Staying Compliant in a Changing World: Best Practices with Niyati Patel

Niyati Patel: 0:00

What are the minimum or must haves that both sides from the drug perspective from the device perspective, compliance wise the company needs to meet. So that's sort of that foundation where the company at a minimum needs to meet those requirements. And a lot of times when companies are selecting the software vendors they

Harsh Thakkar: 0:20

What's up everybody, this is harsh from qualtivate.com. And you're listening to the life sciences 360 podcast. On this show, I chat with industry experts and thought leaders to learn about their stories, ideas and insights, and how their role helps bring new therapies to patients. Thanks for joining us. Let's dive in. Alright, welcome to another episode of Life Sciences 360. My guest today is Niyati Patel, she is the Director of Quality Engineering at Getinge (Maquet Cardiovascular) and she's also a part time quality assurance and regulatory consultant for life sciences. So welcome to the show, Niyati.

Niyati Patel: 0:57

Thank you, Harsh. Thanks for having me here.

Harsh Thakkar: 0:59

So I want to ask you this, I asked this pretty much to everybody who is in quality, how did you end up being in quality? Did you always wanted to work in QA? Or was it through one of your jobs that you develop the passion of being in the QA field?

Niyati Patel: 1:13

Yeah. Yeah, I mean, for me, it was a couple of different factors. So early on, in my career, I always had the affinity for science. And hence, you know, I pursued my academic, My academic background, I did a master's in biomedical engineering, but one of the factors was just going into the fields and starting to work pursuing my master's through my graduate school, I had a mentor, a professor, who was sort of that turning factor or turning point for me, because he was working in a in a bio in a medical device company at the time, and he's seeking a strong quality engineer, a young professional to join the company, and take things forward. So that was sort of an attempt to learn quality and see what it's all about. And using my technical background, and I think it played out really well, I didn't really think that I've, I would diverge into the world of compliance, because always meant doing school, during school and beyond, I always thought that I was going to be, you know, one of the engineers that my family was looking forward, to, to be and, you know, I never thought that this will turn into a profession where you know I now am into compliance, and there's a lot of other aspects of this job. So that was one big turning point for me. And it worked out well.

Harsh Thakkar: 2:35

Great.

Niyati Patel: 2:36

And the other one was around that same time, my grandma was going through an open heart surgery. So she was going through bypass surgery. And there were a lot of issues. And so there's emotional value associated with with this as well, that she was going through struggles with recovery she had, there were operating room issues, there was operative care, and all of those factors that sort of went into her recovery. And that really increase my passion towards being involved in this life science industry, particularly in a way that allows me to make decisions to produce better quality products. Yeah, for patients that are in need. So so those were, I guess, the driving factors for me, that made me into who I am today.

Harsh Thakkar: 3:21

Yep. And that story is important to hear, because now that you're in cardiovascular, or that the company that specializing Maquet, cardiovascular, and then the story of your grandmother. So I can see how if you wake up and you work for this company, you open your laptop, it's not just business, it's also the personal side, because your company's products could be taken by millions of other patients who are going through the same journey that your grandmother went through. So that's really interesting. So one of the questions I want to ask you is a thing that I see commonly people get wrong and and they have misconceptions or they're confused. So I work in quality management area and compliance area as well. And many times clients or other industry professionals mix up a business management system and a quality management system. So I want to ask you, what is how do you draw the line between the two? Because to me, they are kind of different, even though they have some overlapping pieces. But can you just shed some light on that?

Niyati Patel: 4:30

Yeah, yeah. So you know, my, I mean, over the time, over 17-18 years now in the industry, I've had an opportunity to work on several quality management systems and other parts of the business where the critical business functions lie. And I think the it's interesting because my belief has changed over the course of time with my experience in that I almost see QMS as a subset of BMS, so it's is an element which is a child, if you call it of a parent right, which which can be your overarching Enterprise Business Management System. So I feel that and there are a lot of qualities or opportunities to have a QMS styled implementation or have you know, BMS that really aligns with those practices. So I, that's my viewpoint that, you know, I feel that companies have functions that are critical to the business and they operate in silos. So a lot of times, you would see that there's the interconnectivity between them is missing. And there's a lot of opportunity there. So I feel like having this this approach of, you know, having your QMS be part of this overarching, you know, structure, which, which we call it as BMS. If you define BMS, it's basically a Business Management System, which comprises of all the critical elements of the business. And these processes working together with each other. So you know, for example, finance, accounting, HR, those are not heard of right, when you talk about QMS, there, yep, there is traditional processes that come to mind are nonconformances, CAPAs, all of the quality related. Yeah, yeah, processes. But we don't talk about other critical functions of a business like CRM, or finance or customer service or sales. And they do for me, I think quality is center of all of those business functions. And if you really think about it, it's smooth beyond regulatory and compliance, it's in the quality of services or at the end, quality of your service and product, that, that that's the approach that goes into it. So that's, I think, my opinion that I feel that having that overarching BMS compliance and having that integration is very important for businesses.

