About the Authors

Robert G. Launsby, M.S. Engineering, President of Launsby Consulting. With over 20 years experience in the high-tech industry, Bob has held positions as Principle Engineer, Program Manager, and Consulting Engineer. He is co-author of the texts Understanding Industrial Designed Experiments, Straight Talk on Designing Experiments, Design for Six Sigma, and Engineering Today's Designed Experiments. Bob has led over 1,000 applications and trained more than 6,000 people in industrial experimentation, Design Control, Process Validation, and Design for Six Sigma.

Suhas Kulkarni is President of FIMMTECH, a consulting firm that specializes in services related to injection molding. He earned his Masters in Plastic Engineering from the University of Massachusetts, Lowell and a Bachelors in Polymer Engineering from the University of Poona, India. He has 18 years of experience as a process engineer. His main area of expertise is Scientific Processing for Injection Molding. Based on his experience, he has developed a custom software, called Nautilus, that aids the complete process development routine to production release. He also teaches a plastics and molding course at the University of California, San Diego and is a contract faculty at the University of Massachusetts at Lowell.

Jayme P. Lahey has a B.S. in Medical Technology, and serves as Technical Director for Launsby Consulting. She has over 20 years experience in the high-tech industry and has held positions as Principle Manufacturing Engineer, Quality Engineer and Qualification Engineer. She is co-author of the books Experimental Design for Injection Molding, Process Validation for Business Success and Engineering Today's Designed Experiments. Jayme has consulted domestically and internationally in the areas of statistical process control, design of experiments and process optimization.

Thomas Oesterle currently works as a Principle New Product Development Engineer for a major medical device manufacturer in the Chicago area. Thomas has outstanding skill and experise in part and complex system design. Previously, Thomas was Director of Engineering at CEA Technologies in Colorado. CEA specializes in system and part design/manufacturing for the medical device industry. Thomas is a graduate of Fachhochschule Rosenheim - Hochschule fur Technik und Wirtschaft.

Introduction

The Medical Device Industry should be very proud of their many wonderful accomplishments...but there is so much more to be done! Medical Device manufacturers have developed some amazing products that are truly making the quality of life fundamentally better for a huge number of people, but there are some tremendous challenges to be better and to do more.  In the developed world, we have access to some phenomenal device and treatments but are finding it increasingly more difficult to pay for these solutions.  Regarding the third world and emerging economies, the cost is far beyond the reach of all but a small percentage of wealthy members of these countries.  If costs were to be dramatically lower, more people in this world would have access to the advanced procedures and human suffering could be reduced. 
Let’s briefly discuss some innovative devices that have had a dramatic impact on our quality of life.  One example is a nebulizer. A nebulizer is a medical and health product that has been used as a way of transforming respiratory medication from liquid form into vapor form so that it can be breathed in through the lungs. This allows it to be absorbed far more quickly into the body than by simply ingesting it as commonly practiced in the past. Those that are suffering from health conditions like asthma and COPD find great comfort in such a device to help them relieve their symptoms and live a more normal life.  My neighbor, Doug, recently had hip replacement surgery as an out-patient!  He was doing great in a matter of weeks.  A leading class II medical manufacturing company has a device that can annihilate cancerous cells without surgery.  It is particularly helpful in cases of brain, prostrate and lung cancer.   Another company is marketing a device in Europe (attempting to get FDA approval in USA) for people with a heart condition called atrial fibulation.  Those fortunate to benefit from these devices and procedures can now go back to living more normal lives. 
Developing these innovative medical devices also includes risks.  (NOTE: For a recall listing see www.fda.gov/safety/recalls).   When there are problems in the field, it can lead to catastrophic problems including loss of life or decreased quality of life.  One recent example involves infusion pumps used in the medical device industry.  These devices can deliver up to three different medications to a patient intravenously.  Unfortunately, a number of companies have experienced problems with these devices in the last decade.  One of the most infamous cases involves an infusion pump marketed by a world renowned medical device company.  In 2010, the FDA asked this company to pull all of their units of a particular model from the market place.  The FDA required the company to destroy many thousands of units due to field failures.  According to a FDA News Release on May 3, 2010, over 500 deaths have been attributed to malfunctions in this device.  Several problems were identified.  One involved an interaction between the batteries and the controlling software.  It seems that if the batteries died the software allowed for a “free flow” of medications to the patient.  In August of 2010, another U.S. medical device company issued a global recall of two hip aid systems after more people than expected suffered pain which required additional surgery.  According to the company, 1 in 8 patients who received the ASR total hip replacement needed a second surgery to fix issues.  These recalls demonstrate that risks must be properly identified during product development and risk management must be continued after process validation.
Why do we have the above stated crises with medical devices?  How can a medical device company enhance their probability of success in the market place and minimize these risks?  What can management do to assure products being produced are timely, low-cost, reliable, FDA compliant, customer delighting, and hit their market window?   As delineated in Chapter 1 of this book, medical device providers need to complete three phases exceptionally well in order to mitigate risk. 

