key: cord-330461-4bncbqsb
authors: Warth, Lucian C.; Noiseux, Nicolas O.; Duncan, Stephen T.; Daines, S. Bradley; Mahoney, Craig R.
title: How Has COVID-19 Affected Our Orthopedic Implant Industry Partners? Implications for the Surgeon-Industry Relationship in 2020 and Beyond
date: 2020-04-28
journal: J Arthroplasty
DOI: 10.1016/j.arth.2020.04.063
sha: 
doc_id: 330461
cord_uid: 4bncbqsb

BACKGROUND: The COVID-19 pandemic has had far-reaching societal and financial consequences. The purpose of this study was to evaluate how COVID-19 has affected AAHKS industry partners and the surgeon-industry relationship, emphasizing education, resource allocation, and strategic direction for the 2nd half of 2020. METHODS: AAHKS industry partners were contacted to participate in a blinded survey and optional interview with the AAHKS Industry Relations Committee. Based on the results, a group of AAHKS member surgeons with disparate practice types were asked to postulate on how the COVID-19 pandemic has and will affect their practice and relationship with Industry. RESULTS: AAHKS industry partner responses indicated decreased resource allocation for regional, “other national,” and AAHKS annual meetings (67%, 55%, and 30%, respectively). Web-based educational content was expected to increase in 2020 and will likely remain a point of emphasis in 2021 (100% and 70% of responders). For Q3/Q4 2020, a significant emphasis was placed on site of service/outpatient TJA and COVID-19-related safety measures (70% and 90% of responders), as well as increased availability of instrumentation and implants (40% and 60%, respectively). CONCLUSION: The COVID-19 pandemic has altered the orthopedic landscape for the foreseeable future. Survey responses by AAHKS industry partners demonstrate a continued commitment to surgeon education with and increasing shift to a web-based platform. Increased resource allocation for outpatient TJA and COVID-19-related safety measures were significant. Articulating optimal mechanisms to aid industry in supporting surgeons with different practice models to meet demand during the second half of fiscal year 2020 will be critical.

The orthopaedic practice of AAHKS members, like virtually every other industry in the United 30 States, has been significantly burdened by the negative economic effects of the worldwide COVID-19 31 pandemic. Elective cases have been essentially eliminated. Fracture cases have slowed, and clinic visits 32 have dropped by as much as 40-90 percent due to social distancing -all of which have contributed to 33 significant strain on orthopaedic practices. 34

The cessation of elective total hip and knee arthroplasty has also had a dramatic effect on 35 AAHKS Industry Partners. Severe dips in 1 st and 2 nd quarter implant sales revenue have forced 36 companies to take pro-active steps to conserve capital and maintain liquidity during these uncertain 37 times. The significant financial resources AAHKS Industry Partners have historically committed to 38 support national and regional orthopaedic meetings, surgeon education, clinical research, 39 surgical/vendor OR support, and technological innovation have required re-distribution to varying 40 degrees to maintain fiscal solvency. 41

Forecasts for when US elective procedures may resume suggest that inpatient procedures could 42 potentially restart in some states by mid-May, and most if not all states by the end of June 2020 1 . 43 Hospitals, orthopaedic groups, and industry must create strategies to address the anticipated increases 44 in demand expected upon a return to 'normalcy'. In the near term, it will be critical to meet volumetric 45 demands, support the orthopaedic workforce, and create more efficient business relationships to 46 maintain continuity in a rapidly changing milieu. Orthopaedic practice models of AAHKS members differ 47 significantly and will be affected to varying extents moving forward; the ability to increase production 48 during the 2 nd half of the fiscal year for the private practice, academic, and hospital employed surgeon 49 must be considered both separately and as a collective; needs in terms of optimal industry support will 50 be heterogeneous. Due to the rapidly changing environment and risk of a resurgent COVID-19 virus, long-term strategies must also be articulated to safely prevent another catastrophic full-scale shutdown 52 of elective cases. 53

