RAW TRANSCRIPT —
What exactly is software as a medical device?
Our guest today, Neha Gupta (Global Digital Product – Ipsen), works extensively in this space and will share with us what Software as a Medical Device (SaMD) exactly is, why it's important for companies to develop capabilities now, and how these solutions will become a significant part of many company portfolios in the years ahead.
Thank you again for joining us for another Insights video with myself, Harsha Kubavat,head of strategic consulting at INOVIS. Today we're going to be talking about software as a medical device and joining us today is Neha Gupta.
Neha, thank you so much for joining us on today's show.
Thank you for the invitation and it's my pleasure. Looking forward to talking about software as a medical device or SaMD as we end up calling it. I think maybe before we get started just remind everyone that this is a recorded conversation it's going to be quite loose and fluid we've got a few topics that we planned in advance but obviously we'll just see how the conversation takes us.
I think before we get started into that in-depth conversation it'd be nice for the viewers and audience to hear a little bit about you how have you ended up working in this digital space now
Absolutely and I love the way that you put it ended up which is which is sort of the theme of how I am here today. So I started in the healthcare space as a healthcare provider where I was working as a periodontist and implant dentist for almost five years. And during this time I wrote a research proposal around how we could use technology to improve patient outcomes. This was my first attempt to actually bring in technology into my healthcare practice and that led me to designing this program with university of Hong Kong through a scholarship. I really enjoyed working in this intersection of health care and technology. I’ve been there for almost seven years now and that also means I’ve not touched a patient in the last seven years. In these seven years I came to Oxford, completed my MBA, worked in a venture capital space looking at digital health investments and was then part of a remote patient monitoring startup based out of London. In my initial years of post MBA finally ended up joining Ipsen as their digital product lead in the neuroscience faculty. So that's a very short summary of how I’ve ended up here and actually work ended up. I think the same applies to many people that work in competitive intelligence and strategic consulting space like me I mean competitive intelligence is uh something that's evolving growing and I don't think I went to school thinking this is what I’m going to do but hey here I am and see where the journey takes me and takes us.
Part of that journey today is about talking about this SaMD software as a medical device um can you tell us what that is in in the simplest terms yeah absolutely so um if we were to just look at the words software as a medical device I think that in itself he tells you that it's a software application that is being used as a medical device so while software is still a well circumscribed word medical device is where things become loose and there is a wider landscape against which this medical device could reside in so software as a medical device could be as simple as a digital thermometer or it could be as complicated and live critical such as a pacemaker with a digital application on top of it right so both of those spectrum would essentially be SaMD they would be classified under different classification spaces the risk that they are introducing into the existing treatment pathways but the overall umbrella would still be software as a medical device your role right now you said you're working at Ipsen in in this space what is it that you're doing day to day uh in this space so my role essentially is more around creating digital solutions digital applications around the uh the needs of the business and because we have and because Ipsen is a speciality care pharmaceuticals I have limited uh needs against which I have I am tasked to to bring these digital applications in into light but in bringing it back to the SaMD side I think the the software as a medical device is a paradigm which is impossible to not interact with when you're in digital health industry and when you're based out of Europe because the new regulations which have come in from the end of may the medical device regulations now essentially reclassified all the uh the digital applications making the digital applications which were not even a class one before class one and those which were class one into class 2a or cluster b right so if you're building digital health applications in targeting Europe and European users EU and even UK then SaMD is part of your is the daily bread and butter so essentially you will have to familiarize yourself with the requirements you will have to familiarize yourself with the risk management controls with the design controls the need for the newer MDR requirements right and this journey for me began in my first role which was part of a startup as a remote patient monitoring solution and it was in this where we were first trying to classify this as a class one medical device which also involved building the QMS and the quality practices and the compliance that allowed you to build a software right that met the certain iso standards that were part of the ISO standards most commonly are the 13485 for the QMS then you have uh the software development iso standard so keeping those in mind familiarizing yourself began there and now as I am part of a pharmaceutical company we have much uh more guidelines and compliance requirements that we have to adhere to and that means that we also now work very closely with dedicated regulatory resources and regulatory experts however that also translate into you understanding the basic requirement from a product perspective and translating that them to your engineering team and the development team right and I suppose you know coming from the life sciences pharmaceutical industry we're very uh aware of uh regulatory aspects at all levels and I suppose digital software is no stranger or will become no stranger to that and will have to conform and follow the guidelines that that are set um if we take this step back and think about um software as a medical devices as you explain you know software does something medically um and we take your hat uh now in in a pharmaceutical space in a in a company such as Ipsen or any other uh speciality company um I suppose there's a bit of a chicken and egg situation in terms of having a product and then putting something digital on top of it you know supporting an existing uh traditional therapeutic whether that's a biologic small molecule whatever we want to talk about or on the other hand not needing that and actually just having uh a software that helps support uh a certain space without applying or administering uh a drug alongside it is that a a good way of thinking about kind of bucketing