BiocompCHATibility Archiv
38 Episoden
23 Minuten
In this episode of NAMSA’s BiocompCHATibility Podcast, our hosts discuss early feasibility studies and the scope of biocompatibility necessary to get started. They highlight the importance of controlling device response in a small patient group and how this approach shapes biocompatibility considerations within the framework of risk management.
“The control measure of just having a few patients is definitely used as a reason why, in part Biocompatibility doesn't need to be as extensive as it needs to be for a pivotal where you have hundreds of people and commercialization where you lose practically all control.” – Don Pohl
“I want to make sure I'm choosing materials that I can support in my plan that I know have a general knowledge of safety.” – Sheri Krajewski
“There's no specific guidance that tells you what you have to do in terms of testing and what you don't, but the concept is you're going to creep up on everything you'll do. You'll do some biocomp for early feasibility.” – Don Pohl
Key Discussion Points:
Crafting a dynamic biological safety plan that evolves over time
Establishing a robust evaluation strategy from the beginning to prevent missing important tests later
Designing studies for high-risk cardiovascular implants and the importance of addressing biocompatibility and safety concerns
“The control measure of just having a few patients is definitely used as a reason why, in part Biocompatibility doesn't need to be as extensive as it needs to be for a pivotal where you have hundreds of people and commercialization where you lose practically all control.” – Don Pohl
“I want to make sure I'm choosing materials that I can support in my plan that I know have a general knowledge of safety.” – Sheri Krajewski
“There's no specific guidance that tells you what you have to do in terms of testing and what you don't, but the concept is you're going to creep up on everything you'll do. You'll do some biocomp for early feasibility.” – Don Pohl
Key Discussion Points:
Crafting a dynamic biological safety plan that evolves over time
Establishing a robust evaluation strategy from the beginning to prevent missing important tests later
Designing studies for high-risk cardiovascular implants and the importance of addressing biocompatibility and safety concerns
40 Minuten
n this episode of NAMSA’s BiocompCHATibility podcast, we welcome back Dr. Phil Smiraldo (Principal Toxicologist, NAMSA) for his third appearance as an honorary host. The discussion centers on the complexities of equivalency in biocompatibility, examining how equivalency can range from simple to complex and how a predicate device does not always equal equivalency.
Listen in as we explore these topics with Dr. Smiraldo and gain insights into the intricate world of biocompatibility and the challenges faced when trying to establish equivalence between medical devices.
“The world of equivalency runs the spectrum from incredibly simple to probably way too complex.” – Don Pohl
“When we do these types of extractions on, we'll say prior devices and change to device, we're going to have variability within our experiments.” – Phil Smiraldo
“You know whether you call it an equivalency assessment or change control assessment. Whatever you want to call it, I mean [10993] part one tells us if there's a change, you have to evaluate it.” – Don Pohl
“I guess long story short, you could theoretically go through this whole exercise and end up with the two devices that are equivalent from a systemic toxicity perspective and that's it.” – Phil Smiraldo
Key Discussion Points
Importance of confirming identical materials of construction, device categorization, and the IFU to ensure that the device remains equivalent
The detailed process required to establish proof of equivalence
The critical role of adhering to standards in biocompatibility assessments
Listen in as we explore these topics with Dr. Smiraldo and gain insights into the intricate world of biocompatibility and the challenges faced when trying to establish equivalence between medical devices.
“The world of equivalency runs the spectrum from incredibly simple to probably way too complex.” – Don Pohl
“When we do these types of extractions on, we'll say prior devices and change to device, we're going to have variability within our experiments.” – Phil Smiraldo
“You know whether you call it an equivalency assessment or change control assessment. Whatever you want to call it, I mean [10993] part one tells us if there's a change, you have to evaluate it.” – Don Pohl
“I guess long story short, you could theoretically go through this whole exercise and end up with the two devices that are equivalent from a systemic toxicity perspective and that's it.” – Phil Smiraldo
Key Discussion Points
Importance of confirming identical materials of construction, device categorization, and the IFU to ensure that the device remains equivalent
The detailed process required to establish proof of equivalence
The critical role of adhering to standards in biocompatibility assessments
35 Minuten
In this episode, our hosts are joined by Charles Ducker, PhD (NAMSA's Senior Director of Analytical Services) who recently returned from Korea, where he provided training to the MFDS (Ministry of Food and Drug Safety) about ISO 10993-18. Throughout this discussion, we review the use of the standard and how it is adopted by Korean authorities. We also explore the challenges that lie ahead for device developers and testing labs.