Executive leadership of AAHKS Industry Partners with a significant footprint in elective hip and 55 knee arthroplasty were contacted to participate in a brief blinded survey (Table 1 ) and optional phone 56 or Zoom interview with a member of the AAHKS Industry Relations Committee (IRC). The survey 57 consisted of questions covering 5 topics to gauge changes in industry support resource allocation and 58 work force including: Resources designated for orthopaedic meetings, Resources designated for 59 surgeon education, Resources designated for strategic points of emphasis, Effect on industry work-force, 60

and Measures taken to meet increased 3 rd and 4 th quarter demand. 61

Results were tabulated and distributed a cohort of AAHKS Member Surgeons with disparate 62 practice models including, Private practice, 'Academic' practice, and Hospital employed practice. 63

Surgeons were asked to consider these results and postulate on how the COVID-19 pandemic has and 64 will affect their specific practice type and relationship with Industry in 2020 and beyond. 65

Executive leadership of AAHKS Industry Partners with a significant footprint in primary elective 67 total hip and total knee arthroplasty were contacted to participate in the survey. Ten responses were 68 received, while 2 declined to participate (83%). Full survey results are listed in Figure 1 . 69

Industry partners noted an expected shift in 2020 toward decreased resources designated for 71 the AAHKS Annul Meeting (30%). Uncertainty with respect to orthopaedic meeting resource allocation 74 persisted amongst a small but significant percentage of responders for 2021 (20-33%), while most 75 responders anticipated a return to standard levels of support (50-78%). Of responders, 30% anticipated 76 increased resource allocation for the AAHKS Annual meeting in 2021. 77

Twenty percent of responding companies anticipated decreased budgeting for resident, fellow, 79 and surgeon specific educational activities in 2020; this was tempered by an across the board increase in 80

Web-Based Recorded and Live Video educational content (100%). Industry support with educational 81 resources in 2021 can be expected to rebound for resident (40%), fellow (40%) and surgeon (50%) 82 education based on survey responses. Support for Web-Based Live and Recorded content was also 83 expected to again increase in 2021 (70%). 84

The most significant trends identified for resources designated for strategic points of emphasis 86 included a decrease in Marketing allocation (60% in 2020), and increased allocation for Site of 87 Service/Outpatient Joint Replacement and COVID-19 Related Operative Safety Measures (70% and 90% 88 of responders in 2020, 70% and 50% in 2021) 89

In anticipation of a Q3/Q4 2020 surge in elective joint arthroplasty, 90% of responding Industry 91

Partners anticipated no significant decrease in their sales workforce. Resources designated to increase 92 available instrumentation and support implant production was expected to increase (40%, 50% 93 respectively) or remain unchanged (60%, 40% respectively). No Industry Partner anticipated decreases

Industry support for AAHKS membership has played a critical role driving success of 97 orthopaedics in general, and elective hip and knee arthroplasty in specific. Resources directed towards 98 the training of residents, fellows and surgeons have improved educational offerings. Industry vendor 99 support in the operative room and through implant development have enhanced operative efficiency 100 and improved patient outcomes. The Surgeon-Industry relationship has become symbiotic to the point 101 where both sides contribute to financial success and viability of a healthcare system which provides 102 access to quality orthopedic care for the American public. An improved understanding of how the 103 COVID-19 pandemic has affected AAHKS Industry Partners and enhanced communication will help 104 optimize our combined response as a profession to uncharted waters ahead. The survey and interview 105 responses provided by AAHKS Industry Partners varied considerably, however strong common themes 106 of continued commitment to education, as well as the expectation for elevated levels of vendor/surgical 107 support in the 2 nd half of 2020 emerged. 108

Indirect Education Support: National and Regional Meetings 109 Industry Partners expressed trepidation in their support of Regional Meetings in 2020 (67% 110 decrease) and a level of uncertainty with regard to the 2020 AAHKS Annual Meeting (30% uncertain, 111 30% decreased resource allocation). Continued commitment to support for the AAHKS Annual Meeting 112 in 2021, however was strong (50% no change, 30% increase). This critical continued resource allocation 113 moving forward indirectly supports the educational mission of our largest arthroplasty society. The 114 extent to which COVID-19 and associated societal scars lingers may very well affect the scope, scale, 115 attendance, and importance of all in person regional and national orthopaedic meetings for the 116 foreseeable future. 117

