Regulatory 4 Reasons Your Medical Device Needs an Expert Testing Lab Now

After countless hours on the drawing board and verifying that every aspect of your medical device is ready to be tested, you’re all fired up. The medical device you’re developing is the next big thing, ready to save lives and rock the world like never before. However, it must pass compliance and regulatory standards to safely and expeditiously make it into your customers’ hands.

Your next challenge? Find a suitable testing laboratory to help your medical device become compliant and market-ready. If you don’t have an in-house testing service for your company, now is the best time to outsource, select, and engage a third-party lab you can trust.

But how do you know which one to choose?

NOT ALL LABS ARE CREATED EQUAL

I wish I could tell you, “That’s easy! All test labs are the same. Just pick one.”

Unfortunately, selecting and engaging a third-party laboratory, especially for medical devices, is not simple. It requires extensive research and asking the right questions to determine if the lab you hire to analyze and evaluate your medical device is competent, skillful, knowledgeable, fully equipped, and accredited. In short, you need experts to do the job.

As a regulatory and testing specialist, I’ve spent nearly fifteen years in the lab evaluating devices for safety and quality. I’ve also participated in a US standards committee for medical electrical equipment.

During my career, I have seen almost all medical devices fail compliance tests on their first try or succeeding attempts. I have also witnessed how such failures put a toll on medical device companies that are forced to spend a tremendous amount of money and time and have to deal with stress and confusion from figuring out what went wrong with their process.

If you’ve struggled with your medical device not passing regulatory standards or want to obtain approval to market on your first try, my advice is to be meticulous in choosing your testing lab. You must only partner with testing and regulatory experts to guide and help you evaluate your device, so you don’t have to go back to the drawing board and start over.

DON’T TRUST THE BLACK HOLE

We all know a medical device goes through a rigorous step-by-step process before commercialization. But sometimes, medical device companies skip the crucial step of properly vetting the testing laboratory and entrusting their devices to an arbitrarily chosen lab.

That’s when they get sucked into the Black Hole.

Let me share a scenario with you:

A medical device company develops an innovative clinical thermometer with a clear predicate.
The company’s technical team knows what testing needs to be performed and develops a compliance strategy.
The company continues to develop the product, including executing bench performance testing and preclinical studies.
The company searches online for random laboratories that can perform third-party compliance testing.
To hasten the process, the company taps into unknown labs without considering the outcome of their selection.
After making the selection, the company sends its medical device to the unknown lab, a.k.a. the Black Hole, for testing.
Weeks later, the Black Hole sends the company the outcome of the test
The company receives the test results, which consist of more than fifty findings, all looking strange with a bunch of regulatory jargon.
The company struggles to decode the results.
After a tremendous investigative effort, the company realizes its medical device is non-compliant.
Weeks from its FDA submission deadline, the company has no clue what to do with its device.
The company fails to obtain FDA clearance. Compelled to hire an expert to guide them to the right path, the company spends more time and money than it originally budgeted.

You need to invest in experts if you don’t want to get sucked into the Black Hole, and obtain FDA approval or clearance from your regulatory body without going back and forth to the drawing board.

Entrusting your company’s premium asset to an odd testing facility that doesn’t give you the advantage to pass compliance should never be an option.

Wade Munsch, NCE

Regulatory Affairs Manager & Laboratory Manager at Criterion

FOUR MAIN BENEFITS OF HIRING EXPERTS

Here are the four main benefits of hiring experts to test and evaluate your medical device. If the lab you’re considering cannot provide these benefits, you should consider expanding your selection until you find the one that can deliver:

1. Early Intervention

As soon as you have a device concept in mind, you should start engaging with your third-party test laboratories. Many expert labs offer evaluation services that can help you identify issues with your design even when all you have are renderings.

Let’s revisit that clinical thermometer we spoke about earlier. A good lab with experienced personnel can identify many potential non-conformities within minutes of seeing your device, such as:

Misidentification of essential performance, including not providing an output temperature or generation of technical alarm conditions
Creepage and clearance issues for batteries, such as providing two means of protection between parts of opposite polarity up to the protective device
Use of unrecognized safety critical components like a generic power supply
Battery constraints related to appropriate standards, short-circuiting, and charging
Package design issues like walls that are too thin which can break/crack during transportation and distribution

Some of the best, most productive meetings I’ve had with clients happened early in the design phase. That’s because:

Things were still so fluid, and there were no hurdles to overcome in making changes.
Many design updates could be made to ensure compliance with a particular test. They could also be avoided altogether, thus saving the clients time and money and the risk of non-conformance.
Since the design was not frozen at the initial stage, the feedback could be incorporated easily, leading to a premium and elegant product (no copper tape, conductive spray coatings, unnecessary glue joints, retrofits, etc.).
The project schedule could be easily updated based on the feedback received. Updating the schedule without feedback could have posed more challenges as the project progressed.

2. Accuracy and Quality

If you select your third-party test laboratory through an internet search and focus on cost, you might be setting yourself up for failure. Instead, base your search on these questions:

Q: Are they accredited?

Accreditation is an independent assessment by a third party that confirms the lab operates within a quality management system, knows what it’s doing, and can prove its findings with objective evidence.

