Periodic Reporting for period 2 - HelpingHAND (A 3D printed, affordable myoelectrical prosthetic hand of personalizeable size for optimal comfort and functionality)
Période du rapport: 2019-08-01 au 2020-10-31
PROBLEM ADDRESSED:
Losing a limb or being born without one is an event with massive implications in the daily life of patients, as simple tasks and easy house chores become challenges often beyond the patients’ capacities. More than the +25k€ that a single hand amputation implies in direct medical care costs, a figure that more than doubles if we consider indirect costs associated with lost production, it is ultimately the burden on the individual patients and their families that truly mirrors the impact caused by this condition. Your hand is the most personal thing you have, as your first and main source of communication from birth to grave.The need of prothetic hands are still widely unaddressed, with 1/5 end-users giving up on prothesis use altogether. Discomfort and poor functionality are key complaints of prosthetic end-users, with >75% considering their current prothesis too heavy and too slow for daily use. In addition, competing myoelectrical prosthetic hands are typical 20-50% heavier than a human hand, resulting in significant pain and discomfort from continuous daily use.
Hy5 has developed a disruptive myoelectrical prosthetic hand (MyHand). Bringing a unique value proposition of advanced gripping functionality and comfort at competitive cost. The core of our prosthesis is its patented hydraulic-based design, combined with highly technically optimized 3D-printed parts for an inmate value-for-money gripping performance and lifelike weight for utmost end-user comfort.
Hy5´s unique design uses a combination of pumps and valves that allows fingers to be moved independently by a single central pumping unit. This not only allows to significantly lower the complexity of the overall system architecture, but also enable advanced gripping functionalities and gesture freedom without significantly ramping the prosthesis cost.
Losing a limb or being born without one is an event with massive implications in the daily life of patiens.
Overall objectives:
1. Undertake the last refinement iteration of Hy5´s current prototype, including preparing its design for mass customization and personalized fitting to patient's anatomy.
2. Develop a new glove for protection of the core prosthesis components and to improve the aesthetic aspects of en-user experience.
3. Showcase Hy5´s prosthesis in a large scale pivotal study, including en-users of different ages and gender to demonstrate the performance across the potentially marketable population.
4. Prepare the CE-mark documentation for market approval.
5. Prepare the documentation required to pursue the administrative pathways required to secure reimbursement in both NO, DK and GER.
6. To prepare production ramp-up, secure a strong supply/distribution network and facilitate business scale-up.
Losing a limb or being born without one is an event with massive implications in the daily life of patients, as simple tasks and easy house chores become challenges often beyond the patients’ capacities. More than the +25k€ that a single hand amputation implies in direct medical care costs, a figure that more than doubles if we consider indirect costs associated with lost production, it is ultimately the burden on the individual patients and their families that truly mirrors the impact caused by this condition. Your hand is the most personal thing you have, as your first and main source of communication from birth to grave.The need of prothetic hands are still widely unaddressed, with 1/5 end-users giving up on prothesis use altogether. Discomfort and poor functionality are key complaints of prosthetic end-users, with >75% considering their current prothesis too heavy and too slow for daily use. In addition, competing myoelectrical prosthetic hands are typical 20-50% heavier than a human hand, resulting in significant pain and discomfort from continuous daily use.
Hy5 has developed a disruptive myoelectrical prosthetic hand (MyHand). Bringing a unique value proposition of advanced gripping functionality and comfort at competitive cost. The core of our prosthesis is its patented hydraulic-based design, combined with highly technically optimized 3D-printed parts for an inmate value-for-money gripping performance and lifelike weight for utmost end-user comfort.
Hy5´s unique design uses a combination of pumps and valves that allows fingers to be moved independently by a single central pumping unit. This not only allows to significantly lower the complexity of the overall system architecture, but also enable advanced gripping functionalities and gesture freedom without significantly ramping the prosthesis cost.
