Sean Fenske, Editor-in-Chief11.14.22
It’s been quite the hiatus since attending the Medica and CompaMed trade shows in Dusseldorf, Germany. My last visit to the event was 2019, prior to all the disruption created by the COVID-19 pandemic. With renewed enthusiasm, I was anxious to get back onto the show floor to meet with those companies attending the 2022 event. In anticipation of my visit, I reached out to a number of companies to get the scoop directly from them on what they are showcasing at the event, what challenges customers have brought them, and where they see their role within the industry in aiding medical device manufacturers. With that in mind, a collection of team members at Velentium, shared the following insights to help you determine if the firm should be a potential services partner for you in 2023 or beyond.
Sean Fenske: What technology or service are you emphasizing at Medica/CompaMed this year?
Ben Trombold (VP of Sales & Marketing): Velentium specializes and excels in helping clients design, develop, manufacture, and bring active medical devices to market—especially devices that apply neurostimulation to address indications anywhere on the body. Whether your device is fully implantable, wearable, or both, Velentium has the expertise to assist you!
Fenske: What’s the most common challenge customers inquire about and how do you address it?
Christopher Gates (Director of Product Security): “Do we really have to secure our medical device?” After eight years of the FDA telling manufacturers we need to create secure medical devices, I am always amazed at how many manufacturers have managed to remain ignorant of this simple fact. How we usually address it is through a quick (hour long) presentation detailing all the expected security activities and artifacts that are needed by the FDA for premarket submission, as well as several other countries and their expectations. It is not uncommon for this presentation to take all the air out of the room. And then—once we all understand what’s required—we can begin to get to work!
Randy Armstrong (CTO): Speed-to-market is a recurring inquiry. We encourage fast producibility proofs for new or unprecedented aspects.
Chris Jensen (VP of Technology): Right now, everyone is suffering with supply chain issues. We have invested in dedicated supply chain experts and have an increased focus on long-term availability of parts starting at the earliest phases of a design.
Satyajit "Sat" Ketkar (Director of Systems Engineering): The three types of consultation we get the most frequently asked for or about are (1) Gap Analysis, (2) DHF remediations, and (3) R&D itself. Gap Analysis (1) is a review of the client’s processes and/or design controls for a product that is either in manufacturing or under consideration for submission. This analysis typically leads to updates to processes, improving the design controls through the DHF, and finally, updates to the product design itself. This leads to DHF Remediation (2), i.e. improving design controls and sometimes design updates [R&D, (3)]. This is not to say that we don’t get requests for (2) and (3) independently. As a matter of fact, if I had to order, it would be (3), (1), and (2).
Fenske: If you could give one piece of advice to companies seeking a manufacturing partner before they make a decision, what would it be?
Gates: Find one that is located as close to your time zone as possible. Trying to triage and fix problems a world away with all the associated delays makes all problems that much harder to identify and fix. Not to mention language and cultural misunderstandings that can slow down any interaction. While the reduced cost of some outsourcing seems attractive, the tradeoff for the low price tag is often local instability, which contributes to external delays and interruptions.”
Armstrong: Select a partner who optimizes design and process risk management, which will reduce project and unit costs. While part and process costs demand attention, optimized risk management reduces product and process complexities, yielding significant savings.
Jensen: Choose a partner that understands your product space and is open and transparent throughout the process.
Ketkar: Ensure they truly understand safety-critical design, development, testing, and manufacturing. Secondarily, make sure they specifically understand medical device development and manufacturing, including design control requirements for medical devices. Bonus, they are ISO certified or understand process standards (ISO 13485), as well as compliance standards.
Fenske: What are the forces driving medical device manufacturers to seek your technology/services over doing it in-house?
Gates: There are many answers to this question, including increasing speed of development; a lack of skilled resources in-house; lower and more controllable cost vs. maintaining an in-house engineering team; lack of proper training for in-house engineers (especially true for cybersecurity), to name a few.
Armstrong: We're comfortable with a wide range of production quantities, so we have a smooth flow between product development, pilot production, and volume production.”
Jensen: Resources, time, and expertise!
Ketkar: We are ISO 13485 certified. This means our QMS and design controls already meet the safety-critical nature of medical device design and manufacturing. We have experts at Velentium that understand the processes, activities, and tasks necessary to achieve a product that meets user need and requirements.
Fenske: In what ways is your company able to aid in getting a product (project) to market faster?
Gates: We are a highly experienced team of engineers spanning multiple disciplines, including systems, firmware, software, electrical, mechanical, cybersecurity, test, mobile and cloud apps, manufacturing, and more. Our engineers see more development activities in six months than most manufacturing-based teams see in two years. As a result, they are used to running at full steam; don’t have to worry about "office politics," thanks to our investment in organizational culture; and are very experienced with the absolute latest tools and techniques. We also have platform technology and a bank of customizable reusable resources including code, design elements, and so on.
Armstrong: The answers to the preceding three questions each directly increase speed-to-market, and also maintain speed-in-market from that point forward.
Jensen: Velentium has teams of engineers with deep experience in designing medical devices, especially active implantable devices. Combined with our technology platform, this pool of experience allows us to focus on the new and unique aspects of a design while rapidly implementing the other, more basic elements.
