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When you ask employees about their impressions of Performance Management processes, the answer is invariably negative or neutral. It’s not often that the process is positively endorsed by those who use it. So where are we going wrong?

As manage

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

rs, we know we need a management system of some kind for all the components of performance:

• getting people to work on things that will help the business achieve its goals

• identifying and overcoming obstacles that might prevent success

• u

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

Examples of combination products may in

derstand and checking our progress regularly

• giving people a forum for talking about what they are doing and how it’s going

• providing the appropriate checks and balances

• recognising and rewarding performance

I believe there are 5 funda

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

ental reasons why Performance Management is not viewed positively.

1. Reviewers don’t have the skills or confidence to give feedback appropriately Giving feedback constructively is a learned skill. Unfortunately for their team members, many ma

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

agers haven’t had any training or support in learning this critical skill. So when it comes to review time, feedback is either:

1. blunt and delivered with no thought for the impact or consequence,

2. not provided at all because the manager wa

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

Combination pro

ts to avoid disagreement or conflict, or

3. is given in such a wishy washy way that the reviewee actually misses the fact they are being given feedback!

This is one of the most critical capabilities a manager can have, with far-reaching positi

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

ve or negative consequences. Providing ongoing coaching and support should be part of the approach to managing performance.

2. Employees don’t see Performance Management (PM) as a 2 way street

Is PM something that is ‘done’ to employees, or is

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

it jointly owned with equal responsibility between the reviewer and the reviewee?

Imagine a review session where the employee turns up having evaluated their own performance, provided examples of how and when they achieved each objective, had r

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

ferences from other people about their attitude and behaviour, and already had drafted some challenges they wanted to work on in the next 12 months. When ownership for the process lies with the employee, this is the result.

Getting to this stag

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

takes time. The business needs to consistently communicate expectations and help the manager’s adapt to the new positioning. Instead of PM being viewed a bureaucratic process over which they have no control, employees own their own performance

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

nd contribute equally to the discussion about performance levels and results achieved.

3. The annual review is the prime focus

If PM consists only of an annual or bi-annual review, the business is really missing the point. Reviews are useful c

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

Following aspects would a

heckpoints, but PM occurs 365 days a year. When review time comes around there should be no surprises. And I mean none. If there is, the manager is not doing their job effectively. Any performance issues, or comments about achievement, need to b

dd to the challenges in developing combination products:

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

given as they arise, not saved up for discussion 3 months later in a review.

On this basis, the review becomes more of a confirmation of what each party already knows. This shouldn’t take long to go through, leaving plenty of time to discuss d

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

velopment needs and new opportunities (see next point).

4. Not enough attention is given to the future

In many cases the entire review is spent dissecting the previous 12 months. Objectives and goals do need to be valuated and measured - don’t

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

get me wrong – but the real value of a review lies in the discussion about the future.

What skills will the employee need to develop to become even more effective in their job? What work-related challenges can they get involved in that will gro

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

them beyond where they are today? How can the business utilize their strengths in other areas? What gaols do they want to set themselves over the next 12 months? How can the manager help them achieve these things?

It’s this focus on future dev

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

Professional from academic institutions, pharmaceutical industries, health care indust

elopment and opportunities that energizes people, makes them feel valued and keeps them engaged with the business.

In an ideal world, reviewing past performance and discussing future skills and opportunities will take equal time in a review.

5

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

There is no follow-up

This is the credibility killer. All throughout the performance year, managers will make commitments to take actions and follow-up. If this doesn’t happen, the whole process loses integrity. Once employees experience this

.

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

irsthand, it’s a long road back.

Commitments must be upheld, and managers and employees equally need to be accountable for their part in this.

Getting employees to think about Performance Management as a positive process that adds value is the

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

Companies that provide selfless information through particip

goal. This only happens when the managers have the right skills, the business adopts an ongoing approach that consists of much more than annual reviews, when commitments are made and kept, and when employees own the process equally with managers

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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