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In this article, the authors explore why medical device innovation has traditionally been geared so thoroughly toward improving performance, with little regard to cost. They argue that the changing incentives in the health care sector and the move to value-based payment models, accelerated by the implementation of the Affordable Care Act, will forc...
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... 5,8,9 Specifically, some authors have suggested that the Affordable Care Act may have deterred continued investment given the growing focus on cost efficiency over innovation, as well as the diminished returns for investors precipitated by the recently repealed medical device tax. 10,11 Similarly, some have expressed concerns that current process of device approval through the Food and Drug Administration continues to be characterized as cost-inefficient and time consuming. 8,12 Subsequently, it has been suggested that these weaknesses could stifle innovation and reduce investor interest into orthopaedic technologies. ...
Background. Innovations in orthopaedic technologies often require significant funding. Although an increasing trend has been observed for third-party investments in other medical fields, no study has examined the influence of venture capital (VC) funding in orthopaedics. Therefore, this study analyzed trends in VC investments related to the field of orthopaedic surgery, as well as the characteristics of recipients of these investments. Methods. Venture capital investments into orthopaedic-related businesses were reviewed from 2000 to 2019 using Capital IQ, a proprietary intelligence platform documenting financial investments. Metrics categorized were investments by year, investment amount, and subspecialty domain as per the American Academy Orthopaedic Surgeons website. The compound annual growth rate (CAGR) for both quantity and dollar amount of investments was calculated over the study period and the two decade-long periods (2000–2009 and 2010–2019). Results. Over two decades, 673 VC investments took place, involving a total of US$3.5 billion. Both the number and dollar value of investments were greater in the second decade (440, US$1.9 billion), compared to the first decade (233, US$1.6 billion). Both quantity and dollar amount of VC investments grew over the first decade, with a CAGR 9.53% and 4.97%, respectively. However, investment growth declined in the latter decade. The largest and most frequent investments took place within spine surgery and adult reconstruction. Conclusion. An initially rising trend in VC investment in orthopaedic-related businesses may have plateaued over the past decade. These findings may have important implications for continued investment into orthopaedic innovations and collaboration between the surgical community and private sector.
... This means prioritising service innovation (eg, digital patient-referral or waiting-list solutions) and making intangibles (eg, patents, algorithms, return on investment models) responsive to public health priority problems; in other words shifting from 'fancy' to 'frugal' and 'less sexy' innovations. 3,6,17,18 As a result, social entrepreneurial strategies can be devised that enhance rather than limit commercial opportunities. Along with a duty at the outset to respond to system-level challenges comes the advantage of getting the innovation publicly-procured and scaled up within a healthcare system. ...
Aligning innovation processes in healthcare with health system demands is a societal objective, not always achieved. In line with earlier contributions, Lehoux et al outline priorities for research, public communication, and policy action to achieve this objective. We endorse setting these priorities, while also highlighting a ‘commitment gap’ in collectively addressing system-level challenges. To acknowledge that stakeholders engaged in dialogue with one another are addressing the commitment gap is not a small step but a giant leap towards realising a socially responsible innovation agenda. Translating system-level demand signals into innovation opportunities is, therefore, the task-cum-art of all stakeholders, one that often prompts them to innovate how they deal with innovations.
... As the share of U.S. gross domestic product that is spent on health care is projected to reach 20% by 2025 [24], reducing cost and improving value of care has become a policy priority [25]. Redirecting research and development in medical devices towards cost-saving innovation has been pointed out as one potential avenue to reach this objective [26]. ...
Objectives:
The study estimated the health economic impact of a latest generation coronary stent with ultrathin struts and bioresorbable polymer coating.
Background:
The recent BIOFLOW V trial, an international FDA approval trial (ClinicalTrials.gov: NCT02389946), has shown that an ultrathin, bioresorbable polymer sirolimus-eluting stent had a significantly lower rate of target lesion failure and target vessel-related myocardial infarction than a thin, durable polymer everolimus-eluting stent at 12 months, driven by a lower rate of peri-procedural myocardial infarction (ppMI).
Methods:
We used a Markov model to project mortality and cost outcomes of that lower ppMI rate from a U.S. health system perspective over a 12-month horizon. Model parameters were derived from BIOFLOW V trial data, a systematic literature review and expert interviews.
Results:
Use of the bioresorbable polymer sirolimus-eluting stent compared to durable polymer everolimus-eluting stent is associated with net reductions in medical cost of $124 (Interquartile Range (IQR) $97-154) per patient in 2018 US$, of which $115 (IQR $76-124) accrues to the initial admission and $10 (IQR $7-72) to cost of follow-up. The lower rate of ppMI translates into a gain of 0.000017 (IQR 0.000011-0.000022) quality-adjusted life-years (QALY) per patient.
Conclusions:
Lower ppMI rates of bioresorbable polymer sirolimus-eluting stent translate into reductions in direct medical cost, while improving patient outcomes. Most of the cost reduction is attributed to the initial admission with moderate savings up to 12 months post-discharge.
... I would refer to the main themes of the dissertation, namely 'understanding' and 'connecting' for the sake of public value. This can lead to new, valuedriven ways of innovating that are more in keeping with 'the era of affordable care: the end of sexy' (Mattke et al., 2016), and 'Era 3 for medicine and health care' (Berwick, 2016). A focus on understanding and connecting also renders a generic implication of dealing with such complex social issues as introducing advanced medical innovations. ...
... I would refer to the main themes of the dissertation, namely 'understanding' and 'connecting' for the sake of public value. This can lead to new, valuedriven ways of innovating that are more in keeping with 'the era of affordable care: the end of sexy' (Mattke et al., 2016), and 'Era 3 for medicine and health care' (Berwick, 2016). A focus on understanding and connecting also renders a generic implication of dealing with such complex social issues as introducing advanced medical innovations. ...
