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SNAPSHOT IN TIME

Each morning I get out early and walk. The light is terrific as the sun rises and I have gotten into the habit of taking my camera along. The details that are revealed i

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

n the pictures often surprise me.

Although strategic planning is about the future, it starts with a clear picture of today. By zooming in and focusing on the environment, the conditions

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

Examples of combination products may in

ithin your business, and what makes you unique, you will find useful information to help develop effective strategies for the coming year. There are many dynamics, both internal and exter

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

al that affect success.

Let's take a closer look inside your business.

INTERNAL ASSESSMENT

How do you gain perspective on the environment that you work in every day?

There are many to

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

ls, methods and practices that focus on different areas that can be useful to assessing your business. Some of the key areas to look at are structure and function, resources, and internal

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

Combination pro

strengths and limitations.

Start with your clients, employees and business partners. Each of these perspectives will provide useful information about your business. A few of the most co

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

mon methods to gather information are focus groups, surveys, assessments, and customer service reports.

As a starting point, ask the following questions:

Are we easy to do business with

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

What are the things we do best? In what areas do we have room for improvement? BUILDING ON STRENGTHS

People are the most important resource in any business. Before you take your b

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

siness in any new directions, it is critical to understand the skills, abilities, knowledge, expertise, natural tendencies, and values that set you and the people in your organization apa

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

rt.

As you begin to map a plan for the future, developing strategies that are based on strengths will be easier and more enjoyable. There are so many different opportunities to grow and

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

evelop. Choose the opportunities that build on what comes naturally.

ORGANIZATION ASSESSMENT

Systematically evaluating all of the components of an organization- e.g. management, staff,

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

Following aspects would a

ales and marketing, operations, financial systems, technology, etc is an important part of the strategic planning process. Many companies use a tool called SWOT (Strengths, Weaknesses, Op

dd to the challenges in developing combination products:

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

ortunities and Threats) to help them organize the information they have gathered.

I invite you to take a look at the following website, which shares an excellent example of a comprehensi

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

ve organizational assessment process (for non-profits). It can be found at the extensive National Endowment for the Arts website http://www.nea.gov/resources/Lessons/WARSHAWSKI.HTML

INDI

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

IDUAL ASSESSMENT

Assessments can provide new ways of understanding yourself and others on a team and can be extremely useful when trying to improve personal effectiveness, satisfaction,

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

r the ability for a team to work together. There are many companies that have designed and validated organizational and personal assessments. Here are a few that I highly recommend to ide

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

Professional from academic institutions, pharmaceutical industries, health care indust

tify:

Sales abilities (Caliper ), motivations (MAPP, Reiss), personality preferences (Myers Briggs), learning styles (Kolb, Hay), conflict-modes (Thomas-Kilman), processing preferences (

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

NLP), Personal Interests, Attitudes and Values (TTI), behavioral styles (TTI DISC, ProScan), and emotional intelligence (ECI) .

If you think assessments might be useful – talk to a certi

.

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

ied facilitator (I welcome your inquiries) to help define your needs, choose the right instruments, facilitate the process, debrief and initiate follow-up with the participants. Assessmen

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

Companies that provide selfless information through particip

s can be extremely powerful when taken together on a team. A skilled facilitator will be able to effectively couple debrief information with team building skills to effect positive change

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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The cleaning chemicals your janitorial company uses every day come in various forms: ready-to-use, concentrated, and dilution control systems. Cleaning companies are using dilution control systems more and more every day. They see the value in having a system that not only mixes what they need for a specific job or building, but also mixes the chemical in the right dilution every time.

Many people considering the role of mortgage advisers as a career are looking at the current trend in interest rates before enrolling in CeMAP training. This article looks at the likely effects of the present rising interest rates on careers after CeMAP.

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