AAMA-CMA test - AAMA Certified Medical Assistant Updated: 2023

The Food and Drug Administration granted marketing approval to a home test for chlamydia and gonorrhea on Wednesday, the first such authorization of a home test to detect the two most common sexually transmitted infections in this country.

The marketing approval was granted to LetsGetChecked’s Simple 2 Test, which allows individuals to collect a sample at home that is then submitted to a laboratory for processing. Prior to this, the only approved tests for these two STIs required samples to be collected at medical facilities such as doctors’ offices.

“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home.”

The Simple 2 Test will be available over the counter and is intended for use by people aged 18 and older. The only other STI test that allows for home sample collection is for HIV.

Jodie Dionne, an STI expert at the University of Alabama at Birmingham, welcomed the news, saying experts in the field have been advocating for this approach for some time.

“It is exciting to see the FDA recognize the value of this type of testing by granting marketing authorization through the premarket review pathway,” Dionne, an associate professor of infectious diseases, said in an email.

“There are many people who would like to be tested for STIs who may not know where to go or who have barriers to accessing medical care. If we are going to do a better job of reaching more sexually active people for STI testing as recommended … we need to be creative about how to get them tested and treated in a way that is highly effective and works for them.”

Alan Katz, an STI expert at the University of Hawaii, said the test deploys the same assay clinicians use to diagnose chlamydia and gonorrhea, an assay that has an excellent accuracy record. And Katz, who is a medical consultant at the Hawaii State Department of Health’s Diamond Head STI/HIV Clinic, said this approach also has other advantages.

“This option is exceptionally useful for individuals who live in rural areas or are geographically distanced from a clinic where STI testing can be done and there is no telehealth option available,” he said via email. “If a person screens positive, they can then contact a healthcare provider for further evaluation and treatment.”

Rates of new infections of chlamydia and gonorrhea have been soaring in the U.S. The Centers for Disease Control and Prevention estimates there were more than 1.6 million cases of chlamydia in 2021, and over 710,000 cases of gonorrhea the same year. Both infections are curable, but if left untreated can trigger serious long-term effects, including infertility.

Home samples are taken either using vaginal swabs or urine samples, which are then submitted to a designated laboratory. Results are delivered online, with follow-up care provided when a diagnosis is positive or ambiguous.

Unapproved home tests for chlamydia and gonorrhea have existed for some time, but until now none has gone through the FDA’s approval process. This approval may make it easier for future such tests to clear the FDA’s regulatory pathway.

At-home tests for sexually transmitted diseases (STD) or sexually transmitted infections (STI) let you know the status of your sexual health without stepping foot in your doctor's office or local clinic. An at-home STD test can also help you minimize the angst of prolonged concerns about your status due to possibly waiting days or weeks for an appointment with a healthcare provider. If you're concerned about exposure to an STD or STI, you're not alone: The US is currently facing record-high numbers of STDs and STIs, with gonorrhea and syphilis especially on the rise, according to the Centers for Disease Control and Prevention. What's even more alarming is the recent study showing there were more than 3,700 babies born with syphilis in 2022, which was over 10 times the number reported in 2012. Furthermore, in 2022, there were 231 stillbirths and 51 infant deaths due to syphilis infection during pregnancy.

Dr Alyssa Dweck, Chief Medical Officer at Bonafide Health, tells us that while the younger generation is disproportionately affected by STD and STI infections, she's noted a rise in sexually transmitted infections in perimenopausal adults and seniors engaging with new partners due to divorce or being widowed. "Many in this demographic don’t necessarily think to use condoms, since contraception may no longer be needed, thus the STI rate increases," she explains. Regardless of age, If you're sexually active it's important to proactively test for common STDs and STIs at least once a year, especially if you have multiple partners.

If you're uncomfortable discussing your sexual health with your doctor or a stranger at a health clinic, fully at-home or hybrid at-home tests that screen for various STDs and STIs are a reliable and fast alternative, "access and affordability are benefits of at-home testing," says Dweck.

What's the difference between an at-home test and a hybrid at-home test?

At-home tests are conducted in the privacy of your home, with all specimens for the test collected by you, and then mailed to an affiliated lab in a prepaid envelope or box included with the test. "I'm an advocate of home tests, and I'm a big advocate of home collection," adds John A. Nelson, director of the AIDS Education & Training Center National Coordinating Resource Center at the Rutgers School of Nursing. Home collection test kits are easy to use, allow for a level of discretion and privacy you can't get in a medical setting, offer the ability to avoid awkward conversations with your doctor or a stranger at a clinic and provide results relatively quickly, he explains.

