PDMonitor interview with Professor K Ray Chaudhuri and Nikos Moschos
It shows that a big majority of the patients also use the mobile app, which is not self-intuitive because these are older patients that are not so familiar with smartphones.
It also shows that patients are doing better or are stable through time. The majority of patients. Now that is actually a major breakthrough because this is by nature a neurodegenerative disease so you would expect the patient to become worse through time. Preliminary evidence shows that a small minority of patients get worse, whereas you would expect most of the patients to get worse and on the contrary most of the patients are either stable or getting better, we still need to validate that, but this makes us very enthusiastic because it’s a major breakthrough in the management of the disease.
There’s a number of reasons why PDMonitor is actually a major breakthrough. First of all, it supports a paradigm shift in the course of a global pandemic, the numbers are really skyrocketing, patients expected to double, and it’s a case study of digital transformation and digital care at home. This on its own is very important because there’s a global trend to take the patient out of the hospital, keep them at home and then at home, optimize and manage these types of diseases. Now, Parkinson’s on its own despite the fact that it doesn’t affect too many people, still is a very costly disease, and also a disease with no cure. So this costly disease is now possibly managed by technology that helps, possibly, save costs, possibly improve quality of life, possibly improve the life of the people around the patient and that has a global impact associated with a high cost of the disease.
We are actually very, I don’t know how to say it, very emotionally satisfied by the fact that recent technology that people adhere to, people like it, and people see the benefit. So we see patients saying that “it has changed my life”, we see patients saying “now I can communicate better with my Physician”, we can see patients saying “I can explain now better how I’m doing and I can communicate with my Physician in a way that helps me become a better patient.” So overall, we see a great causality effect between streamlining of the medication, improvement of the quality of life, improvement of satisfaction, and essentially having the patients lead better lives. This is what keeps us going and this is what makes us very excited about PDMonitor.
A medical device is not a gadget. It has strenuous, regulatory certifications, it follows specific rules in order to be able to be marketed because it is supposed to be used in clinical practice. So a key difference between commercial gadgets and the commercial medical devices is all the regulatory framework around the devices.
PDMonitor monitors all motor symptoms of the disease except rigidity so it also monitors gait impairment, postural instability, freezing of gait, and also it monitors left to right differences in the exacerbation of the symptomatology. This is very important because this disease being very tough to manage and you want all your activity, you want to have a full understanding of the therapy type of the patient, so it’s important that this device can offer all this symptomatology depiction compared to others that cannot do that.
The second difference has to do with the cloud infrastructure. PDMonitor does not need to be back and forth to a base, to a hospital, and then like a holter, sent back to the patient it can stay at the patient’s home as long as needed so you can do continuous optimization, you can do habitual screening across time, and in this combines both staging of the disease across time and treatment optimization when you see that there is a change.
Data is kept for long, based on GDPR we keep the data for 10 years. So you have a powerful electronic base and record with all the trajectory of the patient’s course in the disease through time so you can compare with the past and also you can understand what has happened and possibly anticipate what could happen in the future.
The mobile app is there in order to be able to capture the timing and type of medication, the timing and type of nutrition but also the non-motor symptoms. And also it gives feedback to the patient about how well they’re doing in a very simple graph, in a very simple statistic that, like a FitBit, helps the patient know that they’re doing better or worse and hopefully stimulate them to increase the efforts, wear the device, use the mobile app, and be self managed.
It enables the Physicians to have a holistic view of the patient’s progress in the disease, it supports treatment optimization because you can have a combination, a comparison between the treatment changes and the impact of those changes so that there is a self-features loop between impact and causality. And also because of the fact that the device stays at home, it helps the Physician always know how the patient is doing and put the patient on a screening program in order to do continuous staging and treatment optimization of the patient.
