Balancing Grade vs Quality

Grade vs Quality – it’s not a competition

 

Grade and Quality are distinct concepts that are often confused and merged in MedTech product development. Both are a crucial part of the innovation process, but they are different.

How??

In essence, grade is about the level of performance or features the product offers, while quality is about conformance to requirements and how well the product performs according to its specifications.

 

So, a product can be high-grade or low-grade. A low-grade product is acceptable as long as it meets the specified engineering and quality standards and delivers what it promises. Both low-grade and high-grade products hold value for the customer.

 

In more detail - grade refers to the category or class a product belongs to, based on the intended use or market segment. It indicates the features, functionality, or performance of a product, often relative to others in the same category and positions the product’s intended level of performance.

 

A high-grade product typically offers more features, better performance, or premium materials, while a low-grade product may be more basic with fewer features. Both products may still meet customer expectations based on the price point and intended use.

 

Quality refers to the degree to which a product meets its specifications and satisfies customer requirements. It is about how well a product is designed, manufactured, and maintained to function without defects or issues.

 

Quality is not related to grade, but rather to consistency and reliability. A high-quality product, regardless of its grade, performs as expected and meets customer satisfaction. Poor quality means there are defects or issues that prevent the product from performing its intended function effectively – not an option within MedTech innovation.

 

So for example, a luxury car is of a higher grade compared to an economy car, but both still serve their purpose and meet consumer needs within their respective markets.

A low-grade economy car can still be of high quality if it functions reliably, meets its specifications, and has no defects. Conversely, a luxury car could be of low quality if it frequently breaks down or doesn’t meet performance expectations.

 

Within the MedTech world hip prosthetic systems are a great example. There are a multitude of devices on the market – from metal-on-plastic to ceramic-on-ceramic (and many combinations in between). The ceramic-on-ceramic option is higher grade, and more expensive, as it will typically last for longer and is most likely to be used in younger patients. A metal-on-plastic implant costs less but is still effective and should still deliver a positive outcome for the patient, who would likely be older.

 

The quality of any hip prosthesis from a manufacturer all attain the same quality standards, as they meet their respective engineering, material, process specifications, no matter the grade of the device. If they didn’t meet the specifications then they would fail the quality (verification/validation) processes.

 

So, both low-grade and high-grade products can be high-quality if they meet their respective standards and customer expectations.

 

Archetype’s principal consultant, Dr Stuart Grant, says: “During my time working and living in China, I led a team to design and develop a new knee replacement instrument set for the Chinese and Indian market

 

“These markets requested a lower cost set. A typical set in these countries represents a significant investment of between $20,000 and $30,000, because hospitals don't buy the sets, they loan them from the manufacturer. So, we were tasked with producing a set costing less than $10,000.

 

“To meet this target grade was key to the design strategy. Manufacturing in China reduced the cost by 20%, with no impact to grade, and then we reviewed, with the users, which functions and features were "nice-to-have" and which were essential.

 

“As a result, we removed the largest sizes from the kit, which were used less than 1% of the time and we reduced the fine-tune angle variation, which surgeons indicated would suffice in 95% of cases. These and many more design changes enabled the team to hit the target cost, and meet all quality requirements, but at a lower grade.

 

So, both low-grade and high-grade products can be high-quality if they meet their respective standards and customer expectations.

 

In summary, for MedTech product innovators quality is non-negotiable, but grade must also be considered and stated from the start, to ensure that the right product is being designed for the market, which in turn can mitigate or limit overshooting the product design.