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Just Other Articles - Authentic Communication: Dealing With Moose-on-the-Table
Imagine a team meeting around a conference-room table. They are reviewing progress and making plans. Charts are reviewed, slides are projected, documents are handed out, and calculations are made. Now imagine that stan
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
ding in the middle of the conference-room table is a great big moose.
No one says a word about the moose. Everyone carries on polite and earnest conversation as if this situation is very normal. Meanwhile the moose is
No one says a word about the moose. Everyone carries on polite and earnest conversation as if this situation is very normal. Meanwhile the moose is
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
eating papers at one end of the table while plopping out moose pies at the other end of the table splattering a few participants' business suits. Team members are passing papers around the moose's legs. They shift in 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.
eir chairs to make eye contact with each other under the moose's belly or to see past it to the front of the room. Papers need to be pried out from underneath the moose's huge hoofs. When the moose lifts its head, his
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
massive antlers poke into the meeting room ceiling, raining down chunks of ceiling tile and knocking out a light. No one says a thing about this. The leader carries on blissfully with the meeting.
This, of course, is
This, of course, is
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ot a real scenario (at least, not in my experience!), but a symbolic one. The moose represents an issue that everyone knows is a problem but isn't being addressed. People are trying to carry on as if things are normal.
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
Meanwhile the issue is blocking progress and has caused some team members to tune out of conversations. Like a dysfunctional family with an abuser in its midst, no one wants to confront the problem. By failing to decla
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
re the issue, they further empower it. The moose grows bigger.
The Moose-on-the-Table scenario is one that we run into very often within management teams. The problem is that conversations among the team aren't authen
The Moose-on-the-Table scenario is one that we run into very often within management teams. The problem is that conversations among the team aren't authen
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ic. They don't deal with the real issues that are blocking progress. Some teams have a huge moose to deal with; others have a smaller moose.
Some teams have a whole moose family crowding them out. Do you have a moose
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
n your meeting room table? Here are a few symptoms:
• The real conversations happen in the hallways or office after the meeting. There the moose or issues are clearly named.
• Team members complacently agree to a con
• The real conversations happen in the hallways or office after the meeting. There the moose or issues are clearly named.
• Team members complacently agree to a con
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ensus at the meeting – then go off and do their own thing. They don't voice their disagreements for fear that they'll be labeled as not being team players.
• Commitments aren't kept and deadlines are missed. It's cons
• Commitments aren't kept and deadlines are missed. It's cons
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
idered whining or copping out for a team member to give his or her real opinion about the feasibility of the proposed change.
• Once the team leader gives his or her opinion, everyone else stays quiet or falls in line
• Once the team leader gives his or her opinion, everyone else stays quiet or falls in line
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
behind the executive. Team members suck up to the leader and pretend the moose doesn't exist.
• Sudden surprises often come "out of the blue" – especially from within the organization. The team leader is frequently su
• Sudden surprises often come "out of the blue" – especially from within the organization. The team leader is frequently su
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
prised to see a simmering problem suddenly erupt into a full blown crisis.
• The team leader dominates meetings and most conversations. If he or she wants any of your ideas, he or she will give them to you.
How do yo
• The team leader dominates meetings and most conversations. If he or she wants any of your ideas, he or she will give them to you.
How do yo
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
u deal with Moose-on-the-Table? There are many potential causes of the problem, so there never are any pat answers to that question. Timing is everything. Depending upon the situation and players involved, poorly timed
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
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
or clumsy attempts to deal with "moose issues" can be a CLM (either a career limiting move...or career limiting moose).
One way of dealing with the Moose-on-the-Table is to introduce the concept to everyone in the tea
One way of dealing with the Moose-on-the-Table is to introduce the concept to everyone in the tea
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
and play with it. It's a powerful and fun way to get serious issues out in the open. Some teams have given everyone a little stuffed moose. Others made up Moose Hunting T-shirts after a retreat where we discussed and
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
resolved tough issues. You could get people at a meeting to anonymously write down and hand in a few of the biggest moose they feel are present. Cluster the similar issues and hold a secret ballet vote on the top clust
.
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
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
rs. If you suspect people aren't being open during a discussion, ask "is there a moose-on-the-table we need to talk about?" Or if you see a potential issue emerging you might say, "I'd like to put a little moose-on-the
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
table..."
For all the talk of communication today, there's pitifully little of it going on. As Mark Twain once observed about the weather, many managers talk about communication but too few really do anything about it
For all the talk of communication today, there's pitifully little of it going on. As Mark Twain once observed about the weather, many managers talk about communication but too few really do anything about 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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