What if regulatory affairs were not only viewed as a necessary burden, but actually help a medical device company? Our guest today thinks that is exactly the case.
Phagenesis, a greenlight.guru customer, is a new type of medical device startup company with a fascinating story. Their products are transforming the lives of people with dysphagia by restoring neurological control of swallowing. Nestlé recently struck a deal to acquire Phagenesis as reported by The WSJ.
Today Jon is talking with Rebecca Sheridan, Head of Quality Assurance and Regulatory Affairs at Phagenesis. Join us as Rebecca shares more about her background, the Phagenesis story and the role of regulatory affairs in the medical device industry.
Some of the topics discussed today include:
- Rebecca’s professional background
- Differences between large and small medical device companies and joining Phagenesis
- Involving the whole team in regulatory affairs to make it work for everyone
- Using greenlight.guru as a tool at Phagenesis
- Advice for medical device startups
- Overview of Phagenesis and dysphagia treatments
Quotes by Rebecca:
“Do things right the first time, otherwise it will come back and get you.”
“Always focus on your customer’s needs, even when it’s a quality management system process.”
“Don’t be afraid of regulators, they are there to help and guide us.”
“When you have an easy to use tool, you get easy acceptance.”
Announcer: Welcome to the Global Medical Device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Jon Speer: Hello. This is Jon Speer, the Founder and VP of Quality and Regulatory at greenlight.guru. And I want to give you a little bit of a preview of today's Global Medical Device podcast. I have an opportunity to talk with Rebecca Sheridan. Rebecca is the head of Quality Assurance and Regulatory Affairs at Phagenesis. And Phagenesis is one of these new-breed medical device startups. It's pretty awesome to hear their story, and especially learn a little bit more about Rebecca's background and view on how regulatory matters impact and actually help a medical device company. So, enjoy this episode as Rebecca shares a little bit about her background and the Phagenesis story. It's a good one.
Jon Speer: Hello and welcome to the Global Medical Device podcast. This is your host Jon Speer, the Founder and VP of Quality and Regulatory at greenlight.guru. Today, I'm very excited. I've had this date marked on my calendar for quite some time. And I'm excited, because I get to talk to Rebecca Sheridan. Rebecca is the head of Quality Assurance and Regulatory Affairs at Phagenesis and I've talked with Rebecca several times over the past year, year-and-a-half or so. And every time, I leave that conversation feeling upbeat and positive and smiling and happy. So, I get to be happy the rest of the day Rebecca, because I'm talking to you.
Rebecca Sheridan: Thank you very much.
Jon Speer: Well, welcome to the Global Medical Device podcast.
Rebecca Sheridan: Thank you.
Jon Speer: Well, today, we're gonna talk about a few things. I mean, you're... I can't begin to do your background justice, so I hope you could take a few moments and share with the audience your upbringing in the medical device industry and talk a little bit about the other different roles that you've had. You've worked for some very large companies and now you're working for this startup and maybe, we'll get into the compare and the contrast. So we're gonna talk a little bit about this startup that I've observed a little bit from a distance with Phagenesis, and watching your story unfold. And it's pretty exciting. So, if you can take a moment and tell us a little bit about who you are and your background?
Rebecca Sheridan: Sure, of course. So, I've been in the medical device industry now for just over 20 years. And I did... Beginning my career, I would be an amazing researcher and academic. I quickly learned that that's not really something that is my strength, and I have the utmost respect for people who are good at research and academic research. But I was lucky enough to join the MHRA in their medical devices division in the mid-'90s as a Medical Device Specialist. And I wasn't to realize just...
Jon Speer: I'm just gonna... Lemme just pause for a moment, 'cause some of our listeners may not be familiar. What is the MHRA?
