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If you’re like most small business owners that want to make a difference in the world, I bet you have a beautiful vision and brilliant ideas. You are committed to doing business differently and making real change. Unfortunately, the day-to-day operations ca

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 create stress and overwhelm, and worse, can weigh you down and prevent you from making the impact you so desire.

It’s often difficult to “know what you don’t know” in the midst of running a small business. You are inundated with a huge number of activities

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

Examples of combination products may in

and roles to keep your business functioning. This probably creates stress and constant worry—about getting it all done, being profitable and creating a sustainable business.

Let’s discuss some mistakes that small business owners make so that you can avoid t

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

e pain, frustration, stress and overwhelm in your business. I’ve gathered the top five (although I may have made at least 200) for you:

1. Being Unclear With What You Truly Want in Your Business

Lack of clarity in your business can create immediate overwhel

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

m. Many business owners are clear about the lifestyle they want (i.e. greater flexibility, more work-life balance, traveling), but often fail to have a specific intention and a plan to get there. If you feel uncertain and unclear, your business can feel like

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

Combination pro

a daily struggle. It’s essential to have a picture of your business that includes all your requirements. Create the vision first, then build the business to fit into the vision. (Most people build a business then realize it’s not what they intended for thei

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

r life.)

2. Not Having a Business Plan, or Having an Underutilized One

Similar to having clarity, you’ll want to also have a crystal-clear business plan. Without a plan, you’re very busy but may lack direction and an end goal. In my experience, over 75% of

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

the small businesses I worked with didn’t have a business plan. Only when you have crafted a weekly, monthly, quarterly or yearly plan (with a set of clear endpoints and metrics) can you take the daily actions to fulfilling your business goals. Allow the cl

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

rity of your plan to create more ease (when you understand what needs to be done, you will naturally feel more at ease).

3. Limited Planning Time

When you operate your business with little or no planning time, you may find yourself feeling overwhelmed rather

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

than in control. You become reactive as you “put out fires,” problem solve, and complete your work each day. Rather than planning for the future, you end up working in the business, not on it (principle drawn from Michael Gerber’s book The E-Myth). Give yo

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

rself the gift of time and space to plan. You’ll feel great, reduce your stress and be able to identify those things needed to create the best result.

4. Lack of Self-Care and Personal Time

Most business owners feel they have to sacrifice their personal liv

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

Following aspects would a

es while they are growing their businesses. Unfortunately, the lack of self-care and personal time can actually signal the demise of one’s business. As you shift away from sacrifice and move toward self-care, you’ll be pleasantly surprised. There’s a direct

dd to the challenges in developing combination products:

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

correlation between your personal health and the health of your business. Simply put, if you are overwhelmed, stressed and not vital at work, you are not bringing your best self forward and your performance will inevitably slip. Build in daily self-care tim

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

to renew and revitalize yourself (i.e. music, walking, napping) and put them in your calendar as non-negotiable. You’ll feel better and get more done with less effort!

5. Losing the Passion for Your Business

When your business becomes passion-less, every t

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

ask becomes stressful. You feel pushed to work rather than energized and pulled by your passion. This takes a great toll on you personally as well as on your business. Take a moment to remember your initial reasons for starting the business and what lit you

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

up in the first place (i.e. to make a difference, to offer a new product, to bring your creativity to the world), then figure out how you can add the spice back in. Commit to outsourcing the “un-fun” activities and allow yourself to feel good about your busi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ess again. This will allow you to decrease your stress and will naturally create better results.

I recently recognized the power of addressing these common mistakes with my client Anita, an international PR firm director. She realized that while she had com

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

pleted an initial business plan three years ago, she rarely ever looked at it or conducted her business around it. When we revisited the plan, she reconnected with her passion and commitment to being a socially responsible company. She understood how many cr

.

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

tical pieces from her original plan were missing from her current business actions. After she realized that, she was able to chart a new path with less stress and overwhelm, and much more joy and purpose.

I wish you great clarity and ease in your business so

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

Companies that provide selfless information through particip

that you can make the difference you truly desire. May you know joy, may you know peace and may you work with ease.

Visit www.WorkWithEase.com to receive your free audio program entitled “7 Simple Strategies to End Work Stress and Overwhelm with Confidence.

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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Be part of the international business explosion by earning your international business degree today. With the development of an integrated global economy, marked by free trade and free flow of capital, now is the time to pursue a cutting-edge international business career.

As we all wrestle with getting our employees to recommend and suggest items to customers, perhaps you should consider a different approach. Design the menu to sell for you and, in the process, speed up service times, especially if you have a drive-thru. After I went through another lengthy service experience due to indecisive customers ahead of me in line, it was apparent that until I can place my order online or at a self-service kiosk, something must be done by operators to make ordering easier for customers. So look up at the menu board.

We've all heard how outsourcing and augmenting staff with experts is an avenue for meeting business needs where the technology, skills, knowledge, staff or time is not internally available. In theory outsourcing provides the ability to develop products and services that are not easily achieved through the organization's existing structure, by providing operational and strategic benefit. On the surface the idea seems viable; however, depending on the type of solution and service being outsourced, these relationships may actually increase the demands on the organization that is outsourcing its work. This article highlights six key questions you should answer before outsourcing, and eight things you should keep in mind while writing the contract.

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