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I have watched the dynamics of many groups over the years. There seems to be a surface tension that sticks the members together. They are protective of their group, making sure that the group su

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

rvives at all costs. When a new person arrives on the scene, the adhesion keeps the new person in quarantine until the group figures out if this person is good or a threat.

At a certain point, o

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

Examples of combination products may in

e member will offer a connection. This member may help the new person by meeting with them, or even purchasing from them to solve a specific need. In fact, the other members may not even know th

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 the hand of friendship has been extended.

What happens next is fascinating. The seasoned member reports to the group that they have connected with this new member. A good experience means tha

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

one by one, other members will link to the new member, until all of a sudden the surface tension breaks apart, allowing the new member to be accepted by the old gang.

Mary Nyitray, owner of Opti

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

Combination pro

cal Arts, experienced just such a scenario. She joined The Women’s Entrepreneurial Network (WEN) hoping to increase her eyewear business. Nothing happened. Mary was also a cave dweller feeling

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

hat she was working only when she was at her store. She did not make efforts to meet members outside the meeting. One year later at the time to renew her membership, she almost didn’t write that

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

check. She’s glad she did, because just about that time one member arrived at the meeting wearing really cool glasses. Questioned about them, the member related that she had purchased them from

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

ary Nyitray. The word was out. In the second year of her membership, a steady stream of members went to Mary’s shop to get new frames. It became accepted that if you needed glasses, Optical Art

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

s was the only place to go.

Martin Lawson, National Director of BNI, Great Britain, developed the confidence curve to describe this occurrence. He looked at two factors, time and the number of r

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

ferrals. He drew a graph with the vertical leg labeled number of referrals, and the horizontal leg labeled time. He noticed that for his BNI members, at some point after they joined a chapter, t

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

Following aspects would a

ere would be an explosion of referrals. Until that point the confidence curve was rather flat meaning that few referrals were coming to the new member. At the explosion point, the number of refe

dd to the challenges in developing combination products:

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

rals zoomed upward. When one WEN member purchased and wore eyewear from Mary Nyitray, that was the explosion point. All of a sudden many members were wearing Mary’s frames.

Do new members have

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

to wait for an opening? Those who are willing to be proactive can find ways to penetrate the surface of the group. One option is to schedule meetings with individual members. Another way is to

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

ttend every meeting instead of just coming ever so often, which indicates commitment to the group. Smart new members volunteer for a position where there is plenty of visibility like the registra

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

ion table where each member has to check in. Finally, new members can help the seasoned members to be more successful. Those types of members are wanted additions to any group.

Each chapter, cl

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

Professional from academic institutions, pharmaceutical industries, health care indust

b, group, organization or association will demonstrate a wide spectrum of its willingness to assimilate a new member. Some will have mentoring programs to help the new member get started. Others

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

will take the money and provide little more. Good questions to ask when determining if a group is for you are, “How do you orientate new members?” or “What’s the best way for me to become an act

.

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

ve member of this group?”

For the person who has joined a group to get more business, what he or she needs to know is that the group as a whole will not provide any business, however each individ

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

Companies that provide selfless information through particip

al within the group can provide all the business opportunities wanted. It is important to realize that groups exist, people connect. Now, take an active role in making your group pay off for you

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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This is the third of our three part series on the DA0 record for medical billing of claims through electronic means using NSF 3.01 specifications.

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