Overseas Expansion of Non-Medical Device Products as Medical Devices: Learning from the Case of PARO

​​​While pharmaceutical regulations in Japan, the US, and Europe share some similarities to a certain extent, there are differences by region, and fundamentally, it is necessary to respond according to the circumstances of each country. Here, we will consider the case of the seal-type robot "PARO".

• Product Overview of "PARO"
  • The seal-type mental commit robot "PARO" was developed by Japan's National Institute of Advanced Industrial Science and Technology (AIST) and is one of the world's most successful therapeutic robots. 産総研：人間情報インタラクション研究部門 トピック 柴田崇徳
  • Since its development began in 1993, PARO has gone beyond the framework of a mere pet robot (toy) and has been introduced in over 30 countries worldwide as a non-pharmacological intervention tool that provides dementia care, pain relief, and mental stability.
  • A noteworthy point is that while the hardware is nearly identical in the three major regions—Japan, the US, and Europe—it is socially implemented as a "daily living support robot (welfare equipment)" in Japan, a "medical device" in the US, and "welfare technology" in Europe.
• Japan
  • In Japan, PARO has not received regulatory approval from the Pharmaceuticals and Medical Devices Agency (PMDA) and is a non-medical device. It is positioned as so-called "welfare equipment" and is registered in the "Technical Aids Information System (TAIS)" managed by the Association for Technical Aids. 用具詳細
  • This decision is likely based on the strictness and cost of the medical device approval process in Japan, as well as the difficulty of setting insurance points after approval, in addition to its intended purpose.
  • By utilizing subsidy schemes such as the "Nursing Care Robot Introduction Support Project" implemented by the Ministry of Health, Labour and Welfare, the Ministry of Economy, Trade and Industry, and local governments, nursing care facilities can introduce it at a low cost. 介護ロボット導入支援事業 - 愛知県
  • *On the other hand, there is information that preparations are underway for future medical device classification. 2022-osk04.pdf
• USA
  • In the US, it received approval from the FDA in 2009 as a "Neurological Therapeutic Medical Device (Class II)." Development and spread of therapeutic medical robot, PARO: Innovation of non-pharmacological therapy for dementia and mental health
  • Specifically, it claims effectiveness as a non-pharmacological therapy for the following symptoms:
    • Anxiety
    • Pain
    • Depression
    • Behavioral disorders associated with dementia and PTSD (aggression, agitation, wandering, etc.)
  • In the US, the use of insurance reimbursement is possible; when a physician or qualified therapist (occupational therapist, nurse, etc.) performs therapeutic intervention using PARO, the procedure can be billed as CPT code 90901 (Biofeedback training by any modality).
  • The background to insurance reimbursement being accepted involves "economic evidence" that the introduction of PARO can reduce the dosage of psychotropic drugs. The point that risks and costs associated with drug therapy side effects can be reduced is also a benefit for payers. PARO as a Biofeedback Medical Device for Mental Health in the COVID-19 Era
• Europe
  • In the European region, particularly in the Nordic countries and the UK, while PARO meets regulatory requirements as a "medical device," the mainstream model for social implementation is as "Welfare Technology," where municipalities and state-run medical systems invest budgets to introduce it as infrastructure.
  • Denmark, in particular, has the most advanced public introduction of PARO, with over 80% of municipalities in Denmark adopting PARO in elderly care facilities and facilities for people with disabilities. Playfulness and disruptions: using pet robots in everyday life in a nursing home for people with dementia | Ageing & Society | Cambridge Core
  • While the US emphasizes "therapeutic effects," Denmark emphasizes "improvement in quality of care" and "improvement of the working environment for care staff." Public spending is justified by the logic that if residents' agitated behaviors decrease due to the introduction of PARO, the physical and mental burden on staff decreases, resulting in lower social costs.The benefits of and barriers to using a social robot PARO in care settings: a scoping review - PMC
• Insights
  • An important point suggested by the case of PARO is that there is no need to stick to a single business model when expanding overseas.
  • In fact, in terms of laws and regulations, turning it into a medical device in Japan does not directly lead to ease of overseas expansion.
  • Rather, it shows that responding flexibly to the circumstances of each region is essential for business success.
  • Furthermore, it is noteworthy that clinical trials and demonstration tests were conducted in each location, and social implementation was realized locally over a long period.
  • Although the product appearance looks the same, the contents are repeatedly updated, and specifications differ slightly depending on the region and target users. Also, development is proceeding in stages, such as aiming for medical device classification from general goods in Europe and Japan.
  • It feels important to continue to improve and evolve steadily, rather than trying to do it all at once.