Intertech Engineering Associates, Inc.

Publications

Intertech periodically contributes to the medical device community by sharing our experience and expertise with the industry through trade magazines and journals. Check back often to see what has been added to our library. We've made most of these articles available here for our clients, prospects, workshop attendees and colleagues..

The articles are categorized as shown above. Just click on a topic to see what is available on that topic. Some articles span several topics and are mirrored as appropriate. If you don't see what you are looking for, browse through a similar topic.

If you don't find what you are looking for or just have a suggestion for a future publication, please let us know what you would like to see here by emailing librarian@inea.com.

Risk Management

Biomedical Instrumentation and Techonology, July/August 2006
Software Safety for Every Phase of Software Development (PDF-178KB)
Biomedical Instrumentation and Techonology, July/August 2006

Where does risk management belong, at the beginning of a project or at the end? Many managers choose one or the other, or both. The correct answer is that risk management needs to be considered throughout the software development life cycle. When the risks include the safety of patients or the users of the software, the methods need to be more formal. This article will explain why, and then will provide the how and the how much.

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Software Development

MD&DI

Software User Interface Requirements for Medical Devices (PDF-294K)
MD&DI, August 2007

This article examines how human factors considerations should be handled during the gathering, maintenance, and validation of requirements for medical device user interfaces that are implemented in software. Communicating, developing, and managing software user interface requirements are difficult tasks. Fortunately, guidance documents can help device manufacturers.

DesignFax Online

Agile Methods: Most Are Not Ready for Prime Time in Medical Device Software Design and Development (PDF-129KB)
DesignFax Online, July 2006.

The agile methods community has been gaining strength for almost a decade. A number of medical device manufacturers have started to experiment with these methods to see if, in fact, greater efficiencies can be gained in medical device software development.

Medical Electronics Manufacturing

Communications Protocol Testing: Balancing Technology, Planning and Compliance (PDF-123KB)
Medical Electronics Manufacturing, Autumn 2004.

Data communications is common in today's medical devices. Many devices themselves are multiprocessor architectures with communications between processors. Other devices communicate with external devices or networks.

Testing of the communications protocols is extremely important and highly technical. Proper validation requires some advance planning in product design, and validation strategy.

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Device Validation

Today's Medical Developments

Unit Level Software Testing (PDF-173K)
Today's Medical Developments - May 2007

A unit test strategy thought about during the development phase will assist the developers in structuring its testability, as well as make the code more reliable during the remaining phases of testing.

Medical Product Outsourcing

Solid Strategy, Sound Management: Keys to Testing Software (PDF-169K)
Medical Product Outsourcing, April 2006.

Testing is but one activity in a good software validation program. A good testing program encompasses a diverse collection of test protocols. However, when taken seriously testing (along with all validation activities) can produce solid software that can stand the test of time in the field.(mirrored under Project Management)

Medical Product Outsourcing

Validating Medical Device Software Includes and Goes Beyond Testing (PDF-82KB)
Medical Product Outsourcing, March 2006

A common misperception is that validation of software is synonymous with the testing of software.  This is not at all accurate.

Federal regulation requires software validation, not software testing.  Validation, by the FDA's definition is the "confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.

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Production & Quality System Software Validation

Biomedical Instrumentation & Technology

Medical Device Validation: How Vendors Can Assist Their Customers (PDF-204KB)
Biomedical Instrumentation & Technology November/December 2007.

Vendors can create a market advantage for themselves by helping their customers with validation efforts and regulatory requirements. By providing validated or partially validated software, vendors are helping their clients reduce their validation overhead in acquiring the software, thus reducing the overall ownership cost.

Medical Product Outsourcing

Validating Software for Manufacturing Processes (PDF-116KB)
Medical Device & Diagnostic Industry, May 2006.

The software for medical device processes-engineering, quality, regulatory, and so on-must be validated... but you don’t have to be a software engineer to do it.

Validate it? I just want to use it! Sound familiar?

Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical device. Perhaps not as widely understood or accepted is the regulatory requirement to validate software that is used to automate any process that is part of a medical device manufacturer’s quality system. This broad requirement encompasses manufacturing, engineering, quality, and regulatory functions within the firm.

Medical Product Outsourcing

Ideas for Validating Production Software (PDF-199KB)
Medical Design - September 2005

Manufacturers of medical devices are required by federal law to validate software that is part of the production or quality system. Often those charged with the responsibility for validating this software are not software engineers themselves and do not possess a background in either validation or in regulatory issues. As a result, some device manufacturers fall short of validating the quality system software for its intended use.

One type of software included within the “quality system” and of particular interest for this article is production software. Production software is not the software embedded within the manufactured medical device; it is the software embedded in the production tools, or used for process monitoring or control applications.

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Medical Design Technology

Recipe for Risk Management (PDF-116KB)
Medical Design Technology, February 2005
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Manufacturers of medical devices are required by federal law to validate software that is part of the manufacturing or quality system. But there is confusion about what this means. What software does the FDA regulate? What level of validation is required?

There are no checklists available from the FDA. However, an Association for the Advancement of Medical Instrumentation (AAMI) workgroup has been formed to write a technical information report on the topic of software validation for regulated automated process software. This AAMI report will address in detail some of the issues that are discussed here in a simplified form. Meanwhile, there is good documentation that offers guidance.

CleanTech

Intelligent Cleaning - Value Add for Medical Device Manufacturers through Validation (PDF-96.7KB)
CleanTech, February 2005
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Validation costs can easily exceed the purchase cost of the instrument or software. Whatever the suppliers of software-controlled instruments can do to reduce their customers’ cost of validation, therefore, reduces the overall cost of use of the system. Today, this can be a marketing advantage. Eventually it will become a necessity in order to stay competitive in the medical device market.

