5 Trends to Watch in Implantable Medical Device Manufacturing [2021]

2020 was a year marked by unexpected changes for the medical device industry because of COVID-19, which left many looking to 2021 with hope and anticipation.

Some of the trends from 2020 will continue well into this year, including the reliance on virtual communication and an industry-wide focus on recovery. New trends will also take effect, including device updates to meet upcoming European Union regulation changes.

We’re keeping an eye on the following 2021 trends impacting the implantable medical device manufacturing industry and contract manufacturers like Lowell.

Trend 1: OEMs expand contract manufacturing partnerships to include both medical device machining and medical instrument machining.

 

Surgeons need a perfect fit between a medical device and the medical instruments used to place the implant. To improve the interface between the two, we’ve seen more OEMs interested in having their contract medical device manufacturers also machine the companion surgical instruments.

A plate attached with bone screws is a great example that highlights the benefits of machining both pieces through one supplier.

The surgeon needs to reliably and efficiently use a screwdriver to pick up a bone screw from a tray to attach a plate. For a screw to fit well and stay attached to the screwdriver, the tip of the screwdriver needs to be microscopically smaller.

The contract manufacturer who makes the bone screw already understands the data requirements of the device. This level of attention and understanding makes the contract manufacturer a natural fit to machine the screwdriver that interfaces with the device, if they have those capabilities in house.

Trend 2: Virtual collaboration remains a top way to move projects forward amid COVID-19, and in some ways will be here to stay.

 

Virtual meetings have become the preferred way for manufacturers and customers to collaborate amid COVID-19 for health and safety. While there was a learning curve around new technologies and processes, the industry has adapted to this new way of doing things.

Even as we look forward to again meeting with customers face to face, we know many of these new ways we learned to work are here to stay.

We’ve transitioned our pre-production meetings to a digital format, often using a 3D-printed prototype as a visual aid to support conversations about design details and requirements. We’ve learned how to better use digital platforms to support our manufacturing process and maintain project timelines for our customers.

Trend 3: The medical device industry will focus on recovery from the 2020 downturn because of COVID-19.

 

COVID-19’s impact on the medical device industry was far-reaching, with many device companies finding sales and revenue down.

The pause in elective surgeries was particularly hard for the orthopedic market, with some companies experiencing double-digit declines in sales.

As 2021 moves ahead, the orthopedic industry is beginning to see signs of a recovery, but there isn’t a strong consensus on when or how that will happen.

Trend 4: OEMs will adjust designs and marking requirements for European Union Medical Devices Regulation.

 

After a one-year delay in implementation because of the pandemic, the European Union Medical Devices Regulation (EU MDR) implementation is coming in May 2021.

The new guidelines are wide ranging and will impact most if not all stages of the product development cycle. At this point, we see contract manufacturers’ role primarily as supporting medical device OEMs as they work to comply with the new regulations.

We’ve started to see these EU MDR changes in how parts are marked. With additional characters and complexity in the markings, it’s more important than ever to understand the customer’s marking and data requirements so the parts we make are valid.

Taking the time to discuss marking and packaging at the beginning of a project ensures requirements are kept top of mind throughout production.

Trend 5: Understanding design intent continues to drive meaningful results for complex medical device machining.

 

We are believers in the importance of understanding design intent because we’ve found it’s one of the most important drivers of positive manufacturing and product results.

As demand for smaller and more complex medical devices continues, this continues to be essential for success in 2021.

Design intent goes well beyond the specs of a medical device, to include how the device will be used and why. Understanding this big picture allows your contract manufacturer to make more informed decisions about the manufacturing process.

For example, adjusting an element of a design, such as the tolerance of one feature, may allow us to save time during inspection. This ultimately can save the customer time and money.

As the industry continues to adapt its practices amid COVID-19 and new regulations, we’re interested to see how these trends play out this year and which new trends will emerge.