Jack Kalavritinos, Former HHS/FDA Senior Official and Principal of JK Strategies, discusses the importance and benefits of government affairs in medtech

Jack Kalavritinos is the Founder and Principal of JK Strategies, a communications and public policy firm that helps organizations develop winning communication and policy strategies. Jack is also a former senior government official and appointee in HHS, FDA and DOL. Jack has decades of Washington, DC government, political and business experience including in the medtech sector with Covidien.

In this interview with SmartTRAK, Jack shares his thoughts on the benefits to medtech commercial leaders of developing collaborative relationships with their government affairs colleagues. Specifically, SmartTRAK’s interview with Jack covers the next phases of the COVID-19 public health emergency, the potential impact of the midterm elections and ways companies can work with the FDA.

To find out more, including Jack’s take on how medtech commercial leaders can develop relationships with their Representatives and Senators, click on the following video recorded live via Zoom. Outlined below are specific interview topics by the minute. To download a complete transcript of the interview, click here.

What seems to be on everyone’s mind – COVID-19 recovery and ASC trends

The COVID-19 pandemic reduced the attendance at the 2021 American Academy of Orthopedic Surgeon (AAOS) annual meeting to an estimated 1/5 ^th of its usual number. Many international surgeons found themselves under travel restrictions while some US surgeons were asked by their institutions to forego the meeting. The pandemic also impacted the conversations taking place on the convention floor with two topics seeming to be top of mind – the recovery from COVID-19 and the ongoing move of joint replacement procedures to the outpatient setting.

At AAOS 2021, SmartTRAK spoke with clinicians and industry executives to obtain their view regarding the pandemic and recovery from COVID-19. Although speculation varied depending on individual circumstances,  some companies and healthcare institutions shared that supply chain issues are holding back the increase in business while others are facing regional shutdowns of elective procedures due to the surge of the Delta variant.

In Q420 and into Q121, COVID-19 cases ramped up in the US, impacting US Knee replacement procedures. Several large implant manufacturers reported seeing hip procedures being prioritized over knee replacement cases given their more elective nature. However, revision knee replacements are not always able to be postponed. Craig Della Valle, MD of Midwest Orthopaedics at Rush in Chicago discusses the effects of COVID-19 on revision knee procedures and the changes to care pathways precipitated by the pandemic.

To listen to the interview, recorded live via Zoom, click on the following video. A link to the transcript of the interview is also provided below.

Tracking which procedures will drive growth within the Spine hardware market as we ride the ups and downs of COVID-19.

Following a Q320 rebound in elective procedures sparking a return to growth for the COVID-ravaged Spine market, the recent COVID resurgence has once again dragged US Spine growth rates down. While many companies have yet to report Q420 earnings, early signs point to a downturn, with procedure volumes impacted by hospital resource utilization and renewed restrictions around elective procedures.

In this article, Julianne Burns, SmartTRAK's GM, Spine, looks at the following topics:

• The COVID Impact Update
• Shifts in Cervical Total Disc Replacement (cTDR)
• Growth in Prone Lateral Procedures
• Expansion in SI Joint Fusion
• Innovation in Interbody Materials

As companies ride the latest wave of COVID-19, SmartTRAK predicts the trends and technologies that will continue to advance the trauma industry in 2021 and 2022.

Trend #1: Procedures Return to Near-Normal Levels in 2021

After the first swell of COVID-19 this past March, elective surgeries took a major hit. As most procedures were postponed during this phase of the pandemic, the trauma segment was impacted to a lesser extent. In early 2020, trauma surgeons reported seeing definite decreases in volumes due to stay-at-home orders, with polytrauma being almost negligible in certain US cities. Geriatric fractures also decreased, but to a lesser extent according to the OTA COVID-19 Webinar discussion. Despite the decrease, surgeons treated the majority of trauma fracture fixation procedures and provided conservative treatment in only a small portion of patients who were in facilities or areas heavily impacted by COVID-19.

SmartTRAK reviews the 2020 Virtual EWMA meeting covering the impact of COVID-19, the growing use of digital tools and emerging technologies 

For the first time, the European Wound Management Association (EWMA) annual meeting, held November 18 – 19^th 2020, was an all-virtual event. As the premier wound care conference in Europe, EWMA 2020 showcased the latest news and trends in the market for European Advanced Wound Dressings, which is projected to reach $1.8B in 2020 according to SmartTRAK estimates. It turned into a truly global event thanks to the format that welcomed 9,758 registered participants from 113 countries from all over the world.

MedTech Strategist reported that In May of this year, the Deloitte Center for Health Solutions conducted "an online survey of 50 clinical and service line leaders at US provider organizations on their deferred procedures". With the return of elective procedures being integral to a comeback for the MedTech industry, the results of that survey suggest that the path to resuming these procedures is becoming more complicated.

According to the Deloitte survey, "Respondents expect the return to pre-COVID-19 productivity volumes to take two to six months, with three months the typical estimate. When asked to list their top concerns about resuming deferred procedures, providers say a second coronavirus outbreak is their biggest worry (82%)". It appears that their biggest fear, a COVID-19 resurgence, may be coming to pass.

The following is just a small sampling of recent updates regarding the Life Sciences industry's COVID-related delayed procedures and what an impact a resurgence may have. These updates are compiled, reviewed and posted in real-time by our SmartTRAK analysts, who are constantly monitoring the situation and sifting through the noise to present the most relevant news to our subscribers:

COVID-19 hit the SCS market hard in Q220 as shutdowns and widespread procedure cancellations led to a dramatic decline in SCS revenues.

COVID-19 clobbered the SCS market in Q220 as shutdowns and widespread procedure cancellations led to a dramatic decline in SCS revenues, with the biggest impact in April across all geographies. For Q220, WW SCS revenues tumbled down -38.1% vs Q219, and US SCS revenue dropped by -37.7% YoY according to SmartTRAK Financial Dashboard.

Among the many topics covered in the comprehensive Q220 SCS Market Recap* are:

Q220 brought unexpected strong demand for orthopedic robotics, despite the COVID-19 pandemic.

Despite the COVID-19 pandemic, Q220 brought in unexpected strong demand for orthopedic robotics. Companies rose to the challenge through flexible business models to accommodate limitations in short-term hospital financial constraints through increased financing and implant volume commitments. The unexpected strength in robotics revenues also demonstrated a rebound in elective (total joint) procedures that is expected to normalize in early 2021.

Among the many topics covered in the comprehensive Q220 CAS Ortho Market Recap* are:

Despite a downturn in the CAS spine market and a decrease in the proportion of robotic spine cases in Q220, interest in spine robotics and other enabling technologies remains strong.

Although robotic system placements and procedures declined in Q220, companies remain optimistic with strong surgeon interest in spine robotics and a long runway ahead given the early stage of adoption and under penetration of the market. Additionally, product enhancements, new applications and the development of surgical platforms that span multiple enabling technologies (robotics, AI, surgical planning, patient-specific implants, etc.) are expected to drive growth in the CAS spine space going forward.

Among the many topics covered in the comprehensive Q220 CAS Spine Market Recap* are: