Medical device regulators around the world often have to assess the cost of a new regulation. Typically there is a study to determine the financial effect on industry and the public. This information is often supplied to lawmakers in their respective countries before they pass new legislation. In contrast, and because they are voluntary and not legal requirements, technical standards created by ISO, IEC, and other standards development organizations are not screened or vetted with the same degree of accountability. This is partly why regulators insist that such privately created standards remain voluntary.
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Nonetheless, regulatory requirements are not technical, but legal requirements. Regulators trying to manage the safety of all kinds of medical devices and other goods rely on technical standards as an important benchmark for determining a product’s safety and performance. As such, regulators defer to technical organizations to set the technical bar that companies must meet to ensure the safety of a product. Regulatory authorities have often accepted that a product that has been certified to a particular safety standard has met the legal requirements for safety. In the United States, for example, many electrical products must meet standards written by UL or IEC to gain OSHA approval. However, the increasing complexity and breadth of these product evaluations has caused a dramatic increase in the cost. Other regulatory agencies that use standards are taking notice.
In one case, the third edition of the basic safety standard IEC 60601-1—“Medical electrical equipment—General requirements for basic safety and essential performance” makes it mandatory to apply another standard, IEC 62366—“Medical devices—Application of usability engineering to medical devices.” This collateral standard looks at safety issues related to the “usability” of a medical device.
By “mandatory” we mean that a testing lab cannot certify that your product “complies in full” with the basic safety requirements in the latest version of IEC 60601-1 until all the applicable “normative” (i.e., mandatory) “collateral standards” (i.e., related standards) are also applied to the basic evaluation. This is a new era in the use of collateral standards, and it has caused basic safety evaluation costs to balloon as high as $150,000, even for low-risk medical devices.
As third-party laboratory testing costs continue to skyrocket, it is becoming more important than ever to find reasonable alternatives to using some of these standards. This has become an especially dire concern of small manufacturers that simply cannot afford these costs. The International Trade Administration reports that 73 percent of the U.S. medical device industry has fewer than 20 employees. They cannot afford a $70,000 to $150,000 product-evaluation fee to be certified to IEC 62366. This one “collateral standard,” added to the basic safety standard, now equals a 1,500-percent rise in the evaluation costs since the year 2000, when the first IEC 60601-1 standard entered into use.
To put things in perspective, average car prices have increased a mere 130 percent during the same 14-year period. In fact, the “basic electrical safety” testing alone has climbed high enough to match the average U.S. car price of $27,000. With the added usability evaluation to IEC 62366, the cost is equivalent to four cars or more, which can feel much worse if you’re a manufacturer operating in a developing country.
Figure 1:here
During a recent training session on the role of standards in conformity assessment, many of the attendees from developing economies sounded a voice of desperation about the costs of applying some of the latest IEC safety and “usability” standards. Regulators in Asia are taking notice, especially as these costs are compounded for economies with a lower purchasing power parity (PPP). In essence, for a company in a developing nation, these costs feel even higher. A $100,000 lab test in the United States or Europe would feel like $300,000 in China or $500,000 in India, as seen in figure 1. For manufacturers in some of these countries, a fee of this nature is akin to purchasing a fleet of cars, because they have 25 percent or even less purchasing power than more developed nations.
Does all this sound crazy? Imagine a manual blood pressure cuff that requires some skill to use. Compare it to a battery-powered one with software and user controls that almost anyone can use, making it ideal for those who need to monitor their own blood pressure. Because it is a medical device, the manufacturer might be required to ensure its compliance with IEC 60601-1, third edition; IEC 62304 for software; and IEC 62366, if the “latest standards” have to be applied. This can amount to up to $200,000 in costs, even though the device is fairly simple.
Now imagine that you are a medical device manufacturer in India trying to produce and sell this important and easy-to-use diagnostic tool for use in rural communities. The implications of these costs go far beyond posing an unreasonable burden on a small manufacturer; they can affect society as a whole by limiting the type of equipment available to developing countries.
What are the alternatives?
Two organizations representing medical device regulators, the International Medical Device Regulators Forum (IMDRF) and the Asian Harmonization Working Party (AHWP), have established that products that have a proven record of safety should not have to meet the latest technical standards. IMDRF and AHWP have both issued guidance for regulators to adopt worldwide, which indicate that technical standards are voluntary. They have also indicated that using national and obsolete standards can be acceptable, where they have proven their place in meeting certain essential principles of safety and performance. These “essential principles” are based on the GHTF/SG1/N68:2012 “Essential Principles of Safety and Performance of Medical Devices” guidance document issued by the now-defunct Global Harmonization Task Force, and later adopted by the IMDRF and AHWP. In fact, many IMDRF and AHWP members have adopted this document as their own legal standard, which allows for using older or newer standards, or none at all, under reasonable conditions that prove that the alternative technical approaches work.
They also make it crystal clear that products on the market should not be changed or reevaluated to newer standards, unless a safety issue has been discovered. Only then does the identified safety issue need to be resolved.
All that is well and good, but regulatory auditors often want the easy way out and will simply look to see if you are certified to the latest technical standard. If you aren’t, you are going to have to stand your ground and make the case that your product is legally safe. How a manufacturer chooses to prove its device meets the legal requirements for safety and performance is up to it, but reviewers from a regulatory authority can always disagree. This is why field data should be used to quantify the number of patients treated successfully using the older methods. Providing data that a similar device has treated a million patients with no safety issues gives the authorities more leeway toward accepting an alternative approach. From good data on good products, the manufacturer can begin to transfer what it has identified as “proven methods” to newer devices during the design phase of a new product.
This approach of proving a device is safe and effective by utilizing attributes from proven products is much like the “predicate device” paradigm the FDA Office of Device Evaluation continues to use. It is even better when applied using a risk-management system approach, like that of ISO 14971. ISO 14971 is now widely used by regulators and industry as a means of identifying and managing risks of medical devices.
What does it all mean?
The bottom line is that in many IMDRF and AHWP member countries, medical device manufacturers are legally obligated only to meet a regulatory standard. For most IMDRF and AHWP members, that means following the standard GHTF/SG1 N68:2012—“Essential Principles of Safety and Performance of Medical Devices,” which has been adopted by many regulatory agencies, including the European MDD; Asia, under the ASEAN MDD; and even the U.S. FDA under the FDA Pilot 510(k) program.
On a practical level, however, if you choose one of the alternate methods of proving conformity to the essential principles, you most likely will have to stand your ground with regulators and make your case using your field data.
Addressing legal requirements at the technical level is always critical, but it does not have to cost as much as a fleet of cars. Regulators and industry can find common ground using other methods, and it may be a matter of survival for those smaller businesses, especially among the developing nations.
Comments
there is nothing better than knowledge of your product design
Very interesting article! A great number of SMEs in Medical device world seem to be anxious of the growning costs of compliance to new requirements.
There is nothing better than knowledge of your product design and the current performance of it. Mapping these caracteristics and knowledge nicely versus the added value of compliance will justify you not being 100% compliant. it is not enough to say that the new requirement will bring only cost, one should say the compliance to new requirement will not teach me new things about my product.
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