INNOVATION MANAGEMENT

WBB10202

ASSIGNMENT 1

PREPARED BY: Mazlin Bin Mohd. Ali Mohd ezani Bin mat Yassim 54270208374 54268208404

INTRODUCTION In the organizational context, innovation may be linked to performance and growth through improvements inbefficiency, productivity, quality, competitive positioning, market share, etc. All organizations can innovate, including for example hospitals, universities, and local governments. While innovation typically adds value, innovation may also have a negative or destructive effect as new developments clear away or change old organizational forms and practices. Organizations that do not innovate effectively may be destroyed by those that do. Hence innovation typically involves risk. A key challenge in innovation is maintaining a balance between process and product innovations where process innovations tend to involve a business model which may develop shareholder satisfaction through improved efficiencies while product innovations develop customer support however at the risk of costly R&D that can erode shareholder return. In summary, innovation can be described as the result of some amount of time and effort into researching an idea, plus some larger amount of time and effort into developing this idea, plus some very large amount of time and effort into commercialising this idea into a market place with customers .

INNOVATION PROCESS MANAGEMENT (IPM) With the growing popularity of innovation initiatives, ever more companies are launching their own actions. However, many are going forward in a piecemeal fashion, running a brainstorming event here, trying out an ideas campaign there and promoting innovation in vague ways in marketing communications. Such an approach works, somewhat, but it is not ideal. The best approach is to have a comprehensive innovation process management (IPM) structure that treats innovation as a series of cycles that run within a grand, enterprise innovation process cycle. The Innovation Process Cycle

An innovation process cycle combines creative problem solving (CPS) with scientific peer review evaluation and some typical business tools.

The Challenge The cycle starts with a problem or goal which needs to be formulated into an innovation challenge. Once this is done, the challenge is presented to the problem solving group. This may be done in the form of a brainstorming event, ideas campaign or other activity. The group problem solving group may be a team, all employees in the firm, the public or any other group of people. Collaboration In order to maximise the creative potential of the problem solving group, the idea generation activity should be collaborative in nature. This can be accomplished in many ways. Idea management and innovation process management software often provides on-line collaboration tools, while facilitators of brainstorming and other ideation events should promote collaborative idea development. Combination Because an innovation process cycle starts with a challenge, ideas tend to be interrelated and many are complementary. Hence, before going further, it is best to combine such complementary ideas into larger, more sophisticated ideas so that they can be handled as a single package. This makes the next steps in the cycle more efficient. Scientific Peer Review Evaluation Here is where a lot of innovation initiatives break down: choosing the best ideas. Many poorly thought out approaches use voting, which is a good way to identify the most popular idea, but an appallingly ineffective method for identifying the most potentially innovative idea. I have also seen organisations put a great deal of effort into idea generation, leaving the final decision to a manager who basically picks out her favourite idea. Assuming the manager has suitable business expertise, such an approach is better than voting as it is based on expertise rather than popularity but it is typically far from perfect. The scientific approach of peer review by expert, on the other hand, is ideally suited for identifying the most promising ideas in a cycle. Instead of basing selection on popularity (can you imagine Einstein sending his special theory of relativity to the public for a vote in order to determine its validity?) or the whim of a manager, you apply a set of business criteria to the idea and rank how well the idea meets each criterion. If an idea achieves a sufficiently high ranking, either as is or through additional modification, it should be developed further.

Testing and Development Ideas identified as being potential innovations are now ready to be tested and developed. Here is where typical business tools come in useful. A business case is a useful means of hypothetically implementing an innovative idea and projecting the potential results. Of course it is not perfect, but it indicates possible issues in the implementation of the idea, as well as benefits that may not have been obvious to the original idea developers. Prototypes are an excellent means for testing ideas. Not only do they allow you, your colleagues, customers and others to see how an idea would actually look in implementation, but building and playing with a prototype is a good method of further improving upon the core idea. Prototypes are, of course, ideally suited towards material ideas such as new products. But more abstract ideas, such as new services, process improvements and other concepts can often be prototyped through role-play, building structural models and making diagrams. Implementation Ideas that make it through testing and development are ready to be implemented. Unless the idea is a radical change from your usual activities, you don't need me to tell you how to do this! Review Once ideas have been implemented, they need to be reviewed, probably against an ongoing series of milestones. If an implementation does not achieve a milestone, it needs to modified or killed. Moreover, even the most spectacularly effective and profitable breakthrough innovations need to be improved on a regular basis. New Needs and Inspiration Hence, reviewing the implementation of new ideas should indicate new needs which can be transformed into challenges which, in turn, start a new innovation process cycle. Likewise, implementations can inspire new corporate goals. Again, these can be turned into new challenges and new cycles.

