Latest / Let's Talk Risk! Podcast / LTR 164: Susan Neadle on Combination Device Risk Management

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LTR 164: Susan Neadle on Combination Device Risk Management · Let's Talk Risk! Podcast

• 0:00
  SPEAKER_00: Hi, everyone, and welcome to Let's Talk Risk!.
• 0:02
  SPEAKER_00: I'm your host, Naveen Agarwal.
• 0:04
  SPEAKER_00: Here we explore how leaders in medtech navigate uncertainty,
• 0:08
  SPEAKER_00: make better risk-based decisions,
• 0:10
  SPEAKER_00: and build safe and effective communities who support sustainable growth.
• 0:14
  SPEAKER_00: So I hope you are having a great day.
• 0:17
  SPEAKER_00: Welcome to the show.
• 0:18
  SPEAKER_00: Susan has been just a wonderful friend, mentor,
• 0:22
  SPEAKER_00: connection for me for many,
• 0:23
  SPEAKER_00: many years, and it is such a pleasure to invite her to the show today.
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  SPEAKER_00: Currently,
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  SPEAKER_00: she's the Principal Consultant and President
• 0:31
  SPEAKER_00: at Combination Products Consulting Services.
• 0:33
  SPEAKER_00: But Susan has many, many years of industry experience in leadership roles.
• 0:38
  SPEAKER_00: She's also the Fellow of the Regulatory Affairs Professional Society and many,
• 0:43
  SPEAKER_00: many other professional societies that she contributes to.
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  SPEAKER_00: She is a leading voice in this field,
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  SPEAKER_00: and today we're going to particularly talk about combination products,
• 0:53
  SPEAKER_00: risk management.
• 0:54
  SPEAKER_00: I hope you are excited about this topic, guys.
• 0:56
  SPEAKER_00: As you join in, make sure that you are participating in this discussion.
• 1:00
  SPEAKER_00: You are sharing your perspective, questions, comments, opinions are welcome.
• 1:05
  SPEAKER_00: We are not here to say this is right or wrong.
• 1:07
  SPEAKER_00: We are here to share some ideas and opinions.
• 1:10
  SPEAKER_00: So please share that in the chat, and I'll bring that here as much as possible.
• 1:13
  SPEAKER_00: With that, Susan, welcome to the show.
• 1:15
  SPEAKER_00: How are you today?
• 1:16
  SPEAKER_00: Good.
• 1:17
  SPEAKER_00: How are you doing, Naveen?
• 1:18
  SPEAKER_00: Great.
• 1:19
  SPEAKER_00: Susan, so I want to start by asking you this very fundamental question.
• 1:24
  SPEAKER_00: You know, most of our audience comes from the device world.
• 1:27
  SPEAKER_00: So very briefly, tell us what are combination products?
• 1:30
  SPEAKER_01: So combination products are those products where you've got the medical products
• 1:38
  SPEAKER_01: that make up the product are different, right?
• 1:40
  SPEAKER_01: So I'm going to have one or more types of medical products that when they are Yeah,
• 1:45
  SPEAKER_01: so like an example could be,
• 1:47
  SPEAKER_01: you know,
• 1:47
  SPEAKER_01: auto-injector with a preloaded drug in it and you,
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  SPEAKER_01: you know, inject it and you're supposed to.
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  SPEAKER_01: So it's
• 2:13
  SPEAKER_00: Delivery part, and there's also drug part.
• 2:15
  SPEAKER_00: So that's how I'm thinking about it in a simple way.
• 2:18
  SPEAKER_00: Now, building on that,
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  SPEAKER_00: we know that risk management in 971 already is challenging in medical device world
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  SPEAKER_00: from a practical point of view.
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  SPEAKER_00: And of course, with combination products, there is another layer of, I would say, complexity.
• 2:33
  SPEAKER_00: Help us understand through these basic differences in Now,
• 2:36
  SPEAKER_00: what is different about risk management in combination products compared to just
• 2:40
  SPEAKER_00: a device product?
• 2:41
  SPEAKER_01: So if you're dealing with a standalone medical device
• 2:44
  SPEAKER_01: and you're doing risk management,
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  SPEAKER_01: there is first and foremost, just look at definitions.
• 2:49
  SPEAKER_01: When I look at ISO 14971,
• 2:52
  SPEAKER_01: which is the foundation for device risk management,
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  SPEAKER_01: we talk about risk being the probability of the occurrence of harm and the severity
• 3:00
  SPEAKER_01: of that harm.
• 3:01
  SPEAKER_01: So the focus is safety risk.
• 3:05
  SPEAKER_01: Safety is freedom from unacceptable risk.
• 3:07
  SPEAKER_01: So the focus is on safety associated with the product,
• 3:12
  SPEAKER_01: its manufacturing process, as well as the use of that product, right?
