WHO WE WORK WITH
Experience Across the Healthcare Spectrum
TTi has vast experience in accelerating market opportunities for top manufacturers across the cardiovascular, respiratory, oncology, orthopedic, surgical, wound care, IoMT and mHealth, and other specialties.
We recognize the unique challenges each sector faces in or rapidly-evolving marketplace and can help you position your technology on top. From policy changes to to shifts in marketplace demands, TTi specializes in positioning devices and maximizing revenues within an increasingly competitive market.
Cardiovascular
With rising costs, hospitals that were once quick to adopt promising cardiovascular technologies have become cautious in purchasing decisions, raising the barrier to market entry. For cardiac device manufacturers who can overcome these obstacles, the market can be highly rewarding. With the heights you have to climb to get to market, it’s critical that you have a partner with a complete understanding of the cardiac landscape and the specialized experience to help get you there.
Cardiovascular Market
With rising costs, hospitals that were once quick to adopt promising cardiovascular technologies have become cautious in purchasing decisions, raising the barrier to market entry. Despite its growth, the market for cardiovascular devices is plagued by margin erosion. For cardiac device manufacturers who can overcome these obstacles, the market can be highly rewarding. With the heights you have to climb to get to market, it’s critical that you have a partner with a complete understanding of the cardiac landscape and the specialized experience to help get you there.
As the leaders in medical device market access, we offer cost-effective solutions to navigate the crowded marketplace and accelerate your success.
OUR EXPERIENCE:
Our team has vast experience in accelerating market opportunities for top device manufacturers across cardiac diagnostics, therapeutics, IoT wearables, and more. Having led projects with Federal health agencies like CDC, our team is recognized in the field. Our experience spans HE models, prospective studies, retrospective studies, comparative effectiveness analyses, and point of care patient management programs:
- Cardiac Contractility Modulators (CCM): Facility-perspective health economics models calculating cost savings and improved patient outcomes
- Ambulatory Cardiac Monitors (ACMs): Payer-perspective and facility-perspective health economics Markov models to calculate cost savings and improved patient outcomes associated with the use of ACMs
- Comparative effectiveness analyses of pacemakers, monitors, and other cardiac devices across manufacturers
- Clinical dossiers for a complex, integrated system that made up of an external cardiac rhythm recorder, a machine learning, augmented intelligence algorithm, and an arrhythmia report to inform cardiologists in their treatment plans
- Cost-effectiveness analysis of various aortic endoprosthetics for patients suffering from aortic aneurysms and other conditions of the aorta
- Multi-site evaluation of changes in blood pressure and other cardiovascular risk factors following multi-session lifestyle interventions targeting behavior change
- Mixed mode (retrospective EMR + prospective) study of hospital-based patient care management program to prevent readmissions related to heart failure (HF)
- Health economic model for evaluation of aggressive hypertensions management strategies in persons with chronic kidney disease
- Analysis of risk factors for cardiovascular morbidity and mortality in maintenance hemodialysis patients
- Evaluation of emergency room sepsis and shock protocol and relation to CVD outcomes
Orthopedics
While the orthopedics market was expanding pre-COVID, the outlook remains stable. Recovery will rely on surgeries being rescheduled with overall trends more positive for minimally invasive procedures and robotics. The high prices of orthopedic implants, surgery-induced risk factors, and a growing number of product recalls have elevated the barrier to market entry. It’s critical that you have a partner with considerable knowledge of orthopedic value propositions and specialized experience in this area.
Orthopedics
While the orthopedics market was expanding pre-COVID-19, the outlook remains stable. Recovery will rely on surgeries being rescheduled with overall trends more positive for minimally invasive procedures and robotics. Recent market growth can be largely attributed to an increasing number of musculoskeletal injuries resulting from car accidents and sports injuries, increasing prevalence of bone disorders (e.g. osteoporosis and arthritis) – especially in our geriatric population, high demand for minimally invasive procedures, technological advancements, and government initiatives toward promoting orthopedic healthcare. But even with these forces fueling market growth – the high prices of orthopedic implants, surgery-induced risk factors, and a growing number of product recalls have elevated the barrier to market entry.