Aseptic Processing Packaging

Validation Value (PDF-103KB)
Aseptic Processing Packaging, October 2004
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Medical device manufacturers are required by federal regulation to validate any software that is used in their devices or that is used in the development or manufacture of the device. Suppliers of instruments or subsystems used by medical device manufacturers can create a market advantage for themselves by taking control of validation and assisting their customers with the regulatory requirements.

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Project Management

MD&DI

Using Design Controls to Reduce Time to Market (PDF-238KB)
MD&DI, January 2007

The secret to expediting your product to the market is to increase efficiency. Design Control requirements ensure good engineering practices, and thus increased efficiency and shorter development cycles. (mirrored under FDA interests)

Mass High Tech

How to Avoid the Biggest Mistakes in Medical Device Development (PDF-176KB)
Mass. High Tech, February 20-26, 2006.

A well defined engineering process and the regulatory control of that process can help Medical Device Designers shorten their products time to market as well as make the product more maintainable and reliable. The FDA’s Quality System Regulations, that require “design controls” and “validation” is nothing more than good engineering practices.

Medical Product Outsourcing

Solid Strategy, Sound Management: Keys to Testing Software (PDF-169K)
Medical Product Outsourcing, April 2006.

Testing is but one activity in a good software validation program. A good testing program encompasses a diverse collection of test protocols. However, when taken seriously testing (along with all validation activities) can produce solid software that can stand the test of time in the field.(mirrored under Device Validation)

ECN Magazine

Good Planning Avoids Costly Mistakes with Medical Devices and Medical Device Software (PDF-152KB)
ECN Magazine, November 2005
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How do some medical device firms manage to trip over their own feet? Let us count the ways: trying to get away with “good enough,” leaving risk management and verification & validation for later, and earning a reputation for sloppy work.

Since everyone is a patient eventually, no one wants to believe that medical devices are subject to the same design and implementation flaws that sometimes plague other electronics and software. To prevent that, the U.S. Food and Drug Administration (FDA) regulates the medical device industry.

Medical Device & Diagnostics Industry

Good Products from Good Processes (PDF-96.5KB)
Medical Device & Diagnostics Industry, April 2005
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The complexities of developing a high-tech medical device are so daunting to the inexperienced that it may seem that luck has more to do with success than anything else. Why do companies with similar products sometimes take very different amounts of time to launch new products, and why do they have very different success rates? The performance differences are so consistent that it suggests that maybe luck has little to do with it.

Successful managers and companies adopt disciplined engineering and project- management processes and constantly strive to improve their processes and techniques.

HPC World

Harder Than It Looks: Medical Device Startups (PDF-92KB)
HPC World, Summer 2004
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You saw the prototype working. The preliminary clinical data looked promising. There was a huge market need for the product. It looked like a sure thing.

Then, two years later than anticipated, the product finally gets to market. Development costs millions more than expected. Worst of all, because it took so long to get to market, you now have three competitors that didn’t exist when you made the investment.

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Outsourcing

MD&DI

Good Contracts Lead to Good Relationships (PDF-100KB)
MD&DI Guide to Outsourcing Magazine, August 2005
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Medical device manufacturers might consider outsourcing product development or product testing activities for a number of reasons. In general, if an outsource provider has specific experience that you lack, has more resources available, or doesn’t carry all the overhead of a large corporation, then you may be better off outsourcing. By outsourcing, manufacturers can often eliminate both direct and indirect development costs. These costs can add up to millions of dollars a year that could be better spent on sales, marketing, and new product development.

Handbook of Business Strategy

Best Practices for Dealing with Offshore Software Development (PDF-107KB)
Handbook of Business Strategy, 2005

Offshore outsourcing (offshoring) of software development has been an increasingly popular trend in recent years. The cost benefits are easy to understand when you consider that the average annual salary for an engineer in the USA is $70,000 in 2004, compared with a $13,580 average salary for an engineer in India, according to Electronic Business magazine.

Is cost the only benefit, or are there others? Do you give up anything for the cost savings? The purpose of this article is to examine why US companies outsource software development offshore, and to determine whether the benefits of offshore outsourcing outweigh the drawbacks.

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FDA Interests

Medical Design

Bringing Legacy Devices Into Compliance (PDF-151KB)
Medical Design, July/August 2007
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Device performance, design documentation and the impacts of change must be considered when planning a product improvement. Project risk and safety risk must first be considered if a new release is to comply with FDA regulations, guidances and your own SOPs.

Using Design Controls to Reduce Time to Market (PDF-238KB)
MD&DI, January 2007

The secret to expediting your product to the market is to increase efficiency. Design Control requirements ensure good engineering practices, and thus increased efficiency and shorter development cycles. (mirrored under Project Management)

Controlled Environments

FDA Regulation of Software for Medical Device Manufacturers: A Moving Target? (PDF-78KB)
Controlled Environments, June 2005

While the dizzying array of FDA regulations and changes may seem overwhelming, there is a checklist that can help you stay sane and in compliance.

DesignFax

Which Rules Must We Follow? Sorting Out Compliance Rules, Regulations, Guidelines (PDF-258KB)
DesignFax, May 2004

This article is an engineer’s (or an engineering manager’s) abridged guide to the FDA, regulatory documents, and standards.  It will explain the FDA’s interest in one’s device, the level of control it has over a company, and how to navigate the available regulations and documents. Please note this guide is abridged. There are many documents available from the FDA and standards groups that are not referenced here. This information is just the “tip of the iceburg” of which product designers should have at least a cursory knowledge.

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