“I think they [MFDS] were maybe surprised at the complexity. Laying out the information you have on your materials and the knowledge that you already have that may not lead to doing testing.” – Dr. Charles Ducker
“They were interested in how to apply ISO 10993-1 and how you apply ISO 10993-18 to the standard. And they want to know how to assess whether a laboratory has conducted the test appropriately.” – Dr. Charles Ducker
“One of the things I thought was very interesting… around Part 18, was what is different now versus the outdated version, and what changes came about. We had a lot of discussion about what is required and one of the big ones was AET [Analytical Evaluation Threshold] and how we calculate it.” – Dr. Charles Ducker
“Also, about how we qualify methods, what components go into that and what data you have to have behind the scenes to support the fact that your methods are appropriate for the intended use.” – Dr. Charles Ducker
Topics include:
Korea’s current position with the use of ISO 10993-18
Qualification of a laboratory for chemical characterization testing
Solvents and temperatures, and the justifications for each
“I think they [MFDS] were maybe surprised at the complexity. Laying out the information you have on your materials and the knowledge that you already have that may not lead to doing testing.” – Dr. Charles Ducker
“They were interested in how to apply ISO 10993-1 and how you apply ISO 10993-18 to the standard. And they want to know how to assess whether a laboratory has conducted the test appropriately.” – Dr. Charles Ducker
“One of the things I thought was very interesting… around Part 18, was what is different now versus the outdated version, and what changes came about. We had a lot of discussion about what is required and one of the big ones was AET [Analytical Evaluation Threshold] and how we calculate it.” – Dr. Charles Ducker
“Also, about how we qualify methods, what components go into that and what data you have to have behind the scenes to support the fact that your methods are appropriate for the intended use.” – Dr. Charles Ducker
Topics include:
Korea’s current position with the use of ISO 10993-18
Qualification of a laboratory for chemical characterization testing
Solvents and temperatures, and the justifications for each
38 Minuten
On the latest installment of the BiocompCHATibility podcastis episode, our hosts are joined by Dr. Phil Smiraldo for his third feature3-peat episode on the podcast.
The conversation throughout this episode focuses and we discuss on the new recently published FDA biocompatibility guidance document —issued onn September 7, 2023.
“My favorite nuance is that annex A has slightly been updated because now the X’s and O’s are almost all gone.” – Don Pohl
“Of these materials, you touch them every day, and your clothes are made out of them... Why would we need to do biocompatibility testing as a device? At a high level, that is what [(Attachment G)] says.” – Don Pohl
“There are a few caveats, such as devices made for neonates… they are going to want to see the data. And similar type wording for pregnant woman.” – Phil Smiraldo
“We are not saying it’s never possible, but you’re going to have to really convince us if you only look at Part 1 and not our guidance” – Sheri Krajewski-Bibins
“One thing that I do like about this FDA document is it uses the same language from the ISO 10993 series.” – Phil Smiraldo
Discussion points include:
Verbiage updates to legally market devices and the fineprint.
The Addition of Appendix G and how it can be utilized.
A general overview of other changes by the FDA from their previous document.
The conversation throughout this episode focuses and we discuss on the new recently published FDA biocompatibility guidance document —issued onn September 7, 2023.
“My favorite nuance is that annex A has slightly been updated because now the X’s and O’s are almost all gone.” – Don Pohl
“Of these materials, you touch them every day, and your clothes are made out of them... Why would we need to do biocompatibility testing as a device? At a high level, that is what [(Attachment G)] says.” – Don Pohl
“There are a few caveats, such as devices made for neonates… they are going to want to see the data. And similar type wording for pregnant woman.” – Phil Smiraldo
“We are not saying it’s never possible, but you’re going to have to really convince us if you only look at Part 1 and not our guidance” – Sheri Krajewski-Bibins
“One thing that I do like about this FDA document is it uses the same language from the ISO 10993 series.” – Phil Smiraldo
Discussion points include:
Verbiage updates to legally market devices and the fineprint.
The Addition of Appendix G and how it can be utilized.
A general overview of other changes by the FDA from their previous document.
32 Minuten
In this first BiocompCHATibility Podcast episode of 2023, our hosts are happy to introduce
a new podcast to the NAMSA family, and talk a little bit to the hosts about the insightful
topics to come.
This new, conversational podcast will feature a new set of hosts who dedicate each
episode to trending regulatory and quality affairs topics within the MedTech industry.