Harsh Thakkar: 6:56

So in your experience, being in quality assurance roles, and being a consultant, what are some of the actionable strategies, or best practices for integrating the BMS and QMS? Like, what would if you had a client who hired you to do this? What would you do for them?

Niyati Patel: 7:16

Yeah, so I think it's, it's really important to learn the business. So you know, what are the critical elements of the business is the most crucial thing to know? And then how does quality, what is the role of quality in each of these functions? Because believe it or not, quality is front and center. Yeah, if you really are looking at successful businesses, they're putting quality in front and center, and involving them in each of these areas that are important for the business because they are connected. So my strategy really is to understand the business, the critical elements of the business, and then how those processes or the workflows on a daily basis work, keeping the quality or compliance things in mind. And really understanding those overlapping processes. So coming up with good processes, workflows, understanding the connectivity between different departments, if you call it or different functions of the business is important when you strategize, building a BMS type of system.

Harsh Thakkar: 8:18

Okay, and and it's, it's important, you know, like you said, I think I shared this on on LinkedIn as well, like few days back, where you always need to you being in quality, being in compliance, whichever role you are, you're always going to benefit if you learn other aspects of the business. You don't need to be an expert. Like, you don't need to be an expert in supply chain and manufacturing and engineering. But just having that one meeting, or going to lunch with a co worker in that space, and understanding, Hey, what are you working on? What is the frustrating part that you felt this week? Or what would you love to have happen so that your job becomes easier? These are questions anybody can ask. I don't need a science degree to ask these questions. But when you ask them to people they share and you know that just knowing that information is so important, but people don't do it a lot of the times because they're like, Oh, my job is QA. Like, I don't need to talk to them, unless I have a project then I'll talk to them. But you know, that's that's what separates people who are understanding different aspects of business because then they know how one decision in one department impacts five other departments.

Niyati Patel: 9:34

Yes, you I mean, you're exactly right. And I think there's, it's very important and that's where, you know, the big onus is on leadership, right? How the senior leadership and management think about these these on a daily basis, how they approach different departments of their business and really understanding the backstory behind what are the areas where they have challenges, really learning truly about how to improve from all aspects of the of the organization is important. So leadership has a big role to play in that, I would say because, you know, not in quality leadership, particularly because again, like I said, front and center, you got to be able to understand the nuances of each department and how they work. And the challenges as well as opportunities where you can create equal opportunities by working with them. Because a lot of times when operating in silos, you know, you can do your job perfectly, but it creates hassles or challenges for other departments. So that's something that gets unnoticed.

Harsh Thakkar: 10:35

Yeah. And people that have worked with me or people that are connected with me on LinkedIn, or whatever, they know that I spent most of my career in pharmaceutical and biotech. And because as a consultant now, and having my own consulting practice, I feel like medical devices is an area which I wish I had maybe taken some consulting roles early in my career, just to have that experience, you know, because today, I don't have that. And and, you know, yes, you when you look at a QMS, the fundamentals are similar for all areas, whether you're working for biotech pharma, but there's still certain different characteristics. So I know one area that I'm seeing a lot is combination products, right. So is it a drug? Is it a device? Is it is it a mix? So I know you have more medical device experience or exposure? So what what is it? How are combination products regulated? And how do you even go about implementing a QMS? If you have to consider both the drug and device regulatory landscape?

Niyati Patel: 11:43

Yeah, so it's an interesting area combination products, and it's evolving rapidly. There are lots of innovative products that are being developed and put forth in clinical trials, and they're producing amazing results. But it's an evolving landscape. So when we talk about regulatory compliance, or how how combination products are really regulated, it's an interesting mix. It's the drug side of the regulations that play into part as well as the device side. And with with those integrations, now, recently, FDA has I mean, back in 2013, is when actually the rule came about where you know, the 21 CFR Part Four, which is primarily the combination product regulation, that companies follow, came into play. But just recently, with this evolving landscape, FDA put forth an office for combination products. So it's particularly sort of enduring jurisdiction for combination products, and office that really tackles those questions and challenges and so forth, that come for new development programs. So it's really a combination of all the the areas which control drugs and devices right, there's CBER, for biologics, there's, there's CDRH, and then there is, you know, CDER for drugs. There's requirements from each of these entities that come into play. And hence, this, almost a Bible, if you call it was was created to really understand how these all come together. And it varies from product to product. Because there are certain products where device companies have a combination product coming out. So they're very primarily heavy drug driven, and they have challenges in how to integrate the med device, you know, requirements, and then vice versa, for med device companies producing a combination product. Now they have challenges in understanding, you know, how to translate the drug requirements. So the office of you know, combination products is really now there and exists to support, you know, companies in these questions and these inquiries that come through. But it is interesting, and it definitely varies from the type of company you ran and the business you're in and the type of product you're trying to put out there.