Conversely, if you need an STD or STI panel and prefer to skip a trip to your doctor or health clinic but are uncomfortable drawing your blood or taking the samples needed for the test on your own, you may prefer the hybrid at-home test approach which, just like an at-home test, allows you to purchase the test online and get your results electronically, but when it comes to collecting the specimens, you'll go directly to the lab to have your samples taken — usually about a 5-10 minute process. Dr Kevin Huffman, Doctor of Osteopathic Medicine, tells us a benefit to taking the hybrid at-home test approach is that "proficient experts conduct in-lab testing, which provides a more extensive and precise evaluation."

If you're unsure which route you want to take (at-home or hybrid), below we outline the best at-home STD tests for various needs and conditions that offer the option to either test yourself or go to the lab to have the samples drawn for you. Above all, the following STD tests do not require a visit to your doctor, insurance or a long waiting period.

What's the difference between an STI and an STD?

It's important to point out that even though the terms STI and STD are often used interchangeably, there is a difference: STIs are infections that have not yet developed into diseases, such as bacterial infections, viruses and parasites. Fun fact (or not): There are more than 30 different bacteria, viruses and parasites that can be transmitted sexually, yet no single test screens for all of them.

Also, different STIs are detected in different ways, regardless of the test you choose: Some diseases or infections are detected through urine, while others are best detected via blood or cavity swabs. Whichever test you choose will guide you on the best collection method — and state upfront what you can expect.

What are the best at-home tests for STDs and STIs in 2023?

There's a surprisingly large range of in-lab and at-home tests available that can be purchased both in-store and online. To find the best STD tests and STI tests available for over-the-counter purchase, our team consulted with multiple doctors and testing experts about what to look for in a good test and rated each based on elements such as if the lab used to process the test is ISO/IEC/CLIA-accredited, test accuracy, ease of use, if medical providers were available for consultation, user experience and cost. Every person has different needs, so we made sure to include a range of tests to cover various diseases, infections, needs and budgets.

Everlywell

Test collection method: Blood, swab (women-only), urine (men-only) | Time until results: 2-5 days | Free shipping: Yes

Everlywell, a trusted name in home testing offering a multitude of tests and prescription services, tops our list of at-home STD tests due to offering male- and female-specific tests that you conduct entirely from the privacy of your home, no trip to the doctor or lab needed. This STD test kit checks for the six top sexually transmitted diseases and infections, such as chlamydia, gonorrhea, hepatitis C (HCV), human immunodeficiency virus (HIV), syphilis and trichomoniasis. The testing process is simple: Take a finger prick and vaginal swab (for women) or finger prick and urine sample (for men). Once the samples are ready, drop your specimens in the mail using the included prepaid shipping box. Within a few days, you'll get results via an app or the website. What especially stands out is that if you test positive for an STD or STI, an Everlywell healthcare provider will reach out to go over what everything means, as well as treatment options and prescribe medication if necessary. If you need your test results ASAP, you can opt for express shipping for an extra charge ($30). 

While this test is pricy (which is standard for a test that offers a complete STD and STI panel), you can save 15% by signing up for a semi-annual subscription. All packaging involved is plain and discreet, so you don't have to stress about nosy neighbors or roommates. Insurance coverage depends on your plan, but the tests are FSA- and HSA-approved. 

Pros

• Medical provider guidance included
• Screens for six top STD
• Fast results

Cons

• Expensive
• May not be covered by your insurance plan

$169 at Everlywell

STDCheck.com

Test collection method: Blood, urine | Time until results: 1-2 days | Free shipping: N/A

STDCheck's test detects a whopping 10 STDs and STIs: chlamydia, gonorrhea, syphilis, HIV, early HIV, hepatitis A, hepatitis B, hepatitis C, and herpes I and II. The only caveat to this test (but also why it screens for so many STDs and STIs and the results are returned so quickly) is that a trip to an affiliated local lab is necessary to provide your test samples. 

When you purchase the test online, you'll immediately get an access code to schedule an appointment at one of its 4,800 affiliated nationwide labs of your choosing - you may even find you can schedule your appointment with the lab the same day and have your results back within 12 to 48 hours. 

Another major stand-out feature of STDCheck is that you can add the HIV RNA Early Detection test to your order, which is an FDA-approved test that detects early HIV infection within 9 to 11 days after potential HIV exposure. STDCheck.com also offers a range of tests for individual STIs, should you prefer to test for only one or two conditions.

Pros

• Tests for 10 STIs and STDs
• Rapid results within 24-48 hours
• Care advisors available at any time after purchase

Cons

• Must visit an affiliated local lab to provide specimen samples

$139 at STDCheck

CVS

Test collection method: Urine | Time until results: 1-3 days from the date the lab receives the sample | Free shipping: Yes

CVS brand STI test kit tops our list for best budget-friendly at-home test because it covers the top three common STIs for under $100: chlamydia, gonorrhea and trichomoniasis. The test is conducted fully at home and requires a simple urine sample you drop in the mail and ship to the lab (prepaid postage included). A high-complexity CLIA-certified laboratory will process the specimen and then send the report to an independent physician licensed to practice in your state who will review and approve the findings. The final report will be sent to you via a secure online portal in about 1-3 days after lab receipt of your test. Unlike the aforementioned test kits that have a provider available for consultation, you will need to visit your medical provider should you test positive to discuss the best treatment plan.

