Every once in a while, Japanese Ministry of Health, Labor and Welfare (MHLW) issues notices to announce evaluation principles of “Next-Generation Medical Devices,” to accelerate review and approval process of new medical devices which has high demands and high feasibility of product realization. Since 2008, there have been 27 issuances by MHLW listed in the end of this article.
In this article, we will introduce list of “Next-Generation Medical Devices” that were announced in the past notices as well as were one of the notices issued in September of 2020, “Evaluation Index of Medical Devices for Home Medical Care”.
Evaluation Principles of Medical Devices for Home Medical Care in Japan
1. Definition of Medical Devices for Home Medical Care
Medical Devices for home medical care are devices that are used in an environment other than medical institution, such as home, nursing facility, offices, school, outdoor environment, airplane, and/or vehicles. Users of the devices are defined as someone who operates the device, whether or not this person is a medical professional. Users include patient themselves, patient’s family, non-medical professional, doctor, nurse, caregiver, emergency rescue worker, etc.
2. Main Evaluation Items
(1) Applicable Scopes
Make sure to clarify applicable diseases/medical condition, intended use, efficacy, location of use, scope of patients. Make sure the applicable scopes are suitable for home care
(2) Usage Environment
Make sure to consider environments are different from medical institution. Situations require considerations are such as: falling objects from shelfs, pets and children. Make sure to consider the worst cases. If it is difficult to guarantee the use of medical device under every situation, make sure to take some measures such as limiting users, specifying control management system, and etc.
(a) Accessibility to Medical Institution
Make sure to consider travelling time to medical institution from home care environment. If needed, make sure to clarify requirements about accessibility to medical institution.
(b) Location of Installment
Make sure to discuss requirements for installment location of home care medical device: such as physical interference with home appliances, furniture’s, floors, children, and pets.
(c) Temperature and Humidity
Make sure to consider condition of use and durability of the device. Make sure to evaluate every situation related to stable operation. Make sure to consider the fact that Japan is relatively hotter and more humid than Europe and North America.
(d) Change in Atmosphere Pressure
Make sure to evaluate altitude or change in atmosphere pressure by airplane.
Make sure to consider there will be more vibrations/oscillations under the environment that is not medical institution. Also, make sure to consider contact with pets and falling objects.
(f) Hygiene Control
Make sure to consider that hygiene control is worse than medical institution. For example, pets, pests, cigarette smoke, home use chemical product, food, etc.
(g) Disasters Which May Cause Disturbance of Following Supplies
- Compressed air, oxygen, and other gases
- Power source
- Communication environment such as stale line to call rescue
- Consumable accessories for the use of device
Make sure to discuss and evaluate the outdoor use, daily transportation such as vehicles, airplanes, trains, and travel to foreign countries.
(i) Contact with Liquid
Evaluate contact with liquid used at home, for example, water, drinking water, cleaning product, hand sanitizer, etc.
Make sure to discuss feasible storage method for the device and consumable accessories.
3. Evaluation Items Related to Product Design
(1) Risks for Long-term Use
Make sure to consider durability as device as well as risks of long-term use such as comfortability for its user .
Make sure product devise considers daily life of user, patient, its family that the use of device does not decrease quality of life.
(3) Lock-Out Function
To avoid unintended change in setting of the device, it is important to have a function that locks out its user. However make sure the device does not to rely entirely on the lock-out function.
(4) Daily Maintenance
It is highly desired that frequency and the number of items of maintenance are at minimum level. If periodic maintenance is required, make sure to clarify procedure that is easy for user who is not medical professional.
It is highly desired that home care medical devices do not require calibration. In case required, its process must be easy and minimum, and if possible, device itself should be able to show when the calibration is/should be done.
(6) Mechanical Systems
Make sure to evaluate the strength and characteristics of the device, and consider physical shocks during home use.
(7) Electrical System
Make sure to evaluate the point that that power supply installed are not as stable as medical institutions.
For further evaluation points, please refer to following link or inquire us.
Past “Next Generation Medical Devices” That Were Announced
Clinical Evaluation of High-Function Artificial Heart
Support Device for Bone Fracture Reduction
Support Device for Joint Surgery
Cell Sheet for Severe Heart Failure Treatment
Corneal Epithelial Cell Sheet
Corneal Endothelial Cell Sheet
Computer Aided Surgery Device for Soft Tissue
Neural Function Treatment Device
Cell Sheets for Periodontal Tissue Therapy
Custom-Made Hip Joint for Orthopedics
Computer-Aided Diagnosis Device
Custom-Made Knee Joint for Orthopedics
Diagnosis Device Based on RNA Profiling
iPS Cell-Derived Retinal Pigment Epithelial Cells
Device for Recovering Activity Function
Clinical Evaluation for Medical Device Treating Critical Limb Ischemic Disease
Nasal Cartilage Regeneration
Cardiac Catheter Ablation Device Using 3D Mapping Device
Custom-Made Orthopedic Implants Using 3D Additive Manufacturing Technology Based on Patient’s Data
Diagnostic Device Using Microfluidic Chip
Medical Devices with New Function That Uses Biologically Derived Material
Blood Flow Simulation Software
Image Diagnosis Support System Using Artificial Intelligence
Medical Devices for Home Medical Care
Clinical Evaluation of Intractable Wound Care Devices
Medical Support Device with Closed-Loop Control System
Clinical Evaluation for Anesthesia Support Device with Closed-Loop Control System