Shruti Bhat PhD, MBA, Lean Six Sigma Black Belt
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Lean Innovation, Hoshin Kanrii and Six Sigma (as DFSS) for Product Design, Development and Manufacture via 3D Printing; a Case Study

2/5/2020

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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

Recommended reading:​

  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 !​
​Follow Shruti on Twitter, Facebook, YouTube, LinkedIn


​#ContinuousImprovement   #Innovation  #Lean  #HoshinKanri  #DFSS  #DesignForSixSigma
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Business Turnaround and Innovation Management in a Global Contract Research Organization- A Case Study

10/30/2019

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Business turnaround and innovation management in a global contract research organization_ a case study
​Innovation Management and Business Turnaround Case Study.

Problem:  A Global Contract Research Organization (CRO) was sick and on the verge of being sold out. The management wanted to give a final shot for its revival prior to potential sell off.

All projects were running late. Not a single project milestone was achieved hence, clients had stopped payment. Company’s cash-flow had come to standstill. Many employees were laid off. As the company had no funds to pay vendors, they had stopped supplying raw materials, hence work stopped too. It was turning into a vicious catch 22 situation. No funds- so no project work was happening and clients paid no funds- because no project milestone was delivered.

Due Diligence: Financial and Technical Audits, RCA, Pareto and Ishikawa studies were conducted to evaluate CRO’s financial health, site, systems, products, problems, processes, human capital, customer complaints etc. The objective was to review the CRO and bring back its glory.

Solution: Business process redesign/ re-engineering was undertaken alongside strategic portfolio management. Hoshin, QbD and DOE were installed for strategic innovation management. Lean and Just-in-time methodologies were installed to help cash-flow and prompt project deliveries. 8D and Kaizen models were executed to turnaround the business.

Result Dashboard:
  • The CRO was reviewed in just 9 months! Balance sheet showed first signs of positive growth within 5 months of ‘process change’ implementation.
  • An effective customer relationship management process was introduced which provided repeat business from existing clients.
  • New clients were added. New contract research projects of over $ 35 million was received.  
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

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn


​#ContinuousImprovement #Innovation #BusinessTurnaround #Kaizen #JustinTime #HoshinKanrii #QbD #DOE  #Lean
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Innovation Management, Just-in-time and Kaizen Case Study in a Multi-National Pharmaceutical Company Working on ANDA Para III and IV Drug Products

10/16/2019

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Innovation management _ just_in_time and Kaizen case study in a multinational pharmaceutical company working on ANDA para III and IV drug products
​Innovation Management, Just-in-time and Kaizen Case Study

Problem:  An multi-national pharmaceutical company had an ambitious goal of new product introductions into several developed markets including US (20 products ANDA para III and IV), Brazil (36 products) , Canada (5 products) and Australia (3 products) to be accomplished over a period of 2 years. All the products were new to the company and they wanted to be 2nd or 3rd player in the market.

All the products had to be developed first, followed by regulatory submissions for getting  marketing approvals in US, Canada, Brazil and Australia. The company also wanted to know the LCM for each of the products in order to create appropriate yearly budgets.

Solution:  The Innovation portfolio was strategically designed. Potential value stream maps were designed for each new product and all concerned standard operating processes were put in place. Product development, regulatory, IP, manufacturing, testing, pricing and logistic strategies were developed along with their respective plan for implementation. LCM protocols were submitted to the company’s management board.

Design Thinking, QbD and DOE were employed to succeed with the innovation portfolio. Kaizen and Just-in-time methodologies were applied to bring about a culture of innovation within the organization.

Result Dashboard:  
  • Product approvals for all products was received in time as per schedule.
  • Profit margins further improved as Lean methodology was employed to operations which saved overheads by 18- 20%.
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

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn


​#ContinuousImprovement   #Innovation  #QbD  #DesignThinking  #DOE  #Kaizen #JustinTime #LifeCycleManagement
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How to identify 505 (b)(2) drug product development opportunities- An Innovation Management Case Study

9/18/2019

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how to identify 505_b2 drug product development opportunities _ an innovation management case study
​Innovation Management Case Study:

Problem:   A Global Pharmaceutical Contract Research Organization (CRO) wanted to start a new division that could develop products via the 505 (b)(2) pathway. They had three main requirements- Create appropriate team, Identify 505 (b) (2) product development opportunities and develop the identified products within best possible time line.

Due Diligence:  A due diligence of CRO’s capabilities such as human capital, machinery, facility engineering, marketing plans, logistics, budget etc. was done. It was decided that existing scientific talent (rather than new recruits) shall be trained for this venture. A team Director shall be recruited who could provide leadership to the innovation program.

Solution: Innovation strategy was designed for team building and training of existing employees to prepare them for this new initiative, allocate space for conducting research work, set up budget etc . Appropriate product Life Cycle Management (LCM) opportunities were identified via Brainstorming, mind-mapping and Pareto tools.

