Posted by Sean Jellison on Fri, Jan 27, 2012 @ 03:17 PM
Do you struggle with determining when is the right time to involve a medical device contract manufacturer ?
This can be the most important decision in determining whether your product meets all your manufacturing goals and is released to market on time. Ron Jellison, KMC Systems' VP of Business Development, spoke at the 4th Annual MPO Symposium in 2011 to the importance of how to get the medical device contract manufacturer (CM) involved at the right time.
"We've been involved as early on as the time the OEM selected the designer where they also made the determination of who the manufacturer was going to be.." Jellison said. He went on to say while this is not the most common model, it can be very effective. This allows the manufacturer to be involved in the design reviews and give input into the design of the product. This makes sure that once the product has been transitioned to manufacturing, the product easily fits the manufacturing and testing capabilities for a smooth production and product launch.
Jellison also touched on a more common scenario; "The most common model is where the CM is selected prior to the completion of the development process. For example, you may have an engineering prototype build, then you may be doing another interim build prior to a release to manufacturing, where you involve a CM. This has been a successful model that has worked for us as well."
"The thing you have to remember is that when you outsource to a contract manufacturer you are going to be using the CM's suppliers. That's one of the benefits that the CM brings, is that [supply chain] management. You're better off involving the CM's supplier base during product development while you still have access to the design team ... now you get your first look at fabricated parts coming of the design drawings, and the ability to evaluate whether the design intent has been successfully transferred before you commit to production."
Jellison also spoke to the importance of relationship building and the need for honest, open communication not only to build trust but to truly understand the customer's needs. He gave examples of the way a CM adds value for two different types of customers needs.
1) A start up company that is looking to develop their product and transition to manufacturing is the first type of customer. In most cases, the start up is looking to leverage the CM's FDA audited quality processes as well their design, manufacturing and supply chain management capabilities.
2) An established OEM could be looking to enter the Total Product Life Cycle at any phase needing design or manufacturing services or both. “As far as the OEM goes,” Jellison stated “their going to look to see how they map to your processes ... it all comes down to terminology and how our terms match to their terms. They pretty much want to see how you match to their overall quality system.” The value to an OEM is to find a CM that can be a seamless extension of their own internal organization with the ability to offload their non core related tasks to a CM. Thus, freeing up internal OEM resources to focus on their core competencies.
Watch the final two parts of our MPO Video Series to learn more about WHEN to get a CM involved, and HOW to build and maintain the relationship between OEM and CM.
Posted by Bob Evans on Tue, Nov 22, 2011 @ 02:39 PM
Have you ever thought about how a medical device manufacturer would vet a business opportunity?
Vetting a business opportunity is a critical first step in building a relationship between an OEM and a Supplier.
In the October issue of MPO, a feature article written by Jim Stommen entitled "Let the Vetting Begin" offers insight to the early interactions of an OEM and a supplier as they both evaluate the business partnering relationship. This topic was also discussed recently at the 4th Annual MPO Symposium during the "Building the Bridge Between OEM Design and Outsourced Manufacturing" panel session.
Ron Jellison, Executive Director of Business Development for KMC Systems was one of the panelists that offered insight to the vetting process used at KMC Systems, Inc.
"When evaluating a large OEM business opportunity we look at the types of products in their portfolio, the competition in their industry, their product sales/distribution channel, and the alignment of our quality system to theirs. For a start-up company, having confidence with the management team and their technical, financial and schedule objectives is an essential foundation for a successful business partnering relationship. " stated Jellison.
"Determining the state of the product design is a critical element in understanding what services a CM should offer to provide a smooth transition to manufacturing. A thorough review of the drawing/documentation package is a minimum requirement," advised Jellison.
Jellison commented further that it is not uncommon for a customer to think that they are closer to production then they really are. Because KMC Systems offers both product development and manufacturing services and have transitioned many products from both external and internal development teams, we have the expertise and experience to accurately assess where a product is in the Total Product Life Cycle. This allows us to offer only the needed services for a product design transition to manufacturing project.
Watch the video captured at the MPO Symposium to learn more about the CM perspective of vetting a business opportunity as the first step to a successful OEM - Supplier relationship.
Posted by Bob Evans on Tue, Nov 08, 2011 @ 10:02 AM
At the 4th Annual MPO Symposium hosted by Medical Product Outsourcing (MPO) medical device manufacturers, regulatory, business development, and strategists gathered to discuss and share knowledge and explore outsourcing strategies for improved outcomes.