One reviewer said, "I found this test kit to be extremely user-friendly. The step-by-step instructions were easy to follow, and the entire testing process was efficient." 

Pros

• Checks for the top three STIs
• CAP-accredited and high complexity CLIA-certified laboratory
• reviewed and approved by an independent board-certified physician

Cons

• Urine sample may get messy
• No medical care support included

$90 at CVS

Quest

Test collection method: Blood, urine | Time until results: 3-5 business days | Free shipping: Yes

If the name or logo for Quest is familiar, then it's likely because you have a Quest lab close to you, after all, there are thousands of Quest labs located throughout the US due to many major hospitals and physician offices that use its services. While the major STD and STI panels offered through the Quest website are hybrid tests that require you to buy online and then visit a lab in-person to provide a specimen, there are plenty of at-home tests available that are conducted fully in the privacy of your home.

Quest offers two in-lab STD panel options: A basic STD screening panel ($139) that covers four conditions: Chlamydia, gonorrhea, syphilis, and HIV 1 and 2. There's also the Expanded Screening Panel test ($269) that covers 7 of the most common STDs and STIs: Chlamydia, gonorrhea, hepatitis B, hepatitis C, trichomoniasis, syphilis, HIV-1 and HIV-2. Once you choose a test, you'll make the purchase online, schedule with the lab and then head over to provide your blood and urine samples. The test kit's purchase also includes the option to consult a physician if you happen to test positive, although it will cost you an additional $6. 

In addition to the STD panel tests mentioned above, there are a total of nine STD and STI testing kit options available through the Quest Laboratories website, should you want to zero in on a specific disease or infection or a combination of conditions. At-home and in-lab tests offered by Quest range in condition and price from $45 for the fully at-home HIV 1 and 2 test kit to 19 tests for women's health including a urinary tract infection test (UTI) ($39) and 15 men's health tests, including a test to show health risks based on your genetics.

Pros

• 45+ at-home and hybrid tests available
• Relatively fast results
• FSA and HSA eligible

Cons

• Physician consultation costs extra
• Many test do require a trip to the lab

$139 at Quest

MyLab Box

Test collection method: Blood, urine | Time until results: 2-5 days | Free shipping: Yes

The MyLab Box Love Box is a fully at-home STD test kit specially designed to be inclusive for all couple combinations: male and female, male and male or female and female. In addition to being for couples, the kit costs $378 (with 15% off your first purchase if you join the mailing list ), making it about two-thirds the cost of purchasing two separate complete panel tests at a competitor. Each test screens for the top eight sexually transmitted diseases and infections: chlamydia, gonorrhea, hepatitis C, HIV (I and II), herpes simplex 2, syphilis and trichomoniasis. 

To take the test, you and your partner will first do a finger-prick blood test, then a cavity swab (female) and/or urine sample (male), then drop the samples in the pre-paid box and ship to the lab. A certified CAP and CLIA high-complexity testing lab will then process the specimens. Within 3-5 days after lab receipt, you'll receive your results electronically, and you can rest assured HIPAA web security protocols are enacted to protect your data. If one or both of you test positive, you can consult with a doctor in your state via phone consultation about the next steps and be prescribed treatments if needed. If the tests are negative, you still have the option to consult with a certified STI counselor. The tests are FSA and HSA eligible.

Pros

• Inclusive couples testing options (Male + Female; Male + Male; Female + Female)
• Screens for 8 major STIs and STD
• Specimens collected in the privacy of your home

Cons

• No hybrid lab option
• Expensive

$378 at MyLab Box

Nurx

Test collection method: Blood, swab, urine | Time until results: Within days | Free shipping: Yes

Nurx has a range of STI kits that are covered by most insurance carriers, including the Full Control Kit which checks for five STIs: HIV, chlamydia, gonorrhea, syphilis and hepatitis C. There's also a Basics Covered at-home STI Home Test Kit that screens for the four top STIs: HIV, chlamydia, gonorrhea, syphilis. The Healthy V STI Home Test Kit screens for HIV, chlamydia, gonorrhea, syphilis and trichomoniasis. While there is an easy-to-use app, you can still order via the Nurx website, regardless of method, you'll start by answering a few questions about your personal and sexual health to find the best test for your needs; All at-home tests are conducted fully at home then shipped to Nurx affiliated lab. 

