​First-mover advantage is the ultimate aim behind any new product development. Unlike popular belief, new product development is not the sole responsibility of R&D division. Other functions also play a major role in development and introduction of new products to market. In fact, new product development is an end-to-end process, involving several departments across the organization.

​And, this process must be super efficient in order to ensure high returns on investment (ROI) from new product development.

So, what are the factors that make a positive impact in bringing new products fast to market? Checkout this video to know more about- 9 Key areas for businesses to bring new products fast to market.

This video belongs to my YouTube video series- One-minute guide to continuous improvement where I explain various topics related to continuous improvement for operational excellence and business growth. 

​Watch on ...

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1. One minute continuous improvement guide series.
2. Kaizen explained with examples and case studies.

Keywords and Tags-

​#newproductdevelopmentprocessimprovement #continuousimprovement #kaizen #agile #firstmoveradvanatge  #innovationmanagementprocessimprovement  #agileproductdevelopment  #businessprocessimprovement

​Idea Management is an important and integral part of Innovation Management. There are two schools of thought about idea generation and its management. First, out-of-the box thinking and second, inside-the-box thinking.  

Out-of-the-box thinking as the name suggests is seamless creativity. While inside-the-box thinking means there is a boundary within which ideas are generated and managed. Wider the boundary, deeper gets the creativity.

And if more ideas have to grow from being on paper to becoming a commercialized product, inside-the-box thinking is the way to go.

​Because, for a business there is a budget to follow, expenses to limit, ROI to gain and investors to take care of. Every penny spent on innovation is accounted for i.e. where profits aren’t earned, the R&D expenditure gets written-off. And the objective is always to get the most out of the buck.

Inside-the-box thinking essentially means, innovation is done with a target product profile in mind. The aim is to generate large number of ideas to maximize number of potential ideas-to-product pathways. The picture above depicts innovation management via inside-the-box idea generation.
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Once an idea qualifies for becoming a new product candidate, it must successfully pass through the various stages of product development thru obtaining market approval and subsequent launch, to find its crown in the marketplace.

As you will note from the above picture, not all ideas gain ‘new product candidate’ status. So, what happens to the ideas, that do not get selected. Do they get dumped permanently? The answer is No.
​
Let's analyze the ideas further- Usually, ideas get rejected because of three main reasons-

a. Technically idea commercialization is not possible.
b. Profit wise the ideas are not feasible.
c. The company is not keen to go for such a new product at this point of time.
​
​Hence, let's first segregate the rejected ideas into three buckets as per the above classification and then review them one-by-one.

​Ideas that are not technically feasible now can become great candidates later.

​A classic example of this is Sildenafil citrate tablet. This drug candidate was first evaluated as a treatment for chest-pain. Later, the company found an alternate use of the drug candidate and channeled this molecule thru the development pipeline to launch as Viagra- rest is history!

​The second lot comprises of those ideas that seem not feasible in terms of profitability. Meaning technically, they may be good, but cannot be commercialized because of high cost.

​One of the classic example for this is- the Microwave oven.

Microwave oven was first invented in the 1940s, around world war II era. The first commercialized microwave oven was huge, weighing 750 pounds and costed $2000 USD. Obviously, it did not sell well.

The company worked on the technical aspects and the first domestic microwave was introduced in 1955. And that did not sell too. After many design changes, microwave oven gained access to our homes in 1967 and by 1975, they were in full demand.

A point to note here is that microwave oven invention was both accidental and EVOP (Evolutionary Operation) product development. Also, note the development timeline, from 1940 to 1955 to 1967 to 1975. i.e. 27 to 35 years from being an 'idea' to 'profitable' commercialization!

It is well-known that EVOP drains money. To avoid such bleed, concept of Innovation Management took shape. I shall be writing more about innovation management in a separate blogpost. For now let us visit the third lot of rejected ideas.

Now, let us consider the third lot of ideas- those ideas which the company is not keen to go for at this point of time.