Future topics include:
Refuse to Accept Policy for 510(k)s – This episode will delve into the procedures
and criteria FDA intends to use in assessing whether a premarket notification
(510(k)) submission meets a minimum threshold of acceptability and if it should
be accepted for substantive review.
FDA Releases Draft Guidance: Content of Premarket Submissions for Device
Software Functions – As a follow-up to one of NAMSA’s recent blog posts, our
hosts will describe information that the FDA deems important during its
evaluation of the safety and effectiveness of device software with one or more
device functions.
Compliance Pitfalls (Start-up Focus) – This episode will focus on common
compliance obstacles faced when dealing with documenting procedures,
complaint handling processes, supplier controls, audit & training, laboratory
controls, monitoring and calibration and more.
a new podcast to the NAMSA family, and talk a little bit to the hosts about the insightful
topics to come.
This new, conversational podcast will feature a new set of hosts who dedicate each
episode to trending regulatory and quality affairs topics within the MedTech industry.
Future topics include:
Refuse to Accept Policy for 510(k)s – This episode will delve into the procedures
and criteria FDA intends to use in assessing whether a premarket notification
(510(k)) submission meets a minimum threshold of acceptability and if it should
be accepted for substantive review.
FDA Releases Draft Guidance: Content of Premarket Submissions for Device
Software Functions – As a follow-up to one of NAMSA’s recent blog posts, our
hosts will describe information that the FDA deems important during its
evaluation of the safety and effectiveness of device software with one or more
device functions.
Compliance Pitfalls (Start-up Focus) – This episode will focus on common
compliance obstacles faced when dealing with documenting procedures,
complaint handling processes, supplier controls, audit & training, laboratory
controls, monitoring and calibration and more.
33 Minuten
In this episode, Dr. Phil Smiraldo (NAMSA’s Senior Toxicologist) joins us to discuss the test article and the many challenges with identification and preparation. Throughout this discussion, we explore the many different types of test articles and help define what is considered patient contact and what is not? We also review how you can best work with your laboratory to define your test article preparation and make certain the test article definition is clear to the regulatory agency
Listeners can expect to learn:
How to easily define their test article
Key points to consider when separating patient contacting and non-patient contacting devices
The risks of including non-patient contacting components in an extract
“One of the things we thought we’d elaborate on today is how do I define my test article.”
-Sheri Krajewski
“We are not going to jump into the GLP regulations and jump into that definition, but we
will help define the test article as it relates to biocompatibility.”– Don Pohl
“I’ve even worked through a scenario for a particular device where the customer in fact
came onsite to help take it apart.” – Phil Smiraldo
“This stuff [prep instructions] needs to be written down clearly so anyone can follow.” –
Don Pohl
Listeners can expect to learn:
How to easily define their test article
Key points to consider when separating patient contacting and non-patient contacting devices
The risks of including non-patient contacting components in an extract
“One of the things we thought we’d elaborate on today is how do I define my test article.”
-Sheri Krajewski
“We are not going to jump into the GLP regulations and jump into that definition, but we
will help define the test article as it relates to biocompatibility.”– Don Pohl
“I’ve even worked through a scenario for a particular device where the customer in fact
came onsite to help take it apart.” – Phil Smiraldo
“This stuff [prep instructions] needs to be written down clearly so anyone can follow.” –
Don Pohl
35 Minuten
In this episode, our hosts are joined by NAMSA Associate, Dr. Darin Kent, and second-time guest, Dr Ted Heise, to discuss the new paper released by the FDA and the American Chemical Society. The intention of this latest FDA publication is to examine specific topics that promote continuous discussion around the disparities between where the industry currently stands and how alignment and proper development may occur.
Listen in as these industry experts explore the topics covered by the FDA within this document, as well as the challenges faced by medical device manufacturers and testing laboratories regarding chemical characterization testing. They also examine how the FDA fared in the attempt to answer many industry questions.