To occupy significant share of the orthopedics market, it’s critical that you have a partner with considerable knowledge of orthopedic value propositions and specialized experience in this area.
OUR EXPERIENCE:
Our team of experts has vast experience working with top device manufacturers across disc-preserving technologies, post-orthopedic-surgery rehabilitation services, annular closure devices (ACDs), and more. Our work spans study design and execution, health economics, market access strategy, and reimbursement and sales support. Select experience includes:
- Retrospective analysis of real-world safety related to hip and knee arthroscopic surgeries and deep joint infection specific to facility and patient related characteristics
- Clinical study design to evaluate patient outcomes resulting from use of Forced Air Warming (FAW) technology during hip and knee replacement surgeries
- Post-market safety analysis of adverse event rates and analysis of patient and provider complaints to better knee implant cementing techniques; identification of risk factors for adverse outcomes
- Payer-perspective health economics (HE) model development for an annual closure device (ACD) designed to allow more disc-preserving while reducing the risk of re-herniation and associated reoperations and early readmissions
- Facility-perspective HE model development for surgical treatment of hallux rigidus/arthritis of the metatarsophalangeal (MTP) joint
- Payer perspective interactive HE model and database analysis for an artificial disk technology
- Payer and facility-perspective HE models for multiple post-orthopedic surgery rehabilitation technologies
- HE model and peer-reviewed publication development for an orthopedic device inserted into the subacromial space between the head of the humerus and the acromion to allow for smooth and frictionless gliding between the shoulder bones and decrease pain associated with ruptured tendons following a rotators cuff tear
- Payer and facility-perspective HE model development for a bone graft substitute product for spinal fusion surgery
- Regulatory and clinical development of electrical stimulation of pedicle screws in osteoporotic spinal bone to facilitate health of fractures and allow placement of fixation devices
- US reimbursement landscape for robotic/electric rehab assistive device for both upper and lower extremities
Oncology
The growth of oncology devices has been driven by increased prevalence and incidence of cancer, favorable reimbursement policies for interventional oncology treatments, the desire for less invasive surgical procedures, availability of private and governing funding, a vast need for early detection, and other factors. Rising above the competition requires a partner that knows the oncology landscape, key value drivers, and has the specialized experience to propel you into the marketplace.
Oncology
The growth of oncology devices has been driven by increased prevalence and incidence of cancer, favorable reimbursement policies for interventional oncology treatments, the desire for less invasive surgical procedures, availability of private and government funding, a vast need for early detection, and other factors.
However, there are significant challenges that are restraining market growth including an increasing financial burden on industry players and a high number of product recalls. The market is crowded and competition for entry is exceedingly high. Rising above competing technologies requires a partner that knows the oncology landscape, key value drivers, and has the specialized experience to propel you into the marketplace.
OUR EXPERIENCE:
Our team of experts has experience in accelerating market access opportunities for top device manufacturers across intraoperative and selective internal radiation therapy (SIRT) technologies, probe-based Confocal Laser Endomicroscopy (pCLE) systems, Silver Nitrate Coated Indwelling Pleural Catheters (SNCIPC), and more. Our work spans study design and execution, health economics, market access strategy, reimbursement and sales support, and expert reports. Select experience includes:
- Payer perspective cost-effectiveness analysis of a hydrogel spacer insert capable of reducing clinical outcomes associated with prostate cancer radiotherapy
- Meta-analysis calculating a robust 5-year recurrence rate across numerous heterogeneous studies, enabling clinicians to adopt intra-operative radiation therapy with confidence
- Health economic models for an adaptive radiotherapy planning technology
- Clinical dossiers for a pCLE system intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical tracts when accessed through an endoscope
- Deliverables communicating key value drivers of a surgically-targeted radiation therapy (STaRT) for recurring brain tumors that begins working immediately at the time of tumor removal
- Reimbursement support for a system including a magnetic marker implanted in the breast to temporarily mark a lumpectomy site intended for surgical removal and a non-imaging detection and localization of the magnetic marker
- Payer perspective cost-effectiveness modeling to establish value of a catheter for use in the treatment of locally advanced pancreatic cancer
- Protocol design/incorporation of HE-focused endpoints for a SNCIPC product
- Reimbursement support including hotlines, preauthorizations, and appeals for resin microspheres labeled with Yttrium-90 for use in SIRT of liver tumors
- SEER and SEER-related database analyses pertaining to prevalence, incidence, demographic breakdown, and healthcare resource utilization of various cancers and comorbidities with a special emphasis on lung and prostate cancer
- White paper development on non-small cell and small cell lung cancer based on SEER analyses
Diagnostics
The diagnostics sector is driven by innovation in both equipment and in clinical and research applications. The rising number of diagnostics locations and point of care testing centers has contributed to expansive growth of the in vitro diagnostics (IVD) segment in particular. Reimbursement cuts will put downward pressure on profit margins, making capturing market share in diagnostics challenging. Success in the diagnostics marketplace requires a partner with knowledge of the landscape and specialized experience.
