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Four out of every five adult Americans will experience lower back pain at one time in their lives. Sometimes it’s a mild strai

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 or sprain that goes away after a couple of days. Other times, lower back pain lasts for weeks or months.

Ironically, a simpl

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

Examples of combination products may in

e muscle spasm can cause more pain than a herniated disk. In fact, despite the fear of herniated disks, they are the cause of

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

only four percent of back pain cases in the USA each year.

Looking at the causes of lower back pain

1. Muscle strains from ac

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

tivities including heavy lifting, sports activities, whiplash from a car accident, or twisting 2. Herniated disk (slipped diec

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

Combination pro

) resulting in the disk pressing a spinal nerve 3. Spondylosis, also known as spinal osteoarthritis, is a degenerative disease

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

often found in the elderly. Osteoarthritis results from the breakdown of cartilage in the facet bones of the spine. With no c

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

artilage, stiffness and occurs. 4. Spinal stenosis which is the narrowing of an area of the spine. If a nerve is affected by

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

the narrowing, then pain may occur. Spinal stenosis can ofthen be brought on when walking. Regardless of the symptom, the 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

st plan is to avoid the activity that rings on the pain.

Treating lower back pain

1. Lower back muscle strains: Get ice on th

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

back as soon as possible. Ice your lower back 5 – 6 times per day for 10 -1 5 minutes. Do this for the first 48 hours. If y

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

Following aspects would a

ou are not feeling any better, go and see your physician, but usually for a strain, the pain will begin to subside albeit possi

dd to the challenges in developing combination products:

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

bly slowly.

Over-the-counter anti-inflammatory medicine such as ibuprofen is often recommended by doctors. Call your advice n

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

urse or go and visit your doctor to see what dosage should be taken.

2. Herniated discs: most people recover from herniated di

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

scs within a couple of months. At first your doctor will likely treat a herniated disc similarly to a muscle strain in that ic

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

ng and anti-inflammatory drugs may be involved. In the unlikely event that this dies not solve it, surgery may be an alternati

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

Professional from academic institutions, pharmaceutical industries, health care indust

ve.

3. Osteoarthritis: although this is a degenerative condition, it sounds a lot worse than it is. Treatment may include ant

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

i-inflammatory medicine, muscle relaxants, together with exercises to help support the spine. In 75% of cases, this approach w

.

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

ill succeed.

4. Spinal stenosis: initially treatment may focus on removing the source of the pain, be that walking, running, e

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

Companies that provide selfless information through particip

tc. Ultimately, surgery may be necessary, and the success rate is high resulting in an increase in mobility and activity level

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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I think what I experienced was a moment in time when this was indeed the World’s Best Jack In The Box . . . and perhaps it still is each time Carmen is present. I don’t know that my accolades were ever passed along, but in a world of customer service complaints I hope that she received my complimentary comments. Encouragement is sometimes everything for front-line service workers.

The buyer is the only one – THE ONLY ONE – who has the means, the knowledge, the political influence, and the capacity to align and manage all of the internal elements that need to be addressed before a buying decision can be made. For some reason - sellers, like change managers, coaches, and consultants – believe that because they recognize and understand the area immediately around the problem that their product solves, and they’ve seen it countless times, they know how the buyer needs to buy.

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