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MICRO employs robotics throughout its manufacturing areas. Image courtesy of MICRO
MICRO employs robotics throughout its manufacturing areas.

CMO ‘Excited’ to Support Medtech’s ‘Technological Explosion’

As MICRO celebrates its 75th anniversary, Brian Semcer, president, discusses medtech trends and changes in manufacturing, regulation, and more.

Contract manufacturer MICRO Inc. is currently celebrating 75 years of manufacturing, with a primary focus on the medical device industry. The company has worked to solve a number of medtech industry challenges over the years, including addressing the unprecedented COVID-19 pandemic. 

MD+DI asked Semcer, a third-generation, 25-year veteran at MICRO, a few questions about changes the company has seen over the years and how the company has prepared for the future.

Can you explain how medical device technology has evolved over the last 75 years?

Semcer: Medical device technology has evolved substantially in the last 75 years; it is really a completely different landscape today versus when we first started out as a company. Technology has advanced the field so much that what is commonplace today did not even seem possible nearly eight decades ago. My grandfather was a toolmaker who founded the company in 1945 in Maplewood, NJ, with four partners, three of whom were also toolmakers. The company quickly gained a reputation for handling challenging precision metal stamping jobs, and my father built upon that tradition by constantly investing in the latest technology—he was an early adopter of Bruderer high-speed presses, computer-aided design, and even Mac computers! Today, the third generation of the family is running a company that my grandfather would barely recognize due to its size, breadth, and complexity. 

Today, medical device manufacturers are using 3D printing technology and integrating robotics to transform surgery and outcomes for patients—advances that would have been unheard of when we started out. Software, nanotechnology, and sensor technology have all profoundly impacted medical device development and patient care. Minimally invasive instruments and computer-enabled surgical tools have significantly changed the surgical landscape, and medical devices are more automated, reproduceable, portable, and often cost less to mass produce. For example, handheld surgical instruments have progressed from rigid, inflexible tools to more intricate sometimes articulating instruments that offer more bend, flex, and reach—and thus more freedom for surgeons who require tools for minimally invasive procedures. 

With these technology-driven advances in medical device technology, surgery and healthcare delivery are more efficient, safer, and outcomes are better for patients. I’m not sure we could have imagined this sort of technological explosion and its impact on the industry 75 years ago, and it has been so exciting to be a part of it.

Manufacturing has evolved over the last 75 years. Can you explain some of the specific changes in medical device contract manufacturing, in terms of manufacturing technology and capability as well as in the business relationships?

Semcer: That is a great point. Improved manufacturing processes and the use of advanced technology, along with advances in engineering techniques and materials, have occurred in parallel. Outsourcing today plays a critical role in the manufacture of medical devices, and contract manufacturers have had to find ways to produce more complex and sophisticated parts and products consistently and efficiently to keep costs down and maximize profitability. The design process also has evolved. We realized over time that we can help customers optimize medical device products for production early in the design phase of a development project, rather than further downstream where correcting a design flaw can be costly. 

We have learned from experience the value of a successful partnership between original equipment manufacturers (OEMs) and contract manufacturing organizations (CMO). We view every project as an opportunity to gain experience and expertise to better serve future customers and grow as a business. It is important to fully understand the needs of the customer and align on engineering capabilities, resources, and manufacturing techniques with the customer early during projects. 

We spend a lot of time upfront with every customer to fully understand their sales, marketing, and distribution strategies because these will impact all development milestones and timelines upfront and impact likelihood of success once a product is launched. It is crucial that an OEM-CMO partnership is based on trust and transparency. This is a vitally important component for success, and we have a long track record to attest for it. 

We cultivate and nurture our customer relationships and believe it is important to be in front of customers as much as possible. Accessibility is essential for our customers, and we understand that for MICRO to succeed, customers have to succeed first. Engineering capabilities and know-how are essential of course, but an unrelenting focus on the customer, which has been our company’s foundation, can really set a CMO apart. We work every day to exceed customer expectations through technical expertise, full-service manufacturing offerings, and an in-depth understanding of the customer’s goals. 