• 3:16
  SPEAKER_01: Whoever is going to be touching and interacting with the user interface.
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  SPEAKER_00: When I look at a drug,
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  SPEAKER_01: a standalone drug,
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  SPEAKER_01: ICHQ9 is,
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  SPEAKER_01: or ICHQ9R1,
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  SPEAKER_01: is the foundational document that is used
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  SPEAKER_01: to drive Pharmaceutical Risk Management is actually called Quality Risk Management.
• 3:40
  SPEAKER_01: And the focus of ICHQ-9 is on risks to product quality and process performance
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  SPEAKER_01: because many people will say,
• 3:48
  SPEAKER_01: oh, the product is the process and the process is the product on the pharma side.
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  SPEAKER_01: That's like a frequent saying.
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  SPEAKER_01: So whereas 4971 in medical devices is very focused on hazards,
• 3:59
  SPEAKER_01: which are a potential source of harm,
• 4:01
  SPEAKER_01: Being exposed to those potential sources of harm and then the harm that occurs and
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  SPEAKER_01: at what level of severity and how likely it is to occur.
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  SPEAKER_01: On the drug side, you're focused on, are my critical quality attributes met for my product?
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  SPEAKER_01: And they will be if I appropriately have defined the process controls
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  SPEAKER_01: and my overarching control strategy for the drug.
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  SPEAKER_01: So even though the frameworks are very similar for ICH Q9 and 14971,
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  SPEAKER_01: the focus of them is different.
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  SPEAKER_01: For combination product,
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  SPEAKER_01: you have to think about the quality of the drug,
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  SPEAKER_01: the safety,
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  SPEAKER_01: the reliability,
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  SPEAKER_01: and the usability of the user interface, which is the medical device.
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  SPEAKER_01: And so when you're thinking about what is the foundational unit
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  SPEAKER_01: For what your analysis is based on,
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  SPEAKER_01: it's on the combined use system and all the interactions between
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  SPEAKER_01: the constituent parts.
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  SPEAKER_01: So it's no longer just looking at only the device or only the drug.
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  SPEAKER_01: It's what could affect safety,
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  SPEAKER_01: effectiveness, quality, reliability, or usability of my combination product.
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  SPEAKER_00: Yeah.
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  SPEAKER_00: Yeah, that makes a lot of sense to me.
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  SPEAKER_00: And I guess the difference in focus, we'll address that a little bit.
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  SPEAKER_00: Yeah.
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  SPEAKER_00: The drug approval process,
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  SPEAKER_00: all that years and years of clinical work and data and evidence generation,
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  SPEAKER_00: that safety profile has been established already.
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  SPEAKER_00: So my understanding,
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  SPEAKER_00: and tell me if I'm thinking about it the right way or not,
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  SPEAKER_00: is that once that is baked in,
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  SPEAKER_00: you have to focus 100% on making sure that there is no deviation from anything
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  SPEAKER_00: that could happen from the process.
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  SPEAKER_00: And then we must deliver the specifications.
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  SPEAKER_00: That is why it is so important, right?
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  SPEAKER_00: And on the device side,
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  SPEAKER_00: it seems to me that first of all,
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  SPEAKER_00: we have so much diversity and so much change happens post-market that we have
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  SPEAKER_00: to constantly
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  SPEAKER_01: focus on safety.
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  SPEAKER_00: It's not like we have to ignore on quality.
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  SPEAKER_00: So in my mind,
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  SPEAKER_00: these two focal points are important,
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  SPEAKER_00: but now in the combo world, we have to bring them together.
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  SPEAKER_00: And that is where probably there are some challenges in practice.
• 6:10
  SPEAKER_00: And we'll talk about that.
• 6:10
  SPEAKER_00: So first, help me walk through that and see if I understood that right.
• 6:14
  SPEAKER_00: And maybe you have something, additional points to make on that.
• 6:17
  SPEAKER_01: Yeah, so if I step back, I agree.
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  SPEAKER_01: When you're putting in a submission to get approval for a product in the farm side,
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  SPEAKER_01: it's very, very, very prescriptive.
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  SPEAKER_01: Whatever specification windows you define for your critical quality attributes,
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  SPEAKER_01: your critical process parameters, you're stuck.
• 6:35
  SPEAKER_01: That is the window that you are operating in, period.
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  SPEAKER_01: On the device side, it doesn't end with the specifications.
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  SPEAKER_01: I could create a product that meets all the specifications,
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  SPEAKER_01: but then That product is put into the hands of a user and depending
• 6:49
  SPEAKER_01: on how they interact with that product,
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  SPEAKER_01: I could get safe or unsafe use of that product and I could end up with
• 6:57
  SPEAKER_01: a very different outcome.