Losing a limb or being born without one is an event with massive implications in the daily life of patiens.
Overall objectives:
1. Undertake the last refinement iteration of Hy5´s current prototype, including preparing its design for mass customization and personalized fitting to patient's anatomy.
2. Develop a new glove for protection of the core prosthesis components and to improve the aesthetic aspects of en-user experience.
3. Showcase Hy5´s prosthesis in a large scale pivotal study, including en-users of different ages and gender to demonstrate the performance across the potentially marketable population.
4. Prepare the CE-mark documentation for market approval.
5. Prepare the documentation required to pursue the administrative pathways required to secure reimbursement in both NO, DK and GER.
6. To prepare production ramp-up, secure a strong supply/distribution network and facilitate business scale-up.
Preparation for mass customization. Fully achieved.
Focus the first part of HelpingHAND regards to production and mass customization, have been spent developing a lean production processes used to provide controlled conditions under which production processes are performed within the Operations department of Hy5Pro. Production Quality activities shall follow the principles and best practices outlined in ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes. Through a new lean production process we have reduced production cost, also production and assembly time significantly.
ISO 13485 Certification implementation. Fully achieved.
Hy5 has target ISO13485 certification of its internal procedures, to ensure the ability for Hy5 to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. In other non-medical industries, ISO certification is a “nice to have,” but in the medical device industry it is rare to be ISO 13485 “compliant,” rather than “certified.” The reason for the prevalence of certification is that some countries have made ISO 13485 certification mandatory for a company that wants an Establishment License for distribution of Class I devices, or a Medical Device License for Class II-IV devices. Hy5 MyHand is a Class I medical device. Hy5 was officially ISO13485 certified in June 2019.
Ergonomic optimized glove prototyp for the Hy5 prosthesis. Fully achieved.
The outcome of the protection glove product development is to be able to mass-produce a prosthetic glove that fit the Hy5 MyHand perfectly without diminishing the functionalities of the hand. Durability, material strength, aesthetics and pricing are all important factors that a will affect the end result, and our glove business plan. MyHand is certified to be used with a prosthetic glove, for both function and protection purposes. There are many standard prosthetic gloves in the market, but none of them are a good fit for MyHand. Standard gloves reduce MyHands´s full functionality, and this is mainly due to pre-moulded shape, material thickness and material shore. The MySkin protection glove serves several purposes. First, it protects the components of the Hy5 MyHand prosthesis that may suffer harm if exposed to moisture and dirt. Second, it provides cosmetic appearance to the myoelectric hand. Third, it provides the user and others protection from getting caught or pinched in the mechanical linkages of the hand. Fourth, it plays an important role in grasping and holding objects by supplying additional friction to the grasp.
50 protection gloves have been made.
Large scale user testing.
MyHand user testing have been done globally; in Norway, Sweden, Denmark, Australia, USA, UK, Germany, France, India and Japan (so far).
We are using local clinics in each country, overviewed by local CPO´s(Certified Prosthetic Orthopedics) to overview the user testing in the countries that we cannot or are able to attend our selves. The DASH questionnaire (Disabilities of the Arm, Shoulder and Hand) is used to document feedback from the users. At total of >50 prothetic users will participate in short(1-2 hours) and long term (1-2 weeks) user testing. 28 users have so far participated in the testing.
Pathway to secure reimbursement in NO, DK and GER. Fully achieved.
Current Upper Limb prosthetic market is segmented into two segments across most markets; Basic and Premium. Simple grippers/pinchers or basic myo-electric hands predominate the public health systems. i.e. Basic Segment. High cost multi-articulating hands dominate the private segment in most markets i.e. Premium Segment.
Focus the first part of HelpingHAND regards to production and mass customization, have been spent developing a lean production processes used to provide controlled conditions under which production processes are performed within the Operations department of Hy5Pro. Production Quality activities shall follow the principles and best practices outlined in ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes. Through a new lean production process we have reduced production cost, also production and assembly time significantly.
