Main Subject - Business

You’re at a meeting with key staff. You want some new ideas to address the topic. Looking around at this group of creative, ambitious, bright people, you say, “Let’s get some fresh ideas on this. Who’s got something?”

Suddenly,you feel like the h

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

igh-school teacher who has asked a question about the homework no one did. People find their notepads fascinating, others fumble in their briefcases muttering things no one can hear, still others stare into space seeming lost in thought. No on

; 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 is looking at you.

What’s going on?

There are many reasons for this unproductive response to your query. In my many years of working with groups,I’ve found the reason most often is one of these:

1. People are afraid of looking like idiots i

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

n front of bosses and peers.

2. They don’t entirely understand the question or the topic itself.

3. They worry their ideas are not “fresh” enough or “new” enough for you and offering them will subject them to criticism (and might even show up

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

n their performance review).

4. They’ve seen others who gave ideas be attacked and embarrassed and don’t want to join that elite club.

5. They didn’t realize this was to be an interactive discussion and were thinking about other work and waiti

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

Combination pro

ng for the meeting to end. They’re now caught unprepared.

6. Caught off-guard, their minds are blank.

What can you do to change this situation?

If you could re-do the meeting from the start, you might send out an agenda and indicate on it or

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

the cover note that you’d like people to bring ideas with them on,for example,topic #2. Thus,you’d give the group advance notice and they can consider the task ahead of time. Or at the start of the discussion, when you’re explaining why this

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

topic is important and how the company got to this point, you could warn the team that you’ll be asking for ideas after sharing information. Thus, they’ll gear up their listening and be ready with some ideas when the time comes.

So,that’s w

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

hat you’ll do next time. But now, here you are, trying to make eye contact with your team and wondering what happened to all the bright-eyed thinkers.

Creativity requires two important things: a safe climate and good thinking. People may have

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

insightful and innovative ideas but if the perceived risk of offering them is high, those ideas will never see the light of day. There is the rare chance that you are simply hiring the wrong people – but that’s another issue! So let’s examin

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

the first, far more common, situation.

Why might employees perceive offering ideas to be risky? Look around your company. Are people rewarded who try new things? Are mistakes severely punished? When people make suggestions that seem patently

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

Following aspects would a

impossible, are they met with groans or rolling eyes? In meetings, like the one you’re in, do ideas get ignored, met with silence, discounted? Do status and hierarchy games get played where the lower level people are not heard? Are ideas st

dd to the challenges in developing combination products:

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

olen and presented later as someone else’s?

As the start of this meeting, you can manage the climate. Here are seven things you can do to encourage and elicit ideas:

1. Say something encouraging like, “Let’s get a range of ideas up here on t

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

he flipchart. All ideas are good ideas and I’d like you all to hold off on negative comments or judgments. Later on, we’ll select from the big list.”

2. Give a brief summary of the topic (again, if necessary) not only to remind them of the situa

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

ion but also to give them time to think.

3. Welcome each and every idea, even if it seems you’ve heard it many times before. Your behavior will be closely watched and how you treat ideas will invite more or shut them off.

4. Either you or some

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

one else write up the ideas (on a flipchart if possible) in the words of the giver. This gives encouragement and assurance that their idea is valuable.

5. Notice if ideas are coming from only a few people. Some individuals find the hurly-burl

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

Professional from academic institutions, pharmaceutical industries, health care indust

y of a fast-paced meeting to be uncomfortable. Consider having the group take a minute or two to write down some ideas. Then, first ask for people to talk who haven’t yet had a chance. The quieter, more introspective people will appreciate thi

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

open invitation.

6. Rather than evaluate each idea as it is offered, add it to the list for later selection. You’ll have a wide mix of ideas and can then choose among them for intriguing ones that could benefit from further development.

7.

.

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

Be patient. It’s rare that brilliant ideas emerge right away. In fact, many breakthroughs come from the combination of smaller ideas. Remember that people often give “safe” ideas first and only offer the more creative ones when they’ve gauged th

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

Companies that provide selfless information through particip

e climate to be open-minded.

So, that’s what you can do this time. And use these ideas for next time, so you won’t get the “caught in the headlights” look. It’s really simple, if you’re willing to make the effort. Your staff will thank you for it

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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