Diagnostics
The diagnostics sector is driven by innovation in both equipment and in clinical and research application. The rising number of diagnostics locations and point of care testing centers has contributed to expansive growth of the in vitro diagnostics (IVD) segment in particular. Improvements in computer enhancement and new contrast media, along with development of high-tech molecular imaging techniques, has widened the range of conditions that in vivo imaging can address.
Reimbursement cuts will put downward pressure on profit margins, making capturing market share in diagnostics challenging. However, technology advances will continue to yield new and improved service capabilities, and the aging US population will require more and better laboratory testing and diagnostic imaging services.
Given these challenges, success in the diagnostics marketplace requires a partner with knowledge of the landscape and specialized experience.
OUR EXPERIENCE:
Our team of experts has experience working for top device manufacturers across the spectrum of both in vivo and in vitro diagnostics. Our work encompasses study design and execution, health economics, market access strategy, and reimbursement and sales support. Select experience includes:
- Design and execution of a four-phase research program (consisting of retrospective and prospective pilot studies, a multi-site prospective RCT, and a cost-effectiveness assessment) to evaluate the cost effectiveness of the first EEG biomarker for ADHD, reducing the time it takes to diagnose ADHD, and properly treat those diagnosed with either therapy, medication, or both.
- Clinical dossier development for a complex, integrated cardiac rhythm diagnostic system including a long-term, external cardiac monitor and deep-learning, augmented intelligence algorithm
- Meta-analysis of lymphedema measurement methods used in patients who have been treated for breast cancer to compare traditional body composition measurement methods to a BIS device
- Cost-effectiveness analyses of multi-faceted, community-based screening for carotid artery stenosis, peripheral artery disease, and abdominal aortic aneurysm
- Phased evidence generation program and revenue generation roadmap for a technology which uses traditional scanners to create 4 dimensional images of the lungs to better diagnose COPD
- Facility perspective value analysis model and payer value analysis overview to define value proposition of a cerebral oxygenation monitor for prevention of brain hypoxia in neonates in NICU
- Prospective, single-arm study analyzing the relationship between medication changes, BIS measurements using a rapid, non-invasive home-based BIS device, and hospital readmissions for acute heart failure (AHF) to determine how changes in BIS preempt patient-reported symptoms of AHF that lead to hospital readmission
- Budgetary impact models and reimbursement strategy for a technology that enables better performance of colorectal cancer screening colonoscopies
- Facility perspective budgetary impact models and payor perspective cost-effectiveness analyses regarding the use of BreathID for non-invasive detection (e.g. h. pylori) and monitoring (e.g., liver function ) or a variety of liver disorders
Surgical
Growth in the surgical device market is driven by factors that include an increase in surgical procedures, a growing demand for surgical tools (including robotics), and an increasing incidence of chronic diseases in an aging population. In particular, the surgical robotics segment is expected to vastly expand the market with its potential to revolutionize almost any type of surgery. Gaining a share of the surgical sector requires a partner with advanced knowledge of the landscape and specialized experience.