Nurx is also a great option for those wanting to move to telehealth for sexual and overall wellness needs, including having the option to get prescriptions for birth control, acne control, emergency contraception and even hair loss products, with all medications delivered straight to your home. There's a $15 sign-up fee, but the fee includes access to a year of unlimited messaging with a provider.

One reviewer raved that the process was "EASY AND CONFIDENTIAL," adding that they "Loved this experience. I hate going to doctors, especially around sexual health. The fact that everything can be done without having an in person or video/phone call is AWESOME!"

Pros

• Covered by insurance
• Offers multiple health and wellness Telehealth solutions
• Prescribing medical support

Cons

• Patients using insurance may receive an additional bill from the lab for copays or any additional costs
• $15 sign-up fee

$45 at Nurx

LetsGetChecked

Test collection method: Blood, urine | Time until results: 2-5 days | Free shipping: Yes

LetsGetChecked is all about making you feel informed from beginning to end. There's a detailed video walk-through on what's in your test kit, how to collect your samples, mistakes to avoid during sample collection, how to ship your samples, and what to expect after the lab receives your samples; there's even a walk-through on how to use the company's super easy-to-use app. 

The test screens for five major STIs: chlamydia, gonorrhea, HIV, syphilis and trichomoniasis. If you test positive, a nurse will reach out with information on what to do next, including helping you set up a virtual consultation (for an additional $39) that will include a consultation with a doctor and a prescription for medication if needed. 

"If you have anxiety about going to the doctor and requesting an STD screening, this is a really good alternative," said a user. "Also, I was able to use my HSA to pay."

Pros

• Helpful video tutorial walks you through the test
• Unlimited messaging with provider after sign-up
• Prescribing providers available

Cons

• Video consultations cost and extra $39

$149 at LetsGetChecked

What to consider when buying an at-home STI/STD test

What you're testing for

If you are being proactive about testing after being with a new partner, it may be best to choose a test kit that screens for a wide range of conditions. If you've had a known exposure to a particular STD or STI, you could choose a test that screens for that particular condition or a combination of conditions.

Testing methods

Methods for at-home testing generally include instructions for self-collection at home via a blood sample, urine or internal swab, which is then shipped to a lab to be tested. If home collection is not something you're comfortable with, then choosing a hybrid test that allows you to visit a lab to have your specimen collected may be the better option.

Budget

As you can see from our list, there is a wide range of pricing options for test kits ranging from $45 for screens for one or two conditions to upwards of $300 for panels for 10+ conditions. In some cases, your insurance may cover the test, if not, HSA and FSA are generally accepted with most all at-home and in-lab tests. Figuring out in advance how much you want to spend can help you choose the right test, whether that be a full panel or a screen for the condition you suspect you may have.

Follow-up care

Some tests include counseling from a healthcare provider, while others do not — and Leslie says that's definitely worth considering. "There are issues of follow-up and high anxiety when a test is positive and no healthcare professional is available," he says. You know yourself better than anyone: If you feel like you would be OK waiting to connect with your doctor or someone at your local health care department if you test positive, there's no need to look for a test with a provider connection. But if you know you'd want to talk to a professional immediately about a positive result, a test kit that includes a health care provider consultation may be the best option.

How we chose the best at-home STI/STD tests

To find the best at-home tests, we spoke to multiple doctors for their input on what to look for in an at-home or in-lab STD and STI kits, as well as different types to consider. From there, we researched more than 25 at-home test kits and rated each on elements including sensitivity, ease of use, whether follow-up care is included and good and bad user reviews.

FAQs

How do at-home STI tests work?

There's variety with these tests and the way they work ultimately depends on the individual test. "Some require an oral or genital swab; others require urine or blood samples, which will then go to a lab," women's health expert Jennifer Wider, MD, co-host of the Open Wider podcast, tells Yahoo Life. It's important to read the manufacturer's information carefully in advance to make sure you're comfortable with the testing procedure.

How do I know whether I have an STI?

The only way to know for sure if you have an STI is to get tested. Some sexually transmitted infections don't have symptoms, so you can be positive without knowing, Wider points out. That puts you at risk for health complications such as fertility issues and also increases the likelihood you'll spread the infection.

Are at-home STI and STD tests reliable?

Every test kit has its own sensitivity — meaning, how likely it is to detect an infection. "Many are quite reliable, especially if collected properly and then brought to a lab as quickly as possible," Wider says. Dr Leslie agrees, adding, "The test kits work when done correctly and reach populations that are at risk and might not seek traditional medical help for suspected STDs."

Where can I get a free STI and STD test?

Local health departments and sexual health clinics such as Planned Parenthood usually offer free or very low-cost sexual health tests. If you prefer to try a local clinic, visit your local health department's website to see what's offered; you may even be able to schedule an appointment for testing on the site.

