A Kaizen Transformation roadmap will help you balance two worlds- the 'right now' and the 'next future'.
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Born at Toyota, Lean is a lighter, leaner way to achieve results. A Lean process is ruthless about getting rid of errors, steps, processes and people that don’t add value to a company’s products or services.
Lean is all about focussing on customer needs, reducing defects, creating waste-free processes that result in maximum ROI and Customer value.
Although Lean defined Toyota Production System (TPS) in 1940s, with time, Lean has been extended to other manufacturing verticals such as- electronics, cement, construction, food & beverages, pharmaceuticals, personal products, engineering etc.
The best part about Lean is that, Lean brings in a 3:1 rate of returns for any organization regardless of industry sector, that implements Lean correctly.
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Which companies can use Lean?
LEAN can be implemented by Manufacturing as well as Service based companies.
LEAN is best for incremental improvements, organizations that focus on their people and culture, companies that want a less mathematical and more flexible approach than Six Sigma. But you can strive for a break-through Six Sigma improvement by eliminating waste Lean-style.
In the next part of this article series I shall discuss another time-tested business improvement methodology; TQM
Lean Innovation, Hoshin Kanrii and Six Sigma (as DFSS) for Product Design, Development and Manufacture via 3D Printing; a Case Study
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-
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 …
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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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Shruti is true Thought Leader with over 10 years of demonstrated accomplishments, industry awards, certifications, books, patents and several publications in peer reviewed journals.
Shruti is appreciated for her knowledge, integrity, innovation, and collaborative team approach with effective mentoring as her organizational leadership style.
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