In terms of direct support to surgeon education, a small downtrend of support at each level of 119 training was identified for 2020, however a unanimous increase in resources directed towards web-120 based educational platforms was seen which can potentially benefit all learners. This included 100% of 121 responders directing more resources towards Web-Based Recorded and Live Video educational content 122 in 2020. As physicians are forced to embrace and become comfortable with telemedicine secondary to 123 COVID-19 induced social distancing, remote engagement and education supported by our Industry 124

Partners may become a mainstay to reach a large number of individuals without geographic or temporal 125 limitations in a cost and time efficient manner. 126

Surgical Support During 3rd and 4 th Quarter 2020 127

A common theme across survey responses and phone interviews was a significant commitment 128 to enhanced surgeon support during the anticipated uptick of elective arthroplasty procedure in the 129 second half of the fiscal year. While AAHKS Industry Partners nearly universally articulated an assurance 130 to partner with surgeons to meet increased need, there is significant uncertainly on how to distribute 131 limited resources and optimally support disparate surgeon practice models. Defining the needs of 132 AAHKS members with different practice models and articulating an appropriate response will allow our 133 Industry Partners to help smooth the transition back to the Operative Room for all arthroplasty 134 surgeons. Industry Partners are working to prepare for the expected surge in demand and appear open 135 to guidance. This is a potential action item for AAHKS and national leadership as we look to the future in 136 2020 and beyond. 137

Of Industry responders 70% expected to allocate more resources to 'Site of Service' support 138 such as outpatient joint arthroplasty in both 2020 and 2021. COVID-19 related operative safety 139 measures were also a highly emphasized (90% and 50% in 2020 and 2021 respectively). As this first 140 wave of COVID-19 tamponades, the expected surge of elective cases currently backlogged will likely 141 entail maximally stressing the elective capabilities in certain centers; the needs will be varied and 7 inherently dependent on surgeon practice model. Both sides of the aisle of our profession are currently 143 bracing for the possibility of extended weekday schedules and/or weekend elective schedules where 144 none existed prior. There will be increased emphasis on efficiency of the non-surgical aspects of cases: 145 pre-op preparation, anesthesia time, turn-over times in the OR, etc. Surgical efficiency will also be 146

stressed, yet hopefully maintaining its rightful place behind quality and safety. Our relationship with 147 Industry and our implant vendors can play a critical role during this time. 148

On the vendor side, there could be a significantly greater tug-of-war for implant reps to be 149 present in multiple hospitals or surgery centers at once, even late into the evenings or on weekends. 150

More instrument sets may be needed to do more of the same case per day, or on consecutive days. As 151 such, central sterilization efforts will heavily be put to the test as well. Refill of implants will be 152 demanded more quickly, and more individual units of the same size will be expected to be available at 153 once, to work through the backlog. We expect that the hip and knee implant manufacturers will do their 154 best to provide the supply required, as their sales will have been reduced for 3 months or more. 155

Amid the current shutdown of elective arthroplasty, private orthopedic groups, like any 157 independent service provider, have been put at significant at risk. That said, with the assistance of 158 Industry, private practice groups supporting Orthopaedic Hospitals and physician owned ambulatory 159 surgery centers (ASCs) may have enhanced logistical mobility to ramp up elective case load at a greater 160 rate than hospital employed or academic orthopaedic Surgeons. The ultimate sustainability of private 161 orthopedic practices must come through a resumption of normal business practices. In the meantime, 162 favorable financing structures for capital expenditures and volume based economic incentives are 163 potential opportunities for Industry Partners to help 'weather the storm'.

