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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.​

​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:

• Can your organization benefit from increased workplace productivity?
• Does your team face challenges with reduced R&D budget?
• Does your organization face challenges because of inconsistent or poor cash-flow?
• Do you need to cut corners as you are forced to do more with less?

 
If you answered ‘yes’ to any of the above questions, then Kaizen should be your mantra…​

​This book is a structured approach to designing Kaizen strategies, practices and implementation for pharmaceutical, medical device, and biotech companies.
 
It is an invaluable resource, an essential tool for all professionals within the pharmaceutical, medical device, biotech organizations i.e. all life sciences and health care companies, interested in employing Kaizen in their workplaces and their personal lives. This book will also facilitate running Kaizen in a manufacturing company and do it at a world-class level.

​This book doesn’t simply explain Kaizen process features, implementation, and application. The scope of this book is much wide.  

This book is meant for small to medium-size pharmaceutical, medical device and biotech research, manufacturing and contract services companies. This book is to-

• Demystify Kaizen and help business leaders in pharmaceutical, medical device, biotech, and all life sciences organizations, irrespective of their size or workplace culture.
• Apply Kaizen to what really matters, that is, ‘to achieve business expansion along with increased productivity and profits’.  
• Provide practical and useful examples of Kaizen principles that can be executed at various levels: across the organization; within a specific department, business unit or team, as well as for yourself as an individual to further your personal career.
• Improve revenues and create a lasting change using Kaizen principles and techniques.​

Some salient features of this book

• It shows pharmaceutical & biotech scientists, design engineers, operators and everyone involved in product development, how to utilize Kaizen- to create innovations, shorten product development times, improve first-to-file rates, conduct successful scale-up and technology transfer to manufacturing sites.

 

• It shows everyone associated with manufacturing, how to use Kaizen to decrease cycle times, work-in-process & quarantine inventories, the cost of distribution & logistics, improve equipment efficiency, facility capacity utilization and shift output.

 

• It shows everyone in Human Resources how to use Kaizen to minimize employee turnover, hire and retain talent, and motivate employees to create a difference.

  

• It shows the company’s senior management, stakeholders, finance and other supporting business units, how to use Kaizen to increase ROI (return on investment) while complying with cGMP (current Good Manufacturing Practices) and other regulations, address rising competition and counteract fluctuating market economy.

 

• This book presents useful ideas that one can implement immediately, often at no additional cost.

 

• It shows how to transform a business from ‘good- to- great’. True benefits of Kaizen implementation are realized because, it adds value to your products, increases market share, and drives both top line and bottom line of your business.

 
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.​

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.


Chapter 1:
 
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.​​

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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​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

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#ContinuousImprovement #BusinessProcessImprovement #ProcessImprovement #MergersandAcquisitions  #BusinessTransformation

Today I read a report in Stat News about the first ‘digital pill’ that has been rolled out at a Cancer Treatment center in Minnesota US. The report mentions how chemotherapy pills taken by cancer patients are packaged with a sensor that can alert a physician, pharmacist, or caregiver after the pill has been swallowed.

The report highlights that seven patients — all of whom have colorectal cancer in stage 3 or stage 4 and are being treated in Minnesota — have been provided with this treatment. The idea is that, by tracking when patients take their drugs, health care providers will be better able to ensure medication adherence and to provide treatment guidance, with the goal of improving health outcomes.

How does digital pill work?:

After patients swallow a chemo capsule, the sensor gets activated once capsule gets damp in the stomach fluids. The sensor then pings a signal to a patch worn by patients on their torso; which transmits data on the time of day, the size of the dose, and the type of medication taken to an online portal that the patient can view. If patients choose to allow it, their support team can access this database portal too.

This program in Minnesota appears to be the first one in which a digital pill has been used in oncology. So far, neither patients nor insurers pay anything beyond the typical cost of the medication for this high-tech upgrade.

This news sparked my interest for several reasons-

1. As there is high proliferation of cancer disease world-wide, such digitization of cancer therapy will hopefully bring benefits to a wider population of cancer patients.
2. Despite advances in Oncology, not everything about cancer is understood by researchers, doctors, patients and care givers. The resulting effect is that there is no cure for cancer, especially once cancer has metastasized or is beyond stage 2. Another peculiarity of cancer is that no two types of cancer are same, hence medications and their dosages administered to cancer patients are different. For example, dosage of Tarceva tablets prescribed for a lung cancer patient is different from what is prescribed for a patient with pancreatic cancer. However, the digitization platform done for chemotherapy of colo-rectal cancer can be researched further to extend to other cancer types, which can yield better patient compliance, superior therapeutic modeling and better treatment outcomes to a wider patient population.
3. Additionally, this concept of  'digital pill' can be extended to other disease types too, where patient compliance has always been a problem; for example Tuberculosis, Schizophrenia, hypertension etc. Drug-resistant tuberculosis is worse to treat than regular TB. Hence, a digital TB pill will be  a boon for patients and doctors alike. Similarly, patients forgetting to take their blood pressure pill is usual, especially among older folks. Such non-compliance issues can hopefully be nipped in the bud with digital pharmaceuticals for hypertension.  
4. Such digital pills can substitute the health system services which invest in phone calls and other reminders to patients to help them stay on track with their medications.

'Digital' pill is not only an impressive step in Continuous Improvement for Cancer Therapy, it is a significant step in Continuous Improvement for Health System services too! and, hopefully pave way for Continual Improvement in TB care, hypertension management and patient-centric drug product design.

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