Our experts

Dr Alyssa Dweck, Chief Medical Officer at Bonafide Health

Dr Kevin Huffman, Doctor of Osteopathic Medicine

Dr Stephen W. Leslie, associate professor, Creighton University School of Medicine

Dr Jennifer Wider, women's health expert and co-host of the Open Wider podcast

John A. Nelson, STI screening researcher and director of the AIDS Education and Training Center at the Rutgers School of Nursing

The reviews quoted above reflect the most latest versions at the time of publication.

Originally Published MDDI January 2002

TEST SYSTEMS

Test System Engineering for Medical Devices: A Guide

Developing test systems for R&D through production requires a combination of preparedness and ongoing evaluation.

Tore Johnsen

A large number of medical device manufacturers use automated test and measurement systems during each stage of the product cycle, from R&D to production testing. These systems play an important role in improving the quality of products and helping speed them to market. Purchasing the test equipment is often less expensive than putting it into use; it can cost more to develop the software to run a system than to purchase the instrumentation. Many companies choose to outsource all or a portion of their test system development. Whether it's done internally or by an outside vendor, the critical factors for success remain the same: maintaining good communication between developer and client, following an efficient development process, selecting appropriate development tools, and recruiting people with the skills to do the job correctly.

This article provides a broad overview of test and measurement system development for the medical device industry. Included is a discussion of commonly used instrumentation and tools and an overview of the skills and practices necessary for successful test system development.

HOW AND WHY TEST SYSTEMS ARE USED

In the medical device manufacturing industry, test and measurement systems are used for a wide range of purposes. Some examples include those developed to:

• Demonstrate proof-of-concept prototypes for new equipment used to cauterize heart tissue.
• Research the shrinkage of new dental filling materials as they cure.
• Verify that such implantable devices as pacemakers and neurostimulators function according to specifications.
• Condition and test batteries for implantable devices.
• Simulate the pressing of buttons, turning of knobs, collecting of patient data, and other functions while monitoring and recording a blood-treatment machine's operation.

In order to carry out these tasks, the required systems must be capable of performing such functions as automatically controlling switches and relays, setting and memorizing temperatures, measuring or generating pulse widths and frequencies, setting and measuring voltages and currents, moving objects with motion control systems, using vision systems to detect misshaped or missing parts, and others. The medical device industry's need for test equipment and related sensors and technologies is as varied as the industry itself. No matter what the specific need, however, compliance with the quality system regulation is mandatory.

TEST SYSTEM TRENDS

Some trends have emerged as the popularity of automating test systems has grown. For instance, integrating test systems with a corporate database is becoming more common. A number of test stations can be networked, and data can be stored in the corporate database. From that database, important statistical process data can be gathered and analyzed.

Additionally, manufacturers are growing more interested in using standard Web browsers to view data and in remotely controlling their test systems. Data are routinely passed between test applications and standard office applications such as Microsoft Excel and Word. Both the complexity and number of technologies being incorporated into the systems are growing, and, consequently, so are the demands on systems developers and project managers. Test system developers are using more-efficient software development and project management methodologies to meet these increased demands.

Standardizing specific test system development tools and instrumentation is another increasingly popular way to keep costs relatively low. Using the same development tools from R&D to production has obvious benefits: it reduces training costs, allows for technology reuse, and makes it easier to shift employees from one area to another, depending on demand. If executed with diligence, maintaining consistency also facilitates the creation of a library of reusable code. Standardizing makes compliance with quality systems requirements easier, too.

TEST SYSTEM INSTRUMENTATION

A typical test system is created in one of two ways. It can be built around a PC using a plug-in data acquisition board (DAQ), serial port instruments, or general-purpose interface bus (GPIB). Alternatively, it may be built around a chassis with an embedded computer and various plug-in modules such as switches, multimeters, and oscilloscopes (see Figure 1).

The existing member of the latter family of instrumentation systems is the PXI chassis, which uses the standard PCI-bus to pass data between the plug-in modules and the embedded computer. This technology offers high data acquisition speeds at a relatively low cost. Originally invented by National Instruments (Austin, TX), it is now an open standard supported by a large number of instrument vendors. (For additonal information on this system, visit http://www.pxisa.org).

Manufacturers should keep in mind the several variations that exist on these schemes. To select the optimal instrumentation for any given project, a company must consider both the cost and performance requirements of the project, and the need for compliance with internal and external standards.

An important system-selection criterion is the availability of standardized ready-made software modules (i.e., instrument drivers) that can communicate with the instruments. Because the major instrument vendors are currently involved in a significant instrument-driver standardization effort, it makes sense for companies to check the availability of compliant instrument drivers before purchasing an instrument. The Interchangeable Virtual Instruments Foundation (http://www.ivifoundation.org) works on defining software standards for instrument interchangeability. The foundation's goal is to facilitate swapping of instruments with similar capabilities without requiring software changes. Creating a custom instrument driver can take from days to weeks depending on the complexity of the instrument; if it's not done correctly, future maintenance and replacement of instruments might be more difficult than need be.

