The Medtech industry: The challenges of gaining regulatory approproval

A concept image to illustrate the medtech industry

Leeanne Baker from IMed Consultancy Ltd offers insight into the commercialisation process within the medtech sector and offers some valuable advice.

The medtech industry is one of the fastest growing industry sectors in Europe, encompassing a wide range of healthcare solutions and devices. To keep pace with technological advances, and in order to react to address publicised patient safety issues, such as the PIP Breast Implant scandal, regulation and control in the market is becoming ever stricter. As such, getting a medical device to market is complex, expensive, and challenging for any small business or start-up.

Get it right, and the rewards can be immense and ultimately life changing for the patients. Get it wrong, and these devices will sadly never see the light of day.

The product

If you have a proven concept, you do not have a finished medical device.
Our experience with industry has shown that more often than not, start-ups and small businesses are focused on the core competency of developing their innovative medical technology without due consideration to the regulatory requirements. This can unfortunately lead to prototypes, or perceived production-ready devices, that then require costly and lengthy re-