HOW CONNECTIVITY WILL REMODEL HEALTHCARE
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Expert View HOW CONNECTIVITY WILL REMODEL HEALTHCARE In this article, Marjorie Villien, PhD, and Jerôme Mouly, both Technology & Market Analysts at Yole Développement, provide a forecast of the place of connectivity in the healthcare market and the significant changes it is likely to bring to both devices and the market itself. Healthcare is facing one of its most significant turning “Development of connected solutions points in decades. After penetrating the consumer will not only help patients to better market, the digital revolution estimate the dose of medication to and the IoT (Internet of deliver, but will also alert them should Things) concept are rapidly changing health models. they forget medication and record A confluence of factors their data, leading to better adherence is driving these changes. and avoiding errors that may led to First of all, the prevalence of chronic diseases in modern emergencies and hospitalisations.” societies; as an example more than 400 million people are suffering from diabetes (types units, including over 45 million with the 1 and 2). In addition to genetic factors, capacity for Internet of Medical Things some diabetics’ risk factors derive from (IoMT) connectivity (Figure 1). Diabetes behavioural causes, such as obesity, and respiratory diseases are two major lack of exercise and bad eating habits. chronic medical conditions, patients The incidence of respiratory diseases, of which require regular and accurate asthma for example, is strongly increasing medication. Development of connected due to environmental issues in highly solutions will not only help patients to industrialised cities. The estimated cost better estimate the appropriate dose of of chronic diseases could soon reach medication, but will also alert them should US$1.5 trillion (£1.1 trillion) per year they forget medication and record their for global health organisations, therefore data, leading to better adherence and reducing the impact cost of these conditions avoiding errors that may led to emergencies Dr Marjorie Villien is a matter of urgency. and hospitalisations. Technology & Market Analyst The second factor is a shift in the attitudes Connected inhalers for asthma are E: villien@yole.fr and expectations of patients, who are willing changing patients’ lifestyles. Built as a to manage their health in a manner similar fully integrated solution or as an add- to how they now monitor steps and calories on to standard inhalers, patients record via worn fitness bands connected to their all their inhalations via a Bluetooth smartphones. More than two billion people connection to their smartphone or tablet. are using internet-connected smartphones As an example, 3M is developing its around the world today, fostering the rapid Intelligent Control Inhaler, expected in adoption of connected medical devices. 2018. The inhaler will help patients with Such devices have already generated respiratory diseases to control flow rate $9 billion to date, estimated to grow to and record data. Using an app, patients and Jerôme Mouly $23 billion by 2022.1 physicians can remotely visualise records Technology & Market Analyst and patients are able to access feedback. 3M E: mouly@yole.fr THE CONNECTED DRUG DELIVERY is currently looking for a pharmaceutical DEVICE MARKET IS GROWING partner to gain access to the market. A Yole Développement strong increase is anticipated in the inhaler Le Quartz The global connected drug delivery device market, with a 75% annual growth rate 75 cours Emile Zola 69100 Lyon-Villeurbanne market, including implanted drug delivery forecast for inhalers from 2016 to 2022. France pumps, inhalers, insulin pens and insulin In the area of diabetes, connected pumps, has already reached two million insulin pens are also changing the lives www.yole.fr 4 www.ondrugdelivery.com Copyright © 2017 Frederick Furness Publishing Ltd
Expert View Figure 1: The number of devices capable of connecting Internet of Medical Things is increasing at a rapid, accelerating rate.1 of patients with diabetes types 1 and 2. replace an entire organ or function. at all times but need manual-assist dosing Precise dosage measurements avoid under- Sometimes the use of an artificial organ at mealtimes and during exercise. The next and overdosing of insulin and patients could is a temporary measure, a step in treating generation will be fully automated insulin receive information from their smartphone the disease process, acting as a bridge to closed loop systems, (manual mealtime and to anticipate their needs more accurately, a solution, while other times the artificial exercise boluses will be eliminated) and the thanks to machine learning. Interest shown organ is a