Surgical
Growth in the surgical device market is driven by factors that include an increase in surgical procedures, a growing demand for surgical tools (including robotics), and an increasing incidence of chronic diseases and an aging population. In particular, the surgical robotics segment is expected to vastly expand the market with its potential to revolutionize almost any type of surgery.
Despite its driving forces, reductions in hospital budgets, stringent government regulations, and lack of proper compensation for surgical devices hinder market adoption of many technologies, making capturing market share of surgical devices exceedingly difficult. Gaining a share of the surgical sector requires a partner with advanced knowledge of the landscape and specialized experience.
OUR EXPERIENCE:
Our team of experts has experience working for top device manufacturers across trocars, anesthesia solutions, surgical sealant technologies, robotics, and more. Our work encompasses study design and execution, health economics, market access strategy, and reimbursement and sales support. Select experience includes:
- Facility perspective value analysis of trocars used in laporoscopic surgeries
- Multiple facility perspective value analysis tools for supplies used in endovascular aneurysm repair
- Facility perspective value analysis of alternative anesthesia solutions in outpatient surgery centers
- Meta-analysis demonstrating clinical equivalency of an intraoperative radiation therapy technology to the current standard of care when studies displayed significant heterogeneity
- Retrospective study design and execution, including development of a detailed algorithm to validate the definition of the adverse event of interest, to demonstrate cost-effectiveness of a surgical sealant technology for use in gastrectomy procedures
- Multitudes of analyses examining frequency, health outcomes, and financial impact (both personal and system burden) of surgical procedures pertaining to diseases of the eye (uveitis, macular degeneration, dry eye), respiratory diseases (severe asthma, pulmonary fibrosis) and cancer, gender-specific operations (cervical, hysterectomy, breast, prostate, and testis)
- Conduction of a literature review to identify current reports on levonorgestrel (LNg) intrauterine devices (IUDs), opining on the available epidemiological data regarding secondary (following time of insertion) uterine perforations (often requiring surgical repair) and intrauterine devices (IUDs) to assess adverse events associated with LNg-IUDs, safety and efficacy
- Facility perspective, qualitative study design and implementation to determine facility-specific costs associated with use of a repeated use laryngoscope and to ascertain cost implications of converting from a repeated use to a single use laryngoscope across three distinct facility types
- HE model development to demonstrate cost-effectiveness of a technology designed to allow surgeons to perform a more disc-preserving discectomy while reducing the risk of reherniation and associated reoperations and early readmissions
Wound Care
The wound care market is growing, driven by a growing incidence of chronic wounds, increasing demand for reducing hospital stay – especially in light of COVID-19, a rising number of surgeries, and an aging population. Increases in spending will fuel demand for wound care devices, but increased competition and consolidation are impediments to market access. Given the unique market access challenges of wound care, it’s critical to have a partner with specialized experience in this segment.
Wound Care
The wound care market is growing, driven by a growing incidence of chornic wounds, increasing demand for reducing hospital stay – especially in light of COVID-19, a rising number of surgeries, and an aging population. Chronic and complex wounds represent a predominant challenge to healthcare systems because they are hard to heal and expensive to treat. Increases in spending will fuel demand for wound care devices, but high costs of advanced wound care products are expected to hinder the growth of the market, and increased competition and consolidation are impediments to market access. In addition, the influx of patient hospitalizations has led many facilities to categorize wound care as “non-essential” in the interim. These forces can be enough to cripple a mediocre product launch despite the overall market growth. Given the unique market access challenges of wound care, it’s critical to have a partner with specialized experience in the segment.
