Tutti Toot Ltd is developing a novel medical device designed to address adherence challenges in Airway Clearance Techniques (ACT) for patients with chronic respiratory conditions. The Tutti Toot Trumpet is a gamified musical device that provides real-time Positive Expiratory Pressure (PEP) measurements to facilitate effective therapy.
To support their commercial strategy and strengthen their value proposition, Tutti Toot Ltd required a comprehensive strategic market access review. This aimed to validate the market opportunity, examine the competitive landscape, and navigate the complex procurement and reimbursement environments of both the UK and US markets.
The Technology
Adherence to ACT is a critical issue for patients with conditions such as Cystic Fibrosis and COPD. Traditional methods and devices often lack engagement, leading to suboptimal therapy compliance.
The Tutti Toot Trumpet addresses this need by integrating a musical and gamified approach. The system also includes online resources, peer support and remote-monitoring capabilities, which connect the user with their consultant or physiotherapist via the dedicated clinician-facing dashboard. A key objective of the device is to enhance adherence, provide technique training, and enable accurate remote monitoring of ACT, surpassing the capabilities of traditional approaches. This technology is designed to serve significant patient populations, including the estimated 11,318 people with Cystic Fibrosis in the UK and the 1.1 million people diagnosed with COPD in England.
Supported by Health Tech Enterprise
Enabled by the RTO grant from UK Edge Innovate UK Business Growth, Tutti Toot Ltd approached Health Tech Enterprise (HTE) to build a solid commercial foundation for their technology. Our tailored approach included:
- Strategic Market Access Review: A comprehensive overview of the UK and US markets, including an assessment of market size across varying respiratory sectors (CF, Bronchiectasis, COPD) and a review of competitor products and substitute services.
- Procurement & Reimbursement Strategy: A detailed guide to procurement pathways, including NHS Supply Chain, National Tenders, and the Drug Tariff in the UK. For the US market, the review covered Payors, Health Technology Assessments (HTAs), specific coding requirements (CPT, HCPCS, ICD-10) and reimbursement levels of competing devices from key payors.
- Competitor Landscape Analysis: A thorough analysis of the competitive landscape, reviewing the regulatory status (UKCA/CE/FDA) of incumbent devices and their usage trends in different territories.
Outcomes
The strategic guidance provided by Health Tech Enterprise has equipped Tutti Toot Ltd with the independent validation and commercial intelligence needed to advance their innovation. The project:
- Quantified Market Opportunities: We analysed the types of ACT devices utilised in respiratory segments across the UK and US markets. Our findings highlighted particular barriers to market entry and the necessary evidence required to successfully overcome them.
- Clarified Reimbursement Pathways: Demystified US reimbursement by identifying specific HCPCS codes and highlighting the challenges of securing coverage for COPD patients without specific conditions/comorbidities. Highlighted typical reimbursement levels of competing devices from Medicare & Health Insurers.
- Defined Strategic Roadmap: Delivered a clear path to market that prioritises generating health economic data to demonstrate cost effectiveness over low-cost competitors and detailing the range of NHS procurement routes and processes.
“The Tutti Toot Trumpet is designed to enhance Airway Clearance Techniques (ACT) by offering real-time measurements and training of effective Positive Expiratory Pressure (PEP), whilst making therapy fun. To secure its widespread adoption, we must demonstrate that it delivers superior clinical results and substantial health economic benefits. The comprehensive market analysis has clearly outlined the path to market, enabling us to tailor our strategy to the practical realities of clinical integration.”
Ben Storey, CEO & Co-Founder, Tutti Toot Ltd