permanent solution. Moreover, third generation will be fully automated by pharmaceutical companies will likely some artificial organs are mechanical, multi-hormone closed loop systems. boost adoption by patients. Novo Nordisk, such as an artificial heart or lung; based It is worth considering that the the inventor of the insulin pen, has teamed on biology, such as a bioartificial pancreas performance of a closed loop system is up with Glooko, a developer of remote or liver; or delivering drugs, such as the limited by the speed of insulin absorption monitoring software, and is expected to artificial pancreas. and glucose-sensing inaccuracies, and that launch the new generation of Echo-Pen Presently, the only artificial organ the software has to take these limitations imminently. Moreover, the development operating as a drug delivery device is the into account. In the near future, the next of the artificial pancreas, a (hybrid) closedartificial pancreas. The diabetes epidemic generation of artificial pancreas will loop system that communicates to is truly global, affecting more than 8% of have both myriad embedded sensors to automatically deliver the right dose of the world’s population. Better management monitor the status of the patient and insulin, promises a less constrained life forof diabetic patients is crucial, and this is greater intelligence to take changes in type 1 diabetes patients. where the artificial pancreas is playing a physiology into account (e.g. meals, exercise, major role. The name “artificial pancreas” sleep etc). ARTIFICIAL PANCREAS is something of a misnomer, however, as The software piloting an artificial rather than mimicking an organic pancreas pancreas using such technology must An artificial organ is a device that is an artificial pancreas is simply a smart parallel engineering developments. implanted or integrated into a human insulin delivery device. A more appropriate A plethora of different algorithms exist, – interfacing with living tissue and/ term is “closed loop system”. Indeed, each with their own intrinsic advantages or fluid – to replace the functions of a a closed loop system combines real-time and disadvantages, but all with an internal faulty or missing vital organ. Hence, by continuous glucose measurement (CGM) control law. These span from very simple this definition, the artificial organ has to with an insulin pump by using a control binary answers to fast, complex algorithms be either wearable or implantable and algorithm to direct insulin delivery. The which take into account complicated aim of this system is combinations of multiple data from to improve diabetes various sensors, physical laws and precise “After decades of development, self-care by improving output calculations. Next generation artificial organ products are now ready glucose control to algorithms are currently in development mitigate the risk and major improvements are anticipated. to enter the medical device market. of hypoglycaemia. New, fashionable methods like machine For that reason, the artificial pancreas The systems coming learning (and deep learning when the data segment will experience massive to the market today is available) are entering research through are hybrid closed loop fuzzy logic algorithms. These methods seem growth, with a CAGR2017-2022 of 49%.” systems, since they promising and will permit fully automated employ a closed loop control of the artificial organ. Copyright © 2017 Frederick Furness Publishing Ltd www.ondrugdelivery.com 5
Expert View Yole Développement expects the sensors integrated to connected medical set up, involving these new players in the uptake of the artificial pancreas to be devices are already available from other medical area. Medical device companies both high and rapid throughout the type markets, such as consumer or automotive, like Medtronic and Johnson & Johnson 1 diabetic population, since the solution and are already miniaturised, low cost, have a great interest in this field. Naturally, has been desired for years. As of 2017, offering low power consumption, etc, pharmaceutical companies have an inherent only Medtronic has an artificial pancreas but are not specific to the medical market. interest in giving more value to medical system approved by the US FDA and none After stabilisation and large scale devices associated with the medications that have been granted a European CE mark. adoption of connected medical devices, a they are selling to patients. However, many companies’ products are second wave of innovation is expected. Numerous companies are developing ready for approval and commercialisation. This wave will see the development of sensor smart inhalers and insulin pens There are two collaborations of particular solutions specifically dedicated to medical and are