Image courtesy of MICROMICRO's new R&D center, recently dedicated this anniversary year for 75 years of manufacturing


MICRO's new R&D center, recently dedicated this anniversary year.

 

How have regulatory and standards developments changed over the years?

Semcer: Perhaps not surprisingly, regulatory guidance has become much more complex as the technology itself grows in complexity. Regulatory standards have evolved as new products, technologies, systems, and tools have been introduced into the medical device world. Traditionally, the focus was on production controls including procedural requirements, product testing, and demonstrating products satisfied customer and regulatory requirements. Subsequently, a shift occurred with a renewed focus on the upfront design of product and process, giving rise to design controls used to create new products.

Other changes in the medical device industry include the use of some biologics and tissue-based products regulated as medical devices. The introduction of applying pharmaceutical coatings to medical devices gave rise to the combination product industry, and the regulatory standards also evolved to include combination product guidance. Similarly, the use of implantable electronic devices, such as pacemakers and glucose monitoring devices, has had a significant impact on the medical device industry along with associated regulatory requirements.

As the marketplace has expanded globally, regulations also have added complexity, and there is a lot of variability in market-specific requirements. Contract manufacturers today need to satisfy regulations from any country where they sell product. While there have been efforts to harmonize some standards globally, differences remain and will take time to resolve. The challenge in the meantime is to remain abreast of global regulations and have quality/compliance systems in place that operate according to industry best practices. Safety and quality control standards have always been a large facet of manufacturing. OEMs today are much more resource heavy when it comes to safety standards because of the expansion and complexity of the marketplace, much of it driven by technology.

Your company mentions your environmentally controlled Class 8 cleanroom. Has medical device manufacturing become more stringent over the years? Do you anticipate further controls?

Semcer: The industry has seen a significant shift in cleanrooms and other controlled environments over the last several decades, in large part due to a growing demand for off-the-shelf sterile products. Sterilization processes—including standards for designing and validating controlled environments—have had to evolve as devices have become more technologically sophisticated and complex. Regulatory requirements around this have also expanded over the years as the need for stringent operations to address infection control have increased. This can be seen in tighter particulate standards for various cleanroom classes over the years.

Manufacturers must comply with U.S. FDA and ISO guidance to establish training and environmental monitoring programs and other industry best practices. The regulations change and evolve over time and with advances in processes, technology, and materials. Regulations also vary by country. We maintain an ISO Class 8 cleanroom staffed by highly trained technicians using state-of-the-art production equipment. I imagine controls will continue to evolve to meet the demands of the marketplace and regulatory standards as environmental monitoring and control technologies increase in capability and accuracy for cleanrooms and other controlled environments. 

You also mention optimizing products for production, keeping costs manageable, and maximizing return on investment. Can you explain how these needs have evolved?

Semcer: We have evolved the way we serve our customers as the medical device marketplace evolves to address the needs of patients, cost efficiencies, tight deadlines, product volume and material selection, while ensuring patient safety and optimal outcomes for patients. It is critical to drive efficiencies and improve processes across operations and the business to optimize cycle times and manage costs. When we started out, we had a much more specialized focus. 

Over time the business evolved to become a full-service CMO exceling in prototyping and validation to full-scale production with the use of modern manufacturing techniques and innovative engineering solutions to ensure the consistent development and delivery of high-quality products that have value in the marketplace. 

When companies strive to save costs, value can be misunderstood. It is not always about the lowest price. Instead, it means producing the most cost-effective and efficient product that will be profitable while meeting customer and FDA requirements. Successful partnerships between contract manufacturers and medical device companies will help ensure that quality and value in product development and production are fully realized. 

Has the medical device market become more global? If so, how has this influenced MICRO’s evolution?

Semcer: Absolutely—the medical device industry is a global market today. This was not always the case, certainly not in our early days in business, but the industry, like most industries now, operates globally. While we do have some strategic partnerships overseas and ship globally to our customers, the vast majority of our materials continue to be sourced in the U.S. We have built close relationships with many of our suppliers and do believe it helps us maintain quality and shorten our supply chain. 

What are some of the current challenges facing medical device companies, and how is MICRO helping to address them?

