Six Sigma Case Study in a Biotech company
Problem: A Canadian Biotech company had too many samples for testing in their research lab. How to cut down this analysis load?
Due Diligence: The entire product development process was mapped end-to-end. Possible causes for the problem were identified using RCA. It was found that, there were way too many experiments conducted during product development. For e.g. 85 experiments were conducted to arrive at a base level prototype having minimal features.
Solution: Six Sigma methodology was employed. More of experiment planning was needed during product development. Regardless of type of product or product complexities, the aim was to keep experiments to minimal. Design Thinking and DOE were employed. The development protocol was modified such that final prototype is developed with meager 20 experiments at the maximum. Alongside cutting down analysis load, the process improvement campaign cut down product development time, built-in product quality, and enhanced production output.
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…
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 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.
Get ahead with product innovations, improved laboratory productivity, first to file, increased intellectual property, efficient manufacturing, effective marketing and logistics with KAIZEN.
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-
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!
About the author Shruti Bhat PhD, MBA, CLSSBB
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- Evaluation of pellets prepared using factorial experimental designs.
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- Mistake-Proofing Pharmaceutical Products: What can we learn from Valsartan, Losartan and Irbesartan recalls?
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Business Process Improvement and Training Case Study in a Biotech company
Problem: Acquisition of a company and improving business processes post asset mergers. A Canadian Biotech company was in talks to acquire a sick company and wanted to evaluate merit of such an acquisition. In case the acquisition went through, then re-organization of the product portfolio would also be necessary.
Due Diligence: Due diligence of the sick company’s records, sites, R&D pipeline , patents, regulatory status, machinery, product portfolio, product stability trends etc. were conducted. Audit report, recommendations and execution strategies were forwarded to the sponsor company. Employees from parent and acquired organizations needed training to make working flow smooth and productive.
Solution: A core team was built, to carry out the steps proposed in my report.
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#ContinuousImprovement #BusinessProcessImprovement #ProcessImprovement #MergersandAcquisitions #BusinessTransformation
A Kaizen Transformation roadmap will help you balance two worlds- the 'right now' and the 'next future'.
Top Experts in Kaizen Strategy Design & Training
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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-
- 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.
- 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.
- 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.
- 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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Certified Lean Six Sigma Black Belt
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.
Shruti is a true
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