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It’s hard to believe the year will be half over in just a few weeks. All the planning you did is either turning out great, coming along slowly but surely or hasn’t really gotte

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 off the ground because other issues keep getting in the way.

With so many things to distract you from your small business this time of year – like outdoor activities, yard w

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

Examples of combination products may in

rk, vacations and the kids being home from school, just to name a few – the next 90 days often fly by and you find yourself further down the road and farther away from accompli

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

hing your goals. The key to avoiding the Summertime Blues and running in place until September is to conduct a mid-year check-up.

Success Handler Action: With your team, spend

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

some time discussing what you’ve accomplished so far this year. Focus on the positive things occurring in your small business. Celebrate your successes – however small they are

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

Combination pro

– so everyone recognizes there are indeed good things happening. Here are some questions to help you get started:

~ What is the best thing you’ve done as a company this year?

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

~ Why are you better today than six months ago?

~ Which part of your business has improved the most this year?

~ What are some of the good comments you’ve heard from your cus

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

tomers?

~ How have you personally helped your team achieve their goals?

We get so busy trying to survive the daily onslaught of crises that it’s easy to forget to look at the

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

big picture – to step away from the grind and remember even minor progress is still progress. It’s important to stay focused on continuous improvement, striving every day to be

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

ome a little better. The Japanese call this management philosophy “Kaizen” – making incremental progress one day at a time.

Success Handler Action: Review the goals you made a

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

the beginning of the year. Take a candid look at what you set out to do and whether you’re actually doing it. Gather your team and talk about the reasons you’re not achieving

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

Following aspects would a

he forward momentum you expected. Instead of dwelling on what isn’t happening, choose five attainable goals from your list and create action plans for accomplishing them. Assig

dd to the challenges in developing combination products:

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

specific responsibilities and timelines for completing each item. To help everyone understand the importance of their role in making the second half of the year remarkable, fo

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

low these five steps:

1. Ask your team to repeat their responsibilities, and if they have questions about their parts.

2. Create a buddy system in which two employees work to

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

gether to ensure accountability.

3. Post the action plans in a visible place where everyone sees them each day.

4. Encourage team members to look for opportunities to help ea

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

h other reach their goals.

5. Cheer for small victories by blowing a whistle and recognizing deserving employees.

Rather than overwhelming everyone with yet another plan for

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

Professional from academic institutions, pharmaceutical industries, health care indust

hanging the way you operate your small business, limit yourself to these five goals – focusing on what each person needs to do to complete his/her pieces. Bring your team toget

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

er each week for a brief 15-minute discussion in which every member provides an update on their progress. Encourage them to share roadblocks that are preventing them from movin

.

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

forward, and work on solutions for overcoming delays.

It is important to take time to plan the direction of your small business. However, the only way to achieve your goals i

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

Companies that provide selfless information through particip

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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Are Coffee Shop Franchises a good business? Well consider the average Starbucks does over $80,000 per month. An interesting book primer to learn more about the coffee business might be “Pour Your Heart Into It” by Howard Schultz. It is worth a read and you can find used books on Amazon.com cheap enough, you will be glad you did.

In Australia, a new process for employee reward and recognition was developed through a company's quality committee. It consists of 7 steps which can be used generically for any firm wishing to implement a system for staff recognition and reward.

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