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  SPEAKER_01: So in terms of safety, right?
• 7:01
  SPEAKER_01: Yeah.
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  SPEAKER_01: So this mindset of when I'm doing all my clinical trials and I'm going
• 7:06
  SPEAKER_01: through my quality by design and pharmaceutical development process on
• 7:10
  SPEAKER_01: the drug side,
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  SPEAKER_01: I am purposefully developing and designing A product and a manufacturing process
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  SPEAKER_01: that enables that product so that
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  SPEAKER_01: that product will consistently meet certain specifications.
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  SPEAKER_01: As long as those specifications are met,
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  SPEAKER_01: I'm confident that that product quality will meet the needs of the users,
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  SPEAKER_01: the safety of the users.
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  SPEAKER_01: On the device side,
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  SPEAKER_01: you're applying your design controls,
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  SPEAKER_01: including your human factors controls,
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  SPEAKER_01: your manufacturing controls, your process controls, your training controls.
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  SPEAKER_01: Supplier controls, maintenance controls, monitoring controls.
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  SPEAKER_01: You're applying all these controls over the whole life cycle of that product.
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  SPEAKER_01: And ultimately, you do that validation, right?
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  SPEAKER_01: You're figuring out what are the hazards that lead to the harms that lead to
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  SPEAKER_01: the control strategies.
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  SPEAKER_01: And then you're verifying and validating it all and doing your benefit risk assessment.
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  SPEAKER_01: So you're doing this life cycle monitoring,
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  SPEAKER_01: but there's more things that you're having to bake into it than strictly,
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  SPEAKER_01: did I meet my specs?
• 8:11
  SPEAKER_00: Yeah, yeah.
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  SPEAKER_00: I mean, you could be meeting specs 100%, which is, of course, you know, difficult.
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  SPEAKER_00: But let's say you are meeting perfectly
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  SPEAKER_00: and still you could have uncontrolled hazards in the field that you have to keep
• 8:24
  SPEAKER_00: an eye on.
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  SPEAKER_00: And I guess that's a very important point for us to understand.
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  SPEAKER_00: Safety is important on both sides.
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  SPEAKER_00: It's not less important on the pharma.
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  SPEAKER_00: It's very important on the device side.
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  SPEAKER_00: And so is quality, even though the focus is up.
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  SPEAKER_00: Now let's try to bring it all together.
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  SPEAKER_00: And I know you just shared with me that you are leading the effort
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  SPEAKER_00: on this new 24971 ISO-TR 24971-3 that is under development about Combo product.
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  SPEAKER_00: Let's talk about that.
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  SPEAKER_00: How is that going to help us bridge these two mindsets and bring the best practices
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  SPEAKER_00: for Combo risk management?
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  SPEAKER_01: Yeah, so I'll step back.
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  SPEAKER_01: So I'm The Association for Advancement of Medical Instrumentation, Amy,
• 9:06
  SPEAKER_01: came out with a TIR,
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  SPEAKER_01: Technical Information Report 105,
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  SPEAKER_01: back in 2020 that was intended to help people understand how
• 9:16
  SPEAKER_01: to do combination products risk management.
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  SPEAKER_01: And it gives like the first indications of this is what's expected and why you need
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  SPEAKER_01: to think differently.
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  SPEAKER_01: You know,
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  SPEAKER_01: you need to think about each constituent part and you need to think
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  SPEAKER_01: about their interaction effects.
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  SPEAKER_01: It doesn't dictate or tell you how to do it effectively.
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  SPEAKER_01: It just says,
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  SPEAKER_01: you know,
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  SPEAKER_01: you can do it based on ICHQ9,
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  SPEAKER_01: you can do it based on 14971,
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  SPEAKER_01: but in the end,
• 9:40
  SPEAKER_01: these are the things that you need to take into account,
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  SPEAKER_01: but it doesn't tell you how.
• 9:44
  SPEAKER_01: So we are in the process through a joint working group between ISO and IEC
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  SPEAKER_01: of building ISO 24971.
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  SPEAKER_01: It's a technical spec, so TS.
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  SPEAKER_01: Yeah, so it's going to be TS ISO 14971-3.
• 10:03
  SPEAKER_01: And that particular technical spec is intended to be the how.
• 10:08
  SPEAKER_01: So the same way as you have 24971-2020,
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  SPEAKER_01: which gives the how behind ISO 14971,
• 10:15
  SPEAKER_01: there is not yet an international standard outside of the AIME standard
• 10:21
  SPEAKER_01: that currently helps people understand how.
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  SPEAKER_01: Do I go about integrating my drug and my device approaches to create with
• 10:29
  SPEAKER_01: a comprehensive, safe and effective and reliable and usable combined system?