Harsh Thakkar: 14:11

Right. So when you go into like, the, let's say, like designing a quality manual, or like a quality policy, or anything of that sort for a company that's into combination products. So it sounds like there that you did, from your perspective, you would consider all the device regulations for or QMS guidances plus the drug. And then how does because I'm seeing that it might be a challenge of combining the two so is it just add the two or is it more that there's some overlapping duplicates, which are common, but there's some unique regulations that are only in the device side but not in drug? Do you know of any like unique ones that you can share.

Niyati Patel: 15:01

Yeah, so it is challenging. And that's when if you're forming a team of individuals and experts, it's important to understand SMEs that you have on your team that really are heavy with device experience, and then have the SMEs from the drug side as well. To to have a all rounded theme when you when you talk about developing a QMS. That's combination product driven. So the some of the and the way I have strategized it in the past is really understanding the the two sides of the coin, understanding where the overlapping requirements are, and then understanding the differences. So you really have to consider the overlap. And there are overlapping requirements that are areas that overlap between the devices are regulated by 21 CFR 820. So that's the QSR regulation. And then for drugs, it's primarily 210- 211, there are some overlapping areas between the two. And then there are differences. So particularly the differences I can tell are design and development. Pharma has very different way of, of understanding what really design and development process entails. And sometimes pitfalls and clearly drawing out the the, you know, design inputs versus design outputs, you know, integrating the whole risk management process that that plays a part in this design and development, structure or framework. So there's some pitfalls within the pharma industry where it's not laid out very well plus, it's not mandated. So there is no mandatory regulations around risk management, for example, within the pharma landscape. So it becomes challenging, because from the med device side, it's mandatory to have a risk management program integrated with your device, which you're bringing out there. And with pharma, there are guidelines with ICH Q-9 and Q-10. But they're, they're not mandate. So it becomes difficult, I think integrating those differences is the place where challenges happen. Another part is suppliers. If you if you if you're a drug company, having a medical device component manufacturer, which is an outsource supplier, a lot of times they are following the QSR regulations. But more importantly, they have these certifications that are ISO driven. So they're following these independent ISO guidances, if you call it if you if you talk about ISO 1345, or 9001, and they're being really good guidances. Again, you know, not mandated by law. And the requirements are some of the requirements are very broad, they're more business oriented rather than very specific. So one of the big ones that I know of is the difference where pharma companies struggle with is it the suppliers systems, or QMS, doesn't have the element of production control, or manufacturing material control? There's not clear or specific requirements from ISO 1345 that talks about we the manufacturing material controls, if they have a supplier that they're qualifying, it becomes increasingly difficult to see, you know, how are they controlling their materials, and you know, when we really have to qualify, you go out there and audit them. They're complying with ISO, but there's these gaps that you discover, right? When you you're talking about, you know, integrating the QMS. So these are the, you know, these are the challenges that I'm aware of, and I've experienced, but I think strategically speaking, really having a clearer picture of 21 CFR part four really understanding your product, your processing is how you're going to control them. And then seeing where the overlapping areas are from both sides of the the elements from design and from device and drug. And then seeing the differences and rationalizing how you're going to make those differences into justify the differences and bring them into your QMS is important. So that's where you know, multi faceted cross collaboration and having the right experts in the team when you're doing the mess like that is critical.

Harsh Thakkar: 19:24

Yeah. And also, I don't know if you have faced this situation, but I have come across some projects and clients where they are developing a product, but they don't even know if it's a drug or a device. Like they're still so early that the definition of the drug and device or is it both right, like so as a startup with 20 people when we just have a concept or early stage product? It's challenging now to say is this the drug? Is this a device? Is it a combination? So How? I know that, I don't know maybe you have some insights on that, like for a very small startup like 20 person company? How can they go about interpreting what they should file for? Right? Because they don't want to file for a device, and then get the agency telling them, oh, this is not a device. This is a combination product. So do you have any thoughts on that?

Niyati Patel: 20:23

Yeah, I think one of the good things for very small startup is really engaging with people that have experience with combination products, sometimes companies bring in the specialized consultants, which are very popular with smaller companies to really lean on the experts when it comes to combination products. The other thing is, there's several resources from the agency, as well as now this office of combination products out there to really help small companies. And I'm aware of the small company CBER, or SBAER, I believe in the drug side and drug world, which is particularly geared for small companies that need this assistance. And when they're starting out, from concept onwards, and having questions and kind of gathering that information in making right decisions. So you know, there's these resources out there. But you know, a lot of times small companies have leaned on expert consultants that have experience in working with combination products who really understand both sides of the coin, in getting them through that initial, you know, at least that classification stage, whether it's a combination product, how to be regulated, or does it fall on one side, heavily than the other?