Rebecca Sheridan: Okay. So the MHRA is the Medicines Health Care Regulatory Authority in the UK, and they are the regulatory authority for both devices and pharmaceuticals and bio-technology for the UK. So, I was lucky enough to start with them at the period where it was the transition period for the Medical Device Directive. The active implantable Medical Device Directive was already enforced. And it was there that I learned about regulatory affairs. I was very interested in device safety, having studied biomaterials. But this... Regulations and how we could positively impact, as an industry patient safety, was really fascinating to me. And because I was trained by the people who were involved in developing the directive, I developed a very profound and deep understanding of truly what the intent of the regulations were, and that is to protect public health.
Rebecca Sheridan: So, I was there for less than two years before I joined industry and I joined a company called Guidant, who no longer exist as Guidant. They are between Boston Scientific and Abbott Vascular, and I joined as their Quality and Regulatory Manager covering UK & Nordic. And this is really more downstream regulatory and quality, very much involved with horizon scanning regulations, supporting clinical investigation submissions and post-market surveyance. So, got very hands-on with the sales organization, and I had an opportunity whilst I was there, to become a field clinical engineer; working with the hospitals, with the uses of the medical devices, the cardiac rhythm management devices. And was... Had a wonderful experience, because I really got in front of the patients and really was able to hear the patients' voices. And to have that feedback from the patients, many of them, luckily, just what a fabulous effect these technologies were having on their daily life and how that was also affecting their families, was really inspiring. And that was... Very, very pleased, I took that opportunity to work so deeply in clinicals, but my heart really is in regulatory affairs.
Jon Speer: Right.
Rebecca Sheridan: And I was given an opportunity to join a company called Arrow International, which was later acquired by a Teleflex Medical. And I was responsible for their... I was the first person to do quality and regulatory in their European facilities. And so, again, starting from scratch. But what was really an incredible opportunity for me was that, within a couple of months, I had the manufacturing facilities in Europe also reporting in to me from a quality and regulatory perspective. And for someone based in Europe who has downstream experience with the sales marketing warehouse distribution organizations, it's unusual then to get that opportunity. So, I was therefore involved in the whole lifecycle of the product, and we set up a design facility within one of the facilities in the Czech Republic. So, I really was able to see from the beginning to the end just how we could set up processes to be efficient, to ensure that all the processes spoke to each other not just in the development phase, but in the post-market phase.
Rebecca Sheridan: And after a few years, I was approached by Zimmer because they were going through the transition of the joints replacements becoming Class 3 from Class 2B, and they really wanted to bring somebody into their organization in a leadership role who had a very good, strong understanding of what it means to be... To have Class 3 medical devices in the European system, and how to work positively with the notified body to facilitate timely approvals and timely reviews of your devices.
Rebecca Sheridan: So, I joined Zimmer as the director of regulatory affairs and subsequently, I also took on the post market surveyance roles, and this was a really exciting period of my career because of the people I was working with, based in Switzerland. When you have a team of people who all click and they all want to approach things in an innovative way but embracing the regulations, knowing you're trying to do things which are risky, which of course are in conflict then with the protection of health that regulations give you, but working together with the appropriate regulatory authorities. And we were able to take products from the beginning of design control to having our design examinations certificate in our hand in 15 to 18 months as Class 3 implantable devices.
Jon Speer: That's really impressive.
Rebecca Sheridan: It is, and it's a credit to the whole team that were involved, and also the leadership in our US companies and the Inc, who allowed us to drive the way the company was approaching this. It was a change and we had their support. But one of the things that I was seeing in these big companies, 'cause I then went to Saint Jude Medical to help turn things around with some of their registrations because of FDA warning letter in the United States, we looked at setting up a labeling facility in Belgium to help facilitate registrations in other regions such as China. And was that... I kept going in and cleaning things up, and I was very good at that, and I thought, "Well... What about, [chuckle] what about starting things from scratch and setting things up. So that they... "
Jon Speer: Another approach.
Rebecca Sheridan: Yeah. So that they actually work correctly the first time. One of my favorite sayings is, "Do things right the first time, otherwise it will come back and get you."
Jon Speer: Yeah.