The "Building the Bridge Between OEM Design and Outsourced Manufacturing" session was staffed with an impressive panel of representatives and moderated by Ben Dunn, Managing Director of Covington Associates. Some sage advice was offered by one of the panelists, Ron Jellison, Executive Director of Business Development for KMC Systems, Inc. for how to select a medical device manufacturing partner.
Ron identified three key areas to focus on when considering a medical device outsourced manufacturing partner during the product design phase:
1) Seek medical device manufacturing partners with relevant experience in the technologies offered in your product. Medical device manufacturers that have the pertinent technical knowledge and expertise will likely have the complimentary manufacturing techniques and proven processes.
2) Understand the pricing models that will be used for the finished good cost of your product. Medical device manufacturers can provide pricing models for finished goods before they know what the raw material or labor costs will be. A formula based pricing model can be used to understand the expected finished good cost while the product is being designed utilizing targeted material and assembly/test labor estimates.
3) Assess the quality system of the manufacturer. Many times large OEM's will perform an audit of an outsourced manufacturer to be sure that there is a quality systems alignment. In the case of a start-up OEM, the fact that an outsourced manufacturer can provide a certified quality system can be an asset.
Posted by Bob Evans on Wed, Oct 12, 2011 @ 03:47 PM
Successful medical product design follows a proven process that complies with the applicable regulatory standards. ISO 13485 requires that a comprehensive management system be established and maintained to monitor and control/mitigate risks from product inception through design transfer and into production, referred to by the FDA as Total Product Life Cycle (TPLC). There are various stage gate reviews during the TPLC with the Manufacturing Readiness Review being the final gate for the design transfer to production.
At the point of design transfer to a manufacturing/production environment, many if not all of the identified risks will have been eliminated or mitigated (i.e. by design, process control, labeling). The design history file is complete with supportive verification testing data and the documentation to procure, fabricate, tool, build, and test has been released in support of a production lot build. But ... are you ready ?
A manufacturing readiness review is a key tool of a proven process that provides the insight to determine whether the output of the design process coupled with the manufacturing, supply chain, and quality team preparedness meet all the requirements to move to a production manufacturing environment.
Moving through this gate without completing all the elements could cause costly engineering changes, rework and product recalls in the future. Moving too slowly through this gate could cause product launch delays and potentional erosion of market share. This is why a well planned and executed product development process with meaningful product design stage gates/reviews which culminate in a manufacturing readiness review lead to a smooth design transfer to production.
Come to the MPO Symposium 2011 in Waltham, MA on the 19th of October and talk with Ron Jellison, KMC Systems VP of Business Development, about your Manufacturing Readiness Review. Ron will be leading a roundtable discussion at lunch and participating as a panelist in the "Building the bridge between OEM design and outsourced manufacturing."
Posted by Sean Jellison on Thu, Aug 18, 2011 @ 03:52 PM
KMC Systems will be attending the Next Generation DX Summit in Washington DC from August 23-25.
Not only can you stop by our booth, Booth #5, for any questions, but we will be presenting as well!
On Thursday August 25, Jack Kessler PhD., one of our Sr. Systems Engineers, will be presenting on how to reduce risk earlier in IVD instrument development programs.
Click to enlarge image
As we all know there are varying degrees of risk within any IVD instrument development program. Using a reliable risk assessment tool can reduce risk early by:
- Exposing concealed requirements, design conflicts, and technical risks.
- Providing a platform to resolve issues, revise concepts, and make informed trade-offs.
- Raising project issues before development and capital commitments are made.
- Exposing conflicted marketing requirements.
- Discovering design shortcomings allowing in future concept design optimization for subsequent development phases.
Using simulation between the business case analysis and the completion of the instrument concept can reduce multifaceted risks in an IVD instrument development program.
Visit us to hear more about reducing risks in product development, and our KMC360 suite of services for medical device design and development, manufacturing, and field support.
See you in DC!
Posted by Bob Evans on Wed, Jun 01, 2011 @ 03:45 PM
Rapid product development offers an inherent competitive advantage in the field of medical instruments. There are a number of different strategies that have been utilized in order to achieve results in a minimal amount of time with varying levels of success. 
Over time, one thing has become clear. In order to streamline the entire process of developing medical instruments, a holistic approach is critical. In particular a holistic approach with focus on technologies, processes, healthcare management and people. Here is a closer look at some strategies for successful medical instrument rapid product development and how a holistic approach can address them.