licensing their products to note: one between Diabeloop, Dexcom grade requirements in terms of reliability pharma companies (Figure 3). An example and Cellnovo and one involving TypeZero, and accuracy, as well as new criteria, such being the recent announcement of a Dexcom and Tandem. After decades of as low invasive sensors, taking advantage development agreement between Dexcom, development, artificial organ products are of microelectromechanical systems (MEMS) a manufacturer of continuous glucose now ready to enter the medical device technologies (Figure 2). monitoring devices, and Eli Lilly; the market. For that reason, the artificial Connected inhalers benefit from aim of this partnership being to combine pancreas segment will experience massive the miniaturisation of flow sensors to knowledge and tools to simultaneously growth, with a CAGR2017-2022 of 49%.2 evaluate the volume of medication inhaled. reduce complexity and improve disease Historical artificial organs were made Sensirion, a Switzerland-based company, management for patients with diabetes. of mechanical parts, today they are based has developed a 5x8x5 mm differential The IoMT also represents a huge on electronics and tomorrow they will be pressure sensor, called SDP3x, that could be opportunity for new players such as smart. Sensors and software are playing integrated in smart inhalers. Miniaturisation IBM’s Watson augmented intelligence major roles in the growth of the artificial also enables the progression of systems from system to enter the healthcare market and organ market. If bioartificial pancreases portable to wearable, making them ever to bring computing power to predictive and artificial livers are based on biology, more user-friendly. medicine, as well as relevant infrastructure most other devices are full of electronics, to interoperate connected devices from sensors, emitters and software. The part NEW PLAYERS ENTER THE home, hospitals or anywhere data needs such technologies play can only increase as HEALTHCARE MARKET to be shared. Companies like Qualcomm the healthcare industry moves towards more Life, with its solutions 2net and Capsule, intelligent devices. The IoMT is at the crossroads of are dedicated to IoMT applications. medical devices, telecommunications and It is worth noting that security and THE TECHNOLOGY IS READY information technology (IT). As such, an data privacy are at the forefront of entirely new infrastructure needs to be healthcare administration, to avoid The dual challenges for medical device producers are to integrate sensors, electronics and connectivity into approximately the same footprint as “After stabilisation and large scale adoption of connected equivalent, non-smart devices and to medical devices, a second wave of innovation is expected.” facilitate patient adoption. Most of the Figure 2: The adoption of connectivity in the healthcare market will spur further, more creative innovation.1 6 www.ondrugdelivery.com Copyright © 2017 Frederick Furness Publishing Ltd
Expert View Figure 3: Example of a business model for a connected inhaler.1 unregulated use of information generated cost of connected medical devices (including and also to guarantee the safety of patients (e.g. preventing hacking of implanted architecture). Health insurance incentives or rebates are proposed for patients, ABOUT THE connected medical devices). should they participate in a programme AUTHORS increasing their adherence to medication WHO PAYS AND WHO BENEFITS? by using a connected device that sends data Marjorie Villien, PhD, is a Technology to the patient, their physician and the & Market Analyst and member Current changes in healthcare require insurance company. of the Microfluidic & Medical innovative business models to be realised. This new shift in the healthcare Technologies (MedTech) business unit It is a fundamental change of paradigm for landscape will require an evaluation of at Yole Développement. She is a daily health administration, and the co-existence the performance of this new approach: contributor to the development of of two reimbursement models. From will P4 medicine cost less than MedTech activities with a dedicated evidence-based medicine, connected medical the evidence-based medicine concept? collection of market & technology devices enable the “P4” medicine concept: Ultimately, it is only long term analysis reports as well as custom consulting Preventive, Predictive, Personalised and that will show the true impact. It is projects. After spending two years Participatory. Innovative business models not only insurance companies which will at Harvard, Dr Villien served as a may well be being set up, but who will pay benefit from connected drug delivery research scientist at INSERM in the for prevention? systems. Data generated could have