Results Dashboard:
  • LCM opportunities were identified for 10 products which would be developed using the 505 (b) (2) pathway.
  • The management decided to select 3 out of the total 10 opportunities, to initiate the program. Balance 7 opportunities would be worked upon in a tiered fashion once funds accrue.
  • The team building campaign was a super success. Output from this campaign fetched the CRO immense intellectual property which they would capitalize in due course.
Following three patent inventions involve 505 (b) (2) pathway product development-
  1. Modified release mucoadhesive formulation of Clopidogrel bisulphate (Appl 2162/ MUM/2012)
  2. Novel pharmaceutical composition of Argatroban (Appl 2713/ MUM/ 2011).
  3. Novel formulations of Tetrabenazine (Appl 2716/ MUM/ 2011).
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
​

​​Follow Shruti on Twitter, Facebook, YouTube, LinkedIn


​#ContinuousImprovement   #Innovation 
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Developing ANDA Para II and III Drug Products via QbD (Quality by Design) : Innovation Management Case Study

8/7/2019

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developing ANDA para II and III drug products via Quality_by_design an innovation management case study
​QbD, Innovation Management and Training Case Study

Problem: A multi-national bio-pharma company wanted to develop Three new products via QbD methodology for US (ANDA para II and III) and Canada markets. Their employees weren’t trained in QbD methodology, hence needed both direction for product development as well as training in QbD.

Due Diligence:  A due diligence of product development work conducted so far, machinery,  manufacturing site, testing equipment etc. was conducted. A report comprising the QbD design thru implementation strategies and training programs was presented to the company’s management.

Solution: Appropriate training on QbD was given to the organization’s scientific team in R&D and operations. Training was provided as classroom coaching as well as online courses.

In addition to QbD implementation at design and development phase, a Risk Assessment protocol was developed for procurement of drugs and critical excipients, such that, the company can have the flexibility to choose vendors as needed.

Results Dashboard:
  • All 3 product were developed with QbD compliance and launched on time.
  • Additionally, QbD implementation reduced 10% cost on product analysis in its very first year of implementation.
​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

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn

​#ContinuousImprovement   #Innovation  #QbD
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Popular Workshops & Webinars on 'Continuous Improvement' for Research and Product Development

2/9/2019

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Shorten Product Development Times, Error-Proof Products & Services, Build Quality-by-Design and Increase R&D Productivity with Lean, Kaizen, Six Sigma and Other Continuous Improvement Methodologies

Some of the Popular Continuous Improvement Workshops & Webinars Conducted by Dr. Shruti Bhat to Increase R&D Efficiency -

Lean Innovation workshop by Dr Shruti Bhat
Mistake-proofing with FMEA and Poka Yoke, workshop by Dr Shruti Bhat
building capability and culture for innovation in your organization workshop by dr shruti bhat
design thinking masterclass by Dr Shruti Bhat
product development via quality by design workshop by Dr Shruti Bhat,
DFSS and Hoshin Kanrii for innovation and product development workshop by Dr Shruti Bhat
kaizen masterclass for manufacturing and service industries by shruti bhat
Continuous improvement tools for manufacturing and service industries workshop by Dr Shruti Bhat

    For brochures and other details Contact Us

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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.


​Follow Shruti on Twitter, Facebook, YouTube, LinkedIn
#ContinuousImprovement #QualityImprovement  #Innoworks  #Innovation   #eLearning  #LeanInnovation    #LeanManagement  #KaizenLeaderMasterclass ​
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Kaizen Orientation Training

11/18/2018

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Glad to be invited as Course Director and Instructor for Kaizen Courses at Kaizen Leader Academy, Canada
Here are details of fourth course of the series...​​
Kaizen orientation online workshop by Dr Shruti Bhat
​Kaizen Orientation Training Online Workshop is for Professionals at all levels of Management.
 
  • Get answers to everything you wanted to know about Kaizen continuous improvement.
  • Learn in-depth about 9 types of Kaizen viz. Gemba Kaizen, Lean Kaizen, Modular Kaizen, Blitz Kaizen, Flow Kaizen, Process Kaizen, Personal Kaizen, Daily Kaizen, Agile Kaizen and how each Kaizen type can help you achieve success with your Kaizen initiatives.

The workshop has 2 Modules of self-paced study, training videos and instructor support. The workshop also includes 3 Case Studies of successful Kaizen implementation.

Participants must complete Tests (open-book exam) associated with each study module; successful participants get a Certificate of Completion- Kaizen Orientation online workshop.

After successful completion of the workshop, participants gain the knowledge to apply Kaizen in their organization.

#Kaizen

    Contact Registration Office for Brochure

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    Shruti Bhat
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    Certified Lean Six Sigma Black Belt

    ​Shruti is a ​Global Leader in Lean Innovation, Lean Manufacturing, Business Transformation and Continuous Improvement; Best-Selling Author and Speaker.

    Shruti is a Go-To Scientific Expert and Management Leader within Pharmaceutical, Health Care, Device Technology, Bio- Technology, Life Sciences, Retail industry  and affiliated verticals.

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