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When the ultimate desire is speed, one strategy is to leverage appropriate off the shelf technologies that will not only reduce the amount of development time needed , but will also have the product features that meets the needs of the end user at a value perceived price point.
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The second strategy is to employ processes that provide a balanced quality system approach. If you attempt to bring a medical instrument to market and it doesn't comply with FDA or regulatory requirements then a rapid approach has no value. The key to meeting this requirement is by utilizing quality processes that are firm enough to meet any applicable regulatory requirement and standards, but also flexible enough to allow for the appropriate levels of control throughout each phase of development.
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The third leg of the stool is the resources that make it all happen. Today people from a variety of educational backgrounds and experiences and many times from different geographic locations are assembled to work collaboratively. Communication and the tools that facilitate good communication are vital to success. Product development team documentation and communication needs to be integrated for efficiency and also provide an inherent structure for compliance with the required quality processes.
All three of these components are vital to the successful rapid product development of medical instruments and more importantly, they must all work together cohesively.
Developing medical instruments is a complex process. If you are going to be competitive in bringing new products to the medical marketplace then paying attention to the holistic integration of technology, processes, and people will provide the opportunity to achieve the RAPID that everyone desires.
Posted by Bob Evans on Fri, Feb 25, 2011 @ 09:28 AM
Let's Talk About It!
What are you doing on March 7th and 8th ?
Hopefully you'll be taking advantage of the plethora of discussion topics and industry networking at the MedDevice Summit in Boston.
KMC Systems Inc. is a sponsor of MedDevice Summit and more importantly we are bringing some of our talented engineers to present as well.
We will be presenting and discussing two topics that will surely be of interest to you:
Simulation as a Tool in Feature/Function Tradeoffs for Medical Instrument Product Design
- Discuss Concept Architecture validation for a given set of features/functions
- Hear about rational design concepts which reduce risk in product development costs and schedule
- Ability to evaluate and optimize key marketing product features and yield a feasible Product Requirement Document
Adapting a Quality System to Include Usability
- What's the Goal?
- Why is Usability Important?
- The Usability Engineering Process (UEP)
- The Usability Engineering File (UEF)
- Integration into a QMS
- Planning
- Execution/Interaction
It's not to late to join us and engage with the rest of your peers on these timely topics.
We hope to see you there !
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Posted by Bob Evans on Thu, Jan 20, 2011 @ 10:45 AM
Successful medical product design transition to manufacturing requires attention to detail to avoid unnecessary costs and schedule delays. Here are several tips and techniques to smooth medical product design transition to manufacturing and ensure products are delivered to market on time and on budget.
1) Start the transition process early
The first and perhaps most important tip to smooth the transition from design to manufacturing is to start early. Making changes to the product design once the hand off to manufacturing has occurred will only create additional costs and time delays.
2) Assemble cross functional teams
Members of these teams must bring to bear a broad knowledge base. Combining their diverse skill sets and areas of expertise enables a holistic approach to device manufacturing and the regulatory approval process. Together, they devise well-defined goals and objectives for each phase of development that minimize manufacturing obstacles and ensure devices and instrumentation adhere to U.S. Food and Drug Administration (FDA) and European Union (EU) regulations.
Cross-functional team members working closely together to review product requirements, address technical risks and manage instrument costs reduce development cycles to shorten time to market. By assembling the cross functional experts early ensures that manufacturability, serviceability, reliability, and supply chain issues are dealt with before the product is in production.
3) Rely on proven processes
For a smooth handoff to manufacturing, planning for transition must begin in the product development stage well before the software and system verification and validation efforts have been completed.
A manufacturing test plan and detailed test specifications defining acceptance criteria for system level testing, sub-assembly testing, and spare part testing is essential for a successful transition to manufacturing.
4) Implement staged reviews
Continual checkpoints/reviews should be held throughout the product design and development process. Specification/concept, prototype design, critical design, pilot production readiness and manufacturing readiness reviews should be conducted at a minimum.
The readiness of a product design to begin transition to manufacturing can be determined with a pilot production readiness review . This review records that all appropriate design and program activities at this point in the development process have been completed satisfactorily. The review will provide the confirmation that the manufacturing team has all the necessary tools, processes, and documentation in place for the pilot production build.
5) Train the manufacturing team
For a seamless and speedy manufacturing ramp-up, begin the training and knowledge transfer to the production team during product development phase. Engage the manufacturing team to create detailed assembly instructions when the design matures state. This activity provides an environment for knowledge transfer. It also allows early intervention for the manufacturing team to identify opportnities for improved assembly and test efficiencies.
