Abstract
The design process of innovative medical devices, and especially robotic systems for rehabilitation purposes, entails the collaboration among different stakeholders. Moreover, regulations strongly affect the products development, e.g. providing unexpected technical requirements and design constraints. In this paper, an innovative open innovation-inspired model for the design process of medical devices is presented. This model aims at optimizing the employed resources (such as time and cost) and allows overcoming the limits of the traditional linear design model, and specifies i) which stakeholders are involved in the different phases of the process, and ii) the role of the regulations. Special emphasis is placed on the contribution of users and operators (as physiotherapists or caregivers), in addition to physicians and engineers. The contribution of the regulatory aspect is analysed both from a general point of view, with international validity, and punctually, referring to MEDDEV 2.7/1 guideline as illustrative case study. Strength points and limits of the proposed model are highlighted, evaluating examples of incremental and disruptive innovation, like the adoption of new materials or the implementation of functional innovations.
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References
Hagedorn, T.J., Grosse, I.R., Krishnamurty, S.: A concept ideation framework for medical device design. J. Biomed. Inform. 55, 218–230 (2015)
Azman, N., Muhd Nor, N.H., Hassan, M.F., Jamian, S., Abd Rashid, M.H., Omar, B., Mohd Muji, S.Z., Mohamad, F., Ahmad, M.F., Turan, F.M., Bakar, E.A.: Review on design for medical device. MATEC Web Conf. 135, 1–10 (2017)
Peter, L., Hajek, L., Maresova, P., Augustynek, M., Penhaker, M.: Medical devices: regulation, risk classification, and open innovation. J. Open Innov. Technol. Mark. Complex. 6, 42 (2020)
Barrett, G., Dooley, L., Bogue, J.: Open innovation within high-tech SMEs: A study of the entrepreneurial founder’s influence on open innovation practices. Technovation. 103, 102232 (2021)
Davey, S.M., Brennan, M., Meenan, B.J., McAdam, R.: Innovation in the medical device sector: an open business model approach for high-tech small firms. Technol. Anal. Strateg. Manag. 23, 807–824 (2011)
Ray, P.P., Amaral, J.F., Hinoul, P.: Innovation best practices in the medical device industry. Tech. Vasc. Interv. Radiol. 20, 90–93 (2017)
Amici, C., Faglia, R., Taveggia, G., Mor, M.: Development of user-oriented mechatronic devices for post-stroke rehabilitation: the Experience of UniBS H & W. In: Proc. R&D Manag. Conf. 2016 From Sci. to Soc. Innov. Value Creat. 3–6 JULY 2016 | CHURCHILL Coll. | CAMBRIDGE Conf. Pap. 1–10 (2016)
Chatterji, A.K., Fabrizio, K.R.: Does the market for ideas influence the rate and direction of innovative activity? Evidence from the medical device industry. Strateg. Manag. J. 37, 447–465 (2016)
Chatterji, A.K., Fabrizio, K.R.: Using users: when does external knowledge enhance corporate product innovation? Strateg. Manag. J. 35, 1427–1445 (2014)
Miller, A.M., Behan, R., Smith, I., Griffin, M., Keane, F., Langan, J., O’Rourke, C., McAleenan, N., Pandit, A., Watson, M.: A multidisciplinary approach to online support for device research translation: regulatory change and clinical engagement. Heal. Policy Technol. 10, 95–103 (2021)
Dharmawan, R., Ho, H., Ng, H.H.M., Iyer, N.G., Tan, H.K., Tan, N.C.: Implementing the biodesign process for medical device innovation in head and neck surgery. Surg. Innov. 27, 653–658 (2020)
Qi, W., Zhou, L.: User-centered wearable product design for community elderly care. In: 2019 12th International Congress on Image and Signal Processing, Biomedical Engineering and Informatics (CISP-BMEI) 0–4 (2019)
Lettl, C., Rost, K., von Wartburg, I.: Why are some independent inventors ‘heroes’ and others ‘hobbyists’? The moderating role of technological diversity and specialization. Res. Policy. 38, 243–254 (2009)
Gherardini, F., Renzi, C., Leali, F.: A systematic user-centred framework for engineering product design in small- and medium-sized enterprises (SMEs). Int. J. Adv. Manuf. Technol. 91, 1723–1746 (2017)
