The processes you are describing are very interconnected and come from ISO 9001 way back in the late 1980's and are considered to be good business practices by FDA and other regulators, as well as other industries. Medical devices require more documentation, perhaps.
When developing a product, you may go through numerous prototypes, which are part of the design-development process, before establishing the final
Design Outputs. This appears to be where you may be, trying to develop the final
Design Outputs. When you have arrived at the final
Design Outputs, using the prototypes, perhaps you are ready to move to
Design Verification to show that
Design Output meets
Design Input requirements. At this point, the final
Design Outputs are transferred to the
Device Master Record (FDA term) [
Medical Device File-ISO 13485 term] which is the recipe (and includes other documents as well) to manufacture the product.
Design Transfer is the process of taking the final
Design Outputs and using them and the other documents in the
Device Master Record or
Medical Device File, like QA procedures, equipment specifications, and work instructions for the operators to produce product that meets the
Design Output specifications.
Design Transfer includes
Process Validation. Design Validation and
Process Validation follow successful
Design Verification, which is the activity to show that the
Design Outputs meet the
Design Inputs.
Design Validation may be performed on units from the PQ phase of
Process Validation as they are Production Units. FDA believes that prototypes may be used during design-development process (see Comment 85 in the Preamble to 21 CFR 820), however when reaching the phase where
Process Validation and
Design Validation are conducted, you should be working with production specifications that have been though final
Design Verification and producing
full-scale Production product. Anything less is very expensive. Dr. Joseph Juran used to say the cost increases by a factor of ten at each stage of development. It would be extremely expensive to decide that the product is not correct when you have bought tooling and developed production processes for an incorrect product.
So use prototypes to develop your final
Design Outputs before moving forward. Not to say that the design-development process is serial, many things will be at various stages in development at the same time. You may have one part of the product in
Process Validation and another in creating final
Design Outputs. That is ok. But the product used for
Design Validation should be the final production product. Those who are performing the activities required in
Design Validation should see the product the customer will see.
Unfortunately, Design Controls are not all that clear. You might consider some training on the subject, such as the AAMI Design Control course.
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com------------------------------
Original Message:
Sent: 11-Nov-2019 06:45
From: Richard Jansky
Subject: Design Transfer for Prototypes
In the case of ISO 13485, chapter 7.3 is about "design&development". There, "design transfer" is chapter 7.3.8 implying to me that it should't be considered as an afterthought our even a part of the production (chapter 7.5). The definition of the FDA is in my opinion even more stringent - no *correct* production specs, no production.
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Richard Jansky
Wattwil
Switzerland
Original Message:
Sent: 08-Nov-2019 11:27
From: Julie Omohundro
Subject: Design Transfer for Prototypes
I had not thought of applying the design transfer concept to the transition from prototype to design controls, but I think it's a great idea, both in terms of assuring that all useful information about the prototype is captured and available to the design control process, and as a way to draw a clearer line between where prototyping ends and the development of an actual (reliably manufacturable) product begins.
Just to clarify, when you say "it is still a part of the design&development," what do you mean by "it"?
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 08-Nov-2019 07:01
From: Richard Jansky
Subject: Design Transfer for Prototypes
Hi Julie
that is the essence: "a process to get to a milestone" with my addition/correction that it is still a part of the design&development. Only upon its completion you get into production&service. Both ISO and FDA seem to agree on this.
Best Regards,
Richard
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Richard Jansky
Wattwil
Switzerland
Original Message:
Sent: 07-Nov-2019 12:30
From: Julie Omohundro
Subject: Design Transfer for Prototypes
In practice, all of this stuff is done many different ways, from seat of the pants to very a very formalized process. Startups tend to do more of the former than the latter.