great field of medical imaging. She has Health insurance companies are working value, and pharmaceutical companies spoken at numerous international with employers and telemedicine service are looking to this precious information conferences and has authored or companies to promote services to share the to analyse the impact of medication on co-authored 11 papers and one patent. patients more rigorously and accurately, Marjorie Villien graduated from enhance a personalised medicine approach, Grenoble INP (France) and holds a and accelerate clinical tests. PhD in Physics & Medical Imaging. “From evidence-based Monetisation of data is the next step medicine, connected after data storage in the cloud. Machine Jerôme Mouly serves as a Technology learning and artificial intelligence should & Market Analyst, specialised in medical devices enable help to process and analyse a large microtechnologies for biomedical & the “P4” medicine concept: amount of data. What about Google, medical imaging applications, at Yole Preventive, Predictive, Apple and the other giants of the big data Développement. Since 2000, Jérôme and analytics world? For several years has participated in more than 100 Personalised and the medical device market was far from their marketing and technological analyses Participatory. Innovative field of interest, with low volumes, strict for industrial groups, start-ups and business models may well regulations and long development times. institutes related to the semiconductor The limits of healthcare devices as data & medical technologies industries. be being set up, but who generators are also a consideration; Jérôme holds a Master of Physics from will pay for prevention?” consumer well-being devices have fewer the University of Lyon, France. regulations on data privacy and data Copyright © 2017 Frederick Furness Publishing Ltd www.ondrugdelivery.com 7
D Expert View fo 20 ow r m 18 n l or Me oad e in dia the fo P transfer architectures, which provides more rm ac comfortable territory and generates much at k more data. The monetisation of data is key io for these giants and regulations surrounding n! medical data are more constraining compared with those that apply to the regular consumer 2018 data they are more used to. THE ERA OF CONNECTED DRUG DELIVERY IS TAKING OFF The market share of connected drug delivery devices is expected to increase at a EDITORIAL CALENDAR rapid pace, with a more than 75% CAGR over the next five years for systems used in the context of chronic diseases. A feedback Publication Issue Topic Materials of accurate information will help patients Month Deadline to better monitor their health with fewer constraints, reducing hospitalisations or unnecessary visits to the doctor’s office. DEADLINE Jan 2018 Ophthalmic Drug Delivery The impact on society should be PASSED significant, with lower costs for healthcare organisations as well as better therapeutic Prefilled Syringes & Dec 22nd outcomes for patients, thanks to a Feb 2018 Injection Devices 2017 participative approach to sharing health data. The challenges of data privacy and patient safety will be key, involving Skin Drug Delivery: Jan 20th Mar 2018 new players in the healthcare ecosystem. Dermal, Transdermal Microneedles 2018 Consolidation of the market and the supply chain will occur later, with a series of Feb 19th mergers and acquisitions aiming to gather Apr 2018 Pulmonary & Nasal Drug Delivery 2018 the most innovative products and regroup solutions with high synergies. Injectable Drug Delivery: Mar 19th May 2018 ABOUT THE COMPANY Devices Focus 2018 Founded in 1998, Yole Développement Apr 23rd is a market research & strategy June 2018 Connecting Drug Delivery 2018 consulting company that has grown to become a group of companies providing marketing, technology and strategy May 21st July 2018 Novel Oral Delivery Systems consulting and media in addition to 2018 corporate finance services. Yole has a global vision and customer Jun 25th base. Yole, and its partners, System Aug 2018 Industrialising Drug Delivery Systems 2018 Plus Consulting, Blumorpho, Piseo and KnowMade, support industrial companies, investors and R&D organisations Jul 23rd Sept 2018 Wearable Injectors worldwide to help them understand 2018 markets and follow technology trends to develop their businesses. Prefilled Syringes & Aug 27th Oct 2018 Injection Devices 2018 REFERENCES 1. “Connected Medical Devices and Sep 24th Nov 2018 Pulmonary & Nasal Drug Delivery Business Models report”. Yole 2018 Développement, September 2017. 2. “Artificial Organ Technology & Oct 29th Market Analysis report”. Yole Dec 2018 Connecting Drug Delivery 2018 Développement, September 2017. 8 www.ondrugdelivery.com Copyright © 2017 Frederick Furness Publishing Ltd
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