The hospital lab comes to the patient's home1 October 2012
Rapid innovation in miniaturisation, mobility and connectivity is revolutionising medical diagnostics and treatments. This, in turn, is bringing healthcare directly to the individual. Brian Anthony, director of the Master of Engineering in Manufacturing Program at the Massachusetts Institute of Technology, examines where the trends are taking us.
Continuous monitoring of physiological markers is starting to place capability for the early detection and prevention of disease in the hands of the consumer, shifting to a paradigm of maintaining wellness rather than treating sickness.
Just as the personal computer revolution has brought computation to the individual, this revolution in personal medicine will bring the hospital lab and the physician to the home, to emerging countries, and to emergency situations.
From at-home cholesterol monitors that can adjust treatment plans, to mobile phone-enabled blood labs, these system solutions containing state-of-the-art sensors, electronics, and computation will radically change our approach to healthcare. The new generation of medical systems holds the promise of delivering better quality healthcare while reducing medical costs.
Personal medicine revolution
The revolution in personal medicine will be rooted in fundamental research in microelectronics from materials to sensors, to circuit and system design. This knowledge has already fuelled the semiconductor industry to transform society. It provided the key technologies to continuously increase performance while constantly lowering cost.
Computation has changed from huge expensive systems in a back room serving a few, to affordable personal computers with similar processing power that are accessible to nearly a billion people.
The communication of information both wired (internet) and wireless (mobile phone) has allowed connectivity between people around the world at anytime. Consumer electronic devices such as the digital camera have changed how the younger generation interacts through social networking. The ageing population, soaring healthcare costs, and the need for improved healthcare in developing nations are the driving force for the next semiconductor industry societal transformation: medical electronic devices.
Strong interaction between the microelectronics and medical device industries will transform medical electronic devices. The successful realisation of such a vision also demands innovations in the usability and productivity of medical devices, and new technologies and approaches to manufacture devices. Information technology is a critical component of the intelligence that will enhance the usability of devices; real-time image and signal processing combined with intelligent computer systems will enhance the practitioners' diagnostic intuition.
Medical device trends
The US economic recovery package had $19bn earmarked for electronic medical records - $2bn to develop national systems for computerised health records, and $17bn for increased Medicare and Medicaid reimbursements for doctors and hospitals to adopt technology.
What does this mean for medical devices? Currently, doctors are compensated for a visit to the hospital or to the doctor's office. Changes to the medical record system will allow doctors to be compensated for reviewing and interpreting digital medical records. Intelligent devices - injected, worn or used in the home - will be a significant source of information in your digital medical record.
Intelligent devices in the home for monitoring of chronic conditions, rehabilitation therapies, or proactive baseline health monitoring of mobility weight of medicine to shift from reactive to proactive care, creates baseline health information, and possibly allows treatment and delivery of care to patients in different physical locations and a medical expert providing treatment. The unmet needs of an ageing population demanding to remain athletic and mobile will lead to a proliferation of devices that have health-related functionality.
The wrong time to establish base vital signs - EKG, respiration, blood-pressure - is when you are ill and seeing a doctor. Baseline vital signals recorded from an implantable or a worn device will provide the data to compare to when you're ill. A more connected data-centric healthcare system will lead to smarter, instrument, interconnected medical devices.
Medical devices for condition monitoring, chronic condition management and rehabilitation will be used by patients in their homes or worn on the body.
Highly integrated electro-mechanical-biological devices and sensors will be implanted, injected, and swallowed by patients. These devices will require a high level of systems integration in their design and complex precision equipment for manufacturing. How to analyse, how to manage, and what to do with the data are big questions.
The semiconductor industry has recognised these trends; it has a history of revolutionising other industries and driving down costs in computing and communications. Many view the miniaturisation and proliferation of medical devices as the next huge growth opportunity to drive industry development.
Significant research has gone into the electronics for wearable and minimally invasive devices, for implantable sensors. Executives and engineers from Medtronics, GE and others will tell you that electronics are important, but are only one element of the medical device.
How the electronics interface with sensors or other transduction mechanisms, how they are fixated and interface to the body, the process by which they are manufactured, handled, and stored and injected -the complete use-model of the product - have a profound impact on the device's design, manufacture and delivery, but these elements have received less attention.
The trend towards miniaturisation for implantable injectables requires a system approach to integrating low-power electronics and precision sensors, and mechanics and possibly biologics. Manufacturing and assembly technologies capable of reliably assembling such products will enable the next generation of devices.
New medical devices will include combination products - devices that are part-pharmaceuticals or biologic agent, such as drug-eluting stents or pre-filled syringes. Combination products present unique manufacturing challenges.
The two components are separately regulated; designers are generally familiar with either the device or the drug. The physical design of combining the two, sterilisation, validation and drug/device interaction issues further complicate the design, manufacturing and delivery process.
Versatility, usability, productivity and ease of manufacture are major design considerations that improve the value of a medical device. Intelligent devices that aid or guide the practitioner can reduce training and education requirements.
New biomaterials used in medical devices have unique design requirements. The material's form and size, how it interfaces with the body and its required duration of use will determine its required properties. Awareness and understanding of these materials is critical for an engineer to design a device or manufacturing equipment.
Successful medical devices realisation
It is a challenging proposition to conceive, realise and successfully introduce a medical device into a healthcare system; medical device realisation requires input from a broad set of stakeholders.
Successful devices will satisfy patient or clinical needs as defined by physicians and clinicians; they will be designed and manufactured in a way that is fundamentally safe and effective by engineers and technologists; they will be demonstrated and documented to be fundamentally safe and effective for regulators; and they will have a value proposition that motivates payers (insurance companies, the government, or, sometimes, the patient) to pay for the device and for a company to develop and support the device as a product.
In the realisation process for medical devices, design, manufacturing and use are intimately interconnected. It is critical to understand manufacturing, its limitations, tools and expected variability. Manufacturing and manufacturing innovation are motivated by products that are to be produced with high quality in large quantity. It is critical to understand the patients and medical practioners, models of use, and patient needs and constraints.