Integrated Innovation Process Management An innovative company, however, should not have a single innovation process cycle in operation. Rather it should have many of them! Large cycles are suitable for enterprise-wide innovation. Meanwhile, business units can run somewhat smaller innovation process cycles in order to manage their own ideas (although it should be noted, collaborative groups need not be limited to employees of that business unit). Teams, departments and any other group can also run their own innovation process cycles.

However, these innovation process cycles should not be in isolation. Rather they should inspire and feed other cycles elsewhere in the organisation. For instance, the implementation of a new product idea should inspire innovation cycles in the marketing, sales and customer service divisions as well as at the enterprise level. Managers should watch their colleagues' innovation process cycles and ruthlessly copy ideas as inspirations for their own cycles. The Result: A Highly Innovative Organisation By applying innovation process management across your entire organisation, you can transform it into one which is innovation driven. And that is a sure way to keep well ahead of the competition, survive this financial crisis and make your firm a great place to work.

PROCESS CONSIDERATIONS Considerations Variety of established and developing products Varying complexity Various degrees of process understanding and control Biological and biotechnological products Individualized (customized) therapies Ability to measure meaningful quality attributes of Intermediate Intermediates, Drug Substance, Drug Product? To what degree should robustness be demonstrated? What is the ability to conduct/ extrapolate small scale studies? When is it appropriate to use Generic and Modular validation approaches? What impact does modern process control (e.g., PAT) have on validation? Considerations - What To Validate?

What do I Validate ? What do I Control ? What do I Monitor?

Considerations - What is Critical? Critical A process step, process condition, test requirement, or other relevant parameter or item that must be controlled within predetermined criteria to ensure that the API meets its specification specification. [ICH Q7A] Proposal for Critical & Noncritical Key and Non Non-key variables Important that the manufacturer and regulator knows; a) What variables were considered, what variable impacts the process, what variables affect the product (intermediate) quality, or do not (degree & linkage?) b) How variables are controlled, monitored, validated or not, including how suitable criteria/ limits were determined as applicable Considerations PAT PAT acceptance

Control System - Monitoring - Evaluating - Adjusting Continuous real time time monitoring of product quality attribute (perhaps a surrogate), or process operating parameter Evaluated against data that will allow one to produce an acceptable product or direct evaluation of acceptable product Adjusted (typically automated) to produce an acceptable product System must be performed in a timely manner (e.g., real real-time)

PROCESS LIMITATIONS Limits Process Innovation In Britain Since four in 10 of the British sample had no new or advanced production equipment, it is natural to ask what, if anything, had prevented them. Of course, it is also possible that firms with new or advanced equipment would have liked to invest more in this way: they too could have met constraints. So all firms were asked the question. It transpired that just half the firms felt that they had been prevented from making changes in production techniques which they would have liked to introduce. These firms were also asked to explain what was preventing investment. The great majority put forward lack of finance as the primary stumbling block to changes in production processes. To a much lesser extent, lack of demand (that is, presumably, lack of a market payback for capital investment) was also mentioned as a barrier. These replies stand in striking contrast to those concerning the reasons for lack of product innovation Lack of finance was only an obstacle to product innovation for a single firm in the sample, while market demand was the dominant consideration. This contrast between the obstacles to product and process innovation leads to important conclusions. The fact that the answers given to the two questions were so different must increase confidence in each set of answers being genuine. If it were simply a conventional response to put the blame for lack of progress onto lack of finance, then this would surely have happened both in the case of products and processes. So product innovation emerges as the low-cost (or easy-to-finance) alternative, by comparison with process innovation. And the idea that economically depressed regions can make themselves more competitive by investing in standard, off-the-shelf process technology becomes less plausible, because so far as small firms are concerned, such a policy is much more likely to run into a financing constraint than is the case with product innovation.

PROCESS MODEL Two Models of Idea Management Idea management software tools use one of two models for capturing and processing ideas: I. II. Suggestion schemes Ideas campaigns

Unfortunately, one of these models is almost inevitably doomed for failure within 12-18 months of inception. The other is more effective for a sustainable innovation programme. Suggestion Schemes Many organisations and even idea management vendors envision a software tool that allows anyone in the organisation to submit ideas into a central repository. Ideas in the repository are reviewed by an innovation team who decide which to forward for further development and which to reject. In short, they are imagining a modern suggestion box. But instead of a box with a slot, employees are provided with a software interface for submitting ideas. Although there are variations on how suggestion schemes process ideas, nearly all involve an individual or team who review submitted ideas and decide whether or not to develop them further. The software normally includes tools to automate the review process. The best suggestion schemes will be transparent, allowing idea submitters to review their own and other ideas as well as comment on ideas. However, many schemes are opaque. Ideas are submitted directly to the reviewers and no one can see what happens to them thereafter. At first glance, the suggestion scheme seems a simple yet effective approach to capturing ideas from the workforce. After all, employees have ideas all need is a tool to capture and evaluate those ideas.

REFERENCES:
1. htt http://en.wikipedia.org/wiki/Innovation

2. p://www.jpb.com/jenni/ipm.php