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When a well intentioned project has failed or hit a few bumps in the road, one of the oft-cited reasons for the failure is leadership. There are thousands of books on leadership and what makes

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

great or poor leaders, all penned by someone smarter than I, so rather than investigate what kind of leader should be captaining your ship, let’s investigate which internal organization

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

Examples of combination products may in

should be leading your projects.

There is clearly a good case to be made that many projects should be led by your company’s IT organization. Things like software upgrades, enhancements or opti

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

izations to existing IT systems and the like are generally deferred to the IT department without a second thought. Much as switching your firm’s accountants from Number 2 to Number 3 pencils sh

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

ould not require much input from the larger organization, there are a percentage of projects that can and should remain completely within the IT organization of most companies.

Where many orga

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

Combination pro

izations make a mistake is in assuming that anything involving IT should be managed by the IT department. A perfect example is Enterprise Resource Planning or Customer Relationship Manag

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

ement applications. A company writes a large check to a software company to purchase these applications, and therefore assumes they have bought a piece of software that should be managed

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

and installed by IT. This assumption is nearly always wrong, and often fatal.

Package software really is not just software. As the vendor’s sales people are quick to mention, processes

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

and purported “best practices” are a key component of any package. In addition, most packages offer quite a bit of leeway for individual customizations to the delivered business processes. Alth

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

ugh your IT department is certainly capable of installing Excel, you would not have them design the chart of accounts to be used with Excel. Nor should IT be solely responsible for implementing

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

package software and redesigning the accompanying business processes and procedures.

Too many organizations involve business decision makers and end users of the product late in the process,

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

Following aspects would a

assuming a cursory “requirements gathering” session and some involvement later in testing will be an appropriate way to complete the implementation. However the opposite approach will deliver v

dd to the challenges in developing combination products:

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

stly improved results. The business users affected by the implementation should drive any project involving changes to existing processes or additions of new processes from the beginning

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

, only involving IT when there are specific IT-related tasks to be completed, such as developing enhancements or building a hardware environment.

When building a house it would be foolhardy to

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

bring a group of expert contractors on site on the first day, and begin experimenting with different plumbing schemes or drywall placements before any semblance of a blueprint has been complete

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

d. Rather architects and general contractors plan and drive the work of the builders only when the systems of the house have been designed and planned appropriately. In a systems implementation

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

Professional from academic institutions, pharmaceutical industries, health care indust

business users and key stakeholders should run day to day operations and actively manage the project, rather than deferring those efforts to an IT organization.

Leaving the shop to the IT fol

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

ks often creates a battle weeks or even days before go-live, as business users suddenly realize the new system that has been implemented does not fully meet their needs, or key requirements hav

.

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

been overlooked. All too often an IT-managed project will deliver a technically sound solution that misses many central business and strategic requirements. Only by involving key resources and

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

Companies that provide selfless information through particip

subject matter experts in the project from the beginning, and maintaining their involvement will actually deliver the ROI that was the business driver for the project in the first place

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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All of us are partners with each other. If you help one person, maybe I will get the benefit down the line. If I help another, one day you may reap the same reward...

Our work life always related to organizations, and we are part of organisations which forms part of the Society. Organizations help build people skills, knowledge and attitude which help in the professional progression of employees. But organisations enable objectives to be achieved that could not be achieved by the efforts of individuals on their own and have three factors in common: people, objectives and structure. You need to unite all the people by creating some kind of identity through purpose and co-ordinate their work and split it up at the same time

One way to achieve entrepreneurial success is to not make the following marketing mistakes. It is mostly about common sense and taking the time to think things through.

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