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Sharing information with employees with the aim of fostering greater teamwork and productivity, engaging employees in new and creative ways and giving them unprecedented ownership over their work were just a few of the themes that emerged in our fourth annual “Best Bosses” recognition program, wh

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

ich we recently completed. Once again, this project was a wonderful experience that allowed us to put the best practices of some of the most innovative small and midsize business leaders in North America under the microscope.

This year’s 18 Best Bosses were selected by a panel comprised of acade

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

Examples of combination products may in

ics, two previous Best Bosses honorees and Winning Workplaces board members and staff. The 2006 winners are:

• Richard Caturano – President, Vitale, Caturano & Company

• Linda Dunkel – President and CEO, Interaction Associates, Inc.

• Mike Faith – President and CEO, Headsets.com, Inc.

• Paa

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

Gisholt – President and CEO, SmartPak Equine

• Henry S. Givray – Chairman and CEO, SmithBucklin Corporation

• Megan Glasheen – Managing Member, Reno & Cavanaugh, PLLC

• Mellody Hobson – President, Ariel Capital Management, LLC

• Dan Hoffman – President and CEO, M5 Networks

• Jeffrey A. Holl

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

ender – President and Chief Regeneration Officer, Seventh Generation, Inc.

• Keith Jacob – President, St. Louis Staffing

• Timothy P. Keenan – President and Founder, High Performance Technologies, Inc. (HPTi)

• Michael Lacey – CEO/President, Digineer, Inc.

• Carl La Mell – President, Clearbro

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

Combination pro

k

• David M. Pierce – CEO and Chairman, ENA

• Pete Snyder – CEO, New Media Strategies

• Nicolas Thomley – President and CEO, Pinnacle Services, Inc.

• Graham Weston – Chairman and CEO, Rackspace Managed Hosting

• David Williams – President and CEO, Merkle Inc.

In my editorial on last year’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

Best Bosses, I spoke of the challenges of the economic landscape. These include fierce competition and evolving recruitment methods to land top talent, rising employee health care costs and developing staff to serve the organization’s needs in increasingly dynamic ways. These challenges have only

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

grown more multifaceted in the past year – perhaps one reason that the National Federation of Independent Businesses, a leading small business advocacy group, recently reported that small business owners are, on the whole, the least optimistic that they’ve been in over three years. In other word

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

, small businesses – the backbone of the American economy – are feeling challenged.

Yet, this year’s honorees are weathering those obstacles with more than just a can-do attitude – they’re creating and honing best practices designed to equip their workforces with the knowledge and insight needed

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

to perform at consistently stellar levels. The result? Motivated workers, high customer service ratings and increased productivity that improves the bottom line. Consider: The average growth rate for the past year among our 2006 winners was 40 percent.

Paal Gisholt’s organization, Massachusetts-

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

ased SmartPak Equine, a retailer of horse and small animal products, leads this trend. While adding 20 employees to the 50 already on the payroll over the last two years, he guided his workers to increase sales by a whopping 177 percent. Gisholt was able to do this not by telling his people to hi

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

Following aspects would a

t certain sales targets, but by inspiring them to want to hit those targets – and not just for the company, but for themselves. Practices like employee stock ownership and open book management serve as standalone tools to constantly realign employees with the firm’s core values. “I have become a

dd to the challenges in developing combination products:

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

eliever in letting our culture serve as the primary mechanism to generate alignment of goals within the organization,” he says.

At Ariel Capital Management, the Chicago-based investment management and mutual fund company of winner Mellody Hobson, people-centered best practices include all-compan

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

staff meetings, tuition reimbursement and free breakfast on Thursdays. “People are everything,” Hobson recently told the Chicago Sun-Times. “Unless you figure out a way to create a culture that excites and motivates people, you won’t have a good business.” Hobson’s people return the value she an

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

d the management team place in them in spades. Case in point: When the company relocated its offices downtown, everyone voted.

Of course, effective or innovative use of best practices is not the only thing that defines a great leader. Sometimes, surviving and thriving against overwhelming odds d

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

fines the executive’s path. In the case of Virginia-based information technology firm HPTi, President and Founder Timothy Keenan weathered the storm every leader hopes passes by his or her company: the death of a staff member. In 2003, Keenan – then COO – took the reigns of HPTi after its CEO, ge

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

Professional from academic institutions, pharmaceutical industries, health care indust

eral counsel and accountant were killed in a plane crash. After the tragedy, Keenan resolved to demonstrate to both his customers and his employees that it would not impact HPTi’s viability. That same fateful year ended on a positive note, turning out to be one of the company’s most profitable.

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

While their locations, industries, budgets and talent pools vary widely, this year’s 18 honorees do share some common ground – they have each embraced the core principles of a winning workplace:

• Trust, Respect & Fairness
• Open Communications
• Rewards & Recognition
• Learning &

.

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

Development
• Teamwork & Involvement
• Work/Life Balance

With the above-mentioned challenges – and countless others – defining today’s sometimes rigid, always shifting economic landscape, America’s innovative and creative small business leaders serve as the foundation holding that land

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

Companies that provide selfless information through particip

cape intact in times of turbulence. Our 2006 Best Bosses honorees represent a small sample of these leaders, but a prime sample nonetheless. Stay tuned as we watch for the next big thing to come from these great small organizations.

Mary Corbitt Clark can be reached at info@winningworkplaces.org

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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