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CEOs and others are often more effective when they have highly-effective teams at their disposal. At the point where team members all know the team goals, interpersonal conflict is reas

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

onable, and roles are defined, many teams can still struggle. Even with everyone pointed in the same direction, there can be problems:

some people won’t share information,
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in
i>
some won’t debate the issues,
some perceive a 'kill the messenger' pattern or have a fear of reprisal,
some may exhibit passive aggressive or aggressive beha

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

vior,

some will agree in a meeting to take action, but fail to take it, and

sometimes too many people or the wrong people in the room can cause a problem.

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

To overcome many of these problems, two things have to happen:

team members have to trust the people and the process, and
team members have to be willing to cont

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

Combination pro

ribute to team debates (i.e., they have to be willing to engage in constructive conflict on the work itself). When both these elements are in place, team members can be pas

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

ionate and unguarded in a discussion of the issues. They openly admit mistakes. They respect others’ ideas and opinions. They attack problems, not people. And, even if a decision goes a

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

gainst their position, they often can accept it because their ideas were heard.

Trust takes time to build and it can only be earned. It’s easier with a smaller team which is one of the

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

reasons that many executive coaches suggest a team should ideally consist of less than 10 members. It requires complete honesty (some would say "brutal honesty"), integrity, good commun

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

ication, vulnerability, and behavior that demonstrates that the team goals are more important than an individual’s goals. Without trust, team members don’t participate fully, issue guar

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

ed or political comments, may agree to something in a meeting but fail to buy in, thwart the result or manage to avoid any accountability.

Trust is difficult to create in a competitive

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

Following aspects would a

environment and most companies provide a competitive environment. For example, to get a promotion, you often have to compete with other candidates or if you appear weak, others may try

dd to the challenges in developing combination products:

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

to take advantage. So how can you show weakness or vulnerability in a competitive environment? It’s best if you pick an area that offers little risk such as sharing and asking something

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

of a personal nature: hobbies, where you grew up, and so on. Developing informal relationships at work makes it easier to engage in difficult work discussions with the same people when

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

the need arises. Getting to the next level of trust can be aided by sharing something you appreciate about other team members. A third approach is to use 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

w.momentumcoaching.com/disc.html">DISC, InterPersonal Profile (360° feedback), and/or personality tests to help build trust by allowing people to better understand themselves and ot

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

Professional from academic institutions, pharmaceutical industries, health care indust

hers.

One of the problems with solving a trust issue is you may never know what the underlying issues are if people are not willing to share them. This is often the case, particularly

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

n a multi-person setting. At times like these it’s important to use an approach that promotes trust and provides useful and timely feedback. Recently we recommended a process to check t

.

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

he trust level and communication effectiveness within a team. The feedback surprised some team members who thought everyone was on the same page. Specific issues, now out in the open, c

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

Companies that provide selfless information through particip

uld then be dealt with relatively quickly. Left untended, issues like these can cripple the effectiveness of a team, cause cycle-time delays, and reduce cohesion, team spirit and morale

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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