Regulatory strategy and compliance
OHC helps companies in the medical device and veterinary device sectors targeting:
- A better demonstration of the clinical benefit of their products,
- The development of interactions between human and animal health.
Services focused on 3 main areas:
Animal health - veterinary devices
- Marketing and regulatory strategic feasibility study.
- Identification of the applicable regulations according to the targeted scope of commercialisation.
- Support in preclinical and clinical studies definition and realisation.
Human health - medical devices
- Support in change control and emergency management.
- Improvement in drafting of regulatory justifications in design files, technical documentation and deficiencies response files to authorities and notified bodies.
- Optimization of the quality approach and of the post-market surveillance process.
One health - medical devices and veterinary devices
- Identification of the clinical needs that your device can cover in human and animal health.
- Technical-regulatory positioning strategy.
- Support in the improvement of the adoption of the device: essential performance, safety and durability studies to conduct, information and communication to the user.
Positioning your product
You believe in your device and OHC believes in your device. However, the relevance of your product in the therapeutic strategy must be proven. This proof is part of the regulatory requirements in human health (demonstration of clinical benefit) and also in animal health where, even in the absence of specific regulations, users (veterinarians, owners, guardians) challenge the data showing the interest and safety of the product.
The support made by OHC thus begins with the review of the positioning of your device according to the state of the art. This review will enable:
- The improvement of definition and translation of applicable regulatory requirements,
- The identification of patient and user needs to be taken into account in the design to ensure the adoptability of the product,
- The definition of safety and performance criteria to include in the design of preclinical and clinical studies,
- To highlight medium and long-term product positioning opportunities that can be investigated in post-marketing studies.
Impact on design
The identification of the applicable regulatory requirements is performed together with the review of the device design data.
For a device under development, the regulatory review of preclinical and clinical data will enable you to challenge your verification and validation strategy defined in your design dossier. This review is an opportunity to ensure the effective translation of the regulatory requirements on the product. OHC helps you track any changes.
The approach of anticipating opportunities and minimizing risks also allows OHC to recommend applicable optimization strategies and to help you deploy them by considering the regulatory requirements of different markets or reimbursement as early as possible in the design process of your device.
For veterinary devices for which there are few defined regulatory and normative requirements, OHC helps you build an ideal roadmap and guides you in the process for conducting the studies.
Implementation of the action plan
The implementation of activities according to the defined regulatory compliance strategy and their formalization can be conducted:
- Through the coaching of your teams by OHC: OHC guides your team in the realization while increasing their skills, or
- Managed directly by OHC: regular dedicated monitoring is carried out so that you can follow the progress and take ownership of the solution put in place.
OHC can also assist you in interacting with various organizations as part of this compliance process:
- Service providers and subcontractors: OHC can play the role of facilitator in the exchanges to maintain and strengthen your links with these essential partners while ensuring compliance in a sustainable manner.
- Notified bodies and competent authorities: OHC helps you to communicate to obtain feedback prior to regulatory submissions and to answer the deficiencies raised during review of the dossier, audits, or inspections.
Remediation and improvement
With the effective regulatory compliance made for a given subject, gaps or needs for improvement may be observed for previous projects or for interacting processes.
OHC helps you correct and improve this existing situation by supporting you in:
- The reverse engineering approach,
- Interactions with risk management,
- Traceability of corrections in the quality management system.
OHC also guides you in managing changes related to desired improvements by helping you to:
- Identify the impacts of the targeted modification at technical, documentary, and regulatory level,
- Define transition modalities,
- Formalise the analysis and the justification of the choices made.
Examples of supports provided
Move a project forward
First device – Emergency – Funding
The challenge: a start-up in the field of 3D printing was in the technical and industrial development phase for its first medical device. This company wanted to start collecting clinical cases very quickly on the one hand and was looking for funding for their innovative project on the other. This start-up did not have in-house expert resources in regulatory affairs, quality and clinical affairs.
