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Emerging Trends to Watch in Orthopedic Medtech for The Last Quarter of 2021

We’re past the May 26, 2021 “date of application” for the European Union Medical Device Regulation (EU MDR)—the date by which the new requirements become legally binding. Although it was pushed back a year by the COVID-19 pandemic, the deadline has come and gone and there are changes to packaging and labeling that OEMs need to be tracking and following if they sell medical devices and products in the EU.

A number of OEMs used the yearlong delay to prepare for conversion, but many other manufacturers put conversion aside as the pandemic and economic crises upended business in the first and second quarters of 2020.

Now it’s critical to accelerate conversion while upholding product quality and patient safety—while also not overlooking any of the key changes and additions to the EU MDR. Though the transition has spanned several years, the complexities and intricacies of conversion for compliance takes time. In our competitive industry, time is money—and after the losses of 2020, the pressure is on to protect revenue and recovery.

Let’s take a closer look at what’s involved and what orthopedic OEMs need to know about a superior approach to inventory reallocation to successfully navigate the transition.

Understanding the EU MDR timeline

The full transition will span several years, but higher-risk Class III devices must meet compliance earlier than Class I and Class II devices. Class III devices, of course, include most types of implants.

For these Class III devices to continue to be sold and used in the EU market, OEMs must meet the new sterile packaging and labeling requirements of the EU MDR. Class II devices have until May 2023 and May 2025 to comply with the regulations.

Better for patient safety

There are certainly complexities to managing smooth conversion, from cleaning, organizing, repackaging, and labeling, to getting product back out to the field. Ultimately, though, the new guidelines are better from the perspective of the patient. Sterile-packaged products and devices lower the risk of infection and adverse outcomes. These products are also more efficient for hospitals, as they are ready to use right in the operating room without the need to clean and autoclave on-site.

Minimizing risk during sterile packaging conversion

Converting non-sterile to sterile packaging is a highly complex undertaking—and there are many opportunities for costly delays and other pitfalls as OEMs straddle the conversion period.

Certainly, the first priority should always be patient safety, and OEMs must ensure quality through every step of the conversion process. Other than this, the greatest risks during conversion include:

• Depressed revenue
• Insufficient inventories to meet demand and cover cases
• Difficulty containing cost burden of sterile packaging conversion
• Delays in conversion, which can affect revenue and case coverage
• Poor inventory management, which can drive up cost
• Failure to meet specific compliance guidelines for labels and packaging

Expediting compliance and conversion with strategic inventory reallocation

Knowing what’s at stake, how can orthopedic OEMs streamline conversion while meeting new compliance requirements?

Taking a strategic approach to inventory reallocation with reverse logistics and repackaging is an important and effective first step. This approach helps orthopedic OEMs manage their existing inventory and new product production to accelerate successful conversion while managing costs. Here’s how our expert approach to this complex process works.

1. Reclaim: First, underutilized product is flushed from the field. Millstone has extensive expertise in successful reverse logistics programs and in working with OEMs on incentives to ensure product is returned from hospitals, sales reps, and other places where inventory is parked.
2. Receive: Millstone receives, catalogues, and inspects all inventory, including expired and obsolete items. This includes quality critical inspection with independent source verification, a key quality step for OEMs and their outsourcing partners. Once inspection is complete, Millstone also seeks out all opportunities for cost savings, including cost recoupment from recycling expired and obsolete items.
3. Organize: Lots are organized to ensure the same expiration date for all items. This upholds quality and compliance requirements.
4. Clean: Millstone cleans product as required using ultrasonic cleaning and passivation equipment.
5. Repackage: Products are repackaged in EU MDR-compliant sterile packaging. We perform comprehensive package integrity testing, including sealing validations, distribution testing, and accelerated aging. In addition, in some cases, we can make use of prevalidated packaging that fits up to 80% of spine and orthopedic products, cutting time to market even more.
6. Sterilize: Sterile-packaged products are sterilized using gamma radiation or ethylene oxide sterilization in a controlled, best-in-class process designed to ensure devices are ready for aseptic transfer to patients. Sterile-packaged products are quickly deployed to the field.

The benefits of this strategic approach to inventory reallocation include:

• Accelerated conversion period
• Compliance with EU MDR guidelines and timelines for Class III medical devices
• Revenue protection
• Cost savings through inventory reallocation and minimizing the cost burden of conversion
• Improved inventory utilization
• Better case coverage
• Industry expertise to navigate changes to packaging and labeling—avoiding costly mandatory or voluntary recalls

After the challenges of the last year, orthopedic OEMs should be looking at every revenue reacceleration and cost savings opportunity through a strategic lens. They should also be evaluating what a strategic partner can bring to the process, especially one with industry-leading expertise in cleaning, sterilization, and packaging. Now is the time to meet the challenges of sterile packaging conversion head-on.

At Millstone, we understand the challenges OEMs face in the robotic assisted surgery products market. We have successfully launched and supported packaging for four major orthopedic robot platforms and bring a birds-eye view of the growing robotic assisted surgery products market. Today we offer post-manufacturing and aftermarket services to more than 50 customers, including some of the top 10 orthopedic companies in the world. We are constantly evolving our processes and services to help OEMs achieve sustainable success. We offer clean room packaging, medical device specific warehousing, finished goods distribution, loaner kit management, advanced inspection and reverse logistics services—all with an unparalleled focus on quality.

What could we help you do better? Learn more at https://millstonemedical.com.