GI ENDOSCOPY & BILIARY-PANCREATIC DEVICES
Development and Regulatory Support for GI Endoscopy and Biliary-Pancreatic Devices
MK Consulting supports the development and improvement of gastrointestinal (GI) endoscopy and biliary-pancreatic devices, as well as their regulatory requirements. We also offer consultations on patent applications related to newly developed products and technical improvements.
Our approach is to understand the product, understand its clinical use, and understand the realities of clinical practice. We consider not only a device’s structure and specifications, but also the procedure, the stage of use, and how the device is handled when supporting development and regulatory work.
Our current development and improvement work focuses on plastic biliary and pancreatic stents.
Connecting Clinical Needs with Product Development
“We would like to make this operation easier.” “We would like to improve a difficult aspect of an existing product.” We start by identifying when and how the problem occurs.
We consider the intended procedure, anatomical site, method of operation, and devices used in combination to define the functions and specifications needed. When reviewing materials, outer and inner diameters, length, and tip geometry, we consider both the intended changes and the functions that should be maintained.
Adopting a new structure or specification is not an end in itself. We clarify which clinical need the change is intended to address and provide support appropriate to the project, from early ideas to reviews of prototypes and existing products.
Biliary stent development, approval and post-approval changes
Development and Improvement with a Focus on Plastic Stents
Reviewing Specifications and Structure
For biliary and pancreatic stents, we review the intended purpose, placement site, indwelling period, and plans for removal or replacement to identify the required functions.
We consider specifications such as outer and inner diameters, length, material, tip geometry, side holes, flaps, and pigtails in relation to insertion, placement, drainage, and removal. Comparisons with existing products and feedback from clinical evaluation help identify what should be changed and what needs to be checked as a result.
| Example of a consultation | Matters considered |
|---|---|
| Revising outer or inner diameter or wall thickness | We clarify the purpose of the change and the functions to maintain, such as the lumen, strength, and flexibility. |
| Improving the tip or retention features | We review problems encountered in use and the design intent of features such as the tip, flaps, and pigtails. |
| Changing the material or stiffness | We identify specifications to consider based on the desired properties, processing challenges, and differences from the current product. |
| Responding to requests for improvement from clinical users | We identify the situation in which the issue arose and use this information to review specifications and structure. |
Preliminary Checks Using a Phantom Model
As part of development and improvement work on devices such as plastic biliary and pancreatic stents, we conduct bench evaluations using our phantom model.
These are preliminary evaluations to check general operation and points of concern before a device is tried in a clinical setting, and to obtain information that can inform subsequent development discussions.
Using Clinical Feedback to Guide Improvements
We place importance on clinical feedback when seeking to understand actual handling and problems encountered in use.
Comments such as “difficult to insert” or “difficult to handle” are considered in the context of the conditions and operations involved, and differences from existing products. We compare this feedback with the device specifications and design intent to identify areas for revision and matters to check next.
Information obtained from bench work also serves as a reference as we use clinical evaluations to guide subsequent improvements.
Development Support Tailored to the Project
Development challenges differ by product and development stage. We consider an appropriate approach whether specifications are still being defined, a prototype presents problems, or users have requested improvements to an existing product.
For products other than plastic stents, we ask about the structure, method of use, and current challenges, then explain where our experience can help and which matters require further research. We then agree with you on our tasks and consider the product’s challenges one by one.
When regulatory questions arise during development, we also consider how changes to the intended purpose or specifications affect the evaluation documentation and application content.
Consultations on Patent Applications
We also welcome consultations on patent applications arising from product development and improvements.
Taking account of the product’s structure and functions, differences from existing products, and the purpose of the improvement, we help clarify its technical features to support consideration of a patent application. Our consultations are grounded in an understanding of the problem the product addresses and the technical approach used to solve it.
Regulatory Support for GI Endoscopy and Biliary-Pancreatic Devices
Our regulatory consultations cover biliary and pancreatic stents, ERCP accessories, and EUS-BD devices, as well as GI endoscopy devices used for biopsy, grasping, retrieval, resection, hemostasis, and tissue closure.
Related case study: Support for approval of a pancreatic duct stent
Application Strategy Based on Product Characteristics
We consider the applicable Japanese generic device name, risk classification, and approval, certification, or notification procedures based on the intended purpose, structure, differences from existing products, and available data.
Comparisons with existing products address not only dimensions and materials, but also the method of use, target site, mode of action, and whether the device is left in the body. We identify the documentation needed to explain the product’s characteristics and consider the application strategy.
Evaluation Plans and Documentation
We review the available documentation and additional information needed for performance, safety, and clinical evaluations.
We examine development-stage evaluation results, existing test reports, literature, and clinical data from outside Japan, distinguishing documents that may support the application from matters requiring additional evaluation or explanation. We support evaluation planning and documentation aligned with the product specifications and proposed intended purpose.
Regulatory Consultations, Applications, and Review Responses
We support the preparation of issues for PMDA consultation, consultation and application documents, and responses to questions during regulatory review.
We prepare documentation that presents the product’s characteristics and supporting evidence consistently across the intended purpose, specifications, evaluation results, instructions for use, and package insert. For review questions, we consider the purpose of the question and the actual product when deciding the response content and whether additional explanation or documents are needed.
From Development in Japan to the Introduction of Overseas Products
We support new product development by Japanese manufacturers and reviews of the specifications and structure of existing products. Where prototypes or clinical evaluation results are available, we use them to consider subsequent improvements and matters requiring confirmation.
For products being introduced from overseas, we review the intended use setting in Japan, devices used in combination, specifications, and intended purpose. We consider overseas evaluations, experience in use, test reports, and clinical data to identify product-related and regulatory issues for introduction into Japan.
Reference Information
Consult Us at Any Stage of Development
You can contact us while specifications are still being defined or before problems with a prototype have been fully clarified. We also support discussions on how feedback from clinical users can be reflected in product improvements.
Using the information available, such as a product overview, drawings, specifications, prototypes, and previous evaluation results, we clarify the development objectives and challenges. We then propose the scope of support and how to proceed.
We support development, improvement, and regulatory work through an understanding of the product, its clinical use, and the realities of clinical practice.