#7 - 6 insights about medical device manufacturing

Growth of the medical device manufacturing industry during the last four decades has been nothing short of remarkable. Since 1980, the industry’s contribution to U.S. GDP has increased from 6% to approximately 16%, and that figure is projected to grow.

Solid growth market

In 2021, medical device manufacturing was a $550 billion industry churning out 500,000 different types of medical products. Sector revenue is anticipated to continue climbing to $700 billion by 2026 and projected to reach $850 billion by 2030. In addition to the industry’s ample headroom for revenue growth, there’s a wide variety of device categories offering manufacturing opportunities.

While there’s no existential threat on the horizon for original equipment manufacturers (OEMs), contract manufacturing by small manufacturing enterprises (SMEs) is a growing trend in the industry, offering SMEs entry into this burgeoning industry. As manufacturers focus efforts on device design, sales, and marketing, SME production is consolidating as a sector, accounting for nearly 90% of medical device production in the U.S.

Avenues for market entry

• As notable as the industry’s expected revenue growth is the wide base and range of products supporting it. Consumable medical products such as plastic syringes and diagnostic kits, cutting-edge machinery such as surgical robots and imaging systems, orthopedic implants, and the packaging and cartons to deliver them are all part of this far-reaching industry. Product categories and examples also include:
• Instruments – Surgical tools, catheters, arthroscopic devices, pacemakers, and stents
• Dental products – Crowns, bridges, retainer bars, and implant screws
• Hospital equipment – Surgical tables, hospital beds, and other furnishings and accessories

Complex consumables

One might think producing large volumes of medical consumables would be a straight-forward, set-it-and-forget-it application. However, turning out mass quantities of single-use products such as pipette tips pose very unique manufacturing challenges.

Annually, some 30 million pipette tips are produced throughout the world. Used in laboratories to measure, transfer, and dispense small amounts of liquid for a variety of scientific and medical procedures, pipette tips come in a variety of standard sizes and are molded of polypropylene under very strict tolerances. Product concentricity, dimensional precision, and surface quality are critical. Surface finishes must have an Ra (roughness average) value of ≤0.1µm to avoid liquid sticking to the part surface to allow precise dosages down to 0.1µL. Accordingly, mold tool quality must be superior for production to meet industry demands while remaining cost effective.

Advanced electrical discharge machining (EDM) die sinking with high-precision smart spark control is particularly suitable for manufacturing pipette tip molds. Tracking and controlling individual sparks in terms of energy and where they occur as delivered by GF Machining Solutions’ iGap intelligent spark creation and management can provide reliable and repeatable production along with significant time, cost, and energy savings.

Minimally invasive surgery

Globally, the market for minimally invasive surgery (MIS) devices such as stents, catheter caps, marker bands, and biopsy cannulas was estimated at $8.6 billion in 2020. It’s expected to expand to more than $23 billion by 2030, creating tremendous growth space for manufacturers. However, many challenges must be addressed within that opportunity.

By nature, minimally invasive devices are minute and delicate, presenting difficult-to-machine characteristics. Complex designs integrated into extremely thin-walled tubes pose workholding and clamping obstacles not encountered in general manufacturing. Additionally, high-tolerance surface finishes must be burr-free, and through-holes drilled with the utmost precision.

Technology designed for and dedicated to cutting tubes for medical applications such as GF Machining Solutions’ Microlution line of laser micromachines gives manufacturers the tools necessary for such demanding production. Femtosecond laser machining provides burr-free surface finishing with no heat-affected zone, reducing post-processing operations. Laser technology also features very high repeatability and uses less consumables than other machining technologies for improved cost efficiency.

Laser texturing for osseointegration

Femtosecond laser technology is also enabling manufacturers to etch surface textures on surgical implants promoting optimal bone-implant fusion, osseointegration. Orthopedic devices include joint reconstruction, spinal fusion devices, and dental, trauma, and spinal implants. The market demand for this sector is expected to grow from $47 billion to $66 billion during the next seven years.

Laser texturing holds several advantages compared to traditional methods of implant manufacturing and texturing that involve physical grit blasting or chemical etching. Laser technology uses a clean, non-contact process without harmful surface residues or contaminants that could pose a significant medical risk. The technology eliminates up to five procedures commonly associated with traditional physical and chemical texturing – including some manual operations. Multiple textures can be imparted to the same implant device with a single setup and no masking is required.

Being fully digital, laser texturing enables manufacturers to completely automate their operations to keep pace with the ever-growing product demand. Unlimited pattern duplication and repetition are possible with no loss of performance or quality. Overall quality control and superior consistency are achieved by eliminating batch-to-batch variations in roughness common to traditional texturing methods.

Leverage expertise for success

Despite significant opportunities in a growth market with strong future demand, manufacturers must still manage costs for the most efficient, sustainable production possible. Price pressures in the medical device manufacturing sector are similar to other industries with costs and expenses continuing to rise.

Using the latest machine tools such as GF Machining Solutions’ EDM and laser texturing and machining technology will provide close-tolerance production of complex and delicate parts with minimal waste and scrap and with repeatability that isn’t overly dependent on operator skill. Optimizing processes and streamlining setup and cycle times are also critical to profitable production.

Many machine tool manufacturers have developed special expertise in medical device manufacturing, working with customers to adapt machines and technology to meet the industry’s challenges. In its Medical Center of Competence in Lincolnshire, Illinois, GF Machining Solutions provides collaborative project support and expertise in high-speed milling, EDM, laser micromachining, and automation that can help manufacturers boost productivity and competitiveness. By leveraging existing industry-specific expertise, manufacturers can simultaneously keep pace with the rapidly expanding medical device industry while shortening their learning curves.

GF Machining Solutions
https://www.gfms.com