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Founder of The Parker Pen Company, George Safford Parker, was determined to make a better pen when he couldn’t find one that wrote well and didn’t leak. The name Parker has become synonymous

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

with high quality writing instruments, bringing to mind descriptors such as reliability, dependability, tradition, streamlines, style, prestige, innovation and timelessness. George Parker beg

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

Examples of combination products may in

n his career as a teacher of telegraphy and to supplement his teaching income, he started selling pens for the John Holland Pens Company.

Unexpectedly, the pens he sold, mainly to his telegr

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

aphy students, malfunctioned and he felt obligated to fix them. Soon becoming overwhelmed with repair work, he decided to invent his own version of the fountain pen. In 1888 the Parker Pen Co

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

pany was born. The following year he patented his first fountain pen. In 1891 he found an investor, insurance broker W.F. Palmer, who initially invested $1,000.00 and bought half of Parker’s

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

Combination pro

hares in both the patents and the business.

The first major technological breakthrough for the company came in 1894 with the Lucky Curve ink feed system. The feed system was designed to drai

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

n the ink back into the reservoir by capillary action when the pen was upright in the pocket of its owner. Parker became a major player in the fountain pen industry with the introduction of t

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

e Lucky Curve. In 1900, The Gold Filigree Lucky Curve Pens were introduced. Also that year, Parker patented the taper on the inside of the outer cap, a design improvement to make it fit more

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

ecurely. In 1911, an improved Lucky Curve feed was patented and in 1912, a new form of the safety cap was introduced.

There were several precursors (The Black Giant, The Emblem Pen, The Ster

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

ling Silver and Gold Snake Pen, The Trench Pen and The Jack Knife Safety Pen) to Parker’s next star: The Duofold. In 1921, the company’s biggest and most important launch to date was that of

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

he Duofold fountain pen that earned Parker its reputation as the pen company that produces the most dependable, as well as the most fashionable writing instruments on the market. The Duofold,

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

Following aspects would a

nicknamed “Big Red,” embodied the feel of the Roaring Twenties – big, bold and very jazzy. Now synonymous with vintage fountain pens, The Duofold proved its durability and Parker decided to g

dd to the challenges in developing combination products:

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

uarantee these pens for twenty five years. Parker’s Duofold family expanded in 1926 and 1927 to include Jade Green, Mandarin Yellow, Lapis Blue and Pearl and Black. All of these pens were ava

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

lable in a first-of-its-kind durable plastic called Permanite. The new material replaced the traditional vulcanized rubber, which tended to be brittle.

After years of intensive research, Par

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

er launched the first self-filling fountain pen, the Parker 61, in 1956. Engineered to “self-draw” ink from the bottle, the Parker 61 could hold enough ink to last for six hours of steady wri

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

ting. The British Royal Household awarded Parker the Royal Warrant as its sole supplier of pens and inks in 1962. Also in that year, subsidiaries opened in Peru and Columbia.

Celebrating the

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

Professional from academic institutions, pharmaceutical industries, health care indust

company’s 100th birthday in 1988, Parker relaunched the most famous Parker pen, the Duofold, now recognized as the Duofold Centennial. Parker established the Platinum Club in 1989 in the Unit

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

d States and Australia for Duofold owners, offering elite privileges and complementary services.

For more than a century, Parker has been a leader in the writing instruments industry. Afte

.

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

r years of diligent and determined attempts “to make a better pen,” this world famous idea of George Safford Parker came to life. Today, The Parker Pen Company continues their commitment to s

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

Companies that provide selfless information through particip

rive towards scientific improvements and excellency. With the latest technologies, traditional skills, using the finest materials, techniques and craftsmanship, Parker Pens are “beyond words!

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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