or compartmentalizing software as a medical device are they these kind of standalone pillars or is it very fluid and and mixed in in your opinion so I think that's that's a very uh pragmatic way of classifying the software applications in the digital world space and from my experience most of the established healthcare stakeholders that would be your pharmaceutical companies or medical device companies are they already have established presence and that entails uh uh established that entails a suite of drugs or products or medical devices which are not digital so the digital applications in this small ecosystem are more around companion applications and more around addendums to already existing non-digital applications however if you look in in the the startup ecosystem where the applications are purely being built from scratch right not as built or as a as an addendum to something that already exists that's where you have applications such as remote patient monitoring solution which is purely a digital application has is is targeted towards connecting the healthcare professionals to their patients outside of the health setting it is independent of the medicines it is independent of the medical device that was used it is independent of any physical healthcare uh product yeah or intervention right or intervention exactly now we could tailor remote patient monitoring to a particular disease segment for instance chronic heart failure for instance uh maybe uh elective surgical procedures for instance maybe sir hostels you know you could you could target your remote wanted monitoring to a particular disease segment and that would mean building on that example suppose we are building a remote patient monitoring solution for uh chronic heart failure yeah I would require that these patients vitals around blood pressure weight would be monitored and that's when you then integrate with real physical devices so that there these data data data points are connected on a real-time basis and that's where you start overlapping with existing established healthcare providers and and your application now is also a bit of a companion application to existing healthcare products right there is there is a bit of an overlap between both those definitions and I would say as it is with digital it's a very fluid scape where it's difficult to delineate the or the application basis it's used because as the as the adoption grows there is iteration and then there is a development that happens and evolves from being just one
It evolves to actually encompassing more use cases yeah and I think you um you know touched on a really good point in terms of when we traditionally think about pharmaceutical drug development we think about you know a a need unmet need you know patients potentially and putting a drug through a set of trials and processes to get it approved and and potentially when we think from a digital perspective like you said there may be an existing portfolio where you have an add-on and therefore you're developing something to fit uh meet an unmet need there but then at the same time there's a whole other ecosystem where people are finding unmet needs that don't require therapeutic intervention but a digital element such as monitoring or or management of certain elements could then bring benefit to a patient right yeah absolutely absolutely and I think just to add on to that and complement it that the traditional product development is a very linear process yes I mean if you look at drug development it starts with research then there is development and there is release into the market whereas with the digital product you have a constant iterative development process which is based on a constant user feedback yeah and hence there is and that also sort of leads us to a challenge in adopting a digital development process in established health healthcare uh organizations like pharmaceutical companies and medical device companies because this kind of an iterative feedback loop based development process is is a complete tangent to a linear process with which they are they're familiar and comfortable with okay and that that that outlines the one of the bigger challenges in digital transformation in these companies which is an organizational change that allows such an iterative feedback loop to be part of your development process yeah yeah I suppose it's kind of yeah a new paradigm when you think about having this as part of the the development phase of either something going to market or potentially maybe an easier route would be to have it on market already a drug and then you're supplementing it with a continuously improved product many people that are watching this are going to be sitting in a insights role in a strategic uh brand position within pharmaceutical company um clearly there is a need from from you know what we talk about and common sense that uh digital elements to integrate into the um caregiving world right um but what is it what benefits are there that come as a pharmaceutical provider like life sciences pharma company from having a digital element within the portfolio right I suppose one of the easiest things is you are supporting the patients in receiving potential products that you as a company may be developing or or providing in the market right yeah yeah absolutely so that is definitely one of the advantages where you create you can create digital support programs and that is that are essentially your patient support programs but digital in their format and are disseminated alongside your portfolio of drugs for pharmaceutical companies actually digital innovations have I mean there are a lot of different buckets under which they can be value addition to a pharmaceutical company so you can also these days have it in the pre market phase of drug development so you have digital applications which significantly shorten your clinical trial time they significantly help uh help you conduct virtual clinical trials make from both from from starting from patient recruitment and helping in targeted patient recuperate to clinical trial management which could be done online remotely that is one part of a segment and bucket under which the digital applications can be value addition to pharmaceutical companies actually one of the examples that I would quote here which is a which is very interesting and I think one of the one of the golden examples that I’ve come across is the drug irons if you're aware of it it was it's a breast cancer dedicated drug and uh this this I think two years back fda increased so this drug was running at the end of its patency period and uh using real-world evidence pfizer was able to extend its therapeutic disease spectrum to also include breast cancer patients in males and that allowed them to uh without the need of a clinical trial and using only real world evidence they were able to expand this portfolio for that particular drug and and and increase their revenues and allowed for a longer patency period so I think it's there is a significant