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How do you choose the right people who will support and nourish an innovation initiative? This article will attempt to provide you with a set of important roles together with some at

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

tributes of the people who should fill those roles. Here we are less concerned with titles or hierarchies and more concerned with getting the people who can help drive each critical

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

Examples of combination products may in

ole or task.

In reality, you will find people in your organization that will fit multiple roles; your goal is not to find an individual person for each role listed below, but rather

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

to make sure your team covers each of the areas identified. Many times people can play multiple roles, especially in smaller organizations.

Connector Conn

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

ctors have the ability to connect departments, organisations, and industries that normally would not be connected. Although they may be an expert in their own field, Connectors are g

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

Combination pro

nerally people you'd describe as a mile wide and an inch deep. They know things about a variety of fields and industries and can connect them.

Collector Th

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

e Collector holds the key position of collecting ideas and providing organised access to others who can help build the knowledge base and map what is already there.

Fram

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

r The Framer works with business functions and management to determine the appropriate evaluation schemes and frameworks teams should use to evaluate ideas fairly, tran

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

sparently and consistently. The Framer can construct the evaluation frameworks which your team will use to evaluate your ideas, and ensure the evaluations are consistent and transpar

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

nt.

Judge The Judge evaluates the ideas, using the Framer's framework. Generally speaking there are many "Judges" for any idea - often representing busines

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

functions (sales, marketing, R&D), regions or other business silos. Judges follow the evaluation criteria set by the Framers, who worked with all the entities involved in setting th

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

Following aspects would a

e evaluation framework.

Prototyper Many organisations are comfortable with their new product development (NPD) process. Once they

dd to the challenges in developing combination products:

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

know what to make or offer they are pretty efficient at producing it. The problem they have is how to capture ideas and evaluate them. The people identified above fulfill this need;

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

however, a key person you must have is the Prototyper. Between evaluation and development there is an iterative process-the Prototyper is the master who makes rapid prototyping a rea

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

ity.

Measurer You get what you measure. If you want your organisation to innovate, you have to establish what you will measure to make sure this happens. T

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

ese metrics range from quantitative, such as time from idea submission to launch, to qualitative, such as what was learned from a failing.

Storyteller The

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

Professional from academic institutions, pharmaceutical industries, health care indust

Storyteller is one of the most valuable roles in the organization. The Storyteller's responsibility is to collect, keep, and tell stories about the organization. People respond to st

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

ries better than any other method of communication.

Lookout An important role in the identification of new trends and the analysis of those trends and the

.

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

impacts they may have on your business is held by the Scout.

Scouts scan the future to understand how the industry is likely to change. What are the scenarios we might face? What te

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

Companies that provide selfless information through particip

hnologies are in development that may affect our business? What might a competitor do that would upset our position in the market? What is hot in other industries that we might adapt

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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