Ketkar: By bringing and incorporating “simple elegance” into our design and manufacturing philosophy, we are able to leverage our expertise not only in technologies, but also in process and quality, to ensure an efficient product lifecycle.
Velentium is located at Medica/Compamed in Hall 8B, Booth/Stand M11.
Sean Fenske: What technology or service are you emphasizing at Medica/CompaMed this year?
Ben Trombold (VP of Sales & Marketing): Velentium specializes and excels in helping clients design, develop, manufacture, and bring active medical devices to market—especially devices that apply neurostimulation to address indications anywhere on the body. Whether your device is fully implantable, wearable, or both, Velentium has the expertise to assist you!
Fenske: What’s the most common challenge customers inquire about and how do you address it?
Christopher Gates (Director of Product Security): “Do we really have to secure our medical device?” After eight years of the FDA telling manufacturers we need to create secure medical devices, I am always amazed at how many manufacturers have managed to remain ignorant of this simple fact. How we usually address it is through a quick (hour long) presentation detailing all the expected security activities and artifacts that are needed by the FDA for premarket submission, as well as several other countries and their expectations. It is not uncommon for this presentation to take all the air out of the room. And then—once we all understand what’s required—we can begin to get to work!
Randy Armstrong (CTO): Speed-to-market is a recurring inquiry. We encourage fast producibility proofs for new or unprecedented aspects.
Chris Jensen (VP of Technology): Right now, everyone is suffering with supply chain issues. We have invested in dedicated supply chain experts and have an increased focus on long-term availability of parts starting at the earliest phases of a design.
Satyajit "Sat" Ketkar (Director of Systems Engineering): The three types of consultation we get the most frequently asked for or about are (1) Gap Analysis, (2) DHF remediations, and (3) R&D itself. Gap Analysis (1) is a review of the client’s processes and/or design controls for a product that is either in manufacturing or under consideration for submission. This analysis typically leads to updates to processes, improving the design controls through the DHF, and finally, updates to the product design itself. This leads to DHF Remediation (2), i.e. improving design controls and sometimes design updates [R&D, (3)]. This is not to say that we don’t get requests for (2) and (3) independently. As a matter of fact, if I had to order, it would be (3), (1), and (2).
Fenske: If you could give one piece of advice to companies seeking a manufacturing partner before they make a decision, what would it be?
Gates: Find one that is located as close to your time zone as possible. Trying to triage and fix problems a world away with all the associated delays makes all problems that much harder to identify and fix. Not to mention language and cultural misunderstandings that can slow down any interaction. While the reduced cost of some outsourcing seems attractive, the tradeoff for the low price tag is often local instability, which contributes to external delays and interruptions.”
Armstrong: Select a partner who optimizes design and process risk management, which will reduce project and unit costs. While part and process costs demand attention, optimized risk management reduces product and process complexities, yielding significant savings.
Jensen: Choose a partner that understands your product space and is open and transparent throughout the process.
Ketkar: Ensure they truly understand safety-critical design, development, testing, and manufacturing. Secondarily, make sure they specifically understand medical device development and manufacturing, including design control requirements for medical devices. Bonus, they are ISO certified or understand process standards (ISO 13485), as well as compliance standards.
Fenske: What are the forces driving medical device manufacturers to seek your technology/services over doing it in-house?
Gates: There are many answers to this question, including increasing speed of development; a lack of skilled resources in-house; lower and more controllable cost vs. maintaining an in-house engineering team; lack of proper training for in-house engineers (especially true for cybersecurity), to name a few.
Armstrong: We're comfortable with a wide range of production quantities, so we have a smooth flow between product development, pilot production, and volume production.”
Jensen: Resources, time, and expertise!
Ketkar: We are ISO 13485 certified. This means our QMS and design controls already meet the safety-critical nature of medical device design and manufacturing. We have experts at Velentium that understand the processes, activities, and tasks necessary to achieve a product that meets user need and requirements.
Fenske: In what ways is your company able to aid in getting a product (project) to market faster?
Gates: We are a highly experienced team of engineers spanning multiple disciplines, including systems, firmware, software, electrical, mechanical, cybersecurity, test, mobile and cloud apps, manufacturing, and more. Our engineers see more development activities in six months than most manufacturing-based teams see in two years. As a result, they are used to running at full steam; don’t have to worry about "office politics," thanks to our investment in organizational culture; and are very experienced with the absolute latest tools and techniques. We also have platform technology and a bank of customizable reusable resources including code, design elements, and so on.
Armstrong: The answers to the preceding three questions each directly increase speed-to-market, and also maintain speed-in-market from that point forward.
Jensen: Velentium has teams of engineers with deep experience in designing medical devices, especially active implantable devices. Combined with our technology platform, this pool of experience allows us to focus on the new and unique aspects of a design while rapidly implementing the other, more basic elements.
Ketkar: By bringing and incorporating “simple elegance” into our design and manufacturing philosophy, we are able to leverage our expertise not only in technologies, but also in process and quality, to ensure an efficient product lifecycle.
Velentium is located at Medica/Compamed in Hall 8B, Booth/Stand M11.
