Personalized Human Implant Component
A case study in personalized manufacturing
Micron Products, Inc. was approached by a start-up orthopedic implant company with a novel idea for patient- specific implants – an interesting and disruptive new business model. Their goal was to manufacture patient-specific, personalized large joint implants, each one uniquely different from the next. The implants would be designed to the exact geometry of a patient’s unique bone anatomy. The challenge to Micron was to manufacture the parts quickly, repeatedly, and reliably, yet tailored to each patient’s unique geometry.
According to Micron’s Vice President of Business Development, Daniel White, Micron was a natural choice due to its experience in RP castings, forgings and production machining. “Our company’s culture is deeply engrained with the concepts of lean manufacturing and single-piece flow, which were a perfect fit for the development and manufacturing of a knee system that needed to be a perfect fit for each new patient,” he said.
Using “mass customization” techniques and innovative process engineering, Micron was able provide speed, agility, and quality at a price that can compete with mass-produced items. Micron also manufactures mass-produced orthopedic implant components with the same quality, speed, and efficiency as one might expect from an expert in lean manufacturing. “Customers expect perfect quality, short lead times at a competitive price, but sometimes find it difficult to find a supplier who can provide all three at the same time”, said White.
Micron’s engineering and manufacturing capabilities are uniquely suited to those companies who require an agile company with great quality, price and service. Today, Micron’s customer is a formidable contender in the orthopedic implant market with an excellent array of products. To contact Micron about your unique manufacturing challenges, please email us at email@example.com.
The Blunt Impact Projectile: When it really is about Rocket Science
A case study in a “less lethal” blunt impact projectile
A few years ago, Security Devices International (SDI) approached Micron Products, Inc. with a very unusual project. SDI had heard of Micron’s innovative engineering and manufacturing expertise in plastic injection molding, machining, and coating and was very interested in learning how quickly Micron could help them commercialize an entirely new genre of ammunition.
Security Devices International (SDI) had acquired the patents for a new “less lethal” type of ammunition that could be used by the military, law enforcement, and corrections to reduce the chances of serious injury or death, while delivering a pain penalty sufficient for compliance. At the time, SDI only had a few prototypes and drawings and Micron had no experience in the manufacture of ammunition.
“Within a few weeks, our engineers built a 40 mm grenade launcher actuated by air,” said Salvatore Emma, Jr., Micron’s President and CEO, who at the time was VP of Operations. “We couldn’t simply go out and purchase a grenade launcher off the shelf, so we had to improvise. We purchased a grenade launcher barrel and constructed a very high-tech air gun until we could get our hands on the real thing. Our engineers were on a mission to bring a superior product to market as quickly as possible for our customer.”
Within a few weeks, Micron obtained the necessary Federal Firearms and ITAR licensing and equipment and developed a deep understanding of the challenges to build a very complex assembly that could survive an explosive launch and still mechanically operate at terminal velocity and terminal impact.
The result was SDI’s Blunt Impact Projectile. The Projectile is launched from a military style 40 mm grenade launcher. It expands upon impact, which protects the target from serious injury while delivering the kinetic energy needed to inflict enough pain to get the target’s attention.
“It wasn’t easy, but our engineers had to dive into all aspects of internal and external ballistics, ammunition construction, and experimentation with propellants, materials, velocities, and trajectories – while designing for manufacture of a cost effective assembly. We built the injection molds, molded the components, and assembled the silicone, and EPS materials as well as the casings and brass components. We also had to develop waterproof coating methods and make sure that not only did the product fire and fly accurately and reliably, but that it could survive the rigorous environmental testing of the military,” said Emma. The results were remarkable. Micron was able to manufacture a complete assembly – something that was just an idea just a few weeks earlier.
Today, SDI’s 40 mm blunt impact munitions are among the most accurate and safest in the industry and SDI is known for having the most innovative and effective 40mm less lethal product on the market. Many different variants have since been developed by Micron for SDI, including a payload that can carry Oleoresin Capsicum (pepper), maloderant, marking liquid, and even a DNA round used for forensic investigation. To contact Micron about your unique manufacturing challenges, please email us at firstname.lastname@example.org.
Reaping the Rewards of Innovation with an Agile Company
Nimble, Fast, Strong and Personal: The Case for Contract Manufacturing for Orthopedic Implants
A white paper by Salvatore Emma, Jr., President and CEO of Micron Products, Inc.
In the multi-billion dollar market of orthopedic implant components, there are handful of large companies spending billions of dollars in research, development, and design. According to the most recent data from the Centers for Disease Control and Prevention, there were 719,000 total knee replacement surgeries in the US at an estimated average cost of $45,000 per surgery. (Control, 2010)
While the major orthopedic implant OEMs have great designs and excellent products, it sometimes takes many years to get an idea from concept to mass production. These large companies often find themselves stuck in the quagmire of long development cycles and change management bureaucracy, where it is often difficult to navigate the maze of legacy processes and controls. In the fast-paced and cost-competitive arena of orthopedic implant components, manufacturing agility is an elusive but critical element of success.
