Medtech Matters

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Asha Parekh, a biomedical engineer and CEO of Front Line Medical. She explains how the COBRA-OS can stop internal bleeding to prevent patients from dying due to loss of blood. She also explains how the technology differs from current treatment methods. Specifically, the following questions are addressed.

• Can you please start by telling us a little about Front Line Medical Technologies and your COBRA-OS technology?
• How does the COBRA-OS technology differ from other available solutions?
• When is the COBRA-OS used? Is this used in a hospital or in an emergency situation at the scene (of say an accident)?
• Can you share some of the stats associated with this technology? In other words, how does it measure up to other technologies in survival rate, success rate, etc.?
• What’s next for Front Line Medical Technologies?

Listen to this episode and see what you think of Front Line’s COBRA-OS technology. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at [email protected].

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Bryan Lord, CEO and co-Founder of Pristine Surgical. He provides a number of reasons why disposable endoscopes should be indicated for medical procedures. Lord also highlights some of the challenges with reusable scopes and how single-use solutions help to eliminate them. Specifically, the following questions are addressed.

• Let’s start with a quick overview of what Pristine Surgical is about. Can you tell us about the company and technology?
• Why have there been such problems with the cleaning and sterilization of endoscopes?
• I understand safety in terms of instrument cleaning shortcomings, but has COVID had an impact as well?
• Do you encounter questions regarding durability and/or functionality of single-use scopes? If so, how do you address them?
• When compared to reusable scopes, are there any tasks that can’t be performed with a single-use scope?
• Are the images and videos able to be shared in a similar manner to most companies’ scope offerings?
• When people hear about a single-use product, they think of the trash created. Have you looked at the environmental impact of single-use versus reusable scopes?
• What’s next for Pristine Surgical?

Listen to this episode and see what you think of Pristine’s single-use scope technology. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at [email protected].

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Carlton Weatherby, vice president and general manager of Spine and Biologics at Medtronic. He provides insight on why the organization acquired Mazor and Titan Spine, the strategy for the division to address more of the care continuum, and how trends are being addressed such as AI, data, and MIS. Specifically, the following questions are addressed.

• Medtronic has made two interesting acquisitions in the Spine space. Can you tell us what made Mazor and Titan Spine attractive targets?
• Medtronic has demonstrated an interest in providing a solution for the entire care chain in other therapy areas, such as in diabetes. Is Spine headed in a similar direction?
• As you know, minimally invasive in spine is the trend. How is Medtronic addressing this?
• Another significant trend in medtech is the incorporation of data and artificial intelligence. What is Medtronic doing in these areas with regard to spine?
• What’s ahead? What can you share with regard to Medtronic’s spine future?

Listen to this episode and see what you think of Medtronic’s approach to spine. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at [email protected].

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at ways in which medical device manufacturers can benefit from a commercial strategy standpoint through the leveraging of its regulatory strategy. Knowing how to make the regulatory process more challenging to help prevent “me too” products to reach the market can be a commercial advantage for medtech firms. Specifically, the following questions are addressed:

• First, why don’t we begin with you describing exactly what you mean when you say a company’s regulatory strategy? And is that strategy company-wide or does a regulatory strategy change with each product?
• Who should be involved with the creation of a regulatory strategy if anyone beyond the regulatory representative?
• So how does the regulatory strategy and commercial strategy intertwine?
• What benefits can be realized from this approach?
• Would you please provide some real world example to further help illustrate the relationship between the two when it’s successful?
• What should be the most important considerations for medical device firms to keep in mind regarding their commercial strategy when identifying their regulatory strategy?

In addition, several previous podcasts were mentioned. To listen to those, click on the podcast title below.

Breakthrough Designation Program Update—Mike on Medtech
Beyond 510(k)/PMA: Breakthrough Devices Program—Mike on Medtech
Breakthrough Designation Program—Mike on Medtech
Reimbursement Debate Over FDA Breakthrough Device Designation

De Novo Final Rule—Mike on Medtech
Beyond 510(k)/PMA: De Novo 101—Mike on Medtech

Listen to this episode and see what you think of the intermingling of regulatory and commercial strategy. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Jackie Butler, director of BIO El Paso – Juarez, and Philip Morton, product development lab manager at MCA. They offer insights on how strong the region has been in supporting medical device manufacturers and how their organizations is only building upon that foundation. They explain the benefits of the organizations and the services they provide—free of charge—to U.S.-based companies. Specifically, the following questions are addressed.