OUR EXPERIENCE:
Our team of experts has vast experience in accelerating market opportunities for top device manufacturers across chronic wound prevention technologies, complex sound therapy systems, negative pressure wound therapies (NPWT) and more. Our experience in wound care spans HE and C-E models, value driver assessments, and economic talk tracks. Select projects include:
- Development of a payer playbook inclusive of costs, outcomes, and programmatic data, to show health plans the potential impact of a mobile application for implementing a prevention program focused on reducing chronic. illness such as type 2 diabetes (a condition in which diabetic foot ulcers (DFU) are a limb-threatening complication), on their patient populations in terms of both clinical and economic endpoints, which allowed the client to maximize market access opportunities by assisting existing and prospective users in evaluating the return on investment (ROI) and cost-effectiveness of the application and program
- HE models estimating the clinical outcome probabilities and associated costs of a preventive sensory insole for DFU
- C-E model (presented in an in-person meeting with CMS) describing the cost-effectiveness of a DFU diagnostic technology vs. SOC as an early DFU diagnostic
- C-E models comparing a complex wound therapy system, which transmits a fixed dose of non-ionizing, non-thermal energy to patient wounds from radio weaves, in addition to SOC with SOC alone in managing pressure ulcers, DFU, and venous leg ulcers. Providing HE-focused for inclusion into planned study protocols in DFU; provided tools needed to support client’s market access strategy with the Veteran’s Administration
- Value driver assessments providing significant reimbursement inputs by care setting (for both Skilled Nursing Facilities (SNFs) and Home Health Agencies (HHAs)) for a NPWT
- Economic models conveying value in improving population health, improving patient experience of care, and reducing patient care costs considering 2 wound types (venous leg ulcers and DFU) for each site of service (SNFs and HHAs) using LCR data, paired with economic talk track, for a NPWT
Respiratory
The rising prevalence of respiratory diseases, technological advancements, and increasing applications in home healthcare settings were already fueling the respiratory market prior to the pandemic. In the face of COVID-19, the need for respiratory management has erupted across the globe. Medtech companies are now shifting their focus to develop respiratory equipment, making the future marketplace very competitive. To maximize your revenue, it’s critical to have a partner with considerable expertise in respiratory care.
Respiratory
The rising prevalence of respiratory diseases, technological advancements, and increasing applications in home healthcare settings were already fueling the respiratory market prior to the pandemic. In the face of COVID-19, the need for respiratory management has erupted across the globe. With facilities’ overwhelming need for mechanical ventilation technologies, and relaxing of regulatory restrictions to help mitigate COVID-19’s impact on population health, many medtech companies (and even companies beyond the realm of this industry) are pivoting their focus to developing respiratory equipment, making the future marketplace very competitive. To maximize your revenue, it’s critical to have a partner with considerable expertise in respiratory care.
OUR EXPERIENCE:
Our team has vast experience in accelerating market opportunities for top manufacturers across respiratory diagnostics and management. Our work spans study design and execution, health economics, market access strategy, and reimbursement sales support. Select experience includes:
- Design and implementation of a multi-faceted clinical evidence generation program to: 1) Establish “proof of concept”; 2) Demonstrate performance “as good as” current pulmonary function tests (PFTs); and 3) Establish the technology as “better than” current PFTs for managing patients with severe respiratory disease, and development of a Revenue Generation Roadmap for a pre-regulatory, four-dimensional lung function imaging analysis software
- Conduction of a systematic literature review of all epidemiological, environmental sampling, and toxicological literature related to primary constituents of World Trade Center dust including but not limited to particulate matter, asbestos, PAHs, PCDDs, PCBs, and other volatile compounds to evaluate the respiratory and gastoresophageal adverse health effects experienced by rescue, recover, and clean-up workers and volunteers participating in cleanup of the collapse of the World Trade Center on September 11, 2001
- Design and implementation of a qualitative study to determine facility-specific costs associated with use fo a repeated use laryngoscope and to ascertain cost implications of converting from a repeated use to a single use laryngoscope, and development of a white paper synthesizing all data, to support the facility adoption of a disposable bronchoscope/flexible video scope
- Conduction of a qualitative research and analysis for The Center for Tobacco Prevention and Control within the Maryland Department of Health and Mental Hygiene to evaluate the needs, receptivity, successes, and barriers/challenges with tobacco use cessation of youth tobacco users to support effective promotion and service provision of the Maryland Tobacco Quitline
- Execution of an observational study performed on a set of patients with idiopathic pulmonary fibrosis found within the National Inpatient Sample for a confidential large pharmaceutical company to determine incidence, prevalence, and medical resource use, in which asthma and severe asthma appeared as comorbidities
- Cost-effectiveness model development and development of a peer-reviewed manuscript showcasing the clinical and health economics value of a prescription medicine fo the maintenance treatment of chronic obstructive pulmonary disease (COPD)
Internet of Medical Things (IoMT)
The market for products comprising the IoMT is growing rapidly due to the ability to improve efficiencies, lower care costs, and drive better outcomes in healthcare. The increasing popularity of smart phones, tablets, and other mobile platforms and their ability to track and manage chronic illnesses, and collect large amounts of data, will continue to have a huge impact on healthcare systems. It’s critical to partner with an expert that understands the key value drivers and has specialized IoMT experience.
