The IWA Consulting Team is a dedicated group of regulatory science specialists providing expert services to a range of international private and public clients.

We perform our tasks based on our long-term regulatory experience, in-depth knowledge, and expertise.

We assist biotech, pharma, and medical device companies in achieving their major regulatory milestones, knowing and thoroughly understanding the sense of urgency that applies to this business area. Regulatory science – in every aspect of the discipline – is our core competence.

When you start – start right

The medical device industry is challenged by raising demands for technical documentation and continuous changes in regulations and guidelines. To navigate in this regulatory environment, involving regulatory consultancy companies – like IWA Consulting – in the very early stages of the process can benefit companies significantly.

The challenges, and how to deal with these?

It’s fair to say that the medical device industry has struggled significantly with regulatory challenges over the last years. Implementation of MDR/IVDR, establishment of Medical Device Single Audit Program (MDSAP), needs to adopt the revised quality management standard (ISO/EN 13485:2016) and – as for most industries – the challenges derived from Brexit and COVID-19, just to mention a few.

Both well established, mid-size enterprises and start-up medical device companies do not always have the in-house specialized resources or knowledge needed to manage the complex and extensive regulatory tasks required to develop and market medical devices. Expertise and assistance needed can vary from support to create a regulatory strategy plan to final product approval, either with remote or on-site assistance.

At IWA Consulting we are experienced in using our broad expertise to provide tailored services to the medical device industry. As for many other aspects in life, key elements in successfully reaching a goal are good planning, understanding the relevant steps and the ability mitigate the risks.

For medical devices it is essential to understand some key elements which are critical in paving the way from concept to launch and market of a medical device. Prior to obtaining market approval, the authorities often need to assess and approve technical documentation. As such a step – e.g. obtaining CE-mark – is done at the end of the product development process, it is key to ensure that all supporting documentation is available, sufficient and structured to demonstrate that product safety and performance criteria are met. So - When you start, you have to start right.

The medical device lifecycle processes must for sure be designed and tailored to the individual company’s needs, but the following basic elements are key and address generic elements to support the process from concept, design control, design transfer, market approval, launch and post market surveillance.

  • Concept & Feasibility

  • Preclinical Development

  • Clinical Development

  • Market Approval

  • Commercialization & Post-Market

  • Establishment and maintenance of a Quality Management System

Johnny Hansen, Senior Director, Medical Device 

Concept & Feasibility

Concept and feasibility include fundamental steps to define device specifications, foreseen intended use(s) and indication(s) for use, collection of relevant data to support product safety and performance for a feasibility study.

Especially for breakthrough technologies, medical device companies can benefit from initiation of an early dialogue with a regulatory body, in order to ensure that correct and sufficient measures are included in the product development and registration strategy. Also, reimbursement analysis should be undertaken in order to address market access challenges, current perceptions of standard of care, defining unmet need and gold standard treatments as well as other treatment alternatives.

Preclinical Development

Preclinical development primarily composes of scientific literature review, in vitro tests like animal proof-of-concept studies as well as biocompatibility assessments to confirm feasibility in human.

These studies will lead to the final planning for clinical studies.

Clinical Development

The main objective of medical device clinical development is to evaluate the risk/benefit balance during pivotal clinical studies and hence further validate the labeling claims.

The medical device is tested in a patient population representing the final users, and ideally compared with the therapeutic gold standard or direct competitor.

Health economics data are also gathered, to prepare for demonstrating the product’s value to payers, which are important elements to determine pricing and reimbursement.

Market Approval

In Europe, CE marking procedures encompasses both evaluation of the product technical file and the manufacturer’s Quality Management System (QMS) to ensure compliance with applicable regulations. In the USA, Pre-Market Notification (510k) and Pre-Market Approval (PMA) are required to enter market. For rest of world markets, local market approval requirements applies.

Registration dossiers provide comprehensive information about the product and quality assurance, enabling regulatory bodies to assess quality, safety and performance of the medical device.

Commercialization & Post-Market

Post marketing surveillance (PMS) must be organized to monitor the safety and performance of the product after the product is marketed. Measure to proactively collect and analyze relevant data must be established to ensure a sustainable risk/benefit balance.

E.g. agreements should be established with distributors in particular to define the split of regulatory responsibilities between the different stakeholders (economical operators).

Launch, pricing, and reimbursement strategies aim to yield a favorable evidence-based assessment by national authorities, whose priorities and outcome measurement vary across markets.

Accordingly, the medical device’s core value dossier should be adapted for local reimbursement applications as needed.

Establishment and maintenance of a Quality Management System

When you start you need to ensure that all the above addressed steps and activities are planned, executed and documented in a structured manor, and it is required that a QMS system based on ISO/EN 13485 is implemented right from start of the project.

The QMS must include and address all necessary requirements to demonstrate the organizations ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

For more information about IWA Consulting Medical Device services, please contact Johnny Hansen, Senior Director, Medical Device.

We publish articles at our website

Last published:

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Upcoming webinar at Pharmakon:

  • How to obtain successful market access for a pharmaceutical product - Monday 16th November 2020 from 17.00 - 18.30– sign up here