Periodic Reporting for period 4 - GyroGlove (Development and Commercialisation of an Intelligent Wearable Platforms to Stabilise Hand Tremors in Parkinson’s Disease and Essential Tremor)
Reporting period: 2021-09-01 to 2022-08-31
GyroGear is developing the GyroGlove, an intelligent wearable platform that stabilises hand tremors. Hand functionality is critical to daily activities of living and quality of life. Hand tremors can thus be severely debilitating and detrimental. Furthermore, the stigma and fatigue from tremors further reduce quality of life. Current pharmaceutical options can have a limited life span, considerable side effects and require higher doses with disease progression. Using compact, wearable mechanical gyroscopes ('GyroGlove'), the device’s mechanical gyroscope instantly, and proportionally counteracts any unwanted movement (tremors) whilst permitting deliberate movement. GyroGear listed 6 specific objectives for this SME Phase 2 project:
- Finalise engineering design specification
- Build functional and pre-production prototypes
- Transfer to manufacture
- Conduct clinical trials and gain regulatory approval
- Develop supply chain agreements and commercial contracts ready for full commercialisation
- Prepare for multiple market entry Q4 2023
- Finalise engineering design specification
- Build functional and pre-production prototypes
- Transfer to manufacture
- Conduct clinical trials and gain regulatory approval
- Develop supply chain agreements and commercial contracts ready for full commercialisation
- Prepare for multiple market entry Q4 2023
1. FINALISE ENGINEERING DESIGN SPECIFICATION
Working to finalise the product design specification, GyroGear has:
Refined its user requirements to mitigate the risks of poor product-user fit.
Finalised device’s sizing requirements through a review of primary and secondary anthropometric data.
Created a marketing specification to ensure the aesthetics of the device also meet our user requirements.
Created specifications for the device’s electronic and firmware systems.
Freeze the design.
2. BUILD FUNCTIONAL AND PRE-PRODUCTION PROTOTYPES
In tandem with the refinement and finalisation of the product design specifications, the engineering development team engaged in extensive design, prototyping and testing during the pre-verification stage. This was done to ensure the device meets all requirements before transferring to manufacture and starting the formal verification stage (see more details in attached technical report). In addition to testing, a documentation structure was implemented in preparation for assimilation into our quality management system. The documentation consists of Standard operating procedures, test specifications and reports to be used during the upcoming verification stage.
After the design freeze in the third reporting period, 10 pre-production units were built, and were used in the usability study that took place in July 2021, providing useful feedback for our upcoming Clinical trial.
3. TRANSFER TO MANUFACTURE
Following the successful pre-verification tests described above, GyroGear froze the design of the GyroGlove in October 2020. A set of documents are being drafted to detail the design and track how it meets requirements. GyroGear has started the transfer to manufacture. A manufacturing data package including engineering drawings, CAD files, assembly instructions (Documentation and Videos) and bill of materials were put together to share with our manufacturer to finalise our pricing strategy. The Manufacturers provided the necessary quotations which were analysed. This triggered the technical discussion with a narrower group of the potential manufacturers refining the manufacturability of the GyroGlove and taking us to the final negotiations with the selected manufacturer.
Supplier Agreements were issued and signed with two major manufacturing partners in Q4 2021.
A final set of verification tests will be carried out on units coming out of the production line to ensure the GyroGlove can safely be used in clinical trials. This verification stage will include internal tests (as described in the pre-verification section above) and external lab tests.
4. CONDUCT CLINICAL TRIALS AND GAIN REGULATORY APPROVAL
GyroGear has continued with its risk management activities, finalised its ISO 14971 risk management plan and, in line with this plan, updated risk documentation as new product hazards were identified. GyroGear has also been working in the planning of the clinical trial with the aim to finalise the protocol and start the trial now in Q2 2023. The clinical trial protocol has been developed through an iterative process with GyroGear clinical partners to ensure its scientific and clinical validity.
5. DEVELOP SUPPLY CHAIN AGREEMENTS AND COMMERCIAL CONTRACTS READY FOR FULL COMMERCIALISATION
Despite the global crisis in 2020 & 2021, GyroGear was able to maintain all of its supply chain agreements.
As for commercial contracts, GyroGear has begun conversations with APAC-region medical device distributors based in Singapore. These distributors hold long standing relationships with long-term care providers/doctors in the APAC region with B2B and B2C capabilities that we plan to leverage. They also provide warehousing and services to support delivery. GyroGear is also exploring the possibility of obtaining regulatory approval first in Singapore for local distribution in a single market. The discussions with local regulatory body HSA Singapore and regional distributors will determine if we are able to start selling in Singapore before US FDA approval (Q3 2023).
6. PREPARE FOR MULTIPLE-MARKET ENTRY IN LATE 2023
Since September 2019, GyroGear has expanded and ring fenced further the scope of its IP portfolio to include optimisations in the hardware design (G1A, G2, G3 and G4) and networked software implementations (G5).
GyroGear is ideally aiming for multi-market regulatory approval and multi-market launch. The first markets identified are likely US, EU, UK and Singapore. The commercial team works to build relationships with local and regional stakeholders in manufacturing, warehousing, distribution, provider networks, major payers and potential investors in a few markets at a time - to ensure that once regulatory approval is successful, sales can start as soon as possible.
Working to finalise the product design specification, GyroGear has:
Refined its user requirements to mitigate the risks of poor product-user fit.
Finalised device’s sizing requirements through a review of primary and secondary anthropometric data.
Created a marketing specification to ensure the aesthetics of the device also meet our user requirements.
