After a slowdown in 2020 due to COVID-19, the implant manufacturing market is making a comeback. Elective surgeries are almost back in full swing. As a result, many medical device manufacturers (MDMs) and their contract manufacturers (CMs) are running at full capacity.
"With the improving state of the pandemic, we are seeing electable surgeries coming back into favor," said John Ruggieri, senior vice president of business development for ARCH Medical Solutions, a multi-site U.S.-based provider of precision machining and contract manufacturing for the medical device industry. "The demand for implants is reaching pre-pandemic levels and, in some cases, it is even higher."
Additive manufacturing (AM) continues to capture a lot of attention as new methods and materials enter the market on a steady basis.
"The shift toward additive manufacturing is even more prevalent now than it was five years ago," said Nick Corcoran, vice president of division operations for Stryker, a Kalamazoo, Mich.-based medical technology company that specializes in orthopedic, neurotechnology, and spinal products. "Today, while more traditional subtractive manufacturing is still commonplace, additive manufacturing has become central to the implant manufacturing landscape."
MDMs want to find AM partners that are experienced enough to expertly manufacture innovative designs that traditional methods cannot produce, as well as advise them on material selection, manufacturability and regulatory processes.
"We have been speaking with many companies that continue to look for additional suppliers who have experience with AM for implants," said Brian R. McLaughlin, president and founder of
Amplify Additive, a Scarborough, Maine-based contract designer and manufacturer of additively manufactured titanium implants. "We see an unmet gap in the market for what companies are seeking. The manufacturing market for AM is still extremely fragmented, which is one reason this sector continues to grow."
Even with the ever-expanding popularity of AM, MDMs prefer to use traditional "tried-and-true" methods whenever they can, such as casting, forging, and machining, for parts that do not require the unique structures or geometries that can only be created with AM. Improved capabilities in traditional machining, however, are keeping pace with AM, with better controls and higher precision. In addition to the actual material removal processes--grinding, milling, belting--these capabilities also include integration and automation of secondary operations to reduce the number of "touches" and the opportunities for error, all of which save time and reduce cost.
"Smaller implants that support less-invasive procedures and quicker patient recoveries are also in high demand," added David Francis, general manager of Autocam Medical, a Plymouth, Mass., division of a global contract manufacturer of orthopedic implants, spinal implants, precision instruments, and orthopedic cutting tools. "These devices require more complex machining geometries and tighter tolerancing, which call for higher multiaxis spindle speeds and more precise machining capabilities."
There continues to be a strong focus on AM across the industry. In addition to 3D-printed lattice structures that provide an effective surface for osseointegration, MDMs are also interested in adding coatings to further enhance bone in-growth. Other popular coatings such as anodize, hard coat, chromium coating, tin...