​Such ideas must be worked upon in the lab to develop a small prototype. While prototyping, ensure that you build-in anti-counterfeit measures in your product. Then file a provisional patent application to stake claim to your idea and simultaneously block competition.
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After filing a provisional patent application, you have 12 months to file final PCT patent specification. Additionally, you get thirty months (from date of priority filing) to enter national phase i.e. do national phase patent applications in the PCT countries of your choice.

Hence, the company gets close to 30 months to scout for buyers who would be interested to license your product. Since a prototype as well as the patent is available (for the invention), you stand to gain better licensing fees at the negotiation table.

Also, resources need not be pumped-in immediately, as product development, process validation, scale-up and other related activities can take place over 12 to 30 months timeframe. This has dual advantages- first, R&D budget can be better managed, and second, R&D infrastructure can be better utilized.

Moreover, provisional and/or final PCT patents being intellectual property can be mortgaged on a short-term basis to banks or other financial institutions, to secure funds which in turn may be pumped-in to conduct research work or use it for other areas of the business.
​
The philosophy of Innovation Management is to ensure, every penny spent on R&D must bring-in good return on investment (ROI) both in terms of profits and company reputation.

There are multiple pathways for conducting idea and innovation management successfully. The content presented above is one such pathway.

Also, the choice of idea and innovation management pathways depend on various factors such as- industry vertical, product mix, operating markets, corporate goals and more. Therefore, selecting the best pathway which will yield faster ROI with a first-mover advantage is crucial. 

Your choice of idea and innovation management pathway and its flawless execution will determine your business's very existence, growth and resilience.

An important question to introspect is- Are you building an idea and innovation management strategy which is the best for your organization?

​To know more about how idea-innovation management can help your company expand its product offerings, increase profit and earnings per share for investors, reach out to Shruti.

Keywords and Tags:
​#innovationmanagement #patent #ideamanagement #stopcounterfeits  #blockcompetition

In the first part of this article, I touched upon what is Agile methodology, which industry sectors use it and some dos and don’ts for Agile.

​In this part I shall discuss top 10 frequently asked questions around Agile. By the way, these questions have been taken from my blog reader’s feedback which I regularly receive as direct messages or queries. If you too have questions, please hit the ‘Get-in-touch’ button at the bottom of this blogpost and send me your thoughts …
 
So, let’s begin with top 10 frequently asked questions on Agile business improvement methodology.

​Agile business process improvement methodology is a proven concept to transform or turnaround businesses. Its ability to unlock value has been pressure-tested in different industry sectors belonging to manufacturing as well as service-based setups. Agile is extensively beneficial to startups. A startup could be a new company or a new function or department within an existing company.

​Agile concept emphasizes team collaboration and flexible reassessment of plans based on customer feedback. Agile can be applied to all departments. Agile was first used in the software development and is popular within the IT sector. But since Agile offers fast return on investment, it is gaining popularity in other sectors as well.

​The correct answer to that question is- May be. Because, although Agile can be applied in any industry, it must not be applied blindly. Agile must be applied only after a due diligence around how it would be applied, what benefits it shall bring-in for the organization etc is done. Further, there are several Agile methodologies. One must take cognizance of this and choose the Agile methodology most suitable for your workplace.

​There are several differences. But the most striking difference is that Agile cannot/ must not be applied in the same way across the entire organization. Different sections of an organization benefit from Agile in varying ways. The benefits can be optimized or increased based on the results of blueprinting i.e. identifying the value streams and investigating how each section of the value stream can benefit from Agile, provides valuable input in Agile- based business transformation.

​Agile is not same as Scrum. Agile is a wide concept, Scrum is a type of Agile method.  Scrum is one of the many dynamic Agile methods and emphasizes team collaboration and flexible reassessment of plans for bringing about business transformation.