DEVELOPMENT TOOLS

Development tools designed specifically for PC-based test system development have been in existence for more than a decade. Specialized graphical languages for drawing, rather than writing, programs are useful. One such product from a major instrumentation vendor is LabVIEW (National Instruments). Developing everything from scratch in C is probably not a good idea—unless there is plenty of time and money to spare.

As alternatives to specialized graphical languages, several add-on packages exist that can make a text-based programming language more productive for test system development. For example, one can buy add-ons for both Visual Basics and Microsoft Visual C++. If one's preference is C, for instance, but the benefits of a large library of ready-made code for instrumentation, analysis, and presentation are desired, LabWindows/CVI from National Instruments is a tool to consider.

If what's needed is development of an advanced system to make automated logical decisions about what test to run next and to perform loops and iterations of tests—and store the results in a database—a test executive that can work with the test code is a wise option. Figure 2 shows an example of test-executive architecture. The test system developer writes the test modules and then uses the test executive's built-in functionality to sequence the tests, pass data in and out of databases, generate reports, and make sure all test code and related documentation is placed under revision control (i.e., configuration management).

Although this option still requires significant effort to develop the test modules and define the test sequences, using a standard test executive is, in many cases, far more cost-effective than making one from scratch. This is especially true for such large, ongoing projects as design verification testing and production testing, which require regular modifications of tests and test sequences.

THE NECESSARY SKILLS

A test system development project requires a multitude of skills to achieve success, including project management skills and good communication to keep the project on track and to ensure that all stakeholders' needs and expectations are addressed. Understanding and practicing good software development methodologies are also needed to ensure that the software that is built will actually meet the user's requirements. Test system development also requires that engineers have a thorough understanding of software design techniques to ensure that the software is both functional and maintainable, and an understanding of hardware and electronics to design the instrumentation and data acquisition portions of the system.

Before a test system can be put into production, it needs to be tested and validated. This means that the development team also needs the expertise to put together a test plan and to execute and document the results in a report. The engineers who built the system are not necessarily the best people to test it, so additional human resources are often needed for testing. Finally, because documents are created during the development process, documentation skills are also necessary.

When one considers that the typical project team for a midsize test system consists of two to four developers, one realizes there are more major skills required than there are team members; therefore, one of the challenges is to locate individuals with sufficiently broad skills and abilities to supply both technical and managerial leadership. To ease this burden, make the tasks less daunting, and increase the chances of project success, defining a development process is key. If the test system is used for regulated activities, such as production testing of medical devices, then the test system itself is subject to the quality system regulation and a defined development process is not only desirable, it's mandatory.

THE BENEFITS OF COLLABORATION

Outsourced projects are most successful when the developers and the clients collaborate. Keeping the client involved is the most efficient way of making sure that the system meets the client's needs. It also helps avert surprises—at either end—down the road. Collaboration requires honest and direct communication of issues, successes, and problems as they occur.

Miscommunication sometimes happens even with good collaboration. While it is important to keep the communication channels open so the developers and their clients can discuss issues without too much bureaucracy, it can be hard to keep track of who said what if too many parallel communication channels exist. And when engineers on both sides have ideas of features they would like to add to a particular system, controlling feature creep can become difficult.

Designating a single point of contact for discussing both a project's scope and its content is recommended, and making sure new solutions are reviewed before being accepted can also prevent problems. Instituting a change-control procedure is yet another important step to minimizing unnecessary changes.

THE PROJECT PROCESS

The goal for any project is to add only as much process overhead as is absolutely necessary to satisfy the objectives. When a process must be added because regulations mandate it, the involved parties should keep in mind that the process isn't being instituted merely to satisfy FDA or other agencies; it's being done to build better and safer products. Structure and process improvements can have a significant positive impact on the quality of the finished test system.

The Software Engineering Institute has defined the following key process areas for level 2 ("Repeatable") of the capability maturity model: requirements management, project planning, project tracking and oversight, configuration management, quality assurance, and subcontractor management.¹ The foundations for a project's success are good requirements development and good project planning; if the requirements aren't right, or if a company can't determine how to get the project done, then the project is essentially doomed. What follows is a description of the progression of a few types of test system development projects as well as a discussion of requirements development.

Phases of Test System Development. Whether a formal documented development process is followed or not, there are a few major tasks (i.e., project phases) that must be addressed: requirements development, project planning, design, construction, testing, and release. Should this particular order of tasks always be followed? Probably not. During the 1980s the software industry saw a number of large projects go significantly over budget, become significantly delayed, or be cancelled because they were inherently flawed. One cause of these problems was companies' strict adherence to the waterfall life-cycle model (see Figure 3). In this type of life cycle, the project goes through each phase in sequence, and the phases are completed one at a time. The waterfall model presumes that the requirements development phase results in nearly perfect requirements, the design phase results in a nearly perfect design, and so forth.

