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John F. Kennedy once said, “Nothing compares with the simple pleasure of a bike ride.” I agree. Bicycling combines exercise, transportation and fun into a single activity for

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

people of all ages. What other activity can claim all that?

One of the biggest appeals to bicycling is the simplicity. You get on, pedal and go. So my question is: why are to

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

Examples of combination products may in

day's advancements in bicycling designed to make them more complicated? New advancements such as exotic frame materials and increasingly complex gearing don't make bikes simpl

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

er to operate or easier to maintain. Instead, they do the opposite:

Complex Gearing and Shifting: Today's typical adult chain bike has multiple shifting controls on ea

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

ch hand needed to manipulate chain derailleurs across eleven sprockets to manage 24 gears. How many gears do recreational riders really need? Or use? Plus with all this gearin

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

Combination pro

g equipment, it takes practice to figure out what gear you are in, and when you're away from the bike for a while, you have to learn it all over again.

Specialty Parts = S

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

pecialty Maintenance: With new, advanced components comes a new degree of specialization required to maintain them. According to bike shops surveyed, the only service that

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

should be done on a bike by a non-certified shop mechanic is a tire change. You shouldn't need specialized tools and a degree in bikeology to perform routine maintenance on a

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

bike. It seems today's bikes were designed by people who like to tinker with bikes for people who like to tinker with bikes.

These “advancements” have created a void for thos

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

e who want simple, reliable transportation; not a complex and technical piece of machinery. I think it's time bicycles got back to their roots of simplicity and fun.

Techn

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

ologies That Simplify

Fortunately, not all new technologies for bikes add complexity. Some actually make bikes more user friendly - easier to operate and easier to mainta

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

Following aspects would a

in. One such technology is shaft drive technology which eliminates the chain, and replaces it with a fully enclosed shaft drive (or direct drive). Shaft drives have actually b

dd to the challenges in developing combination products:

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

een around for over 100 years on bikes, using small gears and a spinning shaft rod to transfer power from the pedals to the rear wheel. Shaft drive technology has few moving p

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

arts, is simple to understand, and is very proven - which is why it is now standard on many motorcycles, including all of BMW's motorcycles. Shaft drives are also smoother tha

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

chains, last longer, don't have any external grease to get on hands or clothes, don't have any sharp moving parts, and don't require adjustments and cleanings like chains.

A

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

nother advancement that simplifies bikes is internal gear hubs, which replace the external sprockets and derailleurs. Internal gear hubs reduce the number of gears by 50-80%,

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

Professional from academic institutions, pharmaceutical industries, health care indust

which dramatically simplifies shifting, yet still offer a comfortably wide gear range and more intuitive shifting. Internal hubs are also sealed and protected from the element

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

s and don't have the maintenance or repair costs of sprockets and derailleurs.

Used together, the shaft drive and internal hub create a new breed of bikes - called

.

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

"_new" href="http://www.dynamicbicycles.com">chainless bicycles - that offer a unique combination of performance, simplicity and low maintenance. For most recreational rid

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

Companies that provide selfless information through particip

ers and commuters, chainless bicycles can dramatically simplify bike operation and ownership. And in turn, get more people on bikes more often. After all, isn't that the point

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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