Discussion points include:
Thoughts on where to go from here
FDA’s perspective on alignment in the industry
“State-of-the-art” and where that has us today with the chemical characterization of medical devices
“The paper really is more about what is being done in devices and what is known about the work in devices.” – Ted Heise
“It’s striking really, the lack of literature out there about how these technologies and ideas could be used in an NTA [non-targeted analysis] type situation.” – Darin Kent
“There’s a fundamental need for basic research.” – Darin Kent
“In terms of giving solutions of how to deal with the challenges, I think it’s less true and part of that is simply that the state-of-the-art is just not well enough developed.” – Ted
Heise
“It provides arrows pointing to potential solutions.” – Darin Kent
“Does current state-of-the-art product devices that are safe or are there areas we have not uncovered yet?” – Don Pohl
“What we do better in characterizing medical devices has to bring additional value.” – Ted Heise
“One of the concerns is the level of burden that is imposed by the expectations wrapped up in this work.” – Ted Heise
You can access the full FDA publication for a fee through here: Chemical Characterization and Non-targeted Analysis of Medical Device Extracts: A Review of Current Approaches, Gaps, and Emerging Practices.
Listen in as these industry experts explore the topics covered by the FDA within this document, as well as the challenges faced by medical device manufacturers and testing laboratories regarding chemical characterization testing. They also examine how the FDA fared in the attempt to answer many industry questions.
Discussion points include:
Thoughts on where to go from here
FDA’s perspective on alignment in the industry
“State-of-the-art” and where that has us today with the chemical characterization of medical devices
“The paper really is more about what is being done in devices and what is known about the work in devices.” – Ted Heise
“It’s striking really, the lack of literature out there about how these technologies and ideas could be used in an NTA [non-targeted analysis] type situation.” – Darin Kent
“There’s a fundamental need for basic research.” – Darin Kent
“In terms of giving solutions of how to deal with the challenges, I think it’s less true and part of that is simply that the state-of-the-art is just not well enough developed.” – Ted
Heise
“It provides arrows pointing to potential solutions.” – Darin Kent
“Does current state-of-the-art product devices that are safe or are there areas we have not uncovered yet?” – Don Pohl
“What we do better in characterizing medical devices has to bring additional value.” – Ted Heise
“One of the concerns is the level of burden that is imposed by the expectations wrapped up in this work.” – Ted Heise
You can access the full FDA publication for a fee through here: Chemical Characterization and Non-targeted Analysis of Medical Device Extracts: A Review of Current Approaches, Gaps, and Emerging Practices.
35 Minuten
In this episode, NAMSA’s Senior Product Development Specialist, Ed Arscott, joins our hosts to examine the relationship between packaging and biocompatibility, including: how to evaluate primary packaging for biological safety. The discussion also focuses on the direction provided in ASTM F2475-05 Standard Guide for Biocompatibility Evaluation of
Medical Device Packaging Materials.
Listeners can expect to learn:
Where to look for guidance on packaging evaluation for medical devices
Key points to consider when looking at material contact to medical devices
Evaluating device/package interaction
Assessing cases or primary packaging for reusable devices
“I’m happy to help join between the two realms of biocompatibility and packaging.” – Ed Arscott
“One common thing in the past was that you saw a lot of cytos being performed on primary packaging.” – Don Pohl
“The way that packaging interacts especially with implants; things can occur with packaging and implants that relate directly to product safety.” – Ed Arscott
“Part of figuring out what to do or not to do is based on device/packaging interaction.” – Don Pohl
“Let’s discuss metal trays for instruments; A form of packaging to evaluate as well.” – Sheri Krajewski
“Your level of evaluating for the packaging shouldn’t exceed the evaluation of your device.” – Don Pohl
Medical Device Packaging Materials.
Listeners can expect to learn:
Where to look for guidance on packaging evaluation for medical devices
Key points to consider when looking at material contact to medical devices
Evaluating device/package interaction
Assessing cases or primary packaging for reusable devices
“I’m happy to help join between the two realms of biocompatibility and packaging.” – Ed Arscott
“One common thing in the past was that you saw a lot of cytos being performed on primary packaging.” – Don Pohl
“The way that packaging interacts especially with implants; things can occur with packaging and implants that relate directly to product safety.” – Ed Arscott
“Part of figuring out what to do or not to do is based on device/packaging interaction.” – Don Pohl
“Let’s discuss metal trays for instruments; A form of packaging to evaluate as well.” – Sheri Krajewski
“Your level of evaluating for the packaging shouldn’t exceed the evaluation of your device.” – Don Pohl
45 Minuten
In this episode, our hosts are joined by NAMSA Toxicologist, Michelle Kelly, to discuss the ever-elusive biological equivalency claim. The discussion focuses on how to maintain the balance of the risk and benefit of a medical device without stalling innovation. We also explore equivalency and how it is not only a key concept to the risk analysis but also a challenging concept to prove.
