KMC Systems, Inc. is dedicated to protecting and saving lives through advancing health care technologies that help people on more personal and customizable levels. Working closely with OEMs and start-ups, KMC Systems continually pioneers innovative solutions to meet the increased medical device design and manufacturing market demand.
As a result of these emerging trends, KMC Systems develops medical instrumentation to meet FDA requirements by creating value-added proprietary technical solutions, and utilizing custom automation increasingly in medical instrumentation development.
Healthcare Technology Trends
KMC is seeing emerging opportunities within some types of clinical laboratories. “Centralized hospital labs have seen a lot of attention these past 10 years, but there are certain clinical labs which are not very automated, an area where we see the need to help our OEMs develop more automated systems,” explained Walter Gilde, business development manager at KMC. Specifically, Gilde noted three markets that have much potential for additional automation:
Flow cytometry, which is a laser-based biophysical technology routinely used in the diagnosis of health disorders, especially blood cancers. It is also used in other applications in basic research, clinical practice and clinical trials.
Anatomic pathology, a medical specialty concerned with the diagnosis of a disease based on gross, microscopic, chemical, immunologic and molecular examination of organs, tissues and whole bodies (versus clinical pathology, which is diagnosis of disease through laboratory analysis of bodily fluids and/or tissues).
Microbiology, which typically involves a very manual process of culturing micro-organisms from clinical specimens to isolate, identify and determine drug susceptibility of pathogenic bacteria.
“We have one customer, a major player in microbiology, for which KMC provided medical instrument development services to automate the preparation of a bacterial culture used to test for bacterial identification and drug susceptibility,” Gilde said. “This type of instrumentation is helping to reduce the hands-on time of a technician, and produces consistency and repeatability of results that a technician alone cannot match.”
Gilde also predicts the market will continue to expand within the more recent point-of-care (POC) trend of bringing more diagnostic testing closer to patients versus in hospital laboratories, particularly now that the latest technologies and software developments have helped produce lab quality results. These POC products have different design requirements. For one, they need to be smaller as they cannot take up the same space as the larger systems used in hospitals. Secondly, they typically do not run the same volume of tests as diagnostic testing equipment used in clinical settings. Usually, they analyze one, two or three samples at a time, Gilde said.
Two other new medical product development possibilities are evolving around these health care changes:
1. Newer advances in pharmaceutical development are requiring diagnostics to determine if a drug is suitable for a patient.
2. New breakthroughs are occurring in next generation sequencing for DNA to personalize and improved the outcome of therapeutic treatment for patients.
Medical Device Regulatory Trends
Another area creating new medical device marketing needs is the heightened FDA requirements for user interfaces, particularly usability studies and user validation documentation to accompany regulatory submissions. FDA added this additional requirement to decrease the risk of user mistakes from medical device software being too complex.
As a result of these new standards have reintroduced the science of “User Research.” The science of human factors and usability has finally found it’s recognized place in the medical device industry. All great products have utilized these methods in the past as a way of understanding the user needs and addressing them the first time. Apple products are great examples of sound implementation of these principles. “The FDA has now mandated usability files be included in product submissions,” Gilde explained. “It’s an important to ensure that a manufacturer has followed the process to analyze, specify, design, verify and validate usability, as it relates to safety of a medical device. OEMs who are typically only working on two to three products per year, don’t want to spend the time adding those skills to their team so those services are commonly outsourced.”
Medical Design and Manufacturing Partnering
KMC, in working closely as a partner to its OEMs and start-ups, is also responding diligently to the increase demand for speeding medical devices to market. KMC and its customers are engaged in meaningful and frequent communication to prevent product schedule delays or technical development issues. Both KMC and its partner OEMs each have a core team within their companies that consists of a program manager who oversees technical, quality, financing and scheduling responsibilities.
KMC also recognizes that there are differing needs for start-ups. Many times funded start-up companies with a slick technology emerging from academia have a need to be educated on the medical device product development process.
“Being in a research lab is dissimilar to some of the rigors medical product development,” Gilde explained. “We, therefore, need to manage their expectations a little more closely. Sometimes they don’t understand why things take as long as they do, particularly in the area of requirements and documentation. We make sure there are no ambiguities in what we are doing, and maintain tight communications throughout the development process. Yet, once we show them our plan of tasks and requirements, detailed schedules and a timeframe, and set up their expectations, the medical product development process goes pretty smoothly.”
KMC’s Turn-Key Capabilities
“Our differentiation as a medical design and manufacturing service provider is that KMC has a turn-key capability,” Gilde stressed. “There is no aspect of the medical product life cycle that we can’t address. We have experience and capability in all phases of medical product development and we get involved upfront when customers are still tying down the feasibility of technology.”
By understanding how to ask questions, KMC interfaces to get “voice of customer inputs” to create a well-defined product development document—a comprehensive way of linking all the steps from concept to design to prototype to the verification process leading to manufacturing.
An added component in meeting new market trends to support its OEMs and start-up customers is that KMC is now developing its own reusable technologies. “We consider ourselves partners in medical technology development,” Gilde said. “So, when an OEM, for example, comes to us, we are taking these common cost-efficient technologies needed in the marketplace and applying them to the customer’s medical product requirements, saving both time and money.”
Medical Device Manufacturing Trends
Additionally, KMC is using state-of-the-art tools for creating assembly and test work instructions from CAD files to facilitate the manufacturing design process and educate the customer.
KMC also has developed a home-grown manufacturing execution system (MES), which is an integrated suite of databases that allows manufacturing, quality, and materials supply chain team members to manage and control the medical device manufacturing process.
Taking into account the new trends for 2013 and beyond, particularly all the demand for In Vitro Diagnostics, Gilde concluded: “IVD medical instrumentation is an exciting market with real health benefits, which we’re increasingly bringing to more people. KMC is proud to be part of helping bring such important medical instrumentation to market.”