Useful Advices - Business

One of my clients is in a transition stage with her business. Her practice has become so successful that she no longer has the time to do her administrative work or even the marketing work that helped her become successful.

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

I am working with her developing a plan to hire administrative and functional staff that will allow her to continue to grow her business and enjoy her work life.

One of the issues we are facing which affects many business o

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

Examples of combination products may in

wners is that if she doesn’t have time to do what she’s already doing, where will she get the time to hire new employees, train them and do the marketing that is needed to justify the new employees? She keeps coming home to

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

pile of work and it has created a huge block to her growth. We just returned from a business trip where we learned new ways to grow the business and improve operating efficiencies. During the meetings and initially afterwa

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

rds my client was incredibly excited about the possibilities. But then something disconcerting happened.

I’ve seen this happen before. In fact, it’s happened to me many times and probably has happened to you as well. As m

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

Combination pro

y client started looking at the work that she would need to do to match the new vision she had, she went from excited to overwhelmed. This was painful to witness. I want to see my clients succeed just as much as parents wan

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

their children to. Watching her, I saw the excitement fade and fear and resistance mount. As we condensed our notes from our business meetings, the resistance became stronger and stronger and I heard resignation in her voi

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

ce as we talked about what was needed. The list we had created was long and contained tasks that comprised weeks of work. And in her current mood, she wasn’t about to do it.

As her consultant, it is my job to make this pro

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

ject work for her. What I realized was that she was in the middle of the classic change cycle. Whenever we go through a change, we go through this six stage cycle.

Loss—Whether good or bad, the change will bring about a s

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

nse of loss of what “was”. Doubt– You doubt yourself, the project, the facts, the timing—and you try to find reasons to not move forward. Discomfort— Or more specifically fear— This is the danger area. If you can’t move be

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

yond the fear, the change will be impossible. Discovery—The light at the end of the tunnel. Options and possibilities open up and optimism builds based on your new choices. Understanding—You now really understand the chang

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

Following aspects would a

e and are proactively involved in it. You see it benefits and know its usefulness. Integration—The change has stopped being a change because it has now become a part of you and you have integrated the challenges and success

dd to the challenges in developing combination products:

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

s into your life.

The critical stage in this process is the discomfort or fear stage. If you can’t get beyond the fear, you can’t move forward and you will be stuck. I’ve found that the most useful thing that we can do is

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

acknowledge that we are scared. It’s not easy for most people to say that they are scared of a change at work or at home, especially when they can see the benefits that the change will bring. But speaking up and saying that

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

you are afraid is the most important part of moving ahead.

You may be afraid to speak out the fear because it may seem “silly”. It may be the fear of the unknown, the fear of success, or the fear of failure. It may be 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

nsecurity that you aren’t good enough and the change is going to expose your weakness. You can’t hide from the fear. Dig deep and get it out of you. Put it on paper and take a good look at it. Remember the saying that FEA

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

Professional from academic institutions, pharmaceutical industries, health care indust

R is False Evidence Appearing Real. Now give it to friends, associates, and co-workers and let them help you. They can give you perspective on the change and how it will help you and how you can overcome the fear.

This wil

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

l also help you with stage four, seeing the light at the end of the tunnel. As the fear dissolves, you will start to see options and possibilities and become optimistic about the change. And now you are moving forward again

.

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

embracing the new.

Understanding the six stages of change and especially the critical Fear stage is important for any business’s long-term success. We have to embrace change and be proactive to stay competitive and be profi

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

Companies that provide selfless information through particip

table. Whenever your business is faced with a change, minor or major, be aware of this and work to help everyone involved to move as quickly as possible through the fear stage and into the abundance the change will bring you

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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