“This is often a controversial topic.” – Sheri Krajewski
“You not only have to think about equivalency per 10993-1, but also think about it as one aspect of equivalency that is sitting in the MDR.” – Don Pohl
“Equivalency is one of the key principles that sits in 10993-1.” – Don Pohl
“To think of equivalence as a concept rather than an equation is the best thing to do.” – Michelle Kelly
“We have that word “same” sneaking up on us. I can see that being interpreted differently by reviewers and regulators.” – Don Pohl
“When we developed it [Annex C of 10993-18], we were trying to define toxicological equivalence to help out the working group writing 10993-17.” – Michelle Kelly
Discussion points include:
Equivalence in the 10993 Series, including ISO 10993-18 Annex C
Equivalence under the MDR
Variances in the EU from one Notified Body to another
Challenges with demonstrating and establishing overall MDR equivalence
The concept of “same” and how it is interpreted by regulators
“This is often a controversial topic.” – Sheri Krajewski
“You not only have to think about equivalency per 10993-1, but also think about it as one aspect of equivalency that is sitting in the MDR.” – Don Pohl
“Equivalency is one of the key principles that sits in 10993-1.” – Don Pohl
“To think of equivalence as a concept rather than an equation is the best thing to do.” – Michelle Kelly
“We have that word “same” sneaking up on us. I can see that being interpreted differently by reviewers and regulators.” – Don Pohl
“When we developed it [Annex C of 10993-18], we were trying to define toxicological equivalence to help out the working group writing 10993-17.” – Michelle Kelly
Discussion points include:
Equivalence in the 10993 Series, including ISO 10993-18 Annex C
Equivalence under the MDR
Variances in the EU from one Notified Body to another
Challenges with demonstrating and establishing overall MDR equivalence
The concept of “same” and how it is interpreted by regulators
42 Minuten
In this episode, our hosts are joined by the QB1 (or 4 of them) of GLP (Good Laboratory Practice), NAMSA’s Study Directors. Throughout this podcast, the team delves into the role of the Study Director in biocompatibility and chemical characterization studies, discussing day-to-day activities, legalities, key factors manufacturers should know about working with a Study Director, and the qualifications needed to be an effective Study Director.
Discussion points include:
GLP and what it means for biocompatibility studies
The role of the Study Director in the GLP program
The history of adopting GLP guidance from pharmaceutical studies and how they transfer to medical devices
“GLP is front and center when submitting to global regulators.” – Sheri Krajewski
“GLP is for conducting non-clinical lab studies that support applications and submissions to regulatory bodies with the intent that these studies assure quality integrity of studies.” – Alison Shaffer
“We wear a lot of hats both externally with our customers and with the labs.” – Brandon Hahnlen
“We like to drive things. Not a lot of people know about this industry {and role of a Study Director} and a lot of us take a fortuitous route to get here.” – Theresa Ford-Wells
“One exciting thing is seeing the variety of medical devices. It’s neat to see over the years the trends and types of devices coming that we get to work on prior to anyone knowing they exist.” – William Adamiak
Discussion points include:
GLP and what it means for biocompatibility studies
The role of the Study Director in the GLP program
The history of adopting GLP guidance from pharmaceutical studies and how they transfer to medical devices
“GLP is front and center when submitting to global regulators.” – Sheri Krajewski
“GLP is for conducting non-clinical lab studies that support applications and submissions to regulatory bodies with the intent that these studies assure quality integrity of studies.” – Alison Shaffer
“We wear a lot of hats both externally with our customers and with the labs.” – Brandon Hahnlen
“We like to drive things. Not a lot of people know about this industry {and role of a Study Director} and a lot of us take a fortuitous route to get here.” – Theresa Ford-Wells
“One exciting thing is seeing the variety of medical devices. It’s neat to see over the years the trends and types of devices coming that we get to work on prior to anyone knowing they exist.” – William Adamiak
21 Minuten
In its third year, the North American Biocompatibility Summit (NABS) is a limited-seating event that provides industry insights and expertise sharing on the biocompatibility of medical devices. This year, sessions will include the latest regulatory updates, biological evaluation strategies, and best practices that lead to successful biocompatibility programs in 2021 and beyond.
In this episode, our hosts discuss this upcoming event and what attendees can expect. This includes details on the NABS Scientific Advisory Board, abstract submissions, and how the Board determined what educational opportunities to offer. Listeners will learn more about featured topics, including the overall theme that emerged from the abstracts.