Unfortunately, projects are normally less predictable and run less smoothly than the waterfall model assumes. For example, a company doesn't always know enough at the beginning of a project to write a complete software requirements document. The sequence of actions necessary for project success depends to a large extent on the nature of the project. Because every project is unique, those involved must analyze the project throughout its phases and adapt the process accordingly.

Keeping that in mind, software companies have done much to Boost software development methods since the 1980s. Today, one can find descriptions of a number of life-cycle models useful for different project characteristics. Choosing the appropriate life-cycle model depends on the nature of the project, how much is known at the start of the project, and whether the project will be developed and installed in stages or all at once. Of course, mixing and matching ideas from different life-cycle models can be an effective strategy as well. Even if a company has decided upon and made standard a particular life-cycle model, small modifications should be made to that model when a particular project necessitates it. The trick is to identify high-risk items and perform risk-reducing activities at the start of the project.

Test System Characteristics. The test systems used in the three device development stages—R&D, design verification, and production—each have their own characteristics.

R&D Systems. R&D test systems range in development time from a few days to many months. Scientists use the systems to explore new ideas; R&D test systems are also used to perform measurements and analyses not possible with off-the-shelf equipment and to build proof-of-concept medical equipment. Others are used by physicians for medical research. Vastly varied in both scope and technologies, most R&D test systems have one thing in common: the need for continuous modification and development. As the research progresses, the scientist learns more, generates more ideas, and might decide to incorporate a new functionality or new algorithms, or even try a different approach. Clearly the waterfall life-cycle model doesn't fit such developments. With R&D test systems, one doesn't know what the final product will look like at the start of the project. In fact, there might not be a final product at all, just a series of development cycles that terminate when that particular research project is over and the system is no longer needed.

Assuming that a reasonable idea of the scope of the R&D project is known at the start, one possible life-cycle model to follow is the evolutionary-delivery model (see Figure 4). This model includes the following steps: defining the overall concept, performing a preliminary requirements analysis, designing the architecture and system core, and developing the system core. Then the project progresses through a series of iterations during which a preliminary version is developed and delivered, the client (i.e., the researcher) requests modifications, a new version is developed and delivered, et cetera, until revisions are no longer needed.

Of course, it's wise to try to pinpoint potential changes at the beginning of the test system development project so that the software architecture can be designed to handle the changes that might come later on.

Design Verification Test Systems. There often is a blurry line between R&D and design verification test (DVT) systems. In the final stage of DVT system usage, the output is verification and a report stating that the medical device performs according to its specifications. Before that stage is reached, however, it is not uncommon to encounter several DVT cycles, each delivering valuable performance data back to the device's designers, and each resulting in modifications either to the device's design or to its manufacturing process.

It may be desirable to use the DVT system to test parts of the device or portions of its functionality as soon as preliminary prototypes are available, but it may not always be possible to have the complete test system ready for such applications. In these cases, the staged-delivery life-cycle model (see Figure 5) may be the best choice. According to this model, test system development progresses through requirements analysis and architectural design, and then is followed by several stages. These subsequent stages include detailed design, construction, debugging, testing, and release. The test system can be delivered in stages, with critical tests made available early.

Production Test Systems. A production test system needs to be validated according to an established protocol.² Such a test system is therefore developed and validated using a well-defined process, and the system can normally be well-defined in a requirements specification early on. There is still, however, a long list of possible risk factors that, if realized, can have a serious negative impact on the project if a strict waterfall development life cycle is followed. Research has shown that it costs much more to correct a faulty or missing requirement after the system is complete than it does to correct a problem during the requirements development stage.

A risk-reduced waterfall life cycle might be an appropriate model to follow when developing a production test system. In this life-cycle model, main system development is preceded by an analysis of risks and a performance of risk-reducing activities, such as prototyping user interfaces, verifying that unfamiliar test instruments perform correctly, prototyping a tricky software architecture, and so forth. Iterations are then performed on these activities until risk is reduced to an acceptable level. Thereafter, the standard waterfall life cycle is followed for the rest of the project—unless it is discovered that some new risks need attention.

Requirements Development. As the aforementioned life-cycle models show, requirements development directly influences all subsequent activities. It's important to remember that the requirements document also directly influences the testing effort. Writing and executing a good test plan are only possible when a requirements document exists that clearly explains what the system is supposed to do.

Developing a software or system requirements document is important, but there is no one perfect way to do it. Depending on the nature of the project, the life-cycle model selected, and how well the project is defined at its early stages, the requirements document might use a standardized template and be fairly complete, it might be a preliminary requirements document, or it might simply take the form of an e-mail sent to the client for review. No matter how it's done, putting the requirements in writing improves the probability that both parties have the same understanding of the project.