Rebecca Sheridan: And so apply yourself, do it right, it's the most efficient way and it's also the most cost-effective way. But this was also around the time of the recast as it was called, that we now have the new medical device regulation. And there was a lot of discussion around the table, with the big medical device companies of raising barriers, and I was very concerned because SMEs, and university research, research in hospitals, really is what's driving new approaches, innovation in the medical device industry, and 90% to 95% of our industry is SMEs. So, I was, "Well, they can't really afford to hire people like me, like the people around this table. We're in privileged positions." The big names, it's easy to hire top talent.
Jon Speer: Sure.
Rebecca Sheridan: But what really are the needs of an SME? And it's... I could imagine them, I could guess them, but sometimes you have to live it to truly understand so that we can think about what the best solutions are to help us as an overall industry move forward. And so, I took the opportunity to step away from large business and go into SMEs, first of all, with a company called, CryoTherapeutics, and then secondly, with Phagenesis, who I really was excited to join because, unusually, for a regulatory person, their research and clinical data was incredibly robust.
Jon Speer: Right.
Rebecca Sheridan: So, normally, we have to say, "Well, we need a bit more data than that. Maybe there's a few publications or we're gonna have to do a clinical study." They had done an excellent job, and very thorough research, and very thorough clinical data. And the devices themselves, when I looked at the devices, they were... Had been designed and developed, even though they were the first generation, they were of a very high quality and looked great and clearly, really, a lot of care and a lot of attention to detail had been put into bringing the device as to where it was. And I was brought in to... Because they want to appropriately take the device into the United States, and I thought, "This is... They've got... This is great, they've got all the information they need. They've got this excellent device, a well-designed device, I'm in." And here I am today helping the company move forward to be able to get our product on the market in the US, and of course, working with all the changing regulations that we have in Europe too.
Jon Speer: Right, it's quite a story Rebecca.
Rebecca Sheridan: Thanks. It's varied, it's varied. And... But my passion for medical devices keeps on growing all the time. So hopefully, there's another 20 years left...
Jon Speer: Oh, I'm sure.
Rebecca Sheridan: Of being involved in this industry.
Jon Speer: Yeah, I'm sure. [chuckle] So, the thing that I liked about what you were just sharing is that you come from a perspective where there's a lot of unique aspects. I mean, you've had the opportunity to work on the actual regulator with MHRA, you had a chance to do a lot of research early on in your career. You've had a chance to actually be a field service engineer and interacting with patients. And I love how you have those experiences, because I have a different background. I grew up in... As a product development engineer and then shifted more to quality assurance and then eventually, regulatory affairs. But having that, kinda those different views of the medical device world, I think makes people like you and me a little bit more well-equipped, I think, to be able to understand the needs of other parts of the business.
Jon Speer: I know I've been in organizations where one functional group, like the quality assurance group, dominates and establishes all these firm, rigid rules. And sometimes, those firm, rigid rules, they're not good for the business, and sometimes they're not good for the patient. And so, having that experience, I'm sure that when you came to Phagenesis, that was one of those key things that you wanted to make sure were in place. That the rules were in alignment with compliance and with the regulatory matters that were applicable. But at the same time, you have a business. You're trying to get your products to market.
Rebecca Sheridan: Absolutely, absolutely. And that was one of the things that, when we give people processes to work on or set criteria, they have to be... Well, they have to mean something to the person who's doing the work. So, to not involve them in the process, in the development of the process means that it doesn't... They don't feel they own it. And it has to reflect what people do and it has... We can make things very, very complicated if we choose, but that's the biggest way or the most effective way of getting people to make mistakes. And getting people to have... Create non-conformances for regulatory authorities to pick you up on. And so, I'm very much of the ethic that you make sure your process is simple, it's sufficient, it meets your regulatory requirements, but the people... It delivers the end result to the customer.
Rebecca Sheridan: And the customer of course can be your user, your patient, your regulatory authority, it can be your internal customer. But always focus on your customer needs, even when it's a quality management system process. And be conscious of the person you're handing over information to, that you're handing it over in a way that's usable and for that person then to be able to do their role. And so, that's something which has really benefited the organization. And working with my colleagues, initially, they were concerned, 'cause of course, change is always concerning.