Semcer: Medical device companies today face significant competition with many players in the space advancing innovation to help patients and providers. There is a lot of pressure to optimize cycle times and reduce costs, and speed to market is critical for manufacturers. Seamlessly integrating quality and compliance requirements into daily operations to deliver best in class manufacturing processes is a challenge we recognize and embrace. In a customer-centric bottom-line market, competition and market forces require a high degree of speed and agility in manufacturing. 

A successful commercial project is usually considered one that achieves long-term market presence and profitability as defined by the OEM and the industry as a whole. We address these challenges by helping our customers get their products to market faster, while meeting quality requirements. Design for manufacturability expertise helps meet cost targets, while reducing the need for our customers to maintain costly manufacturing, finishing, and assembly operations. Logistical support helps reduce finished good and component inventories on their end. Each partner can focus on core competencies and maintain lean head count, facilities, and equipment. It is truly a win-win if done correctly.

Like any company operating today, MICRO is navigating the unprecedented COVID-19 pandemic. A big challenge is not being able to meet in person with customers, which is so important to how we conduct business. We and the industry as a whole are rallying around new ways to meet customer and patient needs. The support and camaraderie have been tremendous. 

You mention investing in new technology. Can you explain that in detail?

Semcer: Technology investments are essential for any CMO looking to stay competitive. There is no way around that. Companies need to be technologically savvy to meet customers’ ever-changing needs and provide the right solutions. To be a successful innovator, we need to meet customer needs with advanced technology and engineering know-how while accelerating new frontiers in manufacturing in machine learning, predictive quality, and maintenance, so we can create new and better solutions for customers. We need to make sure our systems and capabilities continually improve to prepare for future growth.

You mention offering “career growth to graduates of top engineering programs as well as high school graduates who elect not to pursue a college degree but want to learn a trade.”  Can you explain how manufacturing and engineering jobs have changed and will continue to change?

Semcer: As a full-service contract manufacturer, we attract engineers from top schools, but we also believe in training and development and we see talent everywhere. MICRO is a family-owned and run company and we always have been. Our commitment to employees, their growth, and development is engrained in the culture and we believe results in a highly motivated, valued and productive workforce. Everyone has an opportunity to be involved and to elevate their position within MICRO. 

At the heart of our company's growth and success are our employees, who we consider family. We are deeply committed to their development, which reflects our core values. Therefore, we routinely invest in our employees through competitive compensation, benefits, and on-the-job training, while our culture allows us to attract and retain top talent. With continued success, MICRO provides opportunities and career growth to graduates of top engineering programs as well as high school graduates who elect not to pursue a college degree but want to learn a trade.

Quality, safety, and innovation remain the cornerstones in manufacturing and engineering as customer needs are constantly changing in response to market demands. Newer approaches and methods are needed to support these rising challenges. For example, automation, which has been around for decades, has rapidly become more affordable and flexible. This allows companies like ours to dramatically increase our efficiencies. It should be noted that these more modern systems are designed in many cases to work well together with human workers. Robots are not designed to replace workers but rather for them to work synergistically. These systems also require highly skilled workers to design, install, and maintain them. In essence, these approaches are making manufacturing workers much more valuable.

Have there been any lessons learned over the years that have prepared you for the next 75 years?

Semcer: MICRO has seen many changes in its history and has experienced both challenges and victories. Our company started off making parts for the vacuum tube industry, which we sold to IBM, RCA, Western Electric, Sylvania, GE, and others. Vacuum tubes amplified electric signals and were a critical component of technology for the first half of the 20th century. We have evolved as technology has evolved and have directed our resources toward supporting the development and manufacture of critical-to-care devices for the healthcare industry. We are operating nimbly in light of the COVID-19 global health crisis, which no one certainly could have predicted. MICRO is weathering the storm as a company and we have managed to meet all of our customers’ needs during this difficult time. If there is a recipe for longevity in contract manufacturing, it might be this: Equal parts customer relationships, technical expertise, good people, a deep knowledge base, and processes that continually improve over time. We have always been resilient and believe that asset will be called upon as we head into the next 75 years, fulfilling our Vision: “To Help Our Customers Save Lives.”

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