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MEDICAL TECHNOLOGY TRENDS AND DEVICE REGULATION

Devasheesh Kamra, Neurosurgeon, All India Institute of Medical Sciences

Medical Technology is making progress at an ever increasing pace. This article uncovers the innovations which have helped mankind achieve better health. Newer medical devices have eased this process remarkably. Stringent regulatory standards ensure that the devices are safe, well studied and have least adverse reactions. Device regulation is therefore necessary to safeguard us against possible adverse effects.

Medical technology has brought us here and technological advancements have fuelled it to reach amazing heights. New innovations have been coming at an ever increasing rate. Artificial intelligence (AI) has enabled machines with humanlike thinking behaviour with reasoning and problem solving skills. Since newer technologies are coming so fast, it becomes our moral responsibility to use them  to shape our future in the right direction and that is where the regulatory part comes in.

We have seen innovations in almost each and every aspect of medical sciences. COVID-19 has tested healthcare standards throughout the world and taught us valuable life lessons. Although we have lost a lot to it, the rate at which we have responded to the situation is also exemplary and has been never seen before in the history of mankind. Never before, vaccines have been released on such short notice and been administered on such a large scale1. Healthcare infrastructure and practices have been tailored to meet the demand. Research has been upscaled like never before. Telehealth is now routinely being used to take care of the health of patients using different video conferencing platforms when a formal physical visit is strenuous for the patient. Though it is suboptimal compared to formal history taking and physical examination, it still helps in addressing the major clinical concerns.

The advent of ECG in the early 20th century paved a way for the future and has its potential further explored by the new trends in healthcare. Cardiac holter has been used for more than 20 years. Mobile cardiac telemetry is able to record and transmit abnormal cardiac rhythms upto 30 days and implantable Cardiac monitors for upto 3 years altogether.2 We have a bluetooth-enabled patient status engine3 to provide more comfort to patients recording valuable data from patient monitoring even with remote transmission. Though it's not widely available, it will certainly be in the years to come and will shape our future.

There has been a significant role of extended reality using simulation to create an environment for training doctors, surgeons in an environment without risking the safety of patients. The trainees are able to practice and master their microsuturing skills, endoscopy skills and anastomosing skills. It is also used to treat childhood disorders like autism to improve social skills. It is also being used to facilitate Cognitive behaviour therapy for various psychiatric disorders.

We have seen growth in almost every clinical specialty and creation of new superspecialities. Had we been born with epilepsy before the eighteenth century, we would have found ourselves in an asylum or in isolation. The scenario has now changed dramatically. The growing knowledge of neurosciences have helped treat this disease in a comprehensive manner. We have advanced from EEG and Stereo- EEG and Magnetoencephalogram have become the standard of care at tertiary centres. What was incurable years ago is now curable with favourable odds. The newer drugs are being discovered and indications of use of already in use drugs are ever increasing.

We are fighting hard against the deadly diseases and have successfully found a cure for Hepatitis-C which was once considered incurable. The latest endoscopy equipment can view the whole gut from inside out and still be able to find a needle in a haystack. When did we ever think that we can have quality images of the inside of the gut using equipment as small as a pill. With Wireless Capsular endoscopy, it's now possible.

There has been an increase in survival for almost all cancers over the timespan of the last 20 years owing to newly developed chemotherapy, immune mediated therapies, better screening tools leading to early detection, rising awareness and research enabling us to increase longevity. Immunotherapies have been on the rise and leading tobetter outcomes. Radiopharmaceuticals are increasing their spectrum and are being used in neuroendocrine tumors of digestive tract and prostate cancer.

With increased longevity and prevalence of diabetes and lifestyle diseases, the demand for dialysis has also been increasing. The need for better outcomes and ease of use has led to questioning ourselves even more. The concept of dialysis is not new and has been in use for centuries, now having given birth to newer modalities like Continuous renal replacement therapy4 (CRRT) and Wearable artificial kidney5. However, we have a long journey ahead to attain perfection in better toxin excretion and functional outcomes.

It is difficult for any individual to live with a thought that they have a brain tumour and there is sometimes a social stigma also associated. Newer technologies and awareness has led to its early detection and good functional outcomes. Brain surgery has made big progress with awake painless surgeries, robotic assisted, navigation guided and neuromonitoring assisted surgeries becoming a new standard of care. The survival rate has considerably increased.

Some common myths about spine surgery include that the patient will have to spend more than a month in bed. That the surgery will cause more pain.Or that if one undergoes spinal surgery they will never be able to walk again.