Accreditation by a third-party lab, such as A2LA, is a higher standard than the conformity assessment standards (ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories) alone. That’s because the requirements part of the process is more than just an assessment against ISO/IEC 17025. It also includes additional requirements related to measurement traceability, proficiency testing (inter- and intra-laboratory comparison), and general requirements, including special requirements in specific fields.

Q: Is my testing within their scope?

After you’ve verified the lab you’re considering is accredited, you need to review its scope of accreditation to determine if the testing you’re requesting is within the lab’s scope. Using the clinical thermometer as an example, one standard you must comply with is ISO 80601-2-56, an electrical safety testing standard, particularly for clinical thermometers.

So, how do you go about checking the lab’s scope?

It’s hard to tell how extensive a lab’s scope can be, so it might be easier to email the lab’s sales department and ask if the ISO testing you’re looking for is within their scope. When reviewing a laboratory’s accreditation scope, remember to note the standard’s year or edition.

Q: What is their expertise?

Another essential factor you should look for in selecting a third-party test laboratory is their area of expertise. Many labs have scopes that span many different product types and technologies.

In my experience, I have found working with a lab that specializes in medical device testing to be the most advantageous. They tend to have more specialized engineers/technicians familiar with many different medical devices from which you can benefit. Remember, using an accredited laboratory with the appropriate scope and expertise is one way to ensure you will receive accurate test results and the highest quality of service.

3. Transparency

Many labs are designed to operate as Black Holes. You throw your product in there, magic happens, and a compliance or non-compliance report pops out. You DO NOT want to work with a lab like that.

Although testing is conducted against written standards, the application of specific tests to your product could be subject to interpretation. You want to partner with a lab that recognizes that and is willing to reach out to you to discuss your particular application.

For example, performing the laboratory accuracy test for a clinical thermometer with a dedicated temperature probe that is remote from the main body of the equipment is very straightforward. But how do you perform the test when the temperature probe is integral to the main body of the equipment, which is so tiny you cannot have part of the equipment in ambient conditions and another piece in the water bath?

The laboratory should:

Be available to answer questions about tests along the way and provide updates.
Have a transparent and clear process.
Allow you to have direct contact with the staff involved in the actual evaluation/testing.
Notify you if a critical non-conformity arises, so you have time to address the issue while the lab continues its assessment.

4. Quick Compliance and Clarity

Before engaging a third-party testing lab for your medical device, you need to ask how the lab handles non-conformities. Some labs may give you unclear or varied answers. Some may leave you clueless, withholding crucial information until the end.

You need to find a lab that utilizes a balanced approach and knows the difference between a minor and major non-conformity. You don’t want to be inundated with emails or phone calls from your lab every few minutes letting you know you’re missing specific texts from your IFU, as those are typically easy to update.

Throwing the book (standard) at you and simply reporting a non-conformity doesn’t cut it either. The lab should help you understand each non-conformity and provide possible mitigations. Remember, professional labs with years of experience testing medical devices can clearly explain the standard’s requirements and provide alternative routes to compliance.

THE CRITERION WAY

Thirteen years in the testing and regulatory environment have molded me to acquire a deeper understanding of the medical device industry. It has also given me sufficient data and knowledge on how I can help businesses like yours thrive by getting your devices approved to market through systematic, robust, trustworthy, and proven testing methods.

Let me start by guiding you to the right path.

At Biotex, a premier medical device manufacturing company with over 25 years of experience in the industry, we tap into the expertise of Criterion, our in-house testing laboratory, to prepare our clients’ devices for successful commercialization. As the current Regulatory Affairs Manager of Biotex and Laboratory Manager of Criterion, I work with medical device companies like yours by delivering a thorough and cutting-edge process to test, evaluate, and re-evaluate medical devices for prompt regulatory approval and successful commercialization.

We can help you, too.

At Criterion, we guarantee:

Early Intervention

Criterion is there for you at any stage of your product development. We want to be by your side at every stage of your journey and see your product succeed.

Accuracy and Quality

Criterion is accredited by A2LA (certificate number 6538.01) in the electrical field of testing for six testing categories and over twenty standards.

Transparency

Criterion offers a transparent process where engineers are available to provide status updates and answers to your questions at every stage of the testing process.

Quick Compliance and Clarity

Criterion understands the importance of early intervention when there are critical non-conformities. It will provide a clear and detailed report based on its expert findings to help you determine your medical device’s specific needs to meet compliance.

Using our broader experience in the medical device industry, we at Criterion have an extensive understanding of the market, giving us leverage in providing better assessments and evaluations for those who seek our help, including you.

Because Biotex and Criterion have been in the medical device design, development, and manufacturing business for more than two decades, we can assure you that we have walked your path and worn your shoes. We also understand and can deeply relate to the blood, sweat, and tears you have poured into your product.

We want to be there with you at every step of your journey, from designing your product to seeing your medical device get approved for marketing, so it can thrive, save lives, and rock the world like never before.

That’s our standard in testing, and that’s the Criterion Way.

Visit us at Criterion to learn more.

About the author:

Wade is the Director of Regulatory Affairs for Biotex, Inc. and the Laboratory Manager for Criterion, a Biotex, Inc. service. He has worked in compliance for over 14 years, including standards development and electrical safety evaluations with a specialty in medical devices. Throughout his career, Wade has worked for Certification Body (CB) and Nationally Recognized Testing Laboratory (NRTL) test laboratories and medical device manufacturers.