There is also risk moving forward that further interruptions in business could be anticipated in 165 the fourth quarter. Some epidemiologists and infectious disease experts have predicted that COVID-19 166 infections will drop precipitously over the summer, only to come roaring back in the late fall and winter 2 . 167

Hospitals will inevitably shoulder the burden of treating infected patients, as they have currently. Site of 168 care, including outpatient surgery centers and physicians owned hospitals will likely be the 'clean' 169 hospitals moving forward. These sites which will see less viral burden can serve a public role without 170 placing additional stress on hospital systems. In anticipation, industry could play a large role in helping 171 orthopaedic surgeons maintain care pathways that ultimately reduce patient exposure to the Covid-19 172

Academic Practice Perspective 174

The academic arthroplasty surgeon faces a different set of potential pifalls. The 'red tape' 175 commonly associated with large tertiary referral centers may obviate the ability to increase weekday 176 efforts or add weekend shifts. A push for efficiency may also have an extended impact on teaching at 177 academic institutions, wanting to catch up on wait-lists and make up for lost revenue, as a priority over 178 technical instruction. 179

Vendor support may be limited due to more stringent access restrictions in tertiary hospitals 180

where COVID-19 patients are still popping up even after the initial surge has abated. Furthermore, at 181 many institutions there is no contract with one or two manufacturers, but rather a capitation model 182 with a multitude of vendors used for primary and revision joint surgery. It is possible that due to the 183 financial blow of COVID-19, the model currently in place is urged to change in order to produce more 184 savings on implant costs. Finally, the confidence that there is no risk of coronavirus transmission will 185 need to be instilled in the patients proceeding to elective surgery, which may be more difficult at a tertiary care center. Whether this involves increased testing, antibody testing or advanced PPE usage is 187 uncertain. 188

Much like the position of an academic surgeon, the hospital employed orthopaedic surgeon may 190 have to a degree had a buffer against the immediate economic ramifications of COVID-19 fallout. This 191 group however will have highly variable Hospital/Administrative response in the coming months. 192

Industry may be able to play a role in partnering with hospitals to strengthen a previously existing 193 relationship or forge a new partnership. While the hospital employed practice is unlikely to be 194 inundated with a surge of semi-urgent revision or infection cases compared to a tertiary referral center, 195 control over when and how to increase production is variable and administration dependent. 196

As surgical moratoriums are lifted, is likely that hospital systems will place an emphasis on the 197 rapid resumption of highly profitable elective cases such as total joint arthroplasty to offset fiscal losses 198 imposed by the COVID-19 shutdown 3 . Favorable financing structures for capital expenditures and 199 volume based economic incentives are potential opportunities for Industry Partners to work with 200 hospital systems to support the hospital employed orthopaedic surgeon. 201

In summary, the majority of AAHKS Industry Partner responses indicated a forward-thinking 203 mindset in the face of COVID-19 induced uncertainty. In the short term, and emphasis on educational 204 offerings has not been lost, but has been transitioned to a less hands on and more technologically driven 205 'social-distancing' friendly medium. This may very well become a significant aspect of our profession's 206 'new normal'. Support for 'hands on' training that is a stalwart of total joint arthroplasty education will 207 likely rebound but may take time and patience. 208

It is apparent that arthroplasty surgeons and Industry will have to maximize their efforts to work 209 together safely, cohesively, respectfully and efficiently more than ever before, to weather the tidal wave 210 of surgeries that is sure to come and forge a stronger working relationship and fortify our profession. 211

Early and open communication will be paramount to smoothly adapting to changes in volume and 212 disparate needs of surgeons and practices moving forward. 213

Orthopaedic surgeons, hospitals, and most importantly patients across the United States have 214 benefited greatly from symbiotic partnerships with manufacturers of orthopaedic products and 215

implants. Although the current pandemic threatens massive upheaval across the industry, it also 216 provides an opportunity to strengthen the Surgeon-Industry partnership in 2020 and beyond, enhancing 217 our ability to achieve our ultimate goal -the assurance of access to quality orthopedic care for the 218 American public. 219

MedTech: Forecasting When US Elective Procedures Restart

Canaccord Genuity Capital Markets Industry Update

Med-Tech executives are saying -conclusions from our inaugural (anonymous) survery)

the United States, how has you company modified the following?

How has the shutdown of elective arthroplasty cases affected your Work-Force? (Some have been let go, Some have been furloughed, Hours have been cut, More than one of the above,