Sean Fenske, Editor12.30.15
In entering 2016, MPO decided to reach out to several medical device contract manufacturers to get their temperature on the industry, what makes them unique within it, and how current trends are impacting them. The first of these Q&A sessions is with Mike Kanis, sales engineer at Proven Process Medical Devices. The company is a contract manufacturer for Class II and Class III medical devices, offering services from design through to postmarket offerings.
Kanis touches on an array of issues, from addressing miniaturization and portability in design to ensuring quality. He also addresses several questions involved with selecting the best partner with which to embark on a medical device project with.
Sean Fenske: In such a competitive industry as medical device contract manufacturing, what makes you different from the competition?
Mike Kanis: At Proven Process, we provide fully integrated contract manufacturing services for complex medical devices. With our pilot manufacturing process, we research designs and processes to incorporate iterative improvements early in product development. Our on-site talent and resources ensure the best possible strategy before our clients commit to major capital equipment expenditures.
Fenske: How do you best leverage this to stand out to potential customers?
Kanis: Our pilot manufacturing is a critical step. Through continuous refinement and validation, we ensure that our client’s medical device will seamlessly transition to full-scale production. We have the ability to personalize our approach to each specific device proposal that comes through our doors, reflecting the client’s requirements and budget, which then allows us to create a streamlined process that is customized to their unique needs.
Fenske: As quality is perhaps the single most important factor for medical device OEMs, how do you ensure it at your company?
Kanis: We find that the best way to ensure quality is to establish open and frequent two-way communication. In our opinion, OEMs that adopt a collaborative approach within CM engagements have the greatest success. One of the primary motivations for this sentiment is the fact that the markets demand performance and puts pressure on supply chain personnel to deliver on product and price. If there is a good communication strategy in place where bottlenecks can be collectively solved, it is a win-win for both parties.
Fenske: What trends are having the biggest impact on the contract manufacturing space as it relates to medical device development and manufacturing?
Kanis: Customers are continually raising the bar in terms of expectations and innovations. In addition, price pressures and lean manufacturing are other aspects of our CM business that continue to evolve due to customer-initiated changes.
Fenske: Miniaturization and portability are two trends that are getting a lot of attention in healthcare. How do you address these in your projects?
Kanis: Proven Process Medical Devices has developed implantable devices since its inception. These devices that go into the body are inherently small, so as a normal course of business, we utilize an approach to maximize design and manufacturing options that minimize size.
The wearable trend will continue to grow and we have investigated new flexible electronic technologies. Our electronics engineers have the capability to design down to the chip level so embedding much of the functionality into the chips saves space and allows for designs that are small and flexible, yet at the same time, robust.
Fenske: At what stage do you typically enter the process with a new device project? How does that contrast to what the ideal would be?
Kanis: Proven Process Medical Devices has entered projects at all stages, even taking over aftermarket preventative maintenance services while having no input at any previous phase. We have the ability to support a product through its whole lifecycle. The ideal would be to start the project at the ideation phase. We have the expertise to build in features that ensure high yield rates, a productive manufacturing structure, and minimize ongoing maintenance of the product.
Fenske: When identifying a contract manufacturing partner, what critical considerations do many medical device OEMs overlook?
Kanis: Capacity. It is very difficult to measure the capacity of a CM just from a questionnaire. Good partners will share machine and labor loads. Salesmen will always wrangle an answer that tells a prospective client, “We have the capacity to do and grow.” Diligent OEM supply chain representatives will dig deeper to determine if capacity constraints exist.
Fenske: What’s the most important question a medical device manufacturer can ask of a prospective contract manufacturing partner?
Kanis: Obviously ask if a potential partner has the technical expertise as well as the latest, technically enhanced, physical tools to maximize productivity, quality, and data feedback. Information is valuable in making decisions for future design and purchasing decisions. A CM that offers feedback on design issues that will improve productivity is a valued CM.
Fenske: How do you facilitate clear communication with a customer? Do you employ any technology solutions that “sync” with the customer?
Kanis: A thorough Customer Needs Assessment is the initial step in the development of a medical device. Proven Process assembles a team of managers and engineers that investigate the gaps between our customer’s current product design and the desired use, performance, and cost point of manufacture. A technology and regulatory assessment is conducted collating user needs, human factors, design demands, predicate outcomes, and global regulatory requirements for the proposed diagnostic, surgical, or therapeutic device. We then have the ability to port our electronic document control systems onto the customer's software and vice versa. We have included third party vendors onto those shared platforms. We can then share all the data we have planned easily and seamlessly across the globe.
Fenske: Do you encounter outdated or simply incorrect assumptions about working with a contract manufacturer from medical device OEMs? How do you address them?
Kanis: Some medical device OEMs put a lot of emphasis on questions like, “Have you done the exact assembly, build, or process before?" Great supplier relationships are missed because, in the investigation phase, OEMs do not see the exact product and process they are looking for. Many CMs have great technical know-how that translates across several technologies. Innovation can happen when lessons are learned from a wide experience base.