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  SPEAKER_01: And that's what 24971-3 is about.
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  SPEAKER_00: That is so exciting.
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  SPEAKER_00: I can't wait for it to come out.
• 10:40
  SPEAKER_00: I know there's a long road ahead and a lot of work going on.
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  SPEAKER_00: Can you give us a sense of where you are and what you are finding as you are working
• 10:47
  SPEAKER_00: on this project?
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  SPEAKER_00: What are people telling you?
• 10:49
  SPEAKER_01: So it's been a lot of fun working globally on this project
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  SPEAKER_01: because there's teams representing countries throughout the world
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  SPEAKER_01: that are all providing comments.
• 10:59
  SPEAKER_01: We've put our first Yeah.
• 11:28
  SPEAKER_01: And so here we are trying to integrate the two,
• 11:31
  SPEAKER_01: and you've got some people who are very hard-line about, well,
• 11:35
  SPEAKER_01: it's okay,
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  SPEAKER_01: we can integrate as long as we don't interfere with the way we do it for devices
• 11:40
  SPEAKER_01: with any of the drug information.
• 11:42
  SPEAKER_01: And then you've got drug people who are, well,
• 11:44
  SPEAKER_01: it's okay,
• 11:44
  SPEAKER_01: we don't mind doing it as long as you don't interfere with anything we're doing with
• 11:47
  SPEAKER_01: the device information.
• 11:48
  SPEAKER_01: And those are the two extremes.
• 11:51
  SPEAKER_01: I'd call it the far right party and the far left party.
• 11:53
  SPEAKER_00: Yes, yes, yes.
• 11:55
  SPEAKER_01: And so I'm trying to be the pendulum in between,
• 11:58
  SPEAKER_01: and I know the joint working group is all working together to be able
• 12:02
  SPEAKER_01: to achieve this,
• 12:03
  SPEAKER_01: but we are trying to bring the two disparate perspectives together
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  SPEAKER_01: and help people understand how can we integrate them
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  SPEAKER_01: while recognizing each framework,
• 12:14
  SPEAKER_01: ISO 4297-1 and Q9,
• 12:17
  SPEAKER_01: have a lot of similarities, but they also are distinct from each other.
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  SPEAKER_01: Each one also brings some Distinct differences in approach and focus.
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  SPEAKER_01: And the reality is they're both valuable.
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  SPEAKER_01: So it's getting people to truly not just say, oh,
• 12:32
  SPEAKER_01: I understand risk management because I do Q9 or I understand risk management
• 12:35
  SPEAKER_01: because I do 14971.
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  SPEAKER_01: It's do you genuinely understand it holistically?
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  SPEAKER_01: And are you thinking about your whole combined use system rather
• 12:46
  SPEAKER_01: than just your constituent parts?
• 12:48
  SPEAKER_00: Because you can
• 12:49
  SPEAKER_01: have individual constituent parts that are perfectly in and
• 12:52
  SPEAKER_01: of themselves safe and effective.
• 12:54
  SPEAKER_01: But then when you bring them together, your system's not.
• 12:56
  SPEAKER_00: System's not.
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  SPEAKER_00: So let's walk through an example to highlight that.
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  SPEAKER_00: And I think as we started this conversation,
• 13:02
  SPEAKER_00: you did briefly mention the hazard,
• 13:04
  SPEAKER_00: hazardous situation,
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  SPEAKER_00: harm progression from 14971 and the critical quality attribute focus from ICHQ-9.
• 13:11
  SPEAKER_00: Let's walk through an example to help people understand the connectivity between the two.
• 13:16
  SPEAKER_01: Yeah.
• 13:17
  SPEAKER_01: So first,
• 13:17
  SPEAKER_01: I'm just going to,
• 13:18
  SPEAKER_01: I'll step back for one second and then I'll give you a real example.
• 13:22
  SPEAKER_01: Okay.
• 13:22
  SPEAKER_01: So one really key, people sometimes view 14971 and Q9 as competing frameworks.
• 13:29
  SPEAKER_01: They are not.
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  SPEAKER_01: They are not in competition.
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  SPEAKER_01: They are asking different questions about risk.
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  SPEAKER_01: And combination products require teams to answer both sets of questions, but at the same time.
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  SPEAKER_01: Okay, so 14971 is focusing very heavily on safety,
• 13:47
  SPEAKER_01: users, harm, and there's a really strong relationship for design controls.
• 13:51
  SPEAKER_01: Q9 is focused really heavily on product quality, Process variability and control strategies.
• 13:58
  SPEAKER_01: And there's a strong relationship with quality by design.
• 14:01
  SPEAKER_01: If you are managing a combination product risk management,
• 14:04
  SPEAKER_01: you need to understand both perspectives because the interactions that happen
• 14:09
  SPEAKER_01: between the constituent parts bring a whole additional element,
• 14:13
  SPEAKER_01: which requires that you understand both perspectives.
• 14:16
  SPEAKER_01: So you've got to think about what's the overarching concern.
• 14:19
  SPEAKER_01: So if I'm dealing with my combination product, I've got my drug related risks.
• 14:23
  SPEAKER_01: I've got my device-related risks.
• 14:25
  SPEAKER_01: Maybe I've got biologic-related risks.
• 14:27
  SPEAKER_01: Then I've got all the interface risks, right?
• 14:30
  SPEAKER_01: My drug and my device,
• 14:31
  SPEAKER_01: my device and my user,
• 14:32
  SPEAKER_01: my product and my process,
• 14:34
  SPEAKER_01: my product and the environment that it's being used in, right?
• 14:37
  SPEAKER_01: And then I've got lifecycle risks, like, ooh,
• 14:40
  SPEAKER_01: changes that are happening from suppliers or process changes or labeling changes
• 14:45
  SPEAKER_01: or post-market insights that are going to drive change.
• 14:48
  SPEAKER_01: And all of those require that you have to constantly go back
• 14:52
  SPEAKER_01: to Each constituent part and how they interact with each other.
• 14:55
  SPEAKER_01: To give you an example, let's say I'm just thinking about the typical progression.
• 14:59
  SPEAKER_01: I think you said a lot of the people that follow this are device-led
• 15:04
  SPEAKER_01: or have device-centered businesses.
• 15:07
  SPEAKER_01: So if I were to say, gee,
• 15:08
  SPEAKER_01: what are the potential sources of harm for a combination product,
• 15:12
  SPEAKER_01: but I'm very focused on my device, I would say, let's say it's a pre-filled syringe.
• 15:17
  SPEAKER_01: Oh, my exposed needle, right?
• 15:20
  SPEAKER_01: Or incomplete.
• 15:21
  SPEAKER_01: Dose delivery capability because my device isn't working right.
• 15:24
  SPEAKER_01: Or maybe I get microbial contamination or I've got high voltage.
• 15:29
  SPEAKER_01: So those are a bunch of potential sources of harm.
• 15:31
  SPEAKER_01: And then what are the circumstances where somebody is going to be exposed to,
• 15:36
  SPEAKER_01: you know,
• 15:36
  SPEAKER_01: a person, a product or the environment is exposed to this potential source of harm.
• 15:40
  SPEAKER_01: So what's my hazardous situations?
• 15:42
  SPEAKER_01: A user comes in contact with an exposed needle.
• 15:46
  SPEAKER_01: Or I have an underdose, an overdose, a missed dose, right?
• 15:49
  SPEAKER_01: Those are all the typical things that we would think about.
• 15:52
  SPEAKER_01: And then you get to harm as it's defined under ISO 14971.
• 15:56
  SPEAKER_01: It says physical injury or damage to health or damage to property or the environment.
• 16:01
  SPEAKER_01: That is 14971 definition.
• 16:03
  SPEAKER_01: Now I'm going to step back and talk about ICH Q9R1.
• 16:08
  SPEAKER_01: It's still talking about damage to health,
• 16:10
  SPEAKER_01: but then it adds in this phrase,
• 16:12
  SPEAKER_01: it says,
• 16:12
  SPEAKER_01: including the damage that can occur from Loss of product quality or availability.
• 16:19
  SPEAKER_01: Okay.
• 16:19
  SPEAKER_01: So it's pointing you to additional hazards when it says that.
• 16:23
  SPEAKER_01: Okay.
• 16:23
  SPEAKER_00: Yeah.
• 16:24
  SPEAKER_01: So then I go back to, well,
• 16:26
  SPEAKER_01: what would be some new hazards that I would be thinking about because it's damage
• 16:30
  SPEAKER_01: that can occur from loss of product quality or availability?
• 16:34
  SPEAKER_01: Well, okay, product quality.
• 16:35
  SPEAKER_01: Now I'm very focused on product contamination.
• 16:38
  SPEAKER_01: I'm focused very much on manufacturing variability,
• 16:42
  SPEAKER_01: product degradation,
• 16:44
  SPEAKER_01: product shortages, loss of product availability to the marketplace.
• 16:48
  SPEAKER_01: All of those are things that, yeah,
• 16:50
  SPEAKER_01: you might think of them,
• 16:51
  SPEAKER_01: So it's no longer just about the exposure to the device or
• 16:53
  SPEAKER_01: the device functionality itself.
• 17:09
  SPEAKER_01: The drug that gets administered is now contaminated,
• 17:12
  SPEAKER_01: or the drug is degraded,
• 17:14
  SPEAKER_01: it's no longer full strength,
• 17:16
  SPEAKER_01: or the patient can't receive their dose due to a product shortage,
• 17:19
  SPEAKER_01: or the patient's treatment's delayed because something's not working.
