Healthcare is one of the world’s largest and profitable industries. Robotic surgery, artificial organs etc. gave the impression like sci-fi movies. But the devices and technique has now become a reality. And, this reality has changed the overall perception. The medical device manufacturers are emphasizing on development of innovative devices.

Financial profitability and improved benefits are the major factors of revolution in the field of medical devices. Imagine a robot prescribing 3D printed pills after diagnosing and a drone delivers the required medicine or a robot surgeon performing complex operation.

However, the devices are not the last resort for a sick person where the doctor’s word is the final verdict. It’s also true that not everyone is comfortable with such technological advancement, but a lot many have become tech-savvy through the use of smartphones and computers. The user has more info about his ailments and possible treatment.

The medical devices can be broadly categorized in 6 major sector related to medical treatment.

  • Patient monitoring
  • Diagnostics
  • Digital health
  • Surgical
  • Cardiovascular
  • Neurological

The trends that might affect the medical device manufacturing industry in 2017 are elucidated below:

The bioelectronics sector

Bioelectronics devices must be small enough to be inserted through keyhole surgery and attached to a nerve. GlaxoSmithKline is developing pill-sized implants which work by adjusting nerve signals. The developments would revolutionize the business.

Using Smartphone apps for healthcare

The mobile phone revolution is definitely to transform the healthcare field. Patients prefer to have an online video chat with his doctor through mobile phone, or to order a home delivery of the prescription. This preference as against personal appearance before the doctor is bound to change the medical device industry. Doctors favor monitoring their patients with the help of medical devices.

Growing concerns about cyber security

With greater connectivity comes greater risk of cyber attack. Medical devices are increasingly connected to the internet. And a user would avoid it if a cyber-security is breached. He may totally avoid a site for a particular device if it is hacked and its security is compromised. Therefore, medical device manufacturing companies will have to strengthen cyber-security of its site beside the device.

Assistive Surgery in Remote and Rural Areas

 For performing high risk surgeries in rural and remote areas, Advancement in robotic surgical technologies will change the existing scenario and address the immediate needs of patients in remote and rural areas.

Competitive Factors and Regulatory Regime

Legislative measures such as new policies and programs with a view to reduce costs can influence the demand and pricing for medical products and services. It should be kept in mind that product development requires significant R&D costs. To control costs, Government Measures may check future pricing.

In India, the health ministry has notified Medical Devices Rules, 2017, which will come into effect from January, 2018. The government has also notified 15 devices as drugs and thereby bringing them under price regulation. Apart from catheters, stents and orthopedic implants, the list also includes heart valves, intra-ocular lenses, syringes and needles.Bringing critical medical devices like stents, orthopedic implants and diagnostic equipment under stringent regulation, the new rules would also require these critical devices to undergo trials in India before they are approved for launch. The rules classify medical devices under four categories – A,B,C, and D. The categories are based on the level of risk such as low risk, medium risk and high risk.

Standards for regulations will differ based on the use and risk factor. For instance, implantable devices such as stents will be part of the high risk category and monitored directly by the government regulator.

At present, quality checks for medical devices are weak in the absence of specific rules. While ensuring that medical devices sold in India meet standard quality parameters and are affordable, the new rules are also expected to provide industry players a level playing field and ease of doing business.

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