Based on what we have seen in regulations and standards and what we have observed up close and personal, we all come up with something of our own frameworks and definitions, hopefully not to be confused with stone tablets, but as places to start and then help guide us through the confusions presented by an imperfect world...some parts of it being a good bit less perfect than others, not to name any names. :)
Under my framework, you cannot take a prototype to mass production, because a prototype is by definition a contraption that was not produced with a validated manufacturing process. At that point, it is not a medical device in any useful since of the world. A medical device is neither a design nor a prototype, but a set of verified technical specifications together with a documented manufacturing process that has been validated to reliably produce contraptions that met the specifications. This is what you can take to mass production. It may turn out that you were able to validate the process that was used to make the prototype, so the line gets blurry, but it is still the validated process, not the prototype that is taken to mass production. The prototype gets handed over to marketing, or to the serial CEO for further pitching.
I can interpret "design transfer" as a process by which information regarding a design is transferred from one person or group to another, or for one use to another. Since Karen is talking about a prototype, I think she is asking about the latter, and perhaps the latter as well. I can also interpret it as a design control under 21 CFR 820 or ISO 13485. I'm sure the use of the term in these two documents refer to what industry (not just medical devices) as long referred to more casually as "tossing it over the fence." This is when the design engineers finalize the technical specifications, hand them to manufacturing, wish manufacturing well, and go on to the next project. This is an imperfect way to develop products, but it is indeed an imperfect world, and this practice has been the by far the most common in all industries for a very, very long time.
Thus I go with "a process to get to a milestone," rather than "Design Transfer," by which I think Richard is referring to a formal design control.
(Not sure if these musings might be helpful or confusing to others, but for me it was helpful to work through them.)
------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 07-Nov-2019 07:41
From: Richard Jansky
Subject: Design Transfer for Prototypes
Hi Richard,
I'm unsure I would pass with your explanation with our authorities.
There are 2 parallel definitions:
- Design Transfer is a process to get to a milestone, the
- Design Transfer
The Design Transfer process is also commonly called "industrialization", during which the prototype is taken to a mass-produced product (as you point out "to be taken to a contract manufacturer"). Thus, this process has to be finished to be taken to production.
I wouldn't be permitted to run "initial lots" or perform "validation testing" AFTER a completed Design Transfer.
Otherwise your explanation matches my understanding.
Best regards,
Richard
------------------------------
Richard Jansky
Wattwil
Switzerland
Original Message:
Sent: 06-Nov-2019 06:50
From: Richard Vincins
Subject: Design Transfer for Prototypes
Karen,
Well the process of design transfer is not a singular event as this can occur over a long period of time depending on the device and complexity of manufacturing. The important thing to remember is that when design transfer is "done" then all production is typically done by manufacturing or say a contract manufacturer can now make the finished device. A final step of the design transfer is where the Medical Device File/Device Master Record is "complete" so all component specifications, manufacturing specification, manufacturing instructions, QC test instructions, QC test records, batch record files, etc. etc. are all in place. Wen you ask about design transfer in relation to prototype devices, this really depends. So lets look at an example. You have this prototype device for simplicity is made from 5 major components. A design transfer can occur where 2 of these components are made "in production" by manufacturing personnel. All the materials, component specifications, instructions, etc. are released for these 2 components which are made in production. The other 3 components are still be put together by development/R&D as the component specifications are not formally released and maybe there is no manufacturing instructions exist yet. Thus the 2 components have gone through design transfer, but the other 3 components are still waiting to be finalised from prototype testing or verification testing. In a simple world (smile) design transfer would be completed at end of verification stage so the device has gone through all verification testing and passed. Then design transfer is completed, so production of initial lots is performed. Then these initial production lots are put through the validation testing. Hope that helps, but remember design transfer is a process taking time sometimes even starting in the "prototype" area of design.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 05-Nov-2019 23:03
From: Karen Zhou
Subject: Design Transfer for Prototypes
Hi everyone,
In the process of prototyping before design verification, is there a design transfer process? I understand that once a design has passed verification or validation, a formal design transfer process takes place to translate into production specifications. But the process of converting inputs into outputs for design verification or to make the prototype itself, is this "transfer" documented at all? I have not seen this topic discussed. I am working for a startup so some of these questions probably have no clear-cut answers.
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Karen Zhou
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