• What is Bio El Paso?
• Can you tell me what MCA is?
• What is the connection between BIO El Paso and MCA?
• What’s the impact you are making on the medical device industry?
• The Devise Product Realization Hub offers a variety of services free of charge to companies. Can you discuss these?
• Do you have any success stories you could share?
• What are the next steps for this program and your organizations as they remain relevant to the medical device industry?

Listen to this episode and see what you think of the El Paso/Juarez region. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at [email protected].

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Tom O’Brien, worldwide president of Endomechanical at Ethicon. He shares insights on the company’s approach to the development of surgical instrumentation and reducing surgical complications. O’Brien also offers data from a recent study on the new Echelon Circular Powered Stapler and the improvements it offers for clinicians. Specifically, the following questions are addressed.

• Can you start by explaining what is encompassed within the Endomechanical unit at Ethicon?
• When it comes to the design and development of a surgical device, what are the key priorities for Ethicon and why?
• When companies talk about reducing surgical complications, what do they really mean and how is Ethicon trying to do this?
• Speaking of complications, Ethicon recently had data on a new stapler, the Echelon Circular Powered Stapler. Can you speak to the study about this device and what benefits it provides?
• Are there clinical areas on the horizon you are looking to address (that you can speak about, that is)?

Listen to this episode and see what you think of Ethicon and its approach to surgical instrumentation. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at [email protected].

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the final rule recently announced for the FDA’s de novo regulatory pathway. As part of the discussion, the de novo is explained, when it should be used, why it exists, and what points of interest were included in the final rule. Specifically, the following questions are addressed:

• Can you please briefly explain what the de novo regulatory pathway is?
• How does this option differ from the 510(k) and PMA?
• When is the de novo used?
• Were there any surprises or changes made in the final rule as issued?
• Apparently there was some dissatisfaction with the agency not removing inspection requirements in the final rule. Can you explain why this was an issue?
• What should device makers keep in mind if they are exploring the de novo regulatory pathway for a product?

Listen to this episode and see what you think of the de novo regulatory pathway. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the options available to a medical device firm who thinks the FDA is requiring them to take unfair measures or is being overly burdensome. We discuss the formal and informal options as well as the potential consequences. Specifically, the following questions are addressed:

• If after a 510k submission or pre-sub meeting, is there something you can do if you feel the FDA is being overly burdensome? Can you do something if you think the agency is asking more of you than of your competitors?
• What informal actions can you take?
• If you’ve had no success with the informal options, are there formal actions you can take?
• What about least burdensome? Can you cite that with any success?
• Are there consequences to embarking on any of these actions? Might a company face pushback for questioning the agency?
• What are the most important items medical device manufacturers need to keep in mind if they choose to question the FDA?

Listen to this episode and see what you think of the options available to you in dealing with the FDA if it’s being overly burdensome. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Fazila Seker, president and CEO of MOLLI Surgical. She explains the benefits of the MOLLI Surgical system as compared to the way breast tumors are traditionally located and marked for surgical removal. Further, the magnetic innovation behind the system is discussed. Specifically, the following questions are addressed.

• What is MOLLI Surgical? What is your primary clinical focus areas?
• How does your technology differ from the typical treatment device used for breast surgery?
• Is this the first time a magnetic solution has been used for this type of application in breast surgery?
• What has been the response from surgeons and medical professionals who have used your system?
• What are the next steps for MOLLI Surgical? What can we expect down the road?

Listen to this episode and see what you think of the MOLLI Surgical system. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at [email protected].

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the three systems of risk as they relate to the U.S. regulatory system. While many are familiar with the device classification system, they may not be as familiar with the other two systems or their purpose. Whether or not all three systems are actually needed is also explored. Specifically, the following questions are addressed:

• First, can you explain how we handle risk in medtech manufacturing in the U.S.?
• What is the medical device classification system and why do we have it?
• What is the Significant Risks vs. Non-Significant Risk system?
• What about software? What is the Software classification system?
• How are the three systems of risk related?
• Do we need three separate systems to handle risk?
• What are the most important items medical device manufacturers need to keep in mind with regard to risk?

Listen to this episode and see what you think of the three systems of risk. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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For more medtech news and information, visit https://www.mpomag.com.