A Kaizen Transformation roadmap will help you balance two worlds- the 'right now' and the 'next future'.
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Kaizen for Pharmaceutical, Medical Device and Biotech Industries by Dr. Shruti Bhat- book preview
A few years ago, I was approached by a CEO of a pharmaceutical contract research company to turnaround his sick unit into a profitable enterprise. This company was dealing with the development of solid oral dosage forms. To bring about the necessary change, we initiated several Kaizen campaigns companywide, with 360 degrees focus to overhaul all processes and operational systems. We addressed all key areas across the organization including accounts payable/ receivable, material procurement, order processing, suppliers, R&D, scale-up, production, logistics, product dossiers filings, project management, business development, sales & marketing and PR communication processes.
Another key area where Kaizen helped us in a big way was to integrate various client information data sets maintained within different databases on separate systems.
Before Kaizen, everything was disjointed, delayed and everyone was working in silos, leading to waste and lost revenues.
At the end of nine months, this company’s books started showing profits, and from there on, it kept going from ‘good to great’. It was an excellent example of a successful transformation.
Unfortunately, this contract research company is not alone in the challenges it has faced. Studies indicate that 88% of business owners in North America struggle to maintain consistent cash-flow. Key questions to consider are:
If you answered ‘yes’ to any of the above questions, then Kaizen should be your mantra…
Kaizen is an outstanding business tool that helps organizations to achieve new heights!
Kaizen procedures evolved in the automobile industry. Therefore, most of Kaizen literature, publications, books, cite Kaizen implementation in factories such as Toyota, Ford, Mazda and the like. But work practices within pharmaceutical (medical device and biotech) industry are different from the auto sector.
Regulations, customer demands, competitor landscape, product criteria, facility and environmental needs, employee skills within pharmaceutical (medical devices and biotech) companies are extremely stringent and totally different from the automobile industry. Therefore, ‘as is’ Kaizen practices from auto sector won’t work for pharmaceutical, medical device, and biotech organizations. Kaizen must be customized for these industries, to achieve its full benefits.
So far, there has been no book on Kaizen that is customized to pharmaceutical, medical device, and biotech industries. Having successfully driven more than 250 Kaizen, Lean Six Sigma, and other continuous improvement projects within pharmaceuticals, NHP, medical devices, biotech and healthcare sectors, worldwide for over a decade, I have created real success stories; I felt it will be beneficial to share those techniques and experiences.
This book is meant for small to medium-size pharmaceutical, medical device and biotech research, manufacturing and contract services companies. This book is to-
Kaizen requires very less investment, therefore can be implemented to its full potential even in startups.
Some salient features of this book
Kaizen has mainly been used in Japan and many other SE Asian companies and in Europe. Up until now, it has not gained enough significance in North America, because of which it has not been utilized to its full potential. The root cause is the difference in work culture and corporate governance styles of companies in eastern and western countries; this book totally eliminates this gap.
This book presents Kaizen methodology for direct implementation within a pharmaceutical, medical device, biotech company in east or west. Moreover, this book helps you to customize Kaizen to your company; this book is not a ‘vanilla generic’.
In addition, this book is an excellent resource for Kaizen beginners with a lot of real-life industry examples, case studies and provides several ‘do-it-yourself’ exercises, which is of tremendous value, in absence of a Kaizen coach.
Pharmaceutical industry growth unlike few other industries viz. retail, banking etc. is not completely determined by ‘value’ it brings to its customer. Frustrated customers can easily walk out of a shop and get their product from some other place. In contrast, pharmaceutical products are unique in the sense, the customer (i.e. patient) doesn’t usually have much say in its purchase. Patients usually buy medicines their doctors prescribe or pharmacist dispense (until such time they don’t experience any adverse effects). For the medicines where adverse effects are well-known or documented on the product label, patients really have no choice but to take bitter medicine (pun intended).
Also, a patient on a prescription drug may not always have the option to change medication or brand, because of lack of competing brands due to enforced Exclusivity and Patents laws. Even with the advent of generic medicines which offer price benefits, many patients don’t prefer to change the pill they have been taking over the years.
Moreover, Kano’s model may not strictly apply to Life science industries, because unlike other products, a drug product if not proved safe, efficacious and stable, will just not make it to the market. And this applies to all medicinal products- be it Rx (prescription), OTC (over the counter), medical devices etc.
Pharmaceutical, medical device, and biotech companies are always under federal drug authorities radar for compliance to standards. The very existence of pharma business is based on meeting compliance- be it cGMP, safety, therapeutic efficacy, quality etc.
As federal drug regulations change, companies must upgrade to stay in business. Hence, there is an indirect continuous improvement happening all the time. This is probably one of the reasons why the majority of life science companies have not really attempted formal business process improvement methodologies.
However, Kaizen is not simply a business process improvement technique. Kaizen doesn’t just focus on cost-cutting or quality improvement. Kaizen is a way of life; of becoming ‘better’ every day; of becoming better than the best- consistently, and taking your business from being good to great with its products, market share, governance, and most importantly, Good to Great with PROFITS!
Let’s begin with what is Kaizen?
The name ‘Kaizen’ is an adaptation of the Japanese term that stands for continuous improvement. In Kaizen technique, it is believed that employees need to be empowered to enhance various processes of the company. Kaizen utilizes some of the Lean methodology philosophies to plan, implement and evaluate changes in a variety of roles. Kaizen must be integrated into a company’s daily operations to achieve maximum benefits.
Kaizen hails from the words, "Renew the heart and make it good." Therefore, an adaptation of Kaizen concept requires changes in the "heart of the business", corporate culture and structure; since Kaizen enables companies to translate the corporate vision in every aspect of its operational practice.
Adding to the uniqueness of pharmaceuticals and device industry is that, drug-discovery costs and associated risks keep rising, yet companies have to keep product prices affordable. It is like walking down the stairs of an escalator going up!
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