Interested in sharing your thoughts and opinions? Contact Editor Sean Fenske at sfenske@rodmanmedia.com.
Kanis touches on an array of issues, from addressing miniaturization and portability in design to ensuring quality. He also addresses several questions involved with selecting the best partner with which to embark on a medical device project with.
Sean Fenske: In such a competitive industry as medical device contract manufacturing, what makes you different from the competition?
Mike Kanis: At Proven Process, we provide fully integrated contract manufacturing services for complex medical devices. With our pilot manufacturing process, we research designs and processes to incorporate iterative improvements early in product development. Our on-site talent and resources ensure the best possible strategy before our clients commit to major capital equipment expenditures.
Fenske: How do you best leverage this to stand out to potential customers?
Kanis: Our pilot manufacturing is a critical step. Through continuous refinement and validation, we ensure that our client’s medical device will seamlessly transition to full-scale production. We have the ability to personalize our approach to each specific device proposal that comes through our doors, reflecting the client’s requirements and budget, which then allows us to create a streamlined process that is customized to their unique needs.
Fenske: As quality is perhaps the single most important factor for medical device OEMs, how do you ensure it at your company?
Kanis: We find that the best way to ensure quality is to establish open and frequent two-way communication. In our opinion, OEMs that adopt a collaborative approach within CM engagements have the greatest success. One of the primary motivations for this sentiment is the fact that the markets demand performance and puts pressure on supply chain personnel to deliver on product and price. If there is a good communication strategy in place where bottlenecks can be collectively solved, it is a win-win for both parties.
Fenske: What trends are having the biggest impact on the contract manufacturing space as it relates to medical device development and manufacturing?
Kanis: Customers are continually raising the bar in terms of expectations and innovations. In addition, price pressures and lean manufacturing are other aspects of our CM business that continue to evolve due to customer-initiated changes.
Fenske: Miniaturization and portability are two trends that are getting a lot of attention in healthcare. How do you address these in your projects?
Kanis: Proven Process Medical Devices has developed implantable devices since its inception. These devices that go into the body are inherently small, so as a normal course of business, we utilize an approach to maximize design and manufacturing options that minimize size.
The wearable trend will continue to grow and we have investigated new flexible electronic technologies. Our electronics engineers have the capability to design down to the chip level so embedding much of the functionality into the chips saves space and allows for designs that are small and flexible, yet at the same time, robust.
Fenske: At what stage do you typically enter the process with a new device project? How does that contrast to what the ideal would be?
Kanis: Proven Process Medical Devices has entered projects at all stages, even taking over aftermarket preventative maintenance services while having no input at any previous phase. We have the ability to support a product through its whole lifecycle. The ideal would be to start the project at the ideation phase. We have the expertise to build in features that ensure high yield rates, a productive manufacturing structure, and minimize ongoing maintenance of the product.
Fenske: When identifying a contract manufacturing partner, what critical considerations do many medical device OEMs overlook?
Kanis: Capacity. It is very difficult to measure the capacity of a CM just from a questionnaire. Good partners will share machine and labor loads. Salesmen will always wrangle an answer that tells a prospective client, “We have the capacity to do and grow.” Diligent OEM supply chain representatives will dig deeper to determine if capacity constraints exist.
Fenske: What’s the most important question a medical device manufacturer can ask of a prospective contract manufacturing partner?
Kanis: Obviously ask if a potential partner has the technical expertise as well as the latest, technically enhanced, physical tools to maximize productivity, quality, and data feedback. Information is valuable in making decisions for future design and purchasing decisions. A CM that offers feedback on design issues that will improve productivity is a valued CM.
Fenske: How do you facilitate clear communication with a customer? Do you employ any technology solutions that “sync” with the customer?
Kanis: A thorough Customer Needs Assessment is the initial step in the development of a medical device. Proven Process assembles a team of managers and engineers that investigate the gaps between our customer’s current product design and the desired use, performance, and cost point of manufacture. A technology and regulatory assessment is conducted collating user needs, human factors, design demands, predicate outcomes, and global regulatory requirements for the proposed diagnostic, surgical, or therapeutic device. We then have the ability to port our electronic document control systems onto the customer's software and vice versa. We have included third party vendors onto those shared platforms. We can then share all the data we have planned easily and seamlessly across the globe.
Fenske: Do you encounter outdated or simply incorrect assumptions about working with a contract manufacturer from medical device OEMs? How do you address them?
Kanis: Some medical device OEMs put a lot of emphasis on questions like, “Have you done the exact assembly, build, or process before?" Great supplier relationships are missed because, in the investigation phase, OEMs do not see the exact product and process they are looking for. Many CMs have great technical know-how that translates across several technologies. Innovation can happen when lessons are learned from a wide experience base.
Interested in sharing your thoughts and opinions? Contact Editor Sean Fenske at sfenske@rodmanmedia.com.