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I had an interesting conversation with a customer (who runs a technology user community). Most of hi

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

s users in the community are as we know. In this case its closer to 99-0.95-0.05 (Only 0.05% of his

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

Examples of combination products may in

sers contribute).The one metric they wanted to have improve is the contribution % of his community t

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

a representative 90-9-1. I cant say numbers but going from 0.05% to 1% would be HUGE for this commu

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

ity. We followed a 3 step approach towards understanding the community and ways to increase its part

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

Combination pro

cipation. The one takeaway: Community incentive management (rewarding community

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

embers) is a motivating factor for increased participation.

1. Basic community site survey<

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

strong>: Since my company does consulting in this area, we looked at usability, brand alignment,

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

measurement metrics and demographic analysis. This 3 day effort gave us insights into the details ar

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

und the 0.05 % of the people who contribute and why they were passionate enough to do so.

2.
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

>Detailed user forensics: This involved looking at users from the perspective of time (when

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

Following aspects would a

they post), where they post from (work vs. home), access methods (WiFi vs LAN), Location (Which par

dd to the challenges in developing combination products:

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

of US), what threads they post on, community competition (what other sites vie for their communitie

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

attention) etc.

3. User surveys and interviews: Conducted over 2 weeks we had abo

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

t 25 community members participate from a sample size we targetted of 150. Range of questions from w

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

at would get them to participate more, to what time is best for them to add tot he discussion.

Ther

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

Professional from academic institutions, pharmaceutical industries, health care indust

were a range of suggestions for improvement, but they key we found was most users did not f

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

el they got anything out of participation. There will be about 10-15 members in your commun

.

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

ty that do it for "the greater good" and from the sense of giving something back. To get the next 20

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

Companies that provide selfless information through particip

increase in participation we highly recommend you manage a good incentive system for your community

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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