• 17:23
  SPEAKER_01: It starts to have a different impact on what harms are you thinking about, right?
• 17:28
  SPEAKER_01: So there's additional hazardous situations
• 17:30
  SPEAKER_01: because you have this combined use perspective of hazardous situation.
• 17:35
  SPEAKER_01: And then here's something, if I think about harm, Yeah.
• 17:38
  SPEAKER_01: Yeah.
• 18:01
  SPEAKER_01: When you go to think about your ICHQ9,
• 18:05
  SPEAKER_01: you're always having to add in not just your basic hazards,
• 18:08
  SPEAKER_01: your biological, your chemical, your physical, your electrical, right?
• 18:12
  SPEAKER_01: All those things that are mentioned under 14971.
• 18:16
  SPEAKER_01: You're also having to think about what are the interactions between
• 18:19
  SPEAKER_01: the biologic constituent part and the other constituent parts?
• 18:23
  SPEAKER_01: Is it causing protein aggregation?
• 18:25
  SPEAKER_01: Do I denaturization?
• 18:27
  SPEAKER_01: Do I have...
• 18:28
  SPEAKER_01: Biologic material interactions.
• 18:30
  SPEAKER_01: Or maybe I've got drug device material incompatibility or adsorption,
• 18:35
  SPEAKER_01: extractables and leachables, occlusion.
• 18:39
  SPEAKER_01: There's so many interaction effects that you have to think about
• 18:43
  SPEAKER_01: when you're now thinking about a combination product
• 18:45
  SPEAKER_01: that you aren't necessarily thinking about a standalone device or a standalone drug.
• 18:50
  SPEAKER_01: Even your sterilization, sterilization incompatibility.
• 18:54
  SPEAKER_01: You might have a sterilization process that's perfectly compatible with your medical device.
• 18:59
  SPEAKER_01: But now your biologic gets exposed to that as part of your terminal sterilization process.
• 19:04
  SPEAKER_01: And you just completely, you know, inactivated or denaturized the biologic.
• 19:09
  SPEAKER_01: So every step of the way, there's some different things that you have to think about.
• 19:14
  SPEAKER_00: Yeah.
• 19:15
  SPEAKER_00: Yeah.
• 19:15
  SPEAKER_00: This is wonderful, Susan.
• 19:16
  SPEAKER_00: Thank you for walking us through.
• 19:18
  SPEAKER_00: This is this is fantastic.
• 19:19
  SPEAKER_00: Now, it it makes like when you explain like this, it makes so much sense.
• 19:23
  SPEAKER_00: So I'm kind of struggling a little bit.
• 19:25
  SPEAKER_00: Why?
• 19:26
  SPEAKER_00: It is becoming difficult to bring people together.
• 19:28
  SPEAKER_00: And that in my mind raises the next question about the leadership aspect of it.
• 19:33
  SPEAKER_00: So I have been very curious lately to think about risk management,
• 19:37
  SPEAKER_00: not just from a technical side, but also from the leadership side.
• 19:41
  SPEAKER_00: And I know you have had firsthand experience.
• 19:43
  SPEAKER_00: At the end of the day,
• 19:44
  SPEAKER_00: it requires a judgment call and leaders get paid to make that judgment call.
• 19:49
  SPEAKER_00: My first question is on a personal basis, what does it feel like?
• 19:53
  SPEAKER_00: When you are in that spot and you are having to make a judgment,
• 19:57
  SPEAKER_00: I'm going to start with that and then follow up with another question
• 20:01
  SPEAKER_00: about how do we bring people together to have this mindset collectively focusing on
• 20:06
  SPEAKER_00: the patient?
• 20:07
  SPEAKER_01: Sure.
• 20:07
  SPEAKER_01: So I think a first step is as a leader,
• 20:10
  SPEAKER_01: seeking understanding,
• 20:12
  SPEAKER_01: and then also sharing,
• 20:13
  SPEAKER_01: trying to educate,
• 20:14
  SPEAKER_01: because if you're making a decision to However tough that decision is
• 20:19
  SPEAKER_01: that you're making, right?
• 20:20
  SPEAKER_01: There's benefits and there's risks.
• 20:22
  SPEAKER_01: And you've got to be able to ensure that the overarching final decision
• 20:27
  SPEAKER_01: that you're making is one that takes into account,
• 20:30
  SPEAKER_01: you know,
• 20:30
  SPEAKER_01: be as informed as possible and then make the best decision based on what are
• 20:36
  SPEAKER_01: the risks and how confident are you that the benefits of using something outweigh
• 20:41
  SPEAKER_01: the risks.