“The topics are universal to all medical devices.” Don Pohl
“We receive enough abstracts that we have more than enough to choose from and it’s interesting to see the trends in the industry of what people are struggling or dealing with.” Don Pohl
“There are no cupcake topics at this event, that’s for sure.” Sheri Krajewski
“It’s great to have this opportunity to get out and hear what everyone else is experiencing.” Don Pohl
“This is not just a Minneapolis event; anyone from anywhere is welcome to join us.” Sheri Krajewski
Discussion points include:
What is the North American Biocompatibility Summit and how can one register
Expectations attendees can have from this event; from education to networking time.
The topics of the event including chemical characterization, toxicological risk assessment and alternative test methods
Registration details for the event
In this episode, our hosts discuss this upcoming event and what attendees can expect. This includes details on the NABS Scientific Advisory Board, abstract submissions, and how the Board determined what educational opportunities to offer. Listeners will learn more about featured topics, including the overall theme that emerged from the abstracts.
“The topics are universal to all medical devices.” Don Pohl
“We receive enough abstracts that we have more than enough to choose from and it’s interesting to see the trends in the industry of what people are struggling or dealing with.” Don Pohl
“There are no cupcake topics at this event, that’s for sure.” Sheri Krajewski
“It’s great to have this opportunity to get out and hear what everyone else is experiencing.” Don Pohl
“This is not just a Minneapolis event; anyone from anywhere is welcome to join us.” Sheri Krajewski
Discussion points include:
What is the North American Biocompatibility Summit and how can one register
Expectations attendees can have from this event; from education to networking time.
The topics of the event including chemical characterization, toxicological risk assessment and alternative test methods
Registration details for the event
34 Minuten
NAMSA is pleased to announce that the U.S. Food and Drug Administration (FDA) granted the organization Accreditation Scheme for Conformity Assessment (ASCA) status on July 23. The ASCA Pilot Program, a first-of-its-kind assessment created by the U.S. FDA, reduces the regulatory burden on medical device manufacturers through consensus of biocompatibility testing requirements for efficiency.
In this episode, our hosts are joined once again by Lisa Olson, NAMSA’s Senior Vice President of Global Laboratory Operations to discuss the importance of this accreditation and what it means to NAMSA. But perhaps most importantly, what this status means for manufacturers who choose to do their testing with ASCA accredited laboratories.
“It’s the first time the FDA has done this for a biocompatibility lab.” Sheri Krajewski
“I believe the FDA was really looking at the value of the tests. There are certain tests like cytotoxicity that are incredibly standardized. In essence, many labs are doing them the same. The FDA did a great job of picking out the studies are well established and many labs know how to do them and have established protocolsfor them.” Lisa Olson
“NAMSA is accredited for biocompatibility testing and people would say, aren’t you already? NAMSA has submitted biocompatibility testing for many years. Yes, we have. The difference here is the FDA has taken steps to pre-qualify certain tests.” Sheri Krajewski
“There might be for ASCA studies limited deficiencies and limited review time. Hopefully none (deficiencies) for these (ASCA) studies.” Don Pohl
“What you really care about is the data. And, by having these summary reports, you get rid of all the marketing part of it and some of the ‘fluff’ and get a clean report of results. I think it’s a great way to have both reviewers and labs focus on the most important part.” Lisa Olson
Discussion points include:
What biocompatibility tests are included in ASCA accreditation?
How can manufactures capitalize on utilizing an ASCA laboratory for their biocompatibility testing?
What types of devices are disqualified from ASCA testing?
What are the potential challenges when implementing ASCA?
How do manufacturers “order” ASCA Testing? Is everything ASCA?
In this episode, our hosts are joined once again by Lisa Olson, NAMSA’s Senior Vice President of Global Laboratory Operations to discuss the importance of this accreditation and what it means to NAMSA. But perhaps most importantly, what this status means for manufacturers who choose to do their testing with ASCA accredited laboratories.
“It’s the first time the FDA has done this for a biocompatibility lab.” Sheri Krajewski
“I believe the FDA was really looking at the value of the tests. There are certain tests like cytotoxicity that are incredibly standardized. In essence, many labs are doing them the same. The FDA did a great job of picking out the studies are well established and many labs know how to do them and have established protocolsfor them.” Lisa Olson
“NAMSA is accredited for biocompatibility testing and people would say, aren’t you already? NAMSA has submitted biocompatibility testing for many years. Yes, we have. The difference here is the FDA has taken steps to pre-qualify certain tests.” Sheri Krajewski
“There might be for ASCA studies limited deficiencies and limited review time. Hopefully none (deficiencies) for these (ASCA) studies.” Don Pohl
“What you really care about is the data. And, by having these summary reports, you get rid of all the marketing part of it and some of the ‘fluff’ and get a clean report of results. I think it’s a great way to have both reviewers and labs focus on the most important part.” Lisa Olson
Discussion points include:
What biocompatibility tests are included in ASCA accreditation?