uh opportunity that lies in utilizing the real world evidence shortening the clinical trial space if the regulatory and the quality requirements are met which is the biggest challenge in these cases because the kind of data that you get from real world evidence is in most cases are not aggregate aggregatable it's difficult to make it coherent because it is so badly structured and fragmented and the use cases have not been defined before yeah help in ultimate data uh analysis and assimilation yeah and I suppose you know when you look at drug development and um and the requirements now for um get being approved and and being used right approval is one thing being used is uh or recommended in guidelines and uh reimbursed by by national health bodies there's a growing amount of real world evidence required uh patient reported outcomes and I suppose this is again an area where where software as a medical device can help because it's I suppose uh a regulated uh and recognized add-on if you're monitoring patients through something that's been very well defined and approved in its own right to then build that that evidence package is that a fair thing to say absolutely absolutely in fact that's a very good point that you touched upon there russia that the patient reported outcomes the collecting these digital patient reported outcomes is a huge benefit for us to show how much the treatment outcome was essentially not reported before before being able to collect this in a in a real on a real time basis the patients had to come to the clinical offices and sign and fill in these paper forms but now because of the digital medium you're able to do this from the comfort of their home and and that itself allows you for a more uh accurate collection of these outcomes more timely collection of these outcomes and much easier in terms of the amount of work required from both patient and the nurse or the specialist nurse or the care team member who's collecting it yeah so you've convinced me okay so software medical device I mean seems like something that you should be into regardless of whether you're you're developing or have existing products in the space um you've said you know it can help have a more efficient uh development timeline if you integrate this you know well thought out integration of software in that clinical development program um we've said that ultimately it helps patients potentially receive or manage their their condition better and received the medication that supports their condition and again from the farmer side and from the um the the owner side you've got this insight generation post you know in the real world setting uh and and that can definitely help you're sitting in a pharmaceutical company right now and and many listeners are the same what are the the challenges of integrating or building up this kind of digital capability I think you touched on the iterative part and the way that the the workflow or process is not quite the same and I suppose I want to stay away from regulation as such because it's such a big world but clearly regulation is is another thing in terms of mindset and and uh you know the existing structure of brands teams franchises have you seen any challenges in integrating a digital uh mindset or or structure within a firm so I think from my experience I would say that it's it requires a significant organizational transformation for successful adaption successful adoption of digital development and design processes because they're fundamentally different from what they're used to the the linear process of drug development is a completely different process versus the iterative circular feedback-based development of a digital application and because there is such a fundamental difference the processes that exist today in a pharma company are not they need significant shift to be able to create those iterative processes in in a much less um challenging or in a much more smoother fashion that's I think in my head one of the biggest challenges what I have seen particularly that has helped and this is also basis conversations with other folks who are working in the farmer's space and have a similar sort of roles and responsibilities as me is that creating semi-independent semi-autonomous digital units right expertise of different pharmaceutical functions but still having a certain authority and a remit to be able to securely and safely build processes so that this then that that that becomes your core satellite unit which is building digital processes that is still answerable to the compliance setup of a linear process but can actually translate that so that that compliance is met as well what are the the hot topics right now uh in in this space I suppose one of the things if you're getting into you know digital therapeutic software um in a company maybe looking at other companies and is it partnerships that people are making is it about the the portfolio place what are the the hot topics when you think from a strategic sense in in this space so my thoughts there would be more towards the partnership side of things the uh the flexibility and the suite of functionalities that you gain through partnerships is the fastest and the quickest way of building digital applications to your advantage when you're in a pharmaceutical company and and that allows you to leverage best of both the worlds there where the pharmaceutical companies existing distribution marketing networks can be leveraged at the same time you can actually leverage the independence and the um the agile methodology of the smaller partners outside of the pharma world so I think as a concluding thought I think those partnerships would be the uh they are the the ace that we have brilliant well thank you so much for for sharing your thoughts and and insights um clearly you know the time that we have has only scratched the the surface of the the the topic and I suppose you know regulatory you know developments uh is is one thing as well as I suppose this partnership thing that we're talking about right now and how that has an interplay and I suppose that's another topic for another time absolutely absolutely I think this is a conversation that can go on and on and I’ve been told by my friends that I should not talk about it as much because I do not stop talking but then this is yeah this this requires much more time but we like listening to to people that have uh opinions and insights and and once again for from us and everyone watching uh thank you for your time and hopefully we can have you back in the future and discuss some of the other topics absolutely thank you for having me this video is one of many insight series videos from us at inovis our website and youtube channel have all our episodes available on demand also if you're a pharmaceutical leader in the competitive strategy space why not drop us a line and potentially join us in the hot seat for another one but for now thank you for watching and we look forward to seeing you on another episode sometime soon