• 20:42
  SPEAKER_01: And fundamentally,
• 20:43
  SPEAKER_01: I think that that's what it comes down to and how good is
• 20:46
  SPEAKER_01: the science that's been applied,
• 20:47
  SPEAKER_01: what assumptions are being made in the process,
• 20:50
  SPEAKER_01: but really understanding distinctly what are different people telling you and trying
• 20:56
  SPEAKER_01: to be really open-minded about it.
• 20:58
  SPEAKER_01: And I think where some of the challenges come from when it comes to this is both
• 21:02
  SPEAKER_01: from a practical business perspective where people who are in
• 21:06
  SPEAKER_01: the device world typically,
• 21:08
  SPEAKER_01: I'm going to say the profitability of a product Might not be at the same level
• 21:14
  SPEAKER_01: as it is on the drug side.
• 21:16
  SPEAKER_01: And with budget constraints and resource constraints,
• 21:19
  SPEAKER_01: people don't want to have to invest more than the minimum necessary to be able
• 21:24
  SPEAKER_01: to make an appropriate judgment call.
• 21:26
  SPEAKER_01: Actually, it doesn't matter what the profitability is.
• 21:28
  SPEAKER_01: Nobody wants to have to invest more than what you need to.
• 21:30
  SPEAKER_01: You want to do what is the minimum that's appropriate to make the right decision.
• 21:37
  SPEAKER_01: It's just that The level of documentation that goes with it isn't always so easy,
• 21:41
  SPEAKER_01: and then people draw back.
• 21:43
  SPEAKER_00: What I'm hearing you say is that leaders have to make that decision based
• 21:47
  SPEAKER_00: on many different constraints and criteria, and that is what they do.
• 21:51
  SPEAKER_00: There's a technical side to it,
• 21:53
  SPEAKER_00: there's a business side to it,
• 21:54
  SPEAKER_00: there's a people side to it, and all that is very challenging.
• 21:57
  SPEAKER_00: Susan, we do have a good question that I want to save some time for.
• 22:02
  SPEAKER_00: I'm going to read that.
• 22:03
  SPEAKER_00: Thank you for this informative session.
• 22:05
  SPEAKER_00: Could you please share your thoughts on supplier controls?
• 22:08
  SPEAKER_00: What are the major differences in medical device versus combination products
• 22:11
  SPEAKER_00: for establishing controls for raw material suppliers?
• 22:14
  SPEAKER_01: So I don't think that the controls are that different from each other other
• 22:18
  SPEAKER_01: than some of the formality of the expectations, right?
• 22:21
  SPEAKER_01: Whether you're drug led or device led,
• 22:23
  SPEAKER_01: you're expected to have quality agreements with your suppliers.
• 22:26
  SPEAKER_01: The distinction of having a formal approved supplier list and putting in place
• 22:30
  SPEAKER_01: a qualification process for those suppliers to ensure that they are going
• 22:34
  SPEAKER_01: to meet all the expectations for the specific services or product
• 22:39
  SPEAKER_01: that they're providing,
• 22:40
  SPEAKER_01: I think it gets stepped up for medical devices and especially
• 22:44
  SPEAKER_01: for combination products because you have different roles and responsibilities where
• 22:48
  SPEAKER_01: if I have a supplier that's only providing the device,
• 22:51
  SPEAKER_01: What they may have done
• 22:52
  SPEAKER_01: in doing their base risk management documentation might not have the purview
• 22:57
  SPEAKER_01: that you have for the entire combination product.
• 23:00
  SPEAKER_01: So the supplier may have a lot of great processes in place,
• 23:03
  SPEAKER_01: but ultimately you as a sponsor are ultimately responsible for the whole product,
• 23:07
  SPEAKER_01: period.
• 23:08
  SPEAKER_01: There's no gray in that.
• 23:09
  SPEAKER_01: And that's where I think things get different.
• 23:12
  SPEAKER_01: It's the fact that there's a broader view and that ultimately the sponsor has
• 23:16
  SPEAKER_01: to make sure that they've taken all the differences for each constituent part
• 23:20
  SPEAKER_01: into account.
• 23:21
  SPEAKER_00: Yeah, yeah.
• 23:22
  SPEAKER_00: So what I'm hearing you say is that we know what is supposed to be done.
• 23:25
  SPEAKER_00: Like 13485 also talks about this.
• 23:27
  SPEAKER_00: And the difference might be in exactly how much emphasis you have,
• 23:32
  SPEAKER_00: how much responsibility you have in both those cases.
• 23:35
  SPEAKER_00: So, Susan, we are running short on time.
• 23:37
  SPEAKER_00: Of course, the time flies.
• 23:38
  SPEAKER_00: I want to give you a couple of So if you guys are interested in coming to the show,
• 23:42
  SPEAKER_00: it takes no preparation.