How can manufactures capitalize on utilizing an ASCA laboratory for their biocompatibility testing?
What types of devices are disqualified from ASCA testing?
What are the potential challenges when implementing ASCA?
How do manufacturers “order” ASCA Testing? Is everything ASCA?
33 Minuten
Over the last year, the BiocompCHATibility Podcast hosts have been compiling
questions asked by our listeners and training series attendees. In this episode, we
will answer your frequently asked questions about all things biocompatibility—and
no, we did not answer why Don is funnier than Sheri (it is definitely a growth
opportunity for her).
Highlights include:
The use of clinical data in the biological evaluation
Completing chemistry testing before in vitro/in vivo studies
Gathering historic data -and how much is useful to the evaluation
U.S. FDA and DBT (dose base threshold) values
The truth about “whole lifecycle” evaluation
“I can certainly do a preliminary risk assessment and not have any extractables
testing because part of my plan might be to go do extractables testing; but that
doesn’t mean I always need it.” – Don Pohl
“If you have clinical data and you are doing a preliminary risk assessment to
evaluate the safety of this device, it is general information and cannot be ignored.
But, if you are going to use the data to offset the need for a test, it better speak to
the endpoint very specifically.” – Don Pohl
“For manufacturing, I make sure to understand what was there and what wasn’t
there. Mapping the process out is important for the reader of the assessment to
understand I have performed the evaluation of the manufacturing and any impact
it has on biological safety.” – Don Pohl
questions asked by our listeners and training series attendees. In this episode, we
will answer your frequently asked questions about all things biocompatibility—and
no, we did not answer why Don is funnier than Sheri (it is definitely a growth
opportunity for her).
Highlights include:
The use of clinical data in the biological evaluation
Completing chemistry testing before in vitro/in vivo studies
Gathering historic data -and how much is useful to the evaluation
U.S. FDA and DBT (dose base threshold) values
The truth about “whole lifecycle” evaluation
“I can certainly do a preliminary risk assessment and not have any extractables
testing because part of my plan might be to go do extractables testing; but that
doesn’t mean I always need it.” – Don Pohl
“If you have clinical data and you are doing a preliminary risk assessment to
evaluate the safety of this device, it is general information and cannot be ignored.
But, if you are going to use the data to offset the need for a test, it better speak to
the endpoint very specifically.” – Don Pohl
“For manufacturing, I make sure to understand what was there and what wasn’t
there. Mapping the process out is important for the reader of the assessment to
understand I have performed the evaluation of the manufacturing and any impact
it has on biological safety.” – Don Pohl
49 Minuten
In this episode, our hosts are joined by APS’s Senior Director of Biocompatibility Services, Dr. Yan Chen, to discuss NAMSA’s acquisition of APS and the importance of preclinical studies in the biological evaluation of medical devices.
This podcast discussion revolves around the many synergies of the combined companies, as well as a technical discussion regarding preclinical studies, preclinical study biocompatibility endpoints, and of course, an energetic game of ‘2 Truths and a Lie’ that will surely bring you a laugh.
“We have expanded the possibilities of people who can join us now.”-Sheri Krajewski
“We are very excited. We firmly believe that both companies share the same goals to provide high-quality, comprehensive services for medical device development.” – Dr. Chen
“Companies are beginning to think about biocompatibility when they should early-on with studies like these. These [preclinical] studies can be so powerful in so many ways.” – Don Pohl
“The local tissue response is the most commonly used (biocomp endpoint) in the preclinical study. Sometimes you want a clinically relevant implant site. That is something to keep in mind to combine (preclinical and biocomp) studies.” – Dr. Chen
Discussion points include:
The importance of preclinical testing to the biological
evaluation
Early-stage preclinical studies vs. GLP studies and the value
they bring to medical device regulatory submissions
The challenges of combining preclinical and biocomp studies
This podcast discussion revolves around the many synergies of the combined companies, as well as a technical discussion regarding preclinical studies, preclinical study biocompatibility endpoints, and of course, an energetic game of ‘2 Truths and a Lie’ that will surely bring you a laugh.