ISO 13485 Certification implementation. Fully achieved.
Hy5 has target ISO13485 certification of its internal procedures, to ensure the ability for Hy5 to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. In other non-medical industries, ISO certification is a “nice to have,” but in the medical device industry it is rare to be ISO 13485 “compliant,” rather than “certified.” The reason for the prevalence of certification is that some countries have made ISO 13485 certification mandatory for a company that wants an Establishment License for distribution of Class I devices, or a Medical Device License for Class II-IV devices. Hy5 MyHand is a Class I medical device. Hy5 was officially ISO13485 certified in June 2019.
Ergonomic optimized glove prototyp for the Hy5 prosthesis. Fully achieved.
The outcome of the protection glove product development is to be able to mass-produce a prosthetic glove that fit the Hy5 MyHand perfectly without diminishing the functionalities of the hand. Durability, material strength, aesthetics and pricing are all important factors that a will affect the end result, and our glove business plan. MyHand is certified to be used with a prosthetic glove, for both function and protection purposes. There are many standard prosthetic gloves in the market, but none of them are a good fit for MyHand. Standard gloves reduce MyHands´s full functionality, and this is mainly due to pre-moulded shape, material thickness and material shore. The MySkin protection glove serves several purposes. First, it protects the components of the Hy5 MyHand prosthesis that may suffer harm if exposed to moisture and dirt. Second, it provides cosmetic appearance to the myoelectric hand. Third, it provides the user and others protection from getting caught or pinched in the mechanical linkages of the hand. Fourth, it plays an important role in grasping and holding objects by supplying additional friction to the grasp.
50 protection gloves have been made.
Large scale user testing.
MyHand user testing have been done globally; in Norway, Sweden, Denmark, Australia, USA, UK, Germany, France, India and Japan (so far).
We are using local clinics in each country, overviewed by local CPO´s(Certified Prosthetic Orthopedics) to overview the user testing in the countries that we cannot or are able to attend our selves. The DASH questionnaire (Disabilities of the Arm, Shoulder and Hand) is used to document feedback from the users. At total of >50 prothetic users will participate in short(1-2 hours) and long term (1-2 weeks) user testing. 28 users have so far participated in the testing.
Pathway to secure reimbursement in NO, DK and GER. Fully achieved.
Current Upper Limb prosthetic market is segmented into two segments across most markets; Basic and Premium. Simple grippers/pinchers or basic myo-electric hands predominate the public health systems. i.e. Basic Segment. High cost multi-articulating hands dominate the private segment in most markets i.e. Premium Segment.
Either due to genetic malformation, war incidents or occupational accidents, more than 8 million people worldwide are currently in need of prosthetic solutions to replace missing hands. In developed countries alone, there are around
half a million myoelectrical prosthesis users, representing a potential addressable market worth over €1 billion.Prosthesis weight and closing speed, together with its gripping force and gesture flexibility, are fundamental for the overall usability and functionality of a prosthetic hand. However, even state-of-the-art solutions fail to address these features, and thus a suitable combination of all these elements would be a disruptive breakthrough for end-users. Moreover, the spectrum of commercial hand myoelectric prosthesis is clearly partitioned between simpler grippers and advanced, bionic-like devices, evidencing a mutually exclusive trade-off between cost and functionality.
half a million myoelectrical prosthesis users, representing a potential addressable market worth over €1 billion.Prosthesis weight and closing speed, together with its gripping force and gesture flexibility, are fundamental for the overall usability and functionality of a prosthetic hand. However, even state-of-the-art solutions fail to address these features, and thus a suitable combination of all these elements would be a disruptive breakthrough for end-users. Moreover, the spectrum of commercial hand myoelectric prosthesis is clearly partitioned between simpler grippers and advanced, bionic-like devices, evidencing a mutually exclusive trade-off between cost and functionality.