​Scaling-up Agile has similar challenges as scaling-up any other process improvement methodology. Simply having more teams or conducting more dry runs are not enough. Further, expenses towards Agile scale-up must be factored in the budget before embarking on Agile. My best recommendation is to never begin any process improvement campaign without first doing a cost-benefit analysis.

​There are several differences, but I shall highlight only two main differences here. Since Agile was initiated in software business, let me explain this question using software development as an example.
 
The first main difference is that- When Agile is used in product development, in this example a software, features of the software are delivered frequently, and the testing is done in parallel to development. As a result, testing time is shortened because only small features are need be tested at a time. On the contrary, in the Waterfall methodology, testing take place at the end of the development. As a result, testing time gets lengthy as the entire product must be tested.
 
The second difference is that- Waterfall methodology is a closed process where all stakeholders are not involved in the development activity. In Agile methodology, active participation of all stakeholders as well as customers is a must.
 
Although Agile is traditionally being used in software development, it can be applied for any product development be it- toys, food, chemicals, devices, cosmetics, apparel, electronics, services etc.
 
Agile is especially beneficial for product development where frequent changes in the product come up on a regular basis.

​Speed and flexibility are two key advantages of Agile methodology. This aspect improves employee engagement, collaboration between teams internal and external to the organization which then boosts output. Agile implementations increase productivity as well as ‘value creation’. In fact, Agile’s strength is in 'value creation' rather than fixing crawling productivity. Therefore, if you are looking to create value, go for Agile. If addressing productivity issues is the sole aim, then go for Lean or Kaizen.

There are multiple advantages of utilizing Agile in organizations. Versatility and speed are two of its key benefits. Further, when applied to R&D business processes, Agile accelerates product development; companies can then achieve first-mover advantage. Also, Agile maximizes value throughout the development process and significantly reduces the overall risk of a project. 

Agile must be applied after due diligence.
 
First important limitation of Agile implementation is that- Agile is rapid at small scale; but scaling up takes time. A company-wide full-scale Agile implementation takes 1 to 3 years depending upon the nature and size of business. Therefore, Agile is not for weak-hearted setups.
 
Secondly, Agile is unpredictable with regards to effort planning.  Hence, Agile project planning must be done with caution.
 
Thirdly, Agile is all about being fast- to- market with a product designed as per customer demand. Hence, the mechanism of collecting voice of customer and its interpretation must be flawless. However, combining Hoshin Kanrii with Agile helps to circumvent this issue in a big way.
 
Lastly, Agile methodology has minimal documentation. No elaborate reports etc. Usually, simple burn up and burn down charts are used for documentation purposes. Burn up and burn down charts are visual diagrams which measure a project and show its progress, schedule, status and any outstanding work. If creating and distributing bulky reports is part of an organization’s work culture, then it needs to adapt to a major change if hoping to work with Agile. This must be factored-in while designing change strategy before proceeding with Agile.

In the next part of this article, I shall discuss on how to use Agile to improve business resilience.

Keywords and Tags:

​​#Agile  #AgileProductDevelopment  #BusinessTransformation #AgileFAQ #Scrum #ProjectManagement #WaterfallProjectManagement #AgileProjectManagement #ResearchandDevelopment  #AgileForProcessImprovement  #StrategyBuilding  #ImplementingAgileFramework  #ChangeManagement

Concept wise Quality-by-Design or QbD is not new. The word quality-by-design was introduced by Juran in his work on quality management. And since then organizations have used QbD to introduce quality aspect into products and services.
​
However, in my view QbD is a holistic concept for business improvement and has not been fully explored to its full potential. It can do much more than just build-in quality. In the video below, I have touched upon how QbD can improve business resilience. Watch on…

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• How to cut costs strategically using Kaizen
• Quality-by-Design (QbD) approach means Design for Manufacturing (DFM)
  
• Business Turnaround and Continuous Improvement Tips & Tricks Part 5 of 6: TQM in a Nutshell
  

Keywords and Tags:

#Qualitybydesign #Businessresilience #Juran #QualityManagement #AgileKaizen #DesignThinking #DesignSpace #ProductDevelopment #QbD #BusinessTransformation

​Practising 'Daily Kaizen' has brought about swift turnaround of the sick contract research organization (CRO). Learn how Japanese Kaizen principle was used to speed-up Generic Pharmaceutical Product Development in a contract research company in Asia.