Amici, C., Ghidoni, M., Ceresoli, F., Gaffurini, P., Bissolotti, L., Mor, M., Fausti, D., Antonini, M., Ragni, F., Tiboni, M.: Preliminary validation of a device for the upper and lower limb robotic rehabilitation. In: 23rd International Conference on Mechatronics Technology (ICMT), Salerno (2019)
Borboni, A., Serpelloni, M., Borghetti, M., Amici, C., Aggogeri, F., Fausti, D., Antonini, M., Mor, M., Sardini, E., Faglia, R.: Hand robotic rehabilitation: from hospital to home. In: Advances in Service and Industrial Robotics. RAAD 2017. Mechanisms and Machine Science, pp. 877–884 (2018)
Serpelloni, M., Tiboni, M., Lancini, M., Pasinetti, S., Vertuan, A., Gobbo, M.: Preliminary study of a robotic rehabilitation system driven by EMG for hand mirroring. In: 2016 IEEE International Symposium Medical Measurement Application (MeMeA) (2016)
Tiboni, D., Legnani, M., Lancini, G., Serpelloni, M., Gobbo, M., Fausti, M.: ERRSE: Elbow robotic rehabilitation system with an EMG-based force control. In: Advances in Service and Industrial Robotics. RAAD 2017. Mechanical Machine Science, vol. 49, pp. 892–900 (2018)
Conti, A., Azzalini, E., Amici, C., Cappellini, V., Faglia, R., Delbon, P.: An ethical reflection on the application of cyber technologies in the field of healthcare. In: Advances in Service and Industrial Robotics. RAAD 2017. Mechanisms and Machine Science, vol. 49, pp. 870–876 (2018)
Amici, C., Pellegrini, N., Tiboni, M.: The robot selection problem for mini-parallel kinematic machines: a task-driven approach to the selection attributes identification. Micromachines 11 (2020)
Amici, C., Ragni, F., Ghidoni, M., Fausti, D., Bissolotti, L., Tiboni, M.: Multi-sensor validation approach of an end-effector-based robot for the rehabilitation of the upper and lower limb. Electronics 9(2020), 1751 (2020)
Glasgow, M.E.S., Colbert, A., Viator, J., Cavanagh, S.: The nurse-engineer: a new role to improve nurse technology interface and patient care device innovations. J. Nurs. Scholarsh. 50, 601–611 (2018)
Henschke, C., Panteli, D., Perleth, M., Busse, R.: Taxonomy of medical devices in the logic of health technology assessment. Int. J. Technol. Assess. Health Care 31, 324–330 (2016)
Formicola, R., Ragni, F., Mor, M., Bissolotti, L., Amici, C.: Design approach of medical devices for regulation compatibility: a robotic rehabilitation case study. In: Proceedings of the 7th International Conference on Information and Communication Technologies for Ageing Well and e-Health (ICT4AWE 2021), pp. 146–153 (2021)
Ramakrishna, S., Tian, L., Wang, C., Liao, S., Teo, W. E.: Medical Devices: Regulations, Standards and Practices. Elsevier (2015)
European Commission: MEDDEV 2.7/1 Rev.4: Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC. 1–65 (2016)
Stark, J.: Product Lifecycle Management. Springer International Publishing, Cham (2015)
Ceresoli, F., Aggogeri, F., Amici, C., Borboni, A., Faglia, R., Pellegrini, N., Tiboni, M., Antonini, M., Fausti, D., Mor, M., Petrogalli, G., Vertuan, A.: Differential system for gait rehabilitation. In: MESROB2018, pp. 1–8 (2019)
Stjepandic, J.W., Wognum, P.M.: Verhagen, Concurrent Engineering in the 21st Century. Springer International Publishing, Cham (2015)
Loureiro, B., Curran, A.: Complex Systems Concurrent Engineering. Springer London, London (2007)
International Organization for Standardization: Medical devices—Post-market surveillance for manufacturers (ISO standard No. ISO/TR 20416:2020) (2020)
International Organization for Standardization: Medical devices—Quality management systems—Requirements for regulatory purposes (ISO Standard No. 13485:2016) (2016)
Food and Drug Administration Center for Devices and Radiological Health: Design control guidance for medical device manufacturers. Des. Hist. File. 53 (1997)
International Organization for Standardization: Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process (ISO standard No. 10993–18:2020) (2020)
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Formicola, R., Ragni, F., Borboni, A., Amici, C. (2022). Design Process of Medical Devices for Robotic Rehabilitation: An Open Innovation-Inspired Approach. In: Shamtsyan, M., Pasetti, M., Beskopylny, A. (eds) Robotics, Machinery and Engineering Technology for Precision Agriculture. Smart Innovation, Systems and Technologies, vol 247. Springer, Singapore. https://doi.org/10.1007/978-981-16-3844-2_51
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