Harsh Thakkar: 21:41

So we talked a lot about processes and regulations, I want to jump into the software side of things, right. So as a life science company, if I'm implementing an electronic QMS, if I'm a pharma company that now is I want to implement a QMS, because I'm going into a new area, and I need to consider medical device regulations, or vice versa. So how do you even go about selecting electronic QMS? If you have to follow both pharma and medical device regs, because I working in this space, I know that the medical device, electronic QMS software are like it's a completely separate group of vendors that are that have that market share? And then on the biotech side, there are some vendors who have that market share. So like, how do you pick one if you're doing both pharma and med? Like on the software side of things?

Niyati Patel: 22:40

Yeah. So you know, I think typically, in that sense, you know, that exercise comes handy, you know, really to start, you know, with the baseline or the foundation of, you know, what are the the minimum or must haves, that, you know, both sides from the drug perspective, from the device perspective, compliance wise the company needs to meet. So that's sort of that foundation, where the, the company, at a minimum needs to meet those requirements. And a lot of times, you know, when companies are selecting the, the software vendors, the these, this foundation, or the I guess the critical requirements fall into play when you even selecting a software vendor. So it almost becomes like your purchasing criteria for, for your vendors when you select them. And, you know, a lot of times companies go about that, that, okay, if these are my minimum criteria, and this is how I would need a software vendor that at a minimum has meets these criteria, before I can go go ahead and select a vendor. So that's one approach. And, and then furthermore, there are vendors that work to you know, as you learn about your QMS processes, as you learn about the requirements that you need to put into your QMS. They are open minded, you know, their software's are configurable, there's more flexibility in changing things or configuring things as the as the processes are solidified. So those are sort of the the choice of vendors that a lot of times companies take because they want that flexibility, they know that they're learning as they're going. So they want to be able to modify and adjust as they're moving along this journey. So that's another typical approach that companies want. They don't want to lock themselves in into a very conservative way of working because it limits them in adjusting. And, and that flexibility losing. So I think those are some of the ways I think companies go about, especially small companies that that are going with combination products, or go about selecting software.

Harsh Thakkar: 24:56

Yeah, that's interesting. Yeah. Because I know that not doing that. Exercise upfront. And then if you are, if you are choosing a software vendor and certain features or functionality that don't align with what you're trying to build in the future, then now you're at the mercy of that vendor and the features because there's only so much you can change, right? And it just creates, you're basically now trying to fit your process to what the system does. But the way you should have done it the other way, which is to first define your requirements, and then select the best system that meets it right not, not the other way around I've seen, I've seen that on many projects, it's good, it's good for business, but it's, it's not a good strategy if you are a biotech company, because you should be doing that exercise upfront before you select the vendor. So yeah, listen, this is amazing. Thank you so much for coming on. I really enjoyed talking to you. And I know we've interacted before multiple times on other consulting related stuff and just talking about these topics. So where can people connect with you? Where can people ask you questions or just connect with you?

Niyati Patel: 26:10

So I mean, likewise, you know, again, I had a pleasure of speaking with you, I always enjoy talking with you. And yeah, this was the podcast conversation was amazing. I've, if people would like to be in touch with me they can, can can, the best way to connect is through LinkedIn. I'm very active through that platform. And otherwise, I think I'm open to sharing my contact information. It's available on LinkedIn. And I would love to connect with the community. I hope that you know, this conversation, especially for the ones that are that are in the combination product space, or med device, drug space, feel value out of the conversation, and we answered some of their questions. Yes, yeah, love.

Harsh Thakkar: 26:52

Yeah, absolutely. I learned something new today as well, especially because the BMS QMS topic was something that was on my brain and then combination products is not something I'm much familiar with. So I learned something new today. And yeah, we'll definitely put your links to social media in the show notes. So any any final thoughts before we Any final thoughts for the audience? Before we wrap this up?

Niyati Patel: 27:15

No, I just would like to say it's, it's, it's amazing how the world is connected now. And you know, through this platform, I would love to be able to connect with you know, the community even more, so I would, you know, just a message for the entire community. And again, once again, I would like to thank you for you know, doing this work, I think you're doing an amazing job in bringing professionals you know, together and thought sharing, because it's it's amazing to see everybody's you know, experience and and what value they bring. So thank you again for having me.

Harsh Thakkar: 27:50

Yeah, absolutely. Thank you and have a great week ahead. Thanks.

Niyati Patel: 27:54

You too. Thanks Harsh.

Harsh Thakkar: 27:56

Thank you so much for listening. I hope you enjoyed today's episode, check out the show notes in the description for a full episode summary with all the important links. Share this with a friend on social media and leave us a review on Apple podcast, Spotify, or wherever you listen to your favorite podcast.