Jon Speer: Of course.
Rebecca Sheridan: But what they've seen is things are actually working much more easily. We're actually able, in our quality metrics, to turn things around more quickly. So, we're currently... When I joined, complaint responses, the investigations responses were taking three to six months. And now, they're taking two to four weeks.
Jon Speer: Nice. It's good.
Rebecca Sheridan: It is, it's excellent. And we feel good, the customer feels good. And we're able to take timely decisions on what really matters for our products and for our patients.
Jon Speer: That's so great to hear. And when I first got exposed to Phagenesis, you were... Like, you understood the mission, the vision behind greenlight.guru and all of that maybe better than I did [chuckle] at sometimes, but you really embraced what we were doing in the software solutions that we developed to help medical device companies. Because, like I said, you just saw that vision and it was great for you to just roll up your sleeves literally in some cases. And you grabbed everyone from the Phagenesis team who needed to be involved in... You've been a huge champion for some of the things that we're trying to do within Phagenesis. And as I've gotten to interact and meet and learn a little bit more about the Phagenesis team, you guys have a team of all-stars that are developing medical devices. It's pretty amazing what you guys have assembled.
Rebecca Sheridan: Yes, it is. And it is multi-faceted. So, we have... I suppose one of the things that I really liked also about the organization when I joined, our Chief Medical Officer, Shaheen Hamdy, who was the one who'd done this research in the clinical data, incredibly thorough, incredibly knowledgeable. And I could go and ask the most basic questions about the clinical elements and he would spend his time and explain to me. But explain to me in a way that was very easy for me to understand as this is a new area for me, the treatment of dysphagia. Our chief operating officer has brought products to market before. And again, was responsible for the design and development of a very elegant device, one that was like, "Woah". In the hands of the FDA, when we went to meet with them, the FDA were very impressed with the device.
Jon Speer: Nice.
Rebecca Sheridan: Our chief executive is ex-Medtronic and was responsible for setting up their neuromodulation division within the European sales and marketing organization, which was an... Having worked for one of their competitors, was really a very strong offering which was difficult for us to actually sell against. [chuckle] And we now have a global marketing manager who has come from the pharma and pharma medical device side, and she's got a great deal of experience as an excellent marketeer. So overall, in the leadership team this real wealth of knowledge from large companies but also from the clinical side and also from other SMEs. And so in that respect, in terms of innovation, they were not too difficult to bring around to the solution that was needed. And one of the things that I liked the most about Greenlight Guru was it was plug and play. Because having worked for big companies who have worked... With a very big EQMS solutions, the level of customization and then subsequent validation that needs to occur, we didn't have the bandwidth to do that. So when I found this product, Greenlight Guru that we could plug and play, we don't need to do any validation, so it's just the procedures that... Wow.
Jon Speer: Right.
Rebecca Sheridan: This is great because that really brings the cost down of the use of the product, and any changes is not to the Greenlight Guru which forces us to do validation. It's maybe our process flow around Greenlight Guru and how we use that and take that into our processes. So we've been using Greenlight Guru and as a result, how we now use that for our training requirements and setting up training competences and building up the training profiles of people, we've been able to do that just by using the tags, but it means that we're not having to keep Excel spreadsheets maintained of people's training requirements. We've put them in the tags of the people who are affected by the procedure, 'cause that's in the procedure. You can see it in the tags and... "Oh, you wanna see the training requirements for this position, dear auditor? Ta-la-ta tat ta."
Jon Speer: There you go.
Rebecca Sheridan: Voila. "There it is. You probably want to download it, easily downloaded." So again, what I love also and I was talking with someone last week, is that our sales people use it.
Jon Speer: Nice. How did you manage that?
Rebecca Sheridan: Well, because it's such an easy... It's so easy to use. They're putting their training records on there independently without needing to be asked, they just do it, it took maybe five minutes of training to show them how to do that and off they go. So when you have an easy-to-use tool, you get easy acceptance, and that's what we've seen, and people are using it very well. And I was absolutely delighted when, was it last week? In the past couple of weeks you sent out a survey and the people would go, "Oh, I'm doing my survey, I'm giving... " "How was the feedback?" "It's all very positive." And that was completely unprompted from my perspective to say, "You know, make sure you write something constructive." People are finding it very easy to use.
