Yielding Benefits

Manufacturers who plan to sell their products in the global market will realize even more benefits from their early engagement with a third-party testing partner.

The technological revolution of the past decade has been instrumental in improving healthcare. Physicians can quickly access information about patients, patients have a wealth of knowledge available about how to manage their health, and medical devices themselves continue to advance beyond anyone’s expectations.

In the already fiercely competitive medical device industry, manufacturers seek the advantage of being the first to incorporate new technology, such as wireless connectivity, into their latest devices. However, manufacturers are also well aware of the delicate balance between ensuring their products represent the quality they promise and staying ahead of the competition.
 

Benefits of Early Testing
Creating a high quality product that will meet the medical community’s expectations begins during the product design and development process. Third-party testing partners can be a tremendous resource to manufacturers during these early stages of product design, bringing an external perspective on industry standards that can shed light on opportunities to improve product attributes.

Accepted standards exist to ensure the safe and reliable performance of medical devices. As new technologies emerge, standards will evolve to incorporate these new technologies. There are also numerous areas of crossover among standards; for instance, a medical device that has a light may need to be tested against lighting and medical device standards, whereas a medical device that incorporates wireless technology will have to meet Federal Communications Commission (FCC) requirements in addition to the safety requirements for medical devices. The right third-party testing partner will have an in-depth understanding of all the required standards and specifications for many different types of products and can work with manufacturers to determine to which standards a new product would be subject. This knowledge, taken into account at the beginning of product design, streamlines development and prevents costly flaw identification closer to the point of market entry.

Early testing can also prevent small issues from becoming serious problems. The presence of even the smallest non-compliance issue during safety certification can stop a product launch in its tracks. Rather than inadvertently expending time, money, and energy to create a product that does not meet market access requirements, manufacturers can engage a testing partner to conduct a design review. The design review would reveal areas of non-compliance so the manufacturer could make adjustments. This, in turn, can increase the likelihood that the product will pass later safety tests on the first try.

Creating a high quality product that will meet the medical community’s expectations begins during product design and development.

Manufacturers who plan to sell their products in the global market will realize even more benefits from their early engagement with a third-party testing partner. While globalization provides immense opportunity from a revenue perspective, it is not without its challenges. The regulatory process, and in some cases the standards themselves, differ from country to country. Staying abreast of the various country deviations in safety requirements and the multitude of different processes for obtaining regulatory approval worldwide is a significant undertaking. However, engaging a third-party testing partner with global capabilities early can assist manufacturers in understanding and preparing for different requirements as they progress through the product design and development cycle. This will prevent manufacturers from having to back-step and retrofit to address the country-specific needs once a product is already in production.

There is also a possibility that a manufacturer’s next great idea is so innovative and unique that no standards exist against which to test it. A third-party testing partner’s deep knowledge of industry standards would likely recognize this scenario faster. If this situation arose, the testing partner could help the manufacturer understand what is required to meet an existing standard. This would prevent the manufacturer from wasting time and resources developing a product that is not certifiable for market access, and will never deliver a return on investment.

In any of these situations, waiting until a product is in the production stage to have it tested is clearly a costly mistake. Experience has proven that engaging a testing partner during product design and development significantly increases the likelihood that the product will pass its safety certification test the first time around because areas that may not have been up to par with industry standards will already be identified and addressed. The alternative – failing the assessment – will mean the development team will have to go back through the product’s technical drawings and correct problems with the design, wasting valuable time and creating significant delays in the product’s launch. It will also have a significant financial impact, resulting from the cost of redesigning the product, need for additional testing, and loss or delay of revenue.

Time is money. With the competitiveness and speed of innovation in the medical device industry, this saying holds true now more than ever. Engaging the right testing partner early in the product design and development process creates immense opportunities for medical device manufacturers in terms of saving money, streamlining product development, maintaining a company’s competitive edge, and entering the global marketplace. A testing partner can also provide the expertise to help manufacturers meet industry requirements and provide best in class solutions ahead of the competition.

In the end, manufacturers can be confident that their products exceed the medical community’s high quality standards, which are vital to the health and well-being of the patients.

Intertek
Arlington Heights, IL
intertek.com