Medical Design Briefs: When outsourcing the development of a new medical device or diagnostic, how early should OEM product developers begin working with their outsourcing partner - and why?
Robert Silva, MS: In my experience, early and open collaboration is key. The ideal time to consult with an engineering or manufacturing outsourcing partner is at the concept/breadboard phase, when everyone's full attention can be brought to bear on understanding the scope of the effort and any novel science required, and exposing any design risks. Such early involvement can pay dividends. When every aspect of a project is discussed and agreed upon at the beginning, achievement of customer expectations, regulatory requirements, and market demands can be facilitated.
At KMC Systems, the customer plays a vital role in this collaborative development process. During the concept/breadboard phase, we work with the customer's engineering staff to define product requirements and system risks. These risks are mitigated by the creation of breadboards during the design stages. We continue to work collaboratively with the customer to refine product requirements and ensure the design intent is met.
MDB: How does KMC work with medical product developers to meet design and manufacturing challenges for new devices and diagnostic systems?
Silva: KMC has been in the medical device business for more than 30 years. From this experience we have been able to develop mature processes, including our total product lifecycle model and our approach to manufacturing. Our total product lifecycle model is a staged process that brings onboard all the engineering disciplines - chemical engineering, electrical engineering, mechanical engineering, process engineering, software engineering, systems engineering, and quality control - as early in the process as possible.
We begin by breaking a project into several phases that include concept/breadboard, alpha, beta, manufacturing transfer, and pilot build. Part of the project management planning includes putting together a cross-functional team that encompasses electrical, manufacturing, mechanical, quality, software, and systems engineers. These engineering disciplines, together with project and program managers, define the duration, manpower, and cost of the program.
Early in our design and development process we analyze product features and performance characteristics using simulation tools such as ExtendSim and Matlab/Simulink. We also review system models using SolidWorks. All of this is done to ensure that customer expectations are being met. If there is an area of design that we feel needs independent review, we will consult with industry experts as appropriate. These activities are carried out in collaboration with the customer for full transparency and alignment of expectations.
For instance, when our designs have been completed, the outputs of the design control process must be able to show software- and system-level verification and validation traceability back to the product requirements. Early involvement of the systems engineering team helps to ensure that requirements tracing includes adherence to standards such as ISO 14971 (the risk management standard for medical devices, compiled by the International Organization for Standardization), or IEC 62304 (the medical device software design and development standard, compiled by the International Electrotechnical Commission).
MDB: Technologies are continually changing and advancing. Among the products in KMC's portfolio from the past decade, what design and technology advances do you consider most challenging and important?
Silva: KMC Systems has a large team of engineers who are experts in multiple disciplines and we leverage their vast experience to solve complex challenges. For example, KMC was challenged to design and develop a highly automated and fully integrated blood analyzer with throughput exceeding one sample per minute. The device needed to paint a monolayer of blood cells on a glass slide, stain each cell, analyze cellular morphology, and provide a complete blood count.
KMC conceived and designed the cell counting, smearing, and imaging systems to create a single, integrated instrument. KMC developed the instrument architecture, system electronics, firmware, and mechanical mechanisms, while integrating the optics and image analysis software. To support clinical trials of the device, KMC also performed system integration, and verification and validation testing. The result was a single automated device that is compact, fast, reliable, and precise - and ultimately improves patient care.
MDB: In addition to changes in technology, market and customer needs are also continually evolving. How does KMC Systems remain responsive to such changes?
Silva: KMC is committed to continuous improvement and developing cutting-edge instrumentation. While our primary concern is to meet customer expectations for developing innovative and compliant products, we are also committed to holding down development costs by utilizing technology that improves our productivity.
Because we have many years of laboratory automation experience, we have been able to "standardize" a set of tools that we use in various programs. These tools include configurable robotics that can be modified and adapted to meet the specific needs of multiple programs. We've also developed a proprietary library of motion control tools to drive the robotics, which we call our "Universal Architecture" or UA.
The UA includes hardware that enables us to quickly prototype portions of a product's design, and develop the software that is associated with motion control, sensor, and input/output (I/O) components. By using these tools, we can quickly assess and work through the breadboard phase of design and development, and ultimately reduce our customer's costs.
MDB: What kinds of concerns do the developers of new medical products typically ask about? What do they not ask about - but ought to?
Silva: The questions we encounter typically depend on the developer's level of experience and area of engineering expertise (e.g., electrical, mechanical, software, systems). Less-seasoned developers tend to take a "functions-first" approach, asking for features such as walkaway power, random access assays, or multiplexing, without first establishing the specifications of the product. More-experienced developers approach projects on a broader scale, and are more likely to take a systems perspective, essentially building a product from the ground up, beginning with product specifications, requirements, and risk assessment.
