SmartTRAK looks at the market’s response to the recently finalized LCDs and the potential impact on the US Market for Skin Substitutes.

The popularity of direct anterior approach THA is driving new product introductions.

With the exploding growth of enabling technology, much of the focus on implant solutions in recent years has been on knee replacement systems compatible with enabling technologies. At the same time, minimally invasive techniques for hip replacement using the direct anterior approach (DAA) have rapidly been gaining favor among surgeons. More companies are designing implant solutions to facilitate DAA, for use with and without enabling technologies. At this year’s American Association of Hip and Knee Surgeons (AAHKS) Annual Meeting, manufacturers were showcasing not one, but four new hip systems specifically designed to facilitate the direct anterior approach. Because surgeon adoption of this technique appears to be accelerating, it is potentially a significant opportunity for implant companies. In a 2022 survey of its members, AAHKS found that DAA was the most utilized for primary total hip arthroplasty THA (56%), a significant increase from 2018 when 40% of AAHKS surgeons indicated they used an anterior approach.

The introduction of these new stems almost plays out like a David vs Goliath story with two smaller US market players, NextStep Arthropedix and Corin, facing two of the four largest, Zimmer Biomet and Smith+Nephew. In this downloadable article, SmartTRAK looks at these new stems hitting the US market, including a brief history of the stems, their features and benefits, and the market positioning for each.

Dr. Chris Jeffery, founder and CEO of Convergence Medical, discusses the V01, the world's first arthroscopic surgical robot.

In a recent interview with SmartTRAK, Dr. Chris Jeffery, the founder and CEO of Convergence Medical, discussed the V01, the world’s first dedicated arthroscopic surgical robot. In the interview, Dr. Jeffery shared insights into the V01’s novel design, business model, and technological advancements that position it as the next evolution in arthroscopic innovation. The V01 received FDA breakthrough designation in 2023 and is on track for FDA clearance and a US launch in late 2025.

Click on the following video to watch the interview (59:11 min). A complete transcript of the interview is available here. For more details, interview topics by timecode are provided below.

Interview Topics By Timecode:

• 00:50 Dr Jeffery’s background.
• 10:00 V01 overview.
• 20:25 Performing a repair with the V01.
• 26:50 V01 cost.
• 36:10 Surgeon feedback.
• 40:10 Importance of an arthroscopy-specific robot.
• 42:40 Novel design of the V01.
• 44:45 Commercial path.

Click the button below to download a complete transcript of SmartTRAK's interview with Dr. Chris Jeffrey, CEO of Convergence Medical Sciences, conducted by Andy Knapik, Senior Analyst, Soft Tissue Fixation and Arthroscopic Enabling Technologies.

SmartTRAK examines the market dynamics, innovations and growth drivers for Negative Pressure Wound Therapy.

Since KCI (now  Solventum) introduced the wound V.A.C. to the market in 1996, traditional Negative Pressure Wound Therapy (tNPWT) has become the standard of care in hospitals for the treatment of hard-to-heal wounds .  While tNPWT has and will continue to experience low-single-digit revenue growth over the next several years, most of the growth in this space has been in single-use NPWT (sNPWT). According to SmartTRAK's US External Devices Market Overview, the US Market for sNPWT is forecasted to grow at a 5-year CAGR of roughly +13% . 

 

In this article, SmartTRAK provides an overview of the market dynamics impacting both the tNPWT and sNPWT segments of the US External Devices Market, including:

• Traditional Negative Pressure
  • Solventum and Smith+Nephew (SNN) are two key players in the tNPWT category, with a combined US market share of almost ... (read more)
    
• Single-Use Negative Pressure
  
  • Like the tNPWT market, both Solventum and SNN are key players in the sNPWT segment, together owning the vast majority of the market. sNPWT has been attracting a lot of interest from wound care companies, large and small, due to its sustained double-digit growth globally. SmartTRAK identifies and discusses three market strategies that are currently playing out in sNPWT as companies position themselves to capture share in this fast-growing segment. They are:
    
    • Large Dressing Companies Expanding into the sNPWT Adjacency
    • Start-Ups Focus on Pump-Free Products.
    • Growing the Market Through Expanded Use, Clinical Evidence ... (read more)

Click the button below to access and read the complete "Negative Pressure: Still Innovating, Growing and Expanding" article by Jay Merkel, SmartTRAK Sr Analyst, which highlights key large studies on the use of sNPWT in 2024, breaking them out into the studies that show benefits and the studies with moderate or no benefits.

New spine technologies "pushed the envelope" at MNVC

The Musculoskeletal New Ventures Conference (MNVC) is an annual meeting where early and late-stage companies present their ideas. This meeting occurred in Memphis, Tennessee, from October 28 - 30, with a broad mix of attendees, including surgeons, venture capitalists, the medical device industry and researchers. Forty companies presented this year, a record number for this meeting, focused exclusively on the musculoskeletal industry. In this article, SmartTRAK highlights six companies with new technologies to "push the envelope" in the US Spinal Hardware Market, which SmartTRAK estimates is growing at a 5-year CAGR of +4.7%.