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Keywords and Tags:
​
#Manufacturing #Lean #ContinuousImprovement #Kaizen  #QualityImprovement  #ManufacturingManagement  #LeanInnovation  #Pharmaceutical  #LifeSciences  #Drugs #KaizenLeaderMasterclass  #Kanban  #ProductDevelopment #BusinessTurnaround  #BusinessTransformationofaCRO

Lean Innovation, Hoshin Kanrii and Six Sigma (DFSS- design for six sigma) for product design, development and manufacture via 3D Printing (i.e. Additive Manufacturing) Case Study by Dr. Shruti Bhat, gives benefits of applying Hoshin Kanrii, DFSS and Lean Innovation techniques to a drug product design, development and manufacture via 3D Printing.

The study findings however can be extended to product development across other industry verticals.

Some of the benefits of applying continuous improvement methodologies such as Lean, Hoshin Kanrii and Six Sigma to research and product development include-
​

1. Application of Hoshin Kanrii and DFSS along with Quality-by-Design (QbD) to product development usually brings novelty in product features, process characteristics and/or product utility, thus favors patenting and generation of additional revenues.
2. While, Lean Innovation creates products with effective and efficient production and packaging processes, with no scope for ‘rework’ thus, better Operations Management.

​The study uses Isosorbide dinitrate (ISDN) as model drug, although other drugs can also be used in this therapeutic platform.

2x3 Factorial Design of Experimentation (DOE) was used to design drug beads. The results were evaluated for regression analysis, Main and interaction effects of parameters, Contrast Column Dispersion effects, Normal Probability Plots, Pareto and Process Capability Analysis.

The drug beads were further used as ‘starter’ seeds to develop MUPS (multi-unit particulate system) anti-angina ‘rate-programmed’ drug product.

The pharmacokinetic- pharmacodynamic (PK-PD) modeling was done using Doebrinska- Welling equation. MUPS were developed using 3D Printing technology via a 12- Run Plackett Burman DOE.

All hardware, software applications involved in the study were pre-validated. All qualifications i.e. Design Qualification (DQ), Installation Qualification (IQ),  Operational Qualification (OQ), Performance Qualification (PQ) for each experimental run was done as per USFDA guidelines. Data was analysed statistically using Paired ‘t’ test. Reliability Testing was conducted as per ICH current Good Clinical Practices (cGCP) guidelines.

Product prototype and Reference listed drug (RLD) were compared for bioequivalence compliance. The prototype is ready for commercialization.

This study also gives benefits of using 3D Printing technique for pharmaceuticals and how the technique can be applied to product development across other industry verticals!
​
For details on how to apply Lean Innovation, Hoshin Kanrii and DFSS to product design, development and manufacture, watch the video …

To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp

1. Workshops & Online Courses for Pharmaceutical Research and Drug Product Development by Dr. Shruti Bhat
2. Kaizen for Cost-Savings and Organizational Excellence
3. Mistake-Proofing Pharmaceutical Products: What can we learn from Valsartan, Losartan and Irbesartan recalls?
4. How to develop a culture of ‘Continuous Improvement’ in an organization?
5. ​Innovation is not an initiative. It’s a business process !​

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​​Keywords and Tags:
#ContinuousImprovement   #Innovation  #Lean  #HoshinKanri  #DFSS  #DesignForSixSigma

About Shruti Bhat PhD, MBA, Certified Lean Six Sigma Black Belt
 
Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.


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Keywords and Tags:
​#ContinuousImprovement #QualityImprovement  #Innoworks  #Innovation   #eLearning  #LeanInnovation    #LeanManagement  #KaizenLeaderMasterclass ​