The first set of questions should always involve definition of requirements, assessment of risk, and how to reduce risk through the design process. For example, what are the inputs to the design, and are those inputs defined in a clear, concise, and testable fashion?
MDB: Even seasoned companies can misstep when developing a new product. What kinds of mistakes do you see different companies making all the time during the design and development phase?
Silva: Mistakes are made when the OEMs and their outsourcing partners have poor communication from the start, including poorly defined product specifications, undefined cost expectations, and unclear user requirements. Every customer and every project is different. If there is not clear communication - early and often - expectations may not be met.
From our perspective as a provider of outsourced engineering and manufacturing services, the most important responsibility in the OEM and outsourcing partner relationship is clear communication. Again, this starts with cost and timeline expectations, product specifications and the definition of requirements, and identification of any risks and how they will be mitigated.
MDB:What resources does KMC bring to bear to keep product development on the right course?
Silva: KMC Systems has a core group of seasoned engineers, each with more than 10 years of experience in their individual fields. Their extensive experience has enabled us to structure programs with leads in each of the engineering disciplines. And each of those leads is capable of communicating and collaborating with customers to deliver flexible, scalable designs that meet customer expectations. While this core group of engineers is important, we are always adding to our staff to support customer design needs, and we use the experience of our core staff to mentor new engineering staff.
When coupled with the "plug-and-play" capabilities of our Universal Architecture and library of robotics, the extensive experience of our core staff enables us to be agile and responsive throughout the design process..
MDB: Why is the ability to customize the design of a medical product so important?
Silva: Ultimately, customer needs and market pressures drive the design of new products. These pressures usually take the form of limiting the cost of the product to the end-user. Especially when single-use disposables or consumables are involved, component costs can drive design to the point that off-the-shelf alternatives may not work.
Other market pressures may also implicate specific product features or performance characteristics. If a characteristic such as throughput is considered important from a competitive perspective, the customer may be willing to incur higher development costs in order to achieve the higher throughput that would give them a competitive edge.
MDB: Isn't it more difficult and costly to produce a custom-designed product?
Silva: No. Costs are driven by the complexity of the system being developed, as well as the funding limitations and market pressures that the customer faces - not by custom designs. For example, our Universal Architecture and associated tools for robotics, enable us to quickly produce a motion control design for a specific project with costs equivalent to or less than an off-the-shelf solution.
There have been instances when a customer specified the use of off-the-shelf motion control components, but later realized that they would have had greater design flexibility at equivalent costs if they had used our UA.
Over the years, we have invested the time and effort needed to produce this "library" of functionality and to keep it technically fresh, ensuring that we will always be able to provide viable, contemporary design solutions.
MDB:What about the handoff to manufacturing? Is that more complex with customized devices?
Silva: Setting up a new manufacturing process requires the manufacturer to undertake very specific steps for process verification and validation. The regulatory requirements for those steps remain the same, regardless of whether the manufacturer uses an off-the-shelf solution or a customized design. Since KMC Systems offers total lifecycle management, from concept through production, and our multidisciplinary teams include experts in engineering and manufacturing who collaborate throughout the entire project, we are adept at transitioning to manufacturing.
MDB: How do invention and customization affect the risk profile of a new medical product? Is it easier or harder to implement risk mitigation strategies when working with customized products?
Silva: Invention will lengthen the duration of product development due to inclusion of breadboarding and prototyping activities at the start of a program, ultimately increasing development costs. Additionally, intellectual property restrictions may limit the flexibility that designers have to execute "design-arounds" and resolve technical problems, thereby also increasing the product's risk profile.
Nevertheless, it has been my experience that customization provides designers with the freedom necessary to apply risk mitigation strategies.
MDB: Medical products often have extraordinarily high requirements for quality - in design, manufacturing, and everyday use. How does customization affect a company's quality systems and related regulatory status?
Silva: From a quality systems perspective, a customized design does not change the steps that need to be performed for system and software testing and traceability.
MDB: Is it harder or more time-consuming to bring a customized device to market? Are there market advantages to adopting an approach that makes use of customization?
Silva: The difficulties involved in getting to market usually depend on the complexity of the product and its requirements. A product with complicated requirements might need greater flexibility, making a customized design the best choice. With our Universal Architecture, we have a customized design solution that can be used for simple products, but also offers the flexibility required by more complicated designs. There is a time-to-market advantage for customers who use the UA.
MDB: What new medical technology challenges do you see in KMC's future?
Silva: For a lot of medical device companies, dealing with "Big Data" is an area of challenge. Incorporating into our system designs the ability to interface with hospital and laboratory information systems in a secure fashion will be an ongoing effort. While linking together the systems we design and maintaining an Ethernet backbone for access to data, we will also continue to address the challenges associated with device security. This is an ongoing industry concern for patient security and confidentiality in highly networked, Web-based medical devices of the future.
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