Emily Newton, Editor-in-Chief, Revolutionized10.05.21
Medical device manufacturing can be a complicated business. There will always be high demand for these technologies, painting a positive outlook for future income, but many obstacles stand in the way. Manufacturers must understand and overcome these obstacles for their own benefit and improved public health.
The U.S. medical device market is the largest in the world, with experts expecting it to reach $208 billion by 2026. That creates a profitable opportunity for manufacturers, but achieving these profits isn’t always easy.
Here’s a closer look at the top six challenges in the medical device manufacturing industry and how to overcome them.
The best way to approach this inconsistency is to create consistency on your side. Manufacturers should embrace high-quality standards for all devices, regardless of their legal requirements. Industry-recognized standards like ISO 13495, which outlines quality management systems for medical devices, provide a reliable starting point.
When regulatory discrepancies arise, it’s generally best to aim for the most stringent so you meet as many standards as possible. It’s also a good idea to set up a regulatory compliance committee composed of experts who are deeply familiar with relevant regulations.. Any decisions should pass through them before going into practice.
Medical device manufacturers face increasing pressure to lower product costs, but that can be a challenge with high production expenses. One solution is to opt for disposable products over more expensive, longer-lasting ones. While this may seem counterintuitive from a consumer standpoint, sterilization can cost as much as $10 per instrument, so reusable products don’t always save money long-term.
3D printing can also reduce production healthcare expenses. Since this process adds material instead of cutting it away, it reduces waste and saves energy costs. Total production costs decrease as a result.
Cloud-based collaboration tools can connect disparate clinical systems, consolidating data from multiple sources to provide more comprehensive results. Some of these systems connect more than 20,000 hospitals, helping manufacturers test products across considerable sample sizes. Using the cloud also allows data from all these sources update in real-time, speeding the R&D process.
RPA can combine with these cloud solutions to further accelerate R&D. RPA automates routine tasks like data entry and organization, providing faster results and letting workers focus on value-adding tasks. Clinical trials will be shorter and more accurate with these technologies, reducing costs and leading to faster ROIs.
Hosting Internet of Things (IoT) devices on separate networks from other data and machinery mitigates their risk. This separation will ensure one breached device won’t grant hackers access to the entire facility. Data encryption, frequent software updates, and basic cybersecurity training for all employees will also help.
As for connected medical devices, manufacturers must ensure they have reliable built-in security features. Encryption and a way to authenticate over-the-air updates are two of the most crucial considerations. Devices should also require passwords by default and require manual input to connect to other systems.
Overenthusiasm for lean manufacturing methods exacerbated these disruptions. The solution is to move away from some just-in-time principles in favor of more flexible logistics chains. Instead of getting supplies from a single, international source, manufacturers should look into distributed sourcing and reshoring. That way, they can adapt to any disruptions in one area, and delays won’t be as impactful.
Implementing IoT technologies in the supply chain will also help by improving visibility. IoT tracking will give you a real-time look at shipment locations, conditions and any emerging issues. That way, you can respond to any oncoming challenges faster.
Medical device manufacturers can fight counterfeits by implementing a system to verify their products’ authenticity. Blockchain technology may be the ideal platform. Blockchains provide a transparent, immutable list of records, making it easy to prove a product’s validity.
Manufacturers can assign each product a unique identifier on a blockchain. Shipping partners and recipients can then use it to verify the items when they receive them. If the shipment doesn’t have a blockchain record or doesn’t match what it should, all parties will know it’s a fake.
These challenges may be intimidating, but they’re not impossible to overcome. With careful technological implementation and workflow changes, you can navigate these challenges and experience all there is to gain in the sector.
Emily Newton is the Editor-in-Chief of Revolutionized. She’s always excited to learn how the latest industry trends will improve the world. She has over five years of experience covering stories in the science and tech sectors.
The U.S. medical device market is the largest in the world, with experts expecting it to reach $208 billion by 2026. That creates a profitable opportunity for manufacturers, but achieving these profits isn’t always easy.
Here’s a closer look at the top six challenges in the medical device manufacturing industry and how to overcome them.
1. Regulatory Complications
One of the most pervasive challenges in medical device manufacturing is navigating the industry’s challenging regulatory environment. Manufacturers often face uneven regulations with inconsistent language and standards. It may not always be clear whether something must meet a given set of standards or not.The best way to approach this inconsistency is to create consistency on your side. Manufacturers should embrace high-quality standards for all devices, regardless of their legal requirements. Industry-recognized standards like ISO 13495, which outlines quality management systems for medical devices, provide a reliable starting point.
