In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Tamir Wolf, CEO and Co-Founder of Theator. He discusses his company and why capturing a video record of a surgery is beneficial to physicians. He speaks to the educational advantages that can be realized and also talks about the legal implications of using his technology in a malpractice suit. Specifically, the following questions are addressed.

• Can you please provide a brief overview of Theator?
• Is this technology used for surgical training, surgical planning, or both?
• Does this technology function in real time or is it only outside of the OR?
• What if a surgeon was sued for a mistake during a surgical procedure. Could this technology be used as evidence?
• What’s next for Theator? Where is the company headed?

Listen to this episode and see what you think of capturing surgeries on video with Theator. 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 Amit Phadnis, chief digital officer at GE Healthcare. He makes several predictions for the new year about how technology will impact the delivery of healthcare. Topics of discussion include the reduction of burnout among healthcare workers, continued integration and understanding of AI, reduction of healthcare inequalities, acceleration of telehealth, and other related areas. Specifically, the following questions are addressed.

• You have a number of predictions for 2022 that I’d like to explore. Let’s start with a continued emergence of innovations to reduce burnout. Why are these important and do you have examples of some more recent ones?
• Talk to me about physicians become more particular about AI. Are they overwhelmed or beginning to recognize what’s valuable and what’s not?
• Another prediction you have is that technology will help the workforce reduce healthcare inequalities. What does that mean?
• The pandemic resulted in an incredible acceleration of telehealth. How will we grow from that and find the real value play for it?
• You say that precision health will revolutionize healthcare delivery. What does that mean specifically?
• In what other ways do you see AI and other advanced medical technologies making an impact in 2022?

Listen to this episode and see what you think of Phadnis’ predictions of healthcare and technology in 2022. 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 Andrew Ekdahl, worldwide president of joint reconstruction at DePuy Synthes. He offers insight on the company’s approach to knee replacement, blending a number of technologies to achieve a restoration. Ekdahl also speaks to the impact newer innovations, such as robotic-assisted surgical technologies and data driven solutions, have on knee implants. Specifically, the following questions are addressed.

• I understand DePuy is taking a different approach to total knee replacement. Instead, it’s being looked at as knee restoration. Can you explain what that is and why the differentiation in language?
• How is data driven technologies being used to help with this mission?
• What’s happening in terms of implant development? Are the implants changing to meet with this effort?
• To further enhance this mission to restore the knee, how is personalized medicine (a term we hear often) playing a role here?
• How does this effort meet with the needs (and wants) of surgeons? Is this speeding up surgical procedures?
• What about the instrumentation? Any changes and/or advancements in that space?
• What is this leading to? Where is DePuy headed in terms of the knee, joints, or the larger orthopedic space?

Listen to this episode and see what you think of DePuy's knee restoration strategy. 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 Kathy Lee-Sepsick, founder and CEO of Femasys. She provides an overview of how the company’s technology is helping women who are dealing with infertility. She also speaks about a device that enables a non-surgical means of permanent birth control. Specifically, the following questions are addressed.

• Can you please start off by giving us a little insight on what Femasys is?
• So your technologies are at both end of the spectrum, addressing infertility and also helping to prevent pregnancy. Can you talk a bit about the FemaSeed and how it different from other available infertility technologies?
• What is FemBlock and how does it work?
• What is FemVue and how did it change the current standard for this type of medicine?
• What’s next for Femasys? Where is the firm headed?

Listen to this episode and see what you think of the women’s health technologies from Femasys. 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 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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For more medtech news and information, visit www.mpomag.com.

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

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

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