Test system developers also are well advised to create a user-interface prototype and prototypes of tangible outputs (e.g., printed reports, files, Web pages) from the system. These might take the form of simple sketches on paper or genuine software prototypes. The purpose of the user-interface prototype is to make sure the software maintains the correct functionality. Often, the first time clients see a user interface, they remember features they forgot to tell the developer were needed, and they realize that the system would be far more valuable if greater functionality were added. Creating a user-interface prototype is perhaps the most efficient method for discovering flawed or missing functional requirements. Both parties will want this discovery made during the requirements development phase, not upon demonstration of the final product.

To the greatest extent possible, developers should identify any items that are potential showstoppers, such as requirements that push technology limits or the limits of the team's abilities. Identifying such problems might require some preliminary hardware design to ensure the system actually can be built as specified. High-risk items should be prototyped and developers should try to identify ways to eliminate the need for requirements that push the limits. Waiting until the final testing stage to find out that some requirements cannot be met is not a good idea. Even waiting until after the requirements are signed off to find that some cannot be met is unpleasant—especially if all it would have taken to prevent the problem was a few hours' research.

For outsourced development projects it is essential that the test system developer get feedback from the client and iterate as needed until an agreement is reached and, in some cases, the requirements are signed off. While performing the activities described above, the developer also should review any solutions suggested or mandated by the client. For instance, if the client says it already has the hardware and only wants the test developer to provide the software, the first thing the developer should do is request a complete circuit diagram of that client's hardware solution and carefully explain why it's necessary to fully understand the client's hardware in order to build a good software system. Flaws in the test instrumentation design are very costly to fix after the test system is built, yet it costs comparably very little to review the design ahead of time. Of course, an in-house test system developer also should evaluate the hardware design carefully before starting the software design.

Project Review Timing. It's likely that outside developers who get this far have dealt solely with the client's project team. If the project is large, however, it is not uncommon for the client to bring more people into the picture and conduct a project review after the system is complete. Some of the newcomers will have insights and desires that would result in changes—sometimes expensive ones.

If possible, this type of situation should be avoided. The system developer should insist on a project review by all affected parties before the requirements stage is concluded. It is not enough to just send around the software requirements specifications; people are often too busy with other projects to really go through them as meticulously as they should. A better strategy is to bring everybody together and show them the user-interface prototypes, the report prototypes, and any other important components of the project. Representatives of the end-users should be present as well. Although they should have been consulted during the requirements development process, the end-users are still likely to contribute valuable insights during the review.

By now it should be evident that there is more to requirements gathering than just writing a requirements document and getting it signed off. If the system doesn't work to the client's satisfaction at delivery, then it doesn't matter who is to blame. The project will be remembered by both parties as a painful experience with no winners.

PROJECT PLANNING

Every project needs a plan. The first step in project planning is to define the deliverables, then to create a work breakdown structure (WBS) hierarchy of all the project's required tasks. The WBS is then used to develop a timeline, assign resources, and develop a task list with milestones. A good project plan will also clearly define roles, responsibilities, communication channels, and progress-report mechanisms. It certainly helps to have some background or training in project management in order to plan and control the execution of the project. Some basic project management training is recommended for anyone in charge of a test system development effort. Seminars and classes in project management based on the Project Management Institute's standards are offered worldwide.

CONCLUSION

Successful test system development requires attention to both process and technology. Both clients and developers need to understand and appreciate good software engineering practices. Collaboration and communication are critical for success. Clearly defining roles and responsibilities, using efficient development processes and tools, and handling project risks early on permits problems to be handled at a stage when their effect on cost and schedule will be minimal.

REFERENCES

1. Capability Maturity Model for Software, Version 1.1, Technical Report CMU/SEI-93-TR-024-ESC-TR-93-177 (Carnegie Mellon University, Pittsburg, PA: The Software Engineering Institute/February 1993).

2. Medical Device Quality Systems Manual: A Small Entity Compliance Guide, (Rockville, MD: FDA, 1997).

BIBLIOGRAPHY

A Guide to the Project Management Body of Knowledge. Newton Square, PA: Project Management Institute Standards Committee, 2000.

McConnell, Steve. Rapid Development. Redmond, WA: Microsoft Press, 1996.

McConnell, Steve. Software Project Survival Guide. Redmond, WA: Microsoft Press, 1998.

Wiegers, Karl E. Software Requirements. Redmond, WA: Microsoft Press, 1999.

Tore Johnsen is technical director and en-gineering manager at Computer Solutions Integrators & Products in Woodbury, MN.

Figures 3 and 4 adapted from Rapid Development, with permission of the author, Steven C. McConnell.
Figure 5 adapted from Rapid Development, with permission of the author.

Copyright ©2002 Medical Device & Diagnostic Industry

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