As value-based care gains traction in response to towering healthcare expenditures and issues of healthcare inequity, hospital capacity, and labor shortages, it is important to consider how a value-based approach can be achieved in plastic surgery. Value is defined as outcomes divided by costs across entire cycles of care. Drawing on previous studies and policies, this paper identifies key opportunities in plastic surgery to move the levers of costs and outcomes to deliver higher-value care. Specifically, outcomes in plastic surgery should include conventional measures of complication rates as well as patient-reported outcome measures in order to drive quality improvement and benchmark payments. Meanwhile, cost reduction in plastic surgery can be achieved through value-based payment reform, efficient workflows, evidence-based and cost-conscious selection of medical devices, and greater use of out-patient surgical facilities. Lastly, we discuss how the diminished presence of third-party payers in aesthetic surgery exemplifies the cost-conscious and patient-centered nature of value-based plastic surgery. To lead in future health policy and care delivery reform, plastic surgeons should strive for high-value care, remain open to new ways of care delivery, and understand how plastic surgery fits into overall health care delivery.
Introduction
Healthcare expenses are reaching unaffordable levels worldwide and reverse innovation could play a role in decreasing these expenses and improving healthcare accessibility. The ReMotion Knee, a prosthetic knee primarily developed for low-income countries, could serve as a reverse innovation for people with a lower limb amputation. This study aimed to evaluate the ReMotion Knee as a potential reverse innovation in high-income countries, specifically in terms of functional mobility.
Methods
Nine participants with a transfemoral amputation or knee exarticulation were included in this randomised crossover trial. The ReMotion Knee was compared with the participants’ current prosthetic knee in terms of functional mobility and subjective experiences. The primary outcome in this study was the L test for functional mobility. Secondary outcomes were additional clinical performance tests and subjective experiences (balance confidence, walking comfort, test performance and fatigue).
Results
Participants scored significantly better using their current prosthetic knee than using the ReMotion Knee on primary outcome, the L test (p<0.01, median difference 7.5 s, IQR 6.1–10.6) and all secondary outcomes except experienced test performance and fatigue. All participants were able to safely perform all clinical tests with the ReMotion Knee, even after a short familiarisation period.
Conclusions
The ReMotion Knee has the potential to become a reverse innovation after modifications improving velocity, walking comfort and weight limit. Collaboration between high-income and low-income countries can facilitate further development of the ReMotion Knee and could result in alternative products and treatments that could reduce healthcare costs while still providing a good quality of care.
Trial registration number
NCT04700085 .
The medical device industry has long been subject to criticism for lack of price transparency and minimal regulations surrounding device approval, which have functioned as barriers to providing quality and cost-effective care. Recent health care reforms aimed at overcoming these barriers, including improving market approval regulations, increasing postmarket surveillance, and using comparative effectiveness research, have drastically changed industry practices. These reforms have also prompted increasingly cost-aware health care practices, which have encouraged new trends in medical device innovation such as frugal innovation and deinstitutionalization. This article explores the challenges faced by industry, physicians, and patients in light of these reforms.
Background:
The recent BIOFLOW V trial (ClinicalTrials.gov: NCT02389946) showed that revascularization with an ultrathin strut, bioresorbable polymer sirolimus-eluting stent (BP SES) was associated with lower rates of clinically driven target lesion revascularization (TLR) and target vessel-related myocardial infarction (TVMI) at 24-month follow-up than that with a thin strut, durable polymer everolimus-eluting stent (DP EES). We simulated the impact on cost and mortality.
Methods and results:
We projected the impact of the lower adverse event rates from a U.S. health system perspective over a 48-month horizon with a Markov model using event data from the BIOFLOW V trial and estimates for costs and excess mortality due to adverse events from published sources. All cost estimates were CPI-adjusted to 2018 US$ and future cost discounted by 3%. We estimated that use of BP SES compared to DP EES was associated with cumulative net reductions in medical cost of $2429 per patient over 48 months. Peri-procedural TVMI contributed $124 (5%), TLR in patients without TVMI $810 (33%) and spontaneous TVMI $1496 (62%) of cost. Use of BP SES compared to DP EES was associated with 2603 fewer deaths in one million patients over four years, corresponding to a relative risk reduction of 6%.
Conclusions:
Lower adverse event rates associated with revascularization using BP SES translate into reductions in direct medical cost and mortality. Most of the cost reduction is attributed to reduction in spontaneous TVMI. Given the high volume of coronary procedures, such results are an important consideration for patients, clinicians and payers.
The process of medical device innovation involves an iterative method that focuses on designing innovative, device-oriented solutions that address unmet clinical needs. This process has been applied to the field of biophotonics with many notable successes. Device innovation begins with identifying an unmet clinical need and evaluating this need through a variety of lenses, including currently existing solutions for the need, stakeholders who are interested in the need, and the market that will support an innovative solution. Only once the clinical need is understood in detail can the invention process begin. The ideation phase often involves multiple levels of brainstorming and prototyping with the aim of addressing technical and clinical questions early and in a cost-efficient manner. Once potential solutions are found, they are tested against a number of known translational factors, including intellectual property, regulatory, and reimbursement landscapes. Only when the solution matches the clinical need, the next phase of building a "to market" strategy should begin. Most aspects of the innovation process can be conducted relatively quickly and without significant capital expense. This white paper focuses on key points of the medical device innovation method and how the field of biophotonics has been applied within this framework to generate clinical and commercial success.