Internet of Medical Things (IoMT)
The market for products comprising the Internet of Medical Things (IoMT) is growing rapidly due to the ability to improve efficiencies, lower care costs, and drive better outcomes in healthcare. The increasing popularity of smart phones, tablets, and other mobile platforms and their ability to track and manage chronic illnesses and collect large amounts of data will continue to have a huge impact on healthcare systems. But even with government initiatives and lifestyle changes fueling market growth – the risk of cyber-attack breaches, data standardization challenges, reimbursement uncertainty, and high infrastructure costs have elevated the barrier to market entry.
These challenges and a crowded marketplace make it critical to partner with an expert that understands the key value drivers and has the specialized IoMT experience to bring about your market success.
OUR EXPERIENCE:
Our team of experts has experience in accelerating market access opportunities for top device manufacturers across mHealth applications, AI algorithms, SaaS, and more. Our work spans study design and execution, health economics, market access strategy, and reimbursement and sales support. Select experience includes:
- User playboook inclusive of cost, outcomes, programmatic data, and accounting for heterogeneity across available data sources, for users (healthcare payers, larger employers) to evaluate ROI and impact of an mHealth-based behavioral counseling program for reducing risk of certain health conditions
- Phased evidence generation program and revenue generation roadmap and technology which uses traditional scanners to create 4-dimensional images of the lungs to better diagnose COPD
- HE models for an adaptive radiotherapy planning technology
- Payer perspective HE model to inform development of key value drivers of mHealth application for managing insulin dependent, Type 2 diabetes
- Facility perspective HE model to inform development of key value drivers of a digital therapeutic for oncology practices compared to standard of care for management of grade 1-2 adverse events for cancer treatment
- Clinical dossier development for a complex, integrated arrhythmia diagnostic system including a deep-learning, augmented intelligence algorithm capable of identifying 12 cardiac rhythms when paired with a long-term, external monitor
- Baseline reimbursement landscape for a prenatal outcomes monitoring technology (mobile health app/wearable)
- Facility perspective HE analysis for a mobile health app intended to improve outcomes in hypertension
- Market sizing/reimbursement landscape for wearable in heart failure
- Reimbursement landscape to support mobile health app/wearable in cardiac rehab
- Clinical study design + facility perspective HE analysis for an adaptive radiotherapy planning technology (SaaS)
Precision Medicine
Precision medicine is growing more rapidly than ever. As science propels us into an era of highly personalized medicine, there’s a new demand across the healthcare spectrum for precision medicine and genetic therapies. This new landscape is changing rapidly, with advances in regulatory approval and payer/provider adoption occurring daily, and having an expert in your corner as you commercialize is key to ensuring market success.
Internet of Medical Things (IoMT)
Precision medicine is growing more rapidly than ever. As science propels us into an era of highly personalized medicine, there’s a new demand across the healthcare spectrum for precision medicine and genetic therapies. This new landscape is changing rapidly, with advances in regulatory approval and payer/provider adoption occurring daily, and having an expert in your corner as you commercialize is key to ensuring market success.
The precision medicine market is becoming increasingly crowded as technology and manufacturing for genetic therapies becomes more widely available. This means that prioritizing the right market access strategies at the right time will be key in keeping you ahead of the competition.
OUR EXPERIENCE:
Our team of experts has experience in accelerating market access opportunities for top precision medicine & genetics innovators. Our work spans study design and execution, health economics, market access strategy, and reimbursement and sales support.