Formlabs announced a very unusual partnership that could lead to dramatically increased quality on all of their equipment.
The partnership is with Greenlight Guru, and their business is quite unusual. They have developed a system that can assist product developers to produce high quality medical devices.
Now, you might be wondering what Formlabs has to do with this, but in fact the company has for several years been focusing on the dental market, and indeed has branched out into other healthcare sectors. While they make “3D printers”, they are really “3D printers used in healthcare settings”, and as such must be treated as official “medical devices”.
Any medical device must pass certain regulatory standards to be used, otherwise the manufacturer (Formlabs) could be held liable should something go wrong. For this reason several additive manufacturing companies have sought to obtain the necessary certifications for their products.
Formlabs has done that, particularly with their materials that are used when producing healthcare application items on their equipment. They actually hold a number of these certifications, and are likely to obtain more in coming years.
But what does Greenlight Guru do?
They assist manufacturers by providing systems to help coordinate certifications and other quality aspects throughout the entire product design lifecycle. Their mantra is to change companies from focusing solely on meeting compliance measures, and instead shift to overall quality. They say:
“Focusing on compliance is the problem, not the answer.”
“Just because a restaurant doesn’t get any health violations doesn’t mean they are making great food. And it doesn’t mean that they will be in business tomorrow.”
This is so true, and directly relates to the additive manufacturing industry: just because a provider can say they have a particular certification doesn’t mean the product is the best quality.
Greenlight Guru has an interesting chart showing the differences in company culture that can be found in a “compliance” company versus a “quality” company:
|“Compliance Company”||“Quality Company”|
|Just get by|
Get through a single audit
Remain liable for future audits
View compliance as a necessary evil
Get comfortable kicking the can
Make decisions without the data
Open up unnecessary risk
Plug holes with resources
React to ﬁre drills
|Are more productive and innovative|
Receive fewer complaints, investigations, and open fewer CAPAs
Have lower quality-related product costs than their competitors
Instill customer conﬁdence and loyalty that their devices will perform as intended
Free resources that foster innovation and accelerate new product introduction
Mitigate risk leading to higher business valuation
Formlabs said the partnership would allow them to achieve the following:
- Streamline design and development efforts with Formlabs’ 3D printing solutions for cost-effective design iterations and Greenlight Guru’s multi-level traceability matrix and integrated risk management.
- Maintain compliance with biocompatible materials made in U.S.-based, FDA-registered, ISO 13485 certified facilities and a solution with built-in QMS controls that align with 21 CFR Part 820 and ISO 13485:2016.
- Increase return-on-investment with quality and accuracy throughout development through high-accuracy printers and a quality system that supports auto compilation of design records.
- Decrease time to market and accelerate scaling from prototype to production with a single printing platform alongside leveraging a single source of truth for all product development, regulatory, quality, and manufacturing processes.
That’s certainly good news, but it also poses a challenge for the rest of the 3D print industry.
Let’s be honest; most 3D printers can be flaky. The random combination of machine, material and software rarely results in good results until at least a few iterations have taken place. That’s why many 3D printer manufacturers have taken steps to controlling that equation with downloadable parameter presets. That’s good, but what Formlabs is doing with Greenlight Guru is on another level entirely.
While Formlabs is already well-known for their high quality and ease of use, it’s quite possible their equipment and overall user experience could grow even stronger. The relentless focus on quality that could result from the partnership may generate equipment and materials that are virtually guaranteed to produce a quality result.
That’s something 3D printer operators have dreamt of for decades.