Most of these myths do not hold true. These are just less common or very rare problems being generalised to the whole lot just like driving a car will lead to an accident and likewise. We have robots and O-arm assisted navigation systems that assist in placing the implants in the spine at very difficult trajectories leading to very satisfying outcomes with a very less margin of error. The results of fusion surgeries have improved significantly with newer concepts of sagittal balance, better fusion materials like Bone Morphogenetic proteins and demineralised bone matrix.

Newer technologies like 3D printing have revolutionised the concept of custom made implants and prosthetics with impressive outcomes. These implants outperform the traditional implant methods. The cranial vault reconstruction, bony fractures, and prosthesis are in regular use. In future, developments might lead to invention of 3D printed cardiac valves6 and even as minute as retina. 3D models are used in difficult spine surgeries and difficult intubation that simulate patients anatomy and help safely practice the difficult steps in a controlled environment without concerns of patient safety.

The deficits after brain injury or neuronal loss are severely disabling and affect the quality of life drastically. Though due to some neuronal plasticity7, there is some functional recovery. However, the recovery is never complete and is different depending upon the modality. By developing a brain-computer interface, we might be able to restore functional independence with patients of paralysis or blindness in years to come. We have nothing substantial at present and research is still ongoing.

Medical reforms and newer technology have put mankind in the driving seat. Though moving still at a steady pace, we need both brakes and accelerators to keep moving further without any untoward accident. Medical device regulation is one such measure to keep balance and checks and ensure the technology is moving in the correct direction to prevent any harm to mankind.

The US FDA is the regulatory authority in the US for controlling drugs and medical devices. CDSCO is its Indian counterpart that regulates the approval of new drugs and devices, import registration and licensing, banning of drugs, devices and cosmetics, testing of new drugs and ensures the devices which are available in the market have adequate standards. The devices that come under its purview have been defined in Drugs and Cosmetics Act,1940 Section 3(b) (iv). Medical devices are defined as devices intended for internal and external use in diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals. Just a few more than 100,000 devices have been approved for use by CDSCO in India till date8. The medical devices have been classified into four classes based on risk stratification: class A - low risk, class B - low moderate risk, class C - moderate - high risk and class D - High risk. The high risk devices such as implantable defibrillator, heart valves have to go through more stringent checks and regulations in comparison to low risk devices like thermometers and tongue depressors. The device may also be reclassified into other categories by the authorities if deemed necessary by the authority. Any devices which are deemed unfit for use are recalled. Failure is not the opposite of success, rather it is a part of success. During the last fiscal year 2021 as per US FDA data, 2607 medical products were recalled by the manufacturers9. These failures actually represent all the sincere human efforts which were meant for upliftment of healthcare. We have come so far in technology, but nothing can still replace the clinician’s skill to diagnose and treat the patients.

References:

1 “COVID-19 Vaccines.” WHO | World Health Organization, https://www.who.int/emergencies/diseases/novelcoronavirus-2019/covid-19-vaccines.
2 Medtronic. Heart Monitoring. https://www.medtronic. com/us-en/patients/treatments-therapies/heart-monitors/monitoring.html.
3 Isansys PSE. https://www.isansys.com/en/Patient-Status-Engine.
4 Tandukar S, Palevsky PM. Continuous renal replacement therapy: who, when, why, and how. Chest. 2019 Mar 1;155(3):626-38.
5 Topfer LA. Wearable artificial kidneys for end-stage kidney disease. CADTH Issues in Emerging Health Technologies. 2017 Jan 30.
6 Sedlakova V, McTiernan C, Cortes D, Suuronen EJ, Alarcon EI. 3D bioprinted cardiac tissues and devices for tissue maturation. Cells Tissues Organs. 2021 Mar 5:1-4.
7 Bernhardi RV, Bernhardi LE, Eugenín J. What is neural plasticity?. The plastic brain. 2017:1-5.
8 MD - Medical Devices. https://www.cdscomdonline.gov.in/NewMedDev/Homepage.
9 Health, Center for Devices and Radiological. “2021 Medical Device Recalls.” FDA, Dec. 2021. www.fda.gov, https://www.fda.gov/medical-devices/medical-devicerecalls/2021-medical-device-recall

--Issue 57--

Author Bio

Devasheesh Kamra

The author is a Neurosurgeon and has done his training from prestigious All India Institute of Medical Sciences, Delhi. He has held the position of Associate Consultant Neurosurgery at Max Super Speciality Hospital, Saket, Delhi and is at present pursuing fellowship in Neurovascular intervention.

Harvard Medical School - Leadership in Medicine Southeast Asia47th IHF World Hospital Congress