“We have expanded the possibilities of people who can join us now.”-Sheri Krajewski
“We are very excited. We firmly believe that both companies share the same goals to provide high-quality, comprehensive services for medical device development.” – Dr. Chen
“Companies are beginning to think about biocompatibility when they should early-on with studies like these. These [preclinical] studies can be so powerful in so many ways.” – Don Pohl
“The local tissue response is the most commonly used (biocomp endpoint) in the preclinical study. Sometimes you want a clinically relevant implant site. That is something to keep in mind to combine (preclinical and biocomp) studies.” – Dr. Chen
Discussion points include:
The importance of preclinical testing to the biological
evaluation
Early-stage preclinical studies vs. GLP studies and the value
they bring to medical device regulatory submissions
The challenges of combining preclinical and biocomp studies
36 Minuten
In this episode, our hosts answer listener questions regarding the new ISO 10993-23:2021 from NAMSA’s February 3, 2021 webinar.
The standard recommends that In Vitro testing be completed prior to In Vivo testing, warranting many questions about how to deal with legacy data, regulatory acceptance and timelines. Our hosts will provide podcasters a full episode of responses, possible scenarios and potential recommendations.
“This is an extraction-based evaluation and you will be creating and dosing extracts in most cases. There is not a direct contact equivalent for the In Vitro like there is In Vivo.” Don Pohl
“In the past, you used the intracutaneous or primary skin appropriately, then this In Vitro test is for you.” Don Pohl
“We have heard from one Notified Body that they are going to be giving a one-year grace period, [meaning the standard just issued in January 2021], they are giving folks until January 2022 to switch to the In Vitro method.” Sheri Krajewski-Bibins
“Similar concept to Part 1, if you already have your data collected, it might be worth mentioning in your biological evaluation report. If you feel like you need to [mention] regarding the timing of events, that testing was already planned, executed and performed prior to -23 issuing, therefore, the In Vivo method was utilized.” Don Pohl
“If you are having a pre-sub with the FDA, maybe have that conversation too that you would like to do the In Vitro method, and see what they tell you even though there is no official position.” Sheri Krajewski-Bibins
“The standard has the one sentence that says In Vivo may be needed post In Vitro to clarify, but it doesn’t necessarily say because you failed or found an irritant….. I think you need to still be careful on your due diligence. Look at your failure in the In Vitro level, understand the materials, your manufacturing process, and confirm you didn’t miss anything.” Don Pohl
Discussion points include:
What is in the new 10993-23 and what is it not?
How do you know if an In Vitro irritation test is right for an implant?
Regulatory agency answers on when they will expect In Vitro irritation
Limitations of the In Vitro assay
What to do if you receive an irritant response in the In Vitro assay
The standard recommends that In Vitro testing be completed prior to In Vivo testing, warranting many questions about how to deal with legacy data, regulatory acceptance and timelines. Our hosts will provide podcasters a full episode of responses, possible scenarios and potential recommendations.
“This is an extraction-based evaluation and you will be creating and dosing extracts in most cases. There is not a direct contact equivalent for the In Vitro like there is In Vivo.” Don Pohl
“In the past, you used the intracutaneous or primary skin appropriately, then this In Vitro test is for you.” Don Pohl
“We have heard from one Notified Body that they are going to be giving a one-year grace period, [meaning the standard just issued in January 2021], they are giving folks until January 2022 to switch to the In Vitro method.” Sheri Krajewski-Bibins
“Similar concept to Part 1, if you already have your data collected, it might be worth mentioning in your biological evaluation report. If you feel like you need to [mention] regarding the timing of events, that testing was already planned, executed and performed prior to -23 issuing, therefore, the In Vivo method was utilized.” Don Pohl
“If you are having a pre-sub with the FDA, maybe have that conversation too that you would like to do the In Vitro method, and see what they tell you even though there is no official position.” Sheri Krajewski-Bibins
“The standard has the one sentence that says In Vivo may be needed post In Vitro to clarify, but it doesn’t necessarily say because you failed or found an irritant….. I think you need to still be careful on your due diligence. Look at your failure in the In Vitro level, understand the materials, your manufacturing process, and confirm you didn’t miss anything.” Don Pohl
Discussion points include:
What is in the new 10993-23 and what is it not?
How do you know if an In Vitro irritation test is right for an implant?
Regulatory agency answers on when they will expect In Vitro irritation
Limitations of the In Vitro assay
What to do if you receive an irritant response in the In Vitro assay
