Design Challenges in Medical Devices

Future of healthcare

When we talk about technology, it’s not really limited to a certain section of our society. It goes through them all, it covers them all. Arguably, one of the most important sector’s technology has touched is the Medical Industry.

With continuous developments in this field, we have seen innovations, rapid innovations. After innovations, we see developments that try to make those innovations affordable.

All the innovations and the developments present very magnificent imagery of the Medical Technology(MedTech) industry, but just like any other field, it’s filled up to the brim with challenges. That’s our focus for this article.

Let’s get going deep into the design challenges faced in the manufacturing of medical devices.

Introduction

Medical Technology or MedTech, as it clearly implies, is the integration of technological developments into the field of medicine and healthcare. 

While it includes the larger devices and machines used for quicker diagnosis, better treatment and reduction in rehabilitation times, we have moved to the times where the MedTech industry has reached your daily lives.

With Heart Rate Sensors being integrated into your smartphones, pedometers integrated into small little bands that you can wear throughout the day and night, the MedTech industry is tremendously vast.

The growing business aspect of this industry can be showcased from the graph below.

Growth rate of healthcare
Source: Statista

 

With each passing year, the MedTech industry has registered brilliant figures and forecasts show it will be a $600 Billion US Dollar market by the year 2024. If you had any doubts about the reach of this industry, I’m sure there are none left. These results are based off a survey of sales data of 300 top MedTech companies from the time period of 2011-2018. Starred years are forecasts.

What is the future of healthcare?

If we specifically take Indian Medical Device Market into account, we will see a wide range of products filling it with diversity.

Market size of healthcare industry?
Source : AdvaMed

 

At this moment, it becomes very necessary to go through the problems and challenges that are being faced in this sector. It is important for each one of us to discuss the challenges and try to move one step ahead at a time for a solution. Let’s get to it.

The Challenges!

The major challenges that the MedTech industry is facing revolve around:-

  • Manufacturing of Products: While some products may be ready in theory but the proper technology to implement them in an effective and risk-free manner is not available. This requires the advancement of certain technologies to ensure that such products perform well and without risks. 

  • Industry Hurdles: The MedTech industry faces much tougher regulatory processes in comparison to other manufacturing industries, says Commercial Electronics.

  • User Adoption: After all the initial and middle stage problems, when a product is finally allowed to be pushed out to consumers to use, there are certain privacy and security concerns given what such MedTech devices deal with.

Source: Jabil

 

These results are based on a survey by premier manufacturing solutions provider, Jabil, where more than 200 decision makers of prominent MedTech companies shared their insight and opinions.

Manufacturing Issues

First of all, with all the risks considered, you cannot put the MedTech industry at par with other industries because there is no scope for errors. Experimentation needs to take a back seat and solutions have to be precise and effective. In this case, any ineffective or unsure methodology can cause serious repercussions in line of life and death.

Now, this magnitude of risk often results in abandoning of products before they reach the market. According to the survey mentioned above, it was revealed that at least one in five companies that tried to provide a healthcare solution to solve issues related to technology, compliance and production had to retract it.

A proposed solution to this is for the innovating company to partner with a more experienced company. This is comparatively more prominent in the West but something that’s budding in India as well with Startups rising with focus on providing proper guidance and services on the manufacturing, distribution, commercialization and service of the product.

In the survey held by Jabil, top executives shared their opinions on partnering with other companies and how important partners are for a smooth process. They were asked for each of the following partners on would they be important in bringing your MedTech device to the market.

 

Manufacturing Challenges In Medical Devices
Source: Jabil

 

For the Manufacturing Partners, 65% of the business executives agreed that they’ll be helpful in bringing their MedTech devices to market. This was followed by a 63% result for Technology Partners and 49% for partnering with agencies or companies that can provide proper help in government processes.

Data Management and Data Security

Devices manufactured in the MedTech Industry deals with a humongous amount of data. As we aim for the growth of this industry, we have to consider that with the growth, we will be dealing with data even more enormous in size. Such data which deals with vitals of a patient has to be managed properly and carefully. Any carelessness can be of great harm.

Again, with the kind of data that we are dealing with here, it is very important to ensure proper security and privacy of this data. This security has to be not only against unauthorized viewing but more importantly against accidental damage and loss of such data which can cause a tremendous loss, monetary as well as can risk someone’s life.

IOT
Source: Kellton Tech

 

The proposed solution to this problem is taking the help of technologies such as Big Data and IoT. Internet of Things (IoT) based technologies are used to garner data and access it in a convenient manner. Healthcare Systems are expected to generate a tremendous amount of data that is very different from data expected in smaller industries. Big Data deals with data that is enormous in volume, have a great speed of generation and are of different varieties. Big data handling technologies also enable the data to undergo certain analytics like Data Cleansing and Data Wrangling which gives ensures much better data handling and security.

Tracking of Medical Devices

In every industry, with growth, we need to amp up the technologies to ensure proper support to handle the growth. In the MedTech Industry, the need for this support is greater. With millions of devices in the market, thousands of manufacturers contributing to the continuous growth of this industry, it is important to ensure that information of these devices are properly managed. A basic solution to this problem is the maintenance of a master list of Medical Device Items. But this often requires manual entry which can lead to inconsistency, incomplete data and that makes the system prone to errors. And we have clearly established that errors in this kind of industry can have serious repercussions.

Master Item For Medical Devices
Source: MPO-Mag

 

To tackle this, we have to implement a solution that is normalized, standardized and categorized with such a structure that can power an information system as well as can provide numerous user benefits. We have to go beyond the basic Unique Device Identifier (UDI) system and build an automated knowledge platform that can perform various functions for a device. These functions include identifying, sourcing, document, tracking and billing for the medical devices.

Dealing With The Battery Factor

When we are talking about the MedTech devices, these devices could be the minutely critical Ventilators as well as our daily wearable Fitness Bands. Very often, we would need to work a powerful battery solution for our MedTech devices. There are certain factors that come into play.

Microcontroller
Source: TreeHugger

 

  1. Chemistry – Let us take an example of comparison. NiMH (Nickel Metal Hydride) batteries are cheaper than Lithium-Ion (Li-ion) because NiMH has no transport restrictions. On the other hand, Li-ion batteries have greater potential to evolve. There is also Lithium iron phosphate which offers a longer service life at a comparatively cheaper cost. Such differences have to be taken into account and battery needs to be chosen depending on the application of the product.

  2. Size – Depending on the application of the product, we have to decide the perfect size of the product. It is often desired that the product be small and light. In this case, you have to ensure the usage of proper battery cell sizes. A battery integrator is used to make sure efficient use is made of whatever space is available.

  3. Reliability – Again, coming back to the fact that taking risks in such devices can lead to serious repercussions, we need to ensure batteries used are reliable as well as safe. You cannot be sure of the mains power always powering the product, so the battery power has to be reliable, right down to the individual cells that have been put to use.

Material selection process for medical devices.

Conclusion

It is very important to realise what we are dealing with here. MedTech, the Medical Technology Industry, is not something you can glide along. There is no margin for error.

It is important for us to understand the major challenges that come up when you are trying to design a MedTech device.

In this article, that is exactly what we have made an attempt at. Once these challenges are overcome and a good and error free device are made, there are next steps that are to deal with the government regulations and other commercial aspects.

We will be dealing with those challenges in our upcoming article so do come back for there’s more in store.

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