Analysis and strategic approach: OHC first considered the urgency of the request. The collection of clinical cases being fundamental according to the company’s strategy, OHC used the specific regulatory context (transition period of Directive 93/42/EEC and the regulation (EU) 2017/745 (MDR)) to carry out a short-term compliance plan.
OHC also considered the typology of the team and carried out a compliance diagnosis to perform a gap analysis and remedy the lack of formalization regarding the design and manufacturing data.
Finally, OHC identified the need for writing a formalized state of the art justifying the innovative nature of the system to help the company compile its funding application files.
Results: OHC produced a comprehensive technical documentation covering risk analysis, production data and solutions for compliance with safety and performance requirements. OHC also gave recommendations for good practices in compliance, correction, and formalization.
To anticipate medium-term changes, OHC also provided a strategic regulatory compliance plan for the MDR.
The rational relating to the state of the art written by OHC and integrating:
- Research and critical analysis of literature data,
- A discussion on the justification of the innovative approach,
- The design philosophy deployed to meet identified clinical needs,
Participated in obtaining financing to allow the company to continue its development.
Redesign an existing product
Maintaining on the market – Reverse engineering – Remediation
The challenge: a company had an implantable device of animal origin on the market for more than 30 years. As part of the renewal of the CE marking and with a context of tightening regulatory requirements, the notified body asked many questions relating to the management of the risks related to the animal origin and the maintenance of the clinical benefit.
Analysis and strategic approach: the major causes of non-compliance for a device that has been on the market for many years are the lack of formalization of the initial design choices, of the analysis of the impacts of regulatory and normative watch as well as the lack of traceability of the benefit/risk ratio review.
OHC has chosen an approach based on reverse engineering to overcome this lack of formalization and to analyse the impact on devices already marketed based on a remediation approach. The experience of communication with critical subcontractors also allowed to recover key data from the supplier of the biomaterial.
Results : The notified body has accepted the review file of the requirements applicable to medical devices using animal tissues produced by OHC and containing:
- A design history,
- Reports on the applicability of specific standards and regulations identifying the applicable requirements, the associated proofs of compliance and justifying those that were not applicable,
- A specific risk management file,
- The traceability of the biomaterial (from the selection of the raw material, manufacturing and in-process controls, stability data to controls upon receipt at the manufacturer of the final device) as well as the verification of the conformity of these data on the last batches produced,
- Substantiated review of data relating to inactivation/elimination processes for viruses and TSE agents,
- The justification of the benefit of using a biomaterial of animal origin with regard to existing therapeutic alternatives.
Find the strategic place
Positioning – Regulatory benchmark – Short-term feasibility
The challenge: within the framework of the observation of regenerative properties of a biomaterial in a certain number of cases of dermatological pathologies, a company wished to advance in the development of two topical products whose final claims would have to be formalized taking into account the requirements regulations that may apply.
Analysis and strategic approach: knowing that the company:
- Was at the beginning of the development with product formulations resulting from its proof-of-concept activities (design freeze not carried out),
- Had not defined a target qualification for its products (for example, qualification in cosmetic products),
OHC analysed that the definition of a regulatory strategy identifying the possibilities of qualifying products as drugs, medical devices and cosmetic products as well as the impacts on the feasibility with regard to the initial formulations of the products was the most relevant solution.
The analysis was thus based on:
- Analysis of the composition of the products and their anticipated modes of action in the targeted pathologies,
- Current therapeutic alternatives for the targeted pathologies as well as uncovered clinical needs,
- The impacts of the different qualifications of the products on the claims that could be made in the communication tools with users,
- Regulatory benchmarking identifying existing products on the market, their claims, and their qualifications.
Results: OHC provided a regulatory strategic positioning report. In one case, positioning as a medical device was recommended with regard to possible claims (medical purpose), better positioning compared to existing products on the market and better anticipated adoptability by prescribers and users. In the other case, positioning as a cosmetic product was relevant with regard to the formulation of the product, the therapeutic strategy observed, and the positive cost/time/benefit ratio compared to positioning as a drug or medical device.