• 23:43
  SPEAKER_00: It's not a webinar or a lecture.
• 23:44
  SPEAKER_00: You don't have to make slides.
• 23:45
  SPEAKER_00: It's just a conversation.
• 24:09
  SPEAKER_00: Raise your hand and we'll set up some time and have a chat about that.
• 24:13
  SPEAKER_00: I would love to have you on the show.
• 24:15
  SPEAKER_00: Everyone has something to share in our community and you're all welcome.
• 24:19
  SPEAKER_00: The second announcement is again to let you guys know about the LTR Risk Coach
• 24:24
  SPEAKER_00: that I have developed and it's now available to all of you on
• 24:28
  SPEAKER_00: a limited launch basis.
• 24:29
  SPEAKER_00: It's an AI-based thinking partner, a coaching partner.
• 24:33
  SPEAKER_00: It is not going to tell you a yes-no answer.
• 24:36
  SPEAKER_00: It is going to help you navigate through a Very tricky,
• 24:39
  SPEAKER_00: thorny risk issue that you might be dealing with.
• 24:42
  SPEAKER_00: So it's a conversational risk tool.
• 24:44
  SPEAKER_00: If you guys are interested in trying that out,
• 24:46
  SPEAKER_00: please reach out to me and I'll share more information with you.
• 24:49
  SPEAKER_00: With that, Susan, the floor is yours.
• 24:51
  SPEAKER_00: Please share just a couple of key takeaways with us.
• 24:54
  SPEAKER_01: Sure.
• 24:55
  SPEAKER_01: So I guess the big things I would say is that effective risk management is not a document.
• 25:01
  SPEAKER_01: It's an ongoing lifecycle process and it needs to be informed by
• 25:05
  SPEAKER_01: The constituent parts,
• 25:07
  SPEAKER_01: the product overall,
• 25:08
  SPEAKER_01: the manufacturing process, the user, and your post-market understanding.
• 25:13
  SPEAKER_01: That's not unique to a combination product.
• 25:15
  SPEAKER_01: It's something that applies for all risk management.
• 25:18
  SPEAKER_01: The distinction being, though,
• 25:19
  SPEAKER_01: that on a combination product,
• 25:21
  SPEAKER_01: there may be blinders on some people relative to the full scope of
• 25:26
  SPEAKER_01: the end-to-end human factors and use-related risk.
• 25:29
  SPEAKER_01: Doing the verification process Residual risk analysis, the benefits and risks.
• 25:33
  SPEAKER_01: But ultimately,
• 25:34
  SPEAKER_01: if I'm on the receiving end of the product,
• 25:36
  SPEAKER_01: I don't care about whether you applied Q9 or 14971.
• 25:41
  SPEAKER_01: What I care about is that the residual risks associated with the product that I'm
• 25:45
  SPEAKER_01: about to use are acceptable, which means it's safe.
• 25:48
  SPEAKER_01: So the tools that we're trying to put out there for ISO 24971 Dash 3,
• 25:54
  SPEAKER_01: AMETIR 105, all of these are intended to help people think about it that way, right?
• 26:01
  SPEAKER_01: Who's the end user?
• 26:02
  SPEAKER_01: Make sure you're keeping them safe.
• 26:04
  SPEAKER_01: And I know that that's everybody's intention in the industry that we're serving.
• 26:08
  SPEAKER_00: Yeah, wonderful, Susan.
• 26:10
  SPEAKER_00: The key point there is that The resources you are building will actually help people
• 26:14
  SPEAKER_00: with the how part, how to do it.
• 26:16
  SPEAKER_00: Thank you so much for coming to the show.
• 26:18
  SPEAKER_00: I know you are busy.
• 26:19
  SPEAKER_00: I appreciate your time.
• 26:20
  SPEAKER_00: What a wonderful conversation we have had.
• 26:22
  SPEAKER_00: Guys, let me know how you're feeling.
• 26:24
  SPEAKER_00: Show us your reactions by some emojis if you want to do that.
• 26:28
  SPEAKER_00: A recording of this session will be available later on on the Let's Talk Risk newsletter.
• 26:33
  SPEAKER_00: If you missed this, you can find the recording there by subscribing to the newsletter.
• 26:37
  SPEAKER_00: With that, thank you all for joining once again.
• 26:40
  SPEAKER_00: We will see you in a couple of weeks from now.
• 26:42
  SPEAKER_00: And Susan, thanks once again, and good luck to all the work that you're doing.
• 26:46
  SPEAKER_00: I hope we are able to see this soon.
• 26:48
  SPEAKER_01: Thank you.
• 26:48
  SPEAKER_01: Thanks for having me.
• 26:49
  SPEAKER_01: It was great to participate.