Jon Speer: It's good to hear. I get so excited to hear stories like that. I told everyone at the beginning of our conversation today that I was gonna be smiling, and it wasn't even because we were gonna talk about Greenlight, it's just 'cause I was gonna get a chance to talk to Rebecca, but I appreciate that feedback, that's wonderful to hear. The thing I wanna wrap up our conversation with today is, I talk to startups just about every day, and let's just say, some of them are... How do I say this politely? Some of them know what they're getting into, but many do not. [chuckle]
Jon Speer: And sometimes those who do not, they're like, "Oh, well, what is this thing called design controls? And why do I need a quality system, and so on." So I find myself in this role, where I spend a great deal of time educating people and startups on why this is important and sometimes like, "Oh, I get it, I understand," but it really takes someone with a little bit of vision to think, "All the things that I'm doing now are so important. And the documentation and the records that I'm doing now are important. Because years from now an inspector or an auditor may come in and see what I'm doing now." You know, and at the same time, it takes a special person to appreciate that those things that I'm doing now may need to align with regulations, even though it seems like it's "painful" or more time-consuming and so on. So I'm wondering if you can share a few words of advice to that startup that maybe is battling with, "Do I need to worry about my QMS? Do I need to worry about design controls, can I just wait to do that later?"
Rebecca Sheridan: Yeah, so one of the things that people who are involved in SMEs or they come from... People, "We wanna be innovators, we're innovators." You are, absolutely. And we don't want to be constrained by regulations, but if you have a medical device, you're very focused on your user needs, as in your customer and your patients. Another user is your regulatory authorities. And your regulators have a responsibility for public health and ensuring that the public are safe. So you have this natural tension between the risk which comes with innovation and I suppose the reticence that comes with wanting to make sure that you are protecting public health. So my advice is embrace regulation, because you have to speak the language of the regulators and you have to understand their needs, so that the activities that you're doing to bring your products to market, to support your patients and your users, it aligns with the needs of the regulators, too.
Rebecca Sheridan: When you are in a regulatory authority, it's not that you're sat there thinking, "I'm gonna make people's lives difficult today." You have a job that you have to do, and you are accountable to your leaders. You are then accountable, in most cases, when you're in a regulatory authority, such as the MHRA or the FDA, to the governments you're in. And they have a... It's a big responsibility, in that respect. And it's so nice when you're on the side of the regulator, when you are working with a company who is saying, "I appreciate that these are your needs and this is what you need to do. So, I know I need to provide you this. I'm not quite sure how we're gonna provide you this because we've got an innovative product, and as such, the standards, the harmonized standards or the regulations don't quite cover this, because it's innovative. So, how can we work together to figure out what the right thing is to do, from either a testing perspective, or a clinical perspective, to get the data that is gonna fulfill that requirement?"
Rebecca Sheridan: And by embracing that, and embracing the fact that the regulators are also one of the users of your data, then the whole process can go more smoothly. And that's something that I've always brought to the table. "Don't be afraid of regulators. They're human beings, they're just like us. They have a job to do, just like us." And, actually, if they get to do their job well, they feel great, and they feel really positive, particularly if they can facilitate a novel, innovative therapy treatment to come to market, that then has a really positive effect on the vulnerable people, because our devices are never used on well people, they're always used on vulnerable people.
Rebecca Sheridan: So, we can help bring the regulators into our team if we think of them as users of our data, and that's the advice I would give to SMEs. Don't be fearful of regulators. They are there to help and guide us through the regulatory process, and they will do that, and they will do that with a smile and happiness and passion, if we allow them to.
Jon Speer: That's great advice, great words of wisdom. I appreciate you sharing that. So, I wanna wrap up. I wanna... You've kinda hinted a little bit about what Phagenesis is doing, but dysphagia, what is that, and why is it important? Tell us about what's happening at Phagenesis. And I know you got a lot of exciting things happening right now, so give us a little bit of an overview of dysphagia and why Phagenesis has set out to solve this particular issue.