After a patient receives a knee implant, he or she finds a renewed agility. The patient is nimble again and also fast and strong. In larger corporations too many rules, regulations, procedures, and protocols can be a death knell. In order for large medical device OEMs to find their agility, they need the fresh thinking and nimble innovation of a contract manufacturer. Smaller contract manufacturers understand creativity, speed, innovation and urgency. Decisions are easier when there are just a critical few stakeholders among whom strong personal relationships have been forged in the spirit of strategic partnership and mutual cooperation.
In order to be agile, one needs to first be “Lean.” Most companies like to talk about their Lean Manufacturing efforts but view “Lean Manufacturing” as the destination rather than only one step on the journey toward being agile. Japanese Lean manufacturing concepts drive out waste in the form of motion, time, inventory and defects, and often there is an implied rigidity and structure behind incremental improvement. What Lean is to efficient production and operations, agility is to innovation and a customer-centric solution.
Rapid innovation and reduction of time-to-market are imperative if medical device OEMs are to compete globally. Global market pressure and shrinking reimbursements are driving costs lower. One way OEMs are reducing costs is by engaging contract manufacturers. OEMs can focus on what they do best – research, development and product design, while leaving the specialized processes of manufacturing to smaller, agile manufacturers. When an OEM and CMO truly collaborate, the partnership will make each company stronger and provide for cost savings opportunities and easily scalable growth.
Delight and Enrich the Customer
In an Agile Company, “lean” is second nature, knowledge is nurtured, decisions are distributed, bureaucracy is eliminated, and innovation is instinctive. Management views their role as the provider of the resources that talented personnel need. Agile companies have an entrepreneurial spirit and there is a culture of mutual responsibility for collaborative success from OEM to CMO and into the supply chain.
Recently, a start-up surgical device company came to us with a timeline of weeks – not months or years – to be in full-scale production of a uni-compartmental knee system. Our engineers, quality group, machinists, and production personnel came together with the casting supplier, sterilization and packaging company to develop a cost-effective system for providing a solution to meet the customer’s time constraints. Within weeks, the customer had validation protocols along with a manufacturing process and solid supply chain to meet their milestones. It is this kind of speed, cooperation, and penchant for relationship building that sets agile companies apart.
Cooperation internally and a focus on speed and customer satisfaction is a top priority of agile companies. The objective is to bring quality products to market as rapidly as possible, at the right price. The required competencies in human capital and fulfillment systems are found and used, wherever they exist, inside or outside the organization.
Sell Solutions, Not Implants
The products of an agile company are the solutions that they provide to customers’ problems. Pricing a product can be based on the value of the solution to the customer, rather than on manufacturing costs. Agile applies to more than simply manufacturing and shipping products, it involves engaging the entire organization and supplier partners. From Finance, Procurement, and Engineering to Quality, Production, and Sales, it is about the way the firm treats its people – partnerships – to serve its customers.
Learning to be Agile
The key enablers of agile companies include:
Each customer and product presents a unique set of requirements and challenges to the Agile Company. Agile companies must first work to understand the key drivers of success for its customers and these become the priority and focus of the suppliers. Mutually assured success comes from great communication. An orthopedic implant company approached us at Micron Products, Inc.with a business model for patient-specific implants.
We built a cooperative service model to fulfill the customer’s need for speed, price, and quality by dedicating an entire production line to the customer’s patient-specific product line. Everything from customer service, through programming, production, quality, and fulfillment were dedicated to the customer’s product. Although each implant was of a different geometry, we treated every single piece – each with its own serial number – the same, with a one-piece flow, and customized service. Micron’s production operation became a virtual manufacturing facility for the customer and was designed from scratch to fulfill unique orders in only days.
The Future for Contract Manufacturing
More and more, orthopedic implants are becoming commoditized. It is more difficult for medical device OEMs to differentiate and there is constantly mounting pressure to provide lower cost components. Contract manufacturers are the perfect solution to help large companies facing complex priorities become quick and nimble once again.
Micron Products, Inc., a wholly-owned subsidiary of Arrhythmia Research Technologies, Inc., (NYSE MKT: HRT) has been supplying the medical industry with world-class quality medical components since 1978. Located outside of Boston, Micron Products Inc. is a contract manufacturer offering product design, research, engineering and quality control services in collaboration with a wide variety of medical device companies, including orthopedic implant OEMs, to foster innovation, reduce costs and shorten production cycles.
Control, C. f. (2010). CDC Faststats. Retrieved from http://www.cdc.gov/nchs/fastats/inpatient-surgery.htm