• Step 1: Complete Pre-validation activities in a seamless manner.

• Step 2: Validate processes

• Step 3: Conduct on-going monitoring and control the process.

All three are essential to mitigate risk.  For the previously described catastrophic examples, it is not entirely obvious from the public accounts as to where the root cause(s) lie.  There may have been issues with any of the above three steps or some combination thereof. 
Process validation is one integral element of a company’s risk reduction strategy.  Process validation is a requirement of the Good Manufacturing Practices Regulation for Medical Devices, 21 CFR Part 820.  It is applicable to companies that design and manufacture medical devices, pharmaceutical, and bio-medical devices.  Regardless of whether you are producing a class III, class II, or class I device, compliance is the law.  Completed in an efficient and effective manner, process validation does not have to add excessive cost or bureaucracy to your company, yet many companies have taken paths that do just these things.  As an integral part of an overall product and process design and manufacturing strategy process validation can be an invaluable tool in minimizing risk and cost in a lean manner. 
Some organizations new to the medical device community are convinced that it is not necessary to validate any processes.  Their mode of operation is to test/assemble/test/assemble/and test again at the system level.  This strategy is high cost and not effective.  Even simple tests are not 100% reliable.  Testing of complex systems is even worse.  With any test, there are two fundamental risks.  One is declaring good product bad.  The other is calling bad product good.  This strategy will guarantee you have field failures and excessive manufacturing costs.  It leads to lots of rework and scrap.  It is the antithesis of a low-cost and lean strategy.
There are a lot of medical device manufacturers doing an excellent job with their process validation initiatives.  They got there by thinking through their products and processes and developing process validation strategies that are appropriate for their unique needs. Unfortunately, there are some in the medical device industry that don’t want to think…..just tell me the proper course and I will blindly follow (consultants and company gurus are frequently the guilty party in this regard).  Design verification/validation teams need to have profound design and process knowledge and a working knowledge of company SOP’s and be willing to logically think through the risk and make a logical decision.  The team then needs to document their logic and decision.  You should be the expert on your design and process, not an outside consultant or the FDA.
Process validation need not be a painful process.  In the end, a common understanding of process validation across the organization will actually make everyone’s job easier.  Our belief is that the FDA really wants you to look at process validation from a common sense approach.  You just need to understand the FDA’s requirements, ensure your company policies and procedures are in sync with these requirements, and then rigorously follow these procedures.  A fundamental tenant being driven at FDA presentations we have attended is: 

• Understand risk.

• Document the level of risk.

• Take action as appropriate.

• Document what you have done,

• As new information is obtained update your risk assessment and take actions as deemed appropriate.

It is also important to remember that just because your process validation effort is completed does not mean you are done.  You must have a system of timely, rigorous controls in place.  You must do Process Control!  Dr. Edward Deming, a noted guru on Quality and Management, stated that getting a process to attain a state of statistical control requires a great deal of team work and effort.  This has been our experience as well.  After the process has been validated, it is key to have on-going statistical process control techniques in place.
In this book we will attempt to provide a proactive, logical, thought provoking approach to the process validation, and continued control of a process.  Process validation cannot be completed in a vacuum after design work has been completed.  It must be part of a proactive, integrated, cross-functional team effort.  Individuals need to have a working knowledge of FDA requirements, company Standard Operating Procedures, and profound knowledge of customer needs, product design, and processes.

Reviews

Having been involved in validations and Quality Technology Systems like FMEA and SPC for the past few years, and having clients in the injection molding industry, I wanted to thoroughly understand the validation process for the medical industry. I found Bob's book on this topic to be exactly what I was looking for. He has brought out the essence of validation clearly with his lucidly written text. We have been offering our FMEA software predominantly to the automotive industry. The detailed treatment given to FMEA is this book has highlighted the needs of the medical industry very clearly. It identifies well with what we have been offering the industry. The book also helped me understand what the FDA requirements are. These are usually not clearly understood by non-US companies.

Ravi Khare - Director and CEO - Symphony Technologies Pvt Ltd. - India