Created specifications for the device’s electronic and firmware systems.
Freeze the design.
2. BUILD FUNCTIONAL AND PRE-PRODUCTION PROTOTYPES
In tandem with the refinement and finalisation of the product design specifications, the engineering development team engaged in extensive design, prototyping and testing during the pre-verification stage. This was done to ensure the device meets all requirements before transferring to manufacture and starting the formal verification stage (see more details in attached technical report). In addition to testing, a documentation structure was implemented in preparation for assimilation into our quality management system. The documentation consists of Standard operating procedures, test specifications and reports to be used during the upcoming verification stage.
After the design freeze in the third reporting period, 10 pre-production units were built, and were used in the usability study that took place in July 2021, providing useful feedback for our upcoming Clinical trial.
3. TRANSFER TO MANUFACTURE
Following the successful pre-verification tests described above, GyroGear froze the design of the GyroGlove in October 2020. A set of documents are being drafted to detail the design and track how it meets requirements. GyroGear has started the transfer to manufacture. A manufacturing data package including engineering drawings, CAD files, assembly instructions (Documentation and Videos) and bill of materials were put together to share with our manufacturer to finalise our pricing strategy. The Manufacturers provided the necessary quotations which were analysed. This triggered the technical discussion with a narrower group of the potential manufacturers refining the manufacturability of the GyroGlove and taking us to the final negotiations with the selected manufacturer.
Supplier Agreements were issued and signed with two major manufacturing partners in Q4 2021.
A final set of verification tests will be carried out on units coming out of the production line to ensure the GyroGlove can safely be used in clinical trials. This verification stage will include internal tests (as described in the pre-verification section above) and external lab tests.
4. CONDUCT CLINICAL TRIALS AND GAIN REGULATORY APPROVAL
GyroGear has continued with its risk management activities, finalised its ISO 14971 risk management plan and, in line with this plan, updated risk documentation as new product hazards were identified. GyroGear has also been working in the planning of the clinical trial with the aim to finalise the protocol and start the trial now in Q2 2023. The clinical trial protocol has been developed through an iterative process with GyroGear clinical partners to ensure its scientific and clinical validity.
5. DEVELOP SUPPLY CHAIN AGREEMENTS AND COMMERCIAL CONTRACTS READY FOR FULL COMMERCIALISATION
Despite the global crisis in 2020 & 2021, GyroGear was able to maintain all of its supply chain agreements.
As for commercial contracts, GyroGear has begun conversations with APAC-region medical device distributors based in Singapore. These distributors hold long standing relationships with long-term care providers/doctors in the APAC region with B2B and B2C capabilities that we plan to leverage. They also provide warehousing and services to support delivery. GyroGear is also exploring the possibility of obtaining regulatory approval first in Singapore for local distribution in a single market. The discussions with local regulatory body HSA Singapore and regional distributors will determine if we are able to start selling in Singapore before US FDA approval (Q3 2023).
6. PREPARE FOR MULTIPLE-MARKET ENTRY IN LATE 2023
Since September 2019, GyroGear has expanded and ring fenced further the scope of its IP portfolio to include optimisations in the hardware design (G1A, G2, G3 and G4) and networked software implementations (G5).
GyroGear is ideally aiming for multi-market regulatory approval and multi-market launch. The first markets identified are likely US, EU, UK and Singapore. The commercial team works to build relationships with local and regional stakeholders in manufacturing, warehousing, distribution, provider networks, major payers and potential investors in a few markets at a time - to ensure that once regulatory approval is successful, sales can start as soon as possible.
Based on the current development stage of the GyroGlove, the target users and market size considered in section 2.1 of the DoA are still relevant. GyroGear plans to transform the lives of people suffering with Parkinson’s Disease (PD) and/or Essential Tremor (ET). GyroGear is already working with healthcare providers, insurers, distributors and care homes (as outlined in table 2.1.1 of the DoA). GyroGear also works with all major PD and ET charities worldwide. Distribution channels have been established in multiple countries (EU & US), the FDA has reviewed the GyroGlove application during a pre-sub meeting and initial meetings have taken place with multiple US insurers.
These preliminary results reinforced the potential to improve the quality of life of PD and ET patients. GyroGear has now planned an international clinical trial (USA, UK, EU, Israel and Taiwan) and as consequence, a second pre-submission meeting took place with the FDA (Dec 2020) to approve our final test protocol, feedback was given and the protocol was updated. A third pre-submission meeting with the FDA took place in Sep 2022 to discuss GyroGear’s current regulatory approach for the GyroGlove following previous guidance from the FDA during pre-submission meetings and also confirm that the FDA are satisfied with our final pivotal study protocol draft. US FDA has suggested to incorporate TETRAS assessment as primary outcome rather than secondary outcome with other minor suggestions such as medication usage during in-clinic visits.
These preliminary results reinforced the potential to improve the quality of life of PD and ET patients. GyroGear has now planned an international clinical trial (USA, UK, EU, Israel and Taiwan) and as consequence, a second pre-submission meeting took place with the FDA (Dec 2020) to approve our final test protocol, feedback was given and the protocol was updated. A third pre-submission meeting with the FDA took place in Sep 2022 to discuss GyroGear’s current regulatory approach for the GyroGlove following previous guidance from the FDA during pre-submission meetings and also confirm that the FDA are satisfied with our final pivotal study protocol draft. US FDA has suggested to incorporate TETRAS assessment as primary outcome rather than secondary outcome with other minor suggestions such as medication usage during in-clinic visits.