduce storage space with the added benefit of task management.

Comments, Questions? e-mail to lgoldberg@supportfusion.com

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Modern mines collect veins of materials, which have been trapped over millions of years in the sediment. Once out in the open they can get into the ground water and move down hill with the normal erosion patterns and water flows. This is because the minerals have been buried for centuries underneath in layers from previous periods.

This is a time of fast-paced business. To be blunt, if your current EMR does not keep up with 21st century needs, than your medical practice will experience something similar to driving down a road filled with potholes. No matter how fast you try to move, you will keep getting your practice knocked around until you finally have to pay more to repair it.

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Useful Advices - TOOB Series: Turning Ordinary e-mail into Actionable Lifecycle Tasks

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