It allows us to monitor people wearing these sensors at home it gives us a dashboard of their symptoms which I can access and the patient can access using a web based, cloud based system. It then allows us to monitor and initiate changes in therapy, both, either pharmacological or non-pharmacological to make improvements in these aspects such as their mobility, such as dyskinesias, such as slowness, such as stiffness, more importantly also gait, their movement, risk of falls difficulty with initiation of gait, freezing of gait, problems that we are often unable to address properly by simply history taking, and problems that if not addressed properly makes people isolated and that then leads to a vicious cycle of generation of depression, of anxiety, of apathy, sleep disturbances and some people even think it can lead to cognitive disturbances, so the wearable sensor-based care, which allows us to have a dashboard-based triggered treatment strategy is therefore a great advance.
The monitoring allows us to really evaluate the person at home and that’s critically important because the care that we provide for people with Parkinson’s is really based on whether or not the patient’s condition is improving at home and thereby improving the quality of life, not just of the patient, but also the carer…
Carers often have to give up their work to care for people with Parkinson’s and the other problem is there is inevitable progression of Parkinson’s because there is age-related dopamine loss that we see so it is a growing problem, we need to have better technology and better assessment to improve our care the area where the care needs to be improved the most is the chronic care at home and in the communities and any artificial intelligence enabled device that gives, allows us to do that, this in an easy user friendly manner is what we need.
There is the visible part of Parkinson’s, which is often the tremor or the stiffness but also the invisible part, what I call the hidden face of Parkinson’s, which includes many non-motor problems such as pains, such as depression, anxiety, social inability, isolation, but also balance issues. So to monitor these, all these problems within the context of a short clinic that we can often offer, either in the NHS or the private sector, is often not possible, so we often rely on people’s own recollection of events in the clinic and/or diaries which can be inaccurate, can be retrospectively completed and the advent of artificial intelligence based technologies to monitor patients better, particularly at home, is therefore a crucial unmet need which is now gradually being bridged. The need for this really was highlighted during the COVID pandemic when the home care and home assessment became of great importance and subsequently it has now been underpinned by NHS initiatives, for instance the so-called ‘virtual wards’ is based on the whole premise that we should be able to monitor people’s condition changes from time-to-time at home and really management of that gives somebody a real hold on their clinical improvement and their quality of life and the PDMonitor provides us with that.
I think Parkinson’s is a condition, that can change from time, from hour to hour. And this is very important for Clinicians, for healthcare professionals who are looking after people with Parkinson’s to recognise, otherwise you might end up managing the people in an inappropriate manner, I’m not saying that virtual technology will replace face-to-face examination, however, face-to-face examination or clinic consultations are fraught with problems which again, several of my colleagues from Netherlands, from the US have called the ‘White Coat Effect’, in other words, patients might either put on their best behaviour when they’re in clinic, they might be excessively stressed, so suddenly a tremor might break through and you might be tempted to treat those symptoms which you see. However when the patient leaves the clinic, when they go back to their carpark or when they drive home, the situation is completely different, are often very different but you’re not seeing that. What you’re then relying on, often, is what the carer or the patient is telling you, which can be very inaccurate because we know that recall in Parkinson’s can be affected. So this device therefore gives us this granular insight into what’s going on at home, which is really after all what matters and allows us treatment strategies which can then influence this treatment and management of people with Parkinson’s at home.
So PD Neurotechnology is a young medical device company and the first years of its growth had to do with getting a number of certifications in place in order to be able to be called a Medical Device Company. So in its growth trajectory it is now certified with ISO 13485 for being a Medical Device Company, ISO 27001 for the data management, data security and handling of sensitive patient information, and ISO 27701 with regards to GDPR compliance and things around patient privacy. Also it is a vertical integrated company with R&D, production, clinical studies, regulatory distribution, sales and marketing, all run under the same roof and in this trajectory, in this course of life it has developed its first commercially ready product called PDMonitor, which is a CE marked product since June 2019. It is in the market since September 2020 and within the pandemic situation it still has managed to be used by more than 500 patients either in sales or in studies out of 13 countries. There’s a big pipeline of other products in progress and also a pipeline of sub-specifications and sub-indications of PDMonitor in specific aspects and all this reflects the product pipeline of this company.