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Top 8 Repair Service Challenges for Medical Devices

By | September 12, 2023 | 4 minute read

Life-changing innovation is the perpetual pulse that invigorates medical device manufacturing. From AI-powered point-of-care ultrasounds and reusable, rechargeable respirators to wearable electrocardiograms and a single-sensor ring recorder that assesses sleep quality, leading medical device makers are well-positioned at the forefront in using technology to improve how patients are cared for. 

Even amid supply chain disruptions and other challenges brought on by the COVID-19 pandemic, technology companies have continued innovating to bring to life trailblazing devices to help clinicians do their jobs more efficiently, reinforce hospital safety and — most importantly — improve patient outcomes.

However, with innovation and manufacturing at the core of your business, delivering support, maintenance and repair services for medical devices that are intended for long-term use can get in the way of pioneering new technologies. And the challenges that come with providing those services in-house are aplenty — but finding an outsourcing partner with deep expertise, robust capabilities and an established infrastructure can help.

How to Overcome Repair Service Challenges in the Medical Device Industry

1. Quality Concerns and Product Recalls

Quality-related issues cost the medical device industry billions of dollars each year. Software issues have surpassed device design as the top cause for recalls. Leveraging an outsourcing partner’s engineers and technicians who have expertise in medical device repair can help to ensure both safety and effectiveness of devices, lessening the impact of recalls.

2. Counterfeiting

In 2010, the World Health Organization reported that 8% of all medical devices in circulation are known to be fake — a number that is likely higher today. A partner with end-to-end services that extend beyond repair to cover inventory management, flexible supply chain models and logistics expertise can be instrumental in combating the proliferation of counterfeit parts that don’t meet your quality standards.

3. Regulatory Compliance

After earning regulatory clearance — which can be a challenge in itself — manufacturers must maintain production standards and continue to conduct post-market surveillance across the product’s lifetime. A global partner with medical device repair expertise, certifications and compliant processes can help ensure that you meet all applicable laws and regulations across multiple countries.

4. Supply Chain Disruptions

With supply chain issues and long lead times for semiconductors, electronic components and raw materials potentially affecting repairs, an outsourcing partner can support your forward and reverse logistics as well as inventory management is highly beneficial.

5. Proximity to Customers

A repair services partner with global capabilities can offer medical device repairs in proximity to customers across a wider footprint, reducing the risk of customer downtime that threatens their business and their patients’ health. Closer proximity to customers helps to reduce greenhouse gas emissions, too.

6. Fluctuating Demand

The more products an OEM has in market, the more carefully they must be managed. But ramping services up and down can be costly and — in times of parts or labor shortages — impossible to accomplish in a timely manner. Partnering with a repair services provider who has a global footprint, extensive supply chain relationships and inventory optimization expertise means you’ll have the people, parts and processes to scale effectively when and where needed.

7. Skilled Labor Shortage

Many medical device OEMs are experiencing significant gaps in skill sets, bandwidth and capabilities. A repair services provider with certifications, experience, product familiarity, clinical application knowledge and specialized support capabilities can serve as an extension of your team, enabling you to diminish gaps.

8. Remote Services

Remote IT services that require a platform for linking onsite devices to offsite engineers and tech support are on the rise for software and compliance updates, preventive and corrective maintenance and operational analytics. You can scale, enhance service access and reduce overall costs with a partner whose remote repair capabilities and product expertise allow you and your customers to stay connected 24x7x365.

Tackle Medical Device Repair Service Challenges With Confidence

Outsourcing services to an expert, certified partner can help you more effectively tackle common repair service challenges for medical devices and remain at the forefront more confidently in a highly regulated industry where patient lives may literally depend on the devices you bring to market.

To learn more about overcoming challenges with a repair services provider and  what to look for in an outsourcing partner, download the whitepaper, “How to  Outsource Medical Device Repair Services With Confidence” today. 


Download the whitepaper How to Outsource Medical Device Repair Services With Confidence


About the Author

Steve-Bair-headshotSteve Bair has been with the company since 1997 and currently serves as the Director of Global Engineering for the Repair Services organization within Shyft Global Services. He has extensive experience with and passion for product and services solution design, engineering, delivery and management. He has a proven track record in cross-functional leadership roles as well as weighing and balancing the objectives of the company and the customer to develop innovative solutions that solve complex business needs.