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If you are planning to spend money on diversity training, WAIT!

You may be wasting your money if you haven’t done any foundation building. If diversity and inclusion are not first integrated in

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

to your business strategy, very little will change just by holding one or two day training classes. Organizations in all sectors make this mistake and don’t realize it until it is too late.

If

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

Examples of combination products may in

ou want to leverage the diversity you already have, increase the diversity of your organization, or prevent cultural misunderstandings you need to create a corporate culture that is inclusive at

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

all levels, and in every system and process.

You can get everyone trained by a great trainer, with a great program, but when people leave your organization they take what they learned with the

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

(if they still remember it) and your organization remains the same. Further, reaching resisters and naysayers of diversity efforts is unlikely only with training—a more multi-faceted approach i

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

Combination pro

needed to help these individuals see the value of diversity in their organizations and to bring a greater number of people on board to the initiative.

Simma's Strategies for Creating an Inclus

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

ive Organization

Here are some of the steps that need to be taken in order to create an inclusive organization.

Start at the top. It must be championed and led by the CEO and other people in t

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

e executive team. Leadership of a diversity and inclusion initiative or culture change cannot be delegated. Other people can help drive it, but it must be viewed as coming from the top. That als

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

means you need to start including it in conversations, discussions, newsletters and e-mail.

Assess your organization with surveys, focus groups and interviews in order to identify strengths, c

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

hallenges and areas for improvement as it relates to diversity, inclusion and employee satisfaction in specific areas.

Create a cohesive vision and strategy that is agreed upon by members of th

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

executive leadership team. Know where you are going.

Engage all levels of senior management. They need to be part of the vision and have a clear understanding of concepts, roles, business case

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

Following aspects would a

and benefits, in order to help lead the change.

Develop a communication and information sharing strategy and process in order to share that vision throughout the organization. Send the message

dd to the challenges in developing combination products:

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

in such a way that you create middle manager and employee buy-in. Help them understand how the diversity and inclusion/culture change process will benefit them personally, professionally and as

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

n organization, That will involve internal marketing at all levels.

Use the results of the survey to address specific areas for improvement, most commonly; recruitment, interviewing, hiring, re

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

ention, promotion and performance evaluation. Examine your present organizational culture, and identify ways in which your organization can create a more inclusive environment.

Define skills an

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 behaviors that managers need in order to make the initiative/culture change a success and successfully lead a diverse workforce.

Conduct training for all levels of your organization in areas

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

Professional from academic institutions, pharmaceutical industries, health care indust

elated to diversity and inclusion.

Set up a process for accountability at all levels, relating progress to compensation and evaluations.

Measure results, create the buzz and make it exciting (

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

f its not fun, it won’t be done)

The amount of time, order and the steps themselves depend on your organization and goals, but if you want to go beyond compliance, hear new ideas and best pract

.

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

ices, reduce cultural misunderstanding and miscommunication, hire and retain the best of the best from everywhere, training alone won’t do it. Before you spend your next dollar on diversity trai

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

Companies that provide selfless information through particip

ing, ask yourselves if you just want people to have a good day, learn and forget a few things or do you want ongoing change that will make you a benchmark organization and the employer of choice

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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Many fear this fact of financial life, but once understood, and correctly used, it can be one of the most powerful arrows in your business quiver.

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