How do you qualify your sources or suppliers of titanium and other materials, which type of quality controls do we have before? What are the requirements?
Basically, for the suppliers, we follow the section and the requirements
for supplier management and supplier controls defined by the ISO 13485
standards. So, we have a full procedure compliant with that ISO standards that we use to control our suppliers.
From a business perspective, are there any niche opportunities to scale the business? Maybe, it has to do with technologies, market segments, or other things?
It’s an interesting question because, niche opportunities it turns out that
they exist, because there are, in our opinion, still a lot of applications, especially in the medical device industry that are not printed today. Maybe because it is a niche product, but certainly these can be very interesting for us as a company to have like a first-mover advantage in a certain niche market or niche application to really leverage, our expertise and to scale the business, so, yes, for sure there are opportunities. Additionally, niche doesn't have to mean it is small. We are aware that there are a lot of opportunities in that sense.
Are you looking for opportunities in a specific region, only Europe or worldwide? What's your focus on that?
We are active basically worldwide, but in terms of medical device manufacturing, the majority markets for us are the United States and Europe, but we're open to any geographical market basically.
Is your implant the medical device or the whole printer?
The printer it's not a medical device, right? The implant is a medical device, and the printer is just a piece of equipment that is manufactured, but it's used to manufacture the implant or the medical device.
In that sense, the printer is comparable to just a CNC machine or a forging
machine to just a piece of manufacturing equipment that's used as part of the production workflow to manufacture the medical device.
How do you guarantee your quality in a once-off implant and how is that approved by the notified body?
This is something that there's a lot of attention being put on that aspect
lately by notified bodies as well, but really what that trickle down to is, again,
coming back to very specific product specifications.
We are not the legal manufacturer, we're the contract manufacturer. But our
customer who is the legal manufacturer will need to be very clear in identifying what variables are all available within that one-off implant, what can change, what is critical to the product, and what is the range in which these parameters can change. Based on that, we must make an analysis about what is the worst case, products that can happen or that can be manufactured or oftentimes it will be multiple worst cases, different combinations of certain parameters, and all of those must be validated and confirmed that they can meet the acceptance criteria of the customer.
Does a one-off implant need to go through that whole process with a
notified body before inserting that into the patient?
No, that's not the case as of today. It's more of a ramp-up where you
define your projects, where you define your bookends and your worst cases,
which can take up to a few months, order of magnitude of months, depending on the application. But then once that is defined, every new implant that gets
designed within that scope, within that framework, can just be manufactured
quickly without any resubmission or anything like that.
What's the timeline of manufacturing once you have that in place for one patient? How fast can you move from order to delivery?
Again, depends on the application, but we typically talk about a week if it's
urgent and if everything is set up properly.
Do you offer only the additive manufacturing service or does Amnovis also offer post-processing like CNC milling of screw threats?
The core focus is additive manufacturing, but we also are very aware
that you need a lot of post-processing with the additive manufactured parts. So that's why we offer the full solution to our customer base. We also offer, for
example, the CNC million screws, that's something we offer.
Because you adopted a quality focus/ mindset early in the business, have you found that this has helped with building a stronger company? Many companies find QA, a burden and fail to see the value. Is your experience different?
The short answer is yes. We indeed put a lot of focus on that. Not only by
looking at the mindset and the values of our employees but also by creating a
quality management system that is a tool rather than a burden.
Even people in production after working on a product, come to the office and
say: I have this idea on how we can improve the stability of this process or how
we can reduce the time or the cost that it takes to manufacture this product. Is it okay if I create a change request for that? I think that shows that our quality management system is working for us rather than against us. And we use our change control process to implement these improvements. That's how the quality management system offers improvement into our day-to-day operation.
Do you use an ERP as well next to Scilife?
We do. We use Scilife for all our QMS-related activities, but we use a
commercially available ERP system like a CRM for follow-up, PO, sales orders,
and so on.
Which is the validation process?
Sure. We will not dive into all the details of our validation approach,
because some of it is a little bit of our trade secret and because it will be long to explain.
But what you can imagine is that our validation approach is based on let's say
conventional IQ, OQ PQ methodology, looking at the process rather than the
product. Again, very important, and another aspect that comes into play is that with additive manufacturing, you are manufacturing your raw material while you are manufacturing the product. So compared to CNC, where do you have bar stock, and you manufacture a geometry out of that, we are manufacturing geometry, and raw material properties at the same time. So that complexity, adds on an additional layer of validation activities, that we have integrated within that conventional IQ OQ PQ.
What is your requirement with regards to regulatory information for the material you use?
We look as much through regulatory requirements or information, but
more towards, what our customers are asking from us. Did the customers come to us with either a product and a material that they want to have or that they think they need for the product, or did they come to us with a product with some mechanical requirements? Based on that, we define the material, but regulatory information it's then got boils down to: is this a standardized material? And can we refer to any ISO standard or AFTM standard that we comply with?
Or if not, what guarantees can we give to our customers, regarding chemical
composition, and mechanical proper spike structure that helps them to file for their submission? If that's the case, we can provide that information. But for example, Ruben mentioned that Tanium grades one, a material sort of pure titanium that we have available. There we have a process validation that we can show to our customers and where we can prove to our customers, that this material is fully compliant with all the requirements of ASM F 67, and that makes it easy for them. That gives them all the information that they need for their regulatory submission to say, look, this material is compendial, it meets all the requirements, so it's safe to use.
As a contract manufacturer what kind of tests do you need to do to assure that implants are safe?
Like we briefly mentioned during the webinar, our controls are set up on
two levels: on the process level, every process is controlled to reliably meet its
expected output regarding the characteristics that can be important for an implant, such as chemical composition, mechanical properties, dimensional
accuracy, and cleanliness. For these process-level controls, we set up regular
testing with standardized coupons and test methods, depending on the process variability we observe during our process validation. Then on the product level, whether or not additional testing is required depends mostly on our customers and the critical product characteristics that are defined during the implant development. Often we see that, for the implant to be safe, the assurances we can provide with our process-level controls are sufficient to have confidence that all critical product characteristics are guaranteed to meet the criteria. If however, that is not the case, the kind of tests and the frequency really depends on the product characteristic that needs to be controlled, and the level of statistical confidence that needs to be achieved
So, you have one generic wide implant application?
I think this question is a follow-up to the discussion on one-off implants:
We don’t have one generic wide implant application, because it is virtually
impossible to define a single application that truly covers the worst case of every possible implant feature, and thus working with such a generic worst case can give customers a false sense of security. Instead, we carefully look at the scope of different projects or implant groups and define a minimum number of worst-case implants that are sure to cover the entire range of products
Have you considered the MDR requirements for supply chain
I assume you are referring to the requirements for medical device OEMs.
As Amnovis is a contract manufacturer and not a legal manufacturer, we fully
comply with ISO 13485 and our customer requirements related to supply chain responsibilities.
Do you see/expect an impact of the new medical device regulations in Europe?
Yes and no. Most European medical device OEMs are busy with the
transition from MDD and MDR, which basically means they don’t have the
capacity for new or innovative projects. Which makes it more challenging to find new business opportunities. On the other hand, we already comply with our customer’s requirements and don’t see an impact on our QMS or operations when working with European medical device OEMs.