Main Subject - Business

Teams don’t have to be aligned with the goals of the organization. Teams can work on what they believe to be the right things. They can work diligently on creating the results they think matter. They can be completely committed to 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

ccess from their perspective.

A non-aligned team could enjoy each other and their work. They could accomplish much, and all of that could be completely counter to what the organization needs. Can you see this happening?

It isn’t jus

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

Examples of combination products may in

t a fantasy, I’ve seen it, and I’ll bet you have too. Maybe you’ve even experienced it.

Teams can’t succeed in a vacuum, but far too often that is what organizations expect them to do, and it can lead to the scenarios I’ve just describ

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

d.

Sometimes this vacuum is created by omission – leaders just aren’t thinking about it or are “too busy” to set context for team success. Other times the reason is optimism – leaders believe in their team members and their skills. Af

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

ter all they hired bright people – and bright people will figure it all out.

And sometimes the vacuum is caused by a far more pervasive problem - no clear organizational goals, objectives or strategies exist to align to. Leaders must c

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

Combination pro

reate clear strategies and they must create a clear line of sight throughout the organization, so people and teams can connect their work to the important strategies of the organization.

It takes effort to get a team in alignment with

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

he organization’s goals and strategies. And it is impossible when those goals and strategies don’t exist.

Yes, strategies and goals may exist. And yes, they may have been communicated. This is a good start, but isn’t enough. Teams

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

can’t gain the clear direction they need without conversation. It is the responsibility of leadership to provide that opportunity for conversation. This conversation provides the understanding which provides the team the context they

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

need to clarify their goals and make the decisions that come along during their work.

If you want to build stronger alignment between the team’s work and the organization’s goals, consider the following:

Start at the beginning.

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

Make sure the organization’s goals and strategies are set. If not, there isn’t much chance of the team being highly successful. At a minimum the team needs to understand, from the start, why their work product matters in the bigger p

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

icture and how they can make a positive impact.

Generate conversation. Don’t deliver the goals in the email when you ask people to join the team. Don’t put it in the packet of materials people get when being hired. Make the t

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

Following aspects would a

ime to have conversation. The alignment we are searching for needs to be deep – almost visceral. Help individuals and the team develop meaning and purpose. Help them understand how they can create work that matters.

Get the team’

dd to the challenges in developing combination products:

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

help. Get their input. Remember that you are trying to create alignment and agreement. When people have the chance to shape the goals of the team and when they have the opportunity to have input into those decisions they will ha

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

ve greater agreement with the goals.

Provide a connection. Teams need someone in leadership “above” them that can provide support and resources, someone who can answer questions and keep them on track. Some people call this a

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

team sponsor. The sponsor shouldn’t be on the team; rather they provide leadership, support and connection. The sponsor keeps the team from feeling like they are all alone.

Make them accountable. If the alignment is clear and

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

the goals set, then the team needs to be held accountable for results. In organizations where accountability has been lax in the past, this may seem like a jolt, but it won’t be long before this accountability not only drives results b

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

Professional from academic institutions, pharmaceutical industries, health care indust

ut improves team dynamics too.

It is easy to see how these steps will help a team succeed – it is easier to do that when they know what success is. But more than helping them deliver a desired result, the sense of clarity, meaning and

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

direction that these steps create help teams get over many other hurdles that teams face in terms of commitment and “getting along” with each other.

Why?

Because people want to belong to something that matters, they want to be a part

.

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

of making a difference. They want things to believe in. When we give them those things, collectively they will work through many personal issues and challenges and they also become more committed to the end product.

As leaders we can

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

Companies that provide selfless information through particip

help teams find these things, and at the same time improve our likelihood of getting the results we want. All it takes is effort, communication and commitment to help teams get aligned with the most important goals of the organization

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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Okay so you have already graduated. You have passed your finals, breezed through all your classes and finished your thesis. Now what? Welcome to the real world.

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