This downloadable article provides an in-depth look at the following six companies' innovative new technologies:

SmartTRAK reports on the latest research and innovation in neurointervention from ESMINT 2024. 

The European Society for Minimally Invasive Neurological Therapy (ESMINT) Annual Congress is unique, not only because it addresses issues and trends pertinent to Europe, but because it also provides a worldwide perspective that features cutting edge science, industry symposia, a novel “startup alley” and the latest advancements in therapies and techniques affecting the market for the minimally invasive treatment of ischemic and hemorrhagic stroke.

In this downloadable article, SmartTRAK highlights the top news, research and advances in neurointervention from ESMINT 2024 held September 4-6 in Marseille, France. This includes:

• Innovation in Access Devices
  • Over the last several years, companies have been developing new catheters and access devices designed to better navigate difficult anatomy and tortuous vessels to reach target vessels and achieve rapid access during neurovascular intervention. With this in mind, two companies have developed novel guidewires with remotely shapeable tips that can be used to address different types of anatomy and facilitate successful catheterization ... (read more)
• Advances in Mechanical Thrombectomy from the Following Companies
  • Rapid Medical
  • Q’Apel Medical
  • Balt
  • WallabyPhenox
  • Acandis 
  • Stryker
  • Medtronic
  • PenumbraPenumbra
  • JNJ MedTech
  • Terumo Neuro
  • Vesalio
• Current and Emerging Flow Diverters
  • Since the FDA approved Medtronic’s Pipeline Embolization Device in 2011, flow diversion has revolutionized the treatment of intracranial aneurysms and allowed clinicians to treat a wider range of aneurysms in more complex anatomies. Today, flow diverters continue to evolve and almost every manufacturer of neurovascular devices currently has or is developing a flow diverter as part of its hemorrhagic stroke portfolio. (read more)
    
    

Click the button below to download and read the comprehensive "ESMINT 2024: What's New in Neurointervention" Market Outlook article by Anne Staylor, SmartTRAK Executive Editor VP and GM, Neuro Therapies.

Medtech companies can learn from Pharma’s evidence-based success to evolve their business strategies, expand market access and thrive.

The landscape of life sciences is profoundly shaped by the strategies companies use to gain market access. Pharma and Medtech, two principal sectors within this space, pursue markedly different paths due to their distinct business models and industry demands. Despite the differences, Medtech companies can potentially leverage strategies from Pharma to enhance their own market penetration and product success. In this article, guest writers Brad Maruca, managing director at Deloitte and former divisional vice president at Abbott Neuromodulation, along with John Jaeger, managing director at Deloitte and expert in commercial strategy, delve into the differences between these two sectors and provide a narrative outlining potential lessons Medtech might draw from Pharma's well-established market access strategies.

Among the many topics covered in detail in the complete downloadable article are:

• Business Models and Market Strategies
  • At the core of Pharma's strategy lies a comprehensive engagement model that encompasses policy, payers, patients and clinical guidelines. This sector not only focuses on the initial market entry, but emphasizes the lifetime value of a patient, adopting an annuity model where continuous patient engagement plays a critical role in sustaining revenue. In contrast, Medtech tends to focus on innovation and physician engagement, primarily driving growth through product and procedural innovations. (read more)
• Research & Development and Clinical Approaches
  • Pharma's approach to market access is heavily evidence-driven, relying on long-term, structured, and high-risk clinical trials to build a robust case for insurance coverage. This rigorous evidence generation ensures that once a pharmaceutical hits the market, it is backed by indisputable data that secures its place in treatment protocols. Medtech, however, often relies on shorter, iterative development cycles and may not prioritize extensive evidence generation, sometimes leading to challenges in justifying the product's efficacy and value to payers. (read more)
• Utilizing Data and Analytics
  • While Pharma has long harnessed the power of big data and advanced analytics to inform everything from drug discovery to market penetration strategies, Medtech has been slower in adopting these resources to their full potential. (read more)
• Collaboration and Pricing Strategies
  • Pharma's widespread collaborations with stakeholders across the spectrum—from healthcare providers to research institutions—have fortified its market access strategies. Medtech’s collaborations, though robust with hospitals and clinicians, often miss the broader stakeholder engagement that could drive policy and guideline development. (read more)

Click the button below to download and read the complete "Market Access: What Medtech Can Learn from Pharma" perspective article written by guest writers Brad Maruca, managing director at Deloitte and former divisional VP at Abbott Neuromodulation, and John Jaeger, managing director at Deloitte and an expert in commercial strategy,