Rebecca Sheridan: So Phagenesis has a treatment, our Phagenyx devices, which are used to treat dysphagia, which is a swallowing dysfunction. The risk for patients of dysphagia is that... The most significant risk is of aspiration pneumonia, which, of course, in vulnerable patients can lead to death. So, that's quite significant. But on the other side, as well, if you've got a swallowing dysfunction and you're being fed through a naso-gastric tube or a tube in your stomach, you know what, you can't really enjoy a meal with your family out at a restaurant. The pleasure that we have from eating, you don't get that. So, there's a quality of life element, as well as the fact of this severe risk of aspiration pneumonia. Professor Shaheen Hamdy, our CMO, back in the 1990s started to look at, why do some patients with strokes develop dysphagia, and why do some patients not develop dysphagia? And it was determined... He was able to determine that the swallow function is in both hemispheres of the brain, and generally, one side is more developed than the other. And so, patients who have dysphagia, it's the side which is the dominant side of the brain for the swallow dysfunction that's been affected.
Rebecca Sheridan: So, those patients have the... Who don't get dysphagia, it's the non-dominant swallow side that's been affected. And so, then they looked at, "Well, how can you stimulate the brain to divert the alternative pathways, to reinvigorate the brain with its swallowing function?" And so, they looked at using different types of stimulation, but what they found was the stimulation in the throat, and that a very low current, you could have quite a profound effect on the part of the brain that's responsible for the swallowing function, and you could get that non-dominant side to be reactivated, or to be more activated. And it's a very simple treatment. It's a naso-gastric tube with the electrodes along the length of it, which align with the throat. And it's 10 minutes a day for three days. And the overall, from setting up the thresholds to start the stimulation to the finish of the treatment, is about 30 minutes in total. So it's not even significant, from a... Speech language therapists generally provide this treatment. It's not massive amounts of time from their day. When the current state-of-the-art, which is drinking thick fluids or thin fluids or fizzy drinks, or poking the back of the throat to try and get the muscles to work, that takes up much more of their time.
Rebecca Sheridan: So, there's a number of clinical studies that have been done. We're doing a registry, which is excellent. We're looking at different uses of the device with different brain injuries, but what's really exciting is we have our new generation of catheter coming out in Q1 of next year. And this will really make a difference for the hospitals, because we're gonna have a removable naso-gastric tube that you can replace if it gets clogged, which these things do if you don't flush them out correctly. And so, this is really great, because this has come directly from the post-market surveillance activities and the feedback based upon the initial design of the first generation.
Jon Speer: Wonderful.
Rebecca Sheridan: And we'll also be moving forward into starting our clinical study in the US also. So 2017...
Jon Speer: It's gonna be exciting.
Rebecca Sheridan: It will. And particularly because since September, we have a new partner, and we've entered into a structured buyout deal with Nestle Health Sciences, too.
Jon Speer: Yeah. That was a pretty big deal.
Rebecca Sheridan: Yeah.
Jon Speer: We've all heard of Nestle. So that's awesome, and sharing the details of dysphagia and your treatment. I've had people in my family who have had swallowing issues. And fortunately, it wasn't super extreme, but it can be. And it's wonderful to learn that a treatment such as the Phagenesis device be easily applied and administered, and just prevent long-term downstream health issues. So that's awesome. So thank you for sharing a little bit more about what Phagenesis is doing.
Rebecca Sheridan: My pleasure.
Jon Speer: Well, Rebecca, it's been... I'm smiling. I've got goose bumps. I'm thrilled to tackle the rest of my day, and I get to tell everybody today that I got to talk to Rebecca Sheridan, the head of Quality Assurance and Regulatory Affairs at Phagenesis. Thank you for being the guest on today's Global Medical Device podcast.
Rebecca Sheridan: Thank you.
About The Global Medical Device Podcast:
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.