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A number of years back I was in a meeting with two HR representatives at my company. They were explaining to me how the HR organization wanted to be more "strategic" with its clients and how they wanted to help us with annual resource planning. At the time, our biggest problem wa

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

s filling open positions with qualified candidates; a number of key positions had been open for months with no qualified candidates in the hiring pipeline. When I asked the HR reps about how they were going to help with this problem, they both told me that they didn't have time 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

address the hiring issues because they were tasked with being more "strategic". Needless to say, the meeting went downhill in a hurry because the HR reps were more interested in fulfilling the HR organization's "be strategic" mandate than they were in helping me with my real-life p

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

roblem.

As a longtime client of numerous HR organizations, I've learned to appreciate the value that HR professionals provide and the times my HR partner protected me from potentially difficult situations. When working well, the client, employees, and company as a whole benefit.

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

hen things don't work so well, though, everyone ultimately loses. Through my years as a client, I've locked down on five of the biggest mistakes that an HR professional can make in their relationship with the client, as follows:

Not understanding the client's business - Foundation

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

Combination pro

al to an HR professional's success is a strong understanding of their client's business. What are the key products the client offers? What does the client want to accomplish in the next fiscal year? Is the client's product emerging, stable, or declining? What are the client's ke

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

y business challenges? Does the client face any significant financial issues? Have the professional self esteem to know that the client wants you to invest some time to understand their business. Being a team player means spending time with the team to better understand how your

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

ervices can be best applied in the client's organization.

Trying too hard to get the client to understand the business of HR - Many HR professionals I've worked with wanted to "educate" me on terminology, concepts, or the latest HR trends. While the education was interesting and h

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

elped broaden my horizons somewhat, much of the education wasn't relevant to my job or important for me to know. If there are truly important terms and concepts that the client is going to need to know to get their job done effectively, then by all means educate away. However, if

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

the HR-ese is not material to the client getting their job done, then skip the education session. Help the client with what is need-to-know and keep the rest in your bag of tricks.

Not understanding the basics of employment law - My most valuable experiences with my HR partners we

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

e situations where my HR partner helped me to understand employment law issues and advised me on courses of action to take to minimize legal risk. When an HR professional understands the basics of employment law and can recognize situations where further legal advice may be requir

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

Following aspects would a

ed, potentially hundreds of hours of lost productivity are mitigated. By not having employment law basics down, the HR professional not only puts the client's business at risk but also suffers a credibility hit in the client's eyes. Know enough to advise the client and when additi

dd to the challenges in developing combination products:

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

onal legal help needs to be brought in.

Showing bias in supporting either management or employees - A crucial credibility factor for an HR professional is demonstrating impartiality while dealing with HR issues. If an HR professional has a reputation for being biased toward manag

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

ement, then they get a rap for being a "company" person and potentially legitimate employee issues may never surface. Conversely, when the bias is toward the employee, then they can be accused of holding "witch hunts" against management. The best HR professionals walk this line ca

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

efully and ensure that their thought process and advice represents consideration of sound business and legal thinking. They also need to have the courage of their convictions to tell either management or an employee when and where they think they are going wrong. Don't become a "y

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

es man" or "yes woman" for either side.

Not establishing expectations of work to be performed - Perceptions of the services an HR professional provides can be radically varied from client to client. While one client may see an HR professional as a recruiter, another may see the HR

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

Professional from academic institutions, pharmaceutical industries, health care indust

professional as an employment mediator, while a third may see him or her as an overall generalist. Establish a service-level agreement or contract with the client to ensure a common understanding of services performed, what is expected from the client, and expected timeframes in w

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

ich services will be performed. Key to this is ensuring that the contract is mutually understood and agreed-upon; it's not enough for the HR professional to quote department policy about what will or won't be done for the client. Make it clear about what you'll do for the client,

.

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

what you expect from the client, and in what timeframe the work will be done.

An HR professional that understands the client's business, shields the client from the HR-ese, is unbiased, delivers against clearly set expectations, and protects the company and employee fairly can be a

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

Companies that provide selfless information through particip

n invaluable partner to both the client and the company as a whole. Avoid these five major mistakes and you'll build a high degree of trust and credibility with your client, be viewed as a trusted business partner, and save potentially countless hours of lost productivity and waste

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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