Main Subject - Business

As the manager or owner of a company it is essentially your responsibility to ensure that the company is run smoothly. Most small businesses don’t use a Board of Directors to their fullest capacity due to the fact that most owners and managers on some level are control freaks. It’s okay to admit it because everyone in your compa

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

ny is thinking it. So as the Chief Control Freak in your company keeping a close eye on the health of your business is a crucial function of the business cycle. I want to give you a ten point checklist to a healthier company. In part one of this three-part discussion I want to focus on some crucial foundation principles, cash fl

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

Examples of combination products may in

w, marketing, sales, and quality

(I) Cash-Flow

Cash is king, and simply put if the king has left the building, the company is not too far behind. Undercapitalization is a fierce epidemic in small business; owners struggle to find working capital to keep their companies running, and producing or selling a product or service

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

On a quarterly basis a company’s cash needs to be examined. Some questions to ask are, where is it coming from? Where is it going? Do we have too much cash? (Yes this is actually a problem) Examine the cash-flow cycle, the time it takes to make a sale, the time it takes to collect from the sale, and how long before that money i

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

out the door. These are your turnover ratios, you may find that on average it takes 35 days to collect, but your vendors are requiring payment in 15 days, you have a 20 day gap of cash, and it’s time to sew that gap shut.

Examine also where that cash is going. Are you paying for inventory, subscriptions products or services th

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

Combination pro

t you do not need? Is the equipment that you own leased or purchased? Do you perform a cost-benefit analysis and have internal controls for purchases over a certain dollar amount? This one is the biggest kickers of all, how is your company performing budget wise, if you’re spending more in certain areas it might be time to exami

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

ne why, and justify the expense. On a quarterly basis examine your staffing needs, keeping a worker on staff that is not performing up to standards, or is not providing positively to your bottom line may need to be let go, and those costs redirected. Finally, can you outsource anything to save on costs?

(II) Marketing

If n

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

one knows who you are, where you are, what you’re about, and what you do nearly nothing else matters. Marketing is a basic foundation of business. Marketing is much more then simply running an advertisement, marketing is about positioning your company to whoever you’re targeting. This includes perception, feel, experience, pric

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

, and exposure just to name a few. Review your marketing strategy and campaigns. Are you really reaching who you wanted and are you influencing their decision in your favor? How do your current clients view you? Are they part of your target market? Review you strategy to determine if your core market has changed, and how you can

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

address that change. Maybe who you originally intended didn’t buy you service or product, but someone else did, are you positioning yourself in that new market. Can you expand markets? Do you need to shrink markets? (Expansion does not mean profit one-hundred percent of the time) Are you priced competitively? Is your advertising

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

working, and are you tracking results? When was the last time you issued a press release, and told everyone about your new service or product?

(III) Sales

I wanted to address sales separate because of the complexity of both subjects. After you have addressed any marketing concerns, it’s time to prepare for the return on in

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

Following aspects would a

vestment, the sales cycle. From the initial contact, to the actual exchange of goods and service for a promise of cash, or actual cash how does your company stack up? Some industries have long sales cycle, especially when dealing with high priced services and items. So how often are you closing a deal? Are you losing to a compet

dd to the challenges in developing combination products:

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

tor? If so, why? Are you speaking the language of the customer? Are you giving them what they need to hear to make the sale, or what you think sounds good? Talk to your existing clients and customers, get a feel for why they do business with you and not the guy down the street. What sealed the deal for them?

Some companies deal

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

with larger corporations in their sales cycle, or a company who does a lot of business with the. If they are a majority of your annual sales (smaller companies often sell to large corporations who use their leverage and size to determine volume of sales, price, and collection periods) determine if you have the capacity to add mo

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

e clients and diversify your client base. Selling primarily to one client can have an adverse affect in the long-run on your company financial health. If they get bought out, or if new management comes in, you as the supplier may be pushed out.

Also determine if you can diversify your revenue stream. Adding a service contract t

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

that product may increase sales, or diversify your revenue. Adding several products or services together and packaging them is also a remedy for slow sales, it can also help to relieve you of excessive inventory in a product that’s not taking off. First determine though if it is feasible to do this. Do you have the man power, t

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

Professional from academic institutions, pharmaceutical industries, health care indust

ools, equipment, and space? Assess your risk exposure to the potential downsides. Can you expand into new markets (profitably), and an often overlooked sales technique is harvesting more sales in your current market. Loyal customers are always a good place to look first when it comes to sales.

(IV) Quality

This begins with

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

a review of your product/service. How’s the quality? How’s it viewed in the marketplace, are your clients/customers recommending it, or telling others to avoid it like the plague? Quality is the fourth foundational leg a company needs to stand on. Your sales will dwindle if you lack quality, that affects the cash-flow and no ma

.

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

ter how much you market, nothing helps a poor quality service or product. Quality is really simple to examine, what you’re offering is either great, or it’s not. Check, check, and recheck your processes, refine what you offer. You don’t want to be known is the market place as a low-quality leader, because soon you won’t be known

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

Companies that provide selfless information through particip

at all.

All four of these areas an intermingled, everything works together and cannot work separately of one another. By keeping all of these areas healthy you can run at a minimum a break-even business. In the following two parts we’ll discuss areas that can help propel you beyond your competition and keep your company healthy

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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Main Subject - The Company Check Up - An Examination For Your Company Part I

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