When regulatory discrepancies arise, it’s generally best to aim for the most stringent so you meet as many standards as possible. It’s also a good idea to set up a regulatory compliance committee composed of experts who are deeply familiar with relevant regulations.. Any decisions should pass through them before going into practice.
2. High Healthcare Costs
High costs are another one of the most substantial challenges in the healthcare industry. Roughly 46 million U.S. adults can’t afford quality care. While medical devices aren’t the only contributing factor, high device costs exacerbate this issue.Medical device manufacturers face increasing pressure to lower product costs, but that can be a challenge with high production expenses. One solution is to opt for disposable products over more expensive, longer-lasting ones. While this may seem counterintuitive from a consumer standpoint, sterilization can cost as much as $10 per instrument, so reusable products don’t always save money long-term.
3D printing can also reduce production healthcare expenses. Since this process adds material instead of cutting it away, it reduces waste and saves energy costs. Total production costs decrease as a result.
3. Slow, Expensive R&D
Medical device manufacturing relies on thorough research and development, even more so than other sectors. Running the necessary clinical trials is often a slow and expensive process, delaying time to market and hindering profitability. One promising solution to this issue is embracing technology like robotic process automation (RPA) and the cloud.Cloud-based collaboration tools can connect disparate clinical systems, consolidating data from multiple sources to provide more comprehensive results. Some of these systems connect more than 20,000 hospitals, helping manufacturers test products across considerable sample sizes. Using the cloud also allows data from all these sources update in real-time, speeding the R&D process.
RPA can combine with these cloud solutions to further accelerate R&D. RPA automates routine tasks like data entry and organization, providing faster results and letting workers focus on value-adding tasks. Clinical trials will be shorter and more accurate with these technologies, reducing costs and leading to faster ROIs.
4. Cybersecurity
Cybersecurity is a growing concern in the industry on two fronts. As more manufacturers implement smart factory technologies, they unintentionally provide more access points for hackers, raising the risk of a cyberattack. Medical devices must also feature better cybersecurity features as hacks on healthcare institutions become more common.Hosting Internet of Things (IoT) devices on separate networks from other data and machinery mitigates their risk. This separation will ensure one breached device won’t grant hackers access to the entire facility. Data encryption, frequent software updates, and basic cybersecurity training for all employees will also help.
As for connected medical devices, manufacturers must ensure they have reliable built-in security features. Encryption and a way to authenticate over-the-air updates are two of the most crucial considerations. Devices should also require passwords by default and require manual input to connect to other systems.
5. Supply Chain Disruptions
The COVID-19 pandemic uncovered another challenge in medical device manufacturing: fragile supply chains. As different countries enacted varying lockdown restrictions, disruptions rippled throughout supply chains. This resulted in delayed deliveries and rising material prices, creating financial issues and production bottlenecks.Overenthusiasm for lean manufacturing methods exacerbated these disruptions. The solution is to move away from some just-in-time principles in favor of more flexible logistics chains. Instead of getting supplies from a single, international source, manufacturers should look into distributed sourcing and reshoring. That way, they can adapt to any disruptions in one area, and delays won’t be as impactful.
Implementing IoT technologies in the supply chain will also help by improving visibility. IoT tracking will give you a real-time look at shipment locations, conditions and any emerging issues. That way, you can respond to any oncoming challenges faster.
6. Counterfeits
As medical devices become more in-demand, counterfeits will grow to take advantage of the trend. These fake products can divert revenue from legitimate device manufacturers and endanger the patients who use them.Medical device manufacturers can fight counterfeits by implementing a system to verify their products’ authenticity. Blockchain technology may be the ideal platform. Blockchains provide a transparent, immutable list of records, making it easy to prove a product’s validity.
Manufacturers can assign each product a unique identifier on a blockchain. Shipping partners and recipients can then use it to verify the items when they receive them. If the shipment doesn’t have a blockchain record or doesn’t match what it should, all parties will know it’s a fake.
Medical Device Manufacturing Must Evolve
Medical device manufacturing is a crucial industry. As such, manufacturers must move past these obstacles, ensuring people can get the tools they need without complications.These challenges may be intimidating, but they’re not impossible to overcome. With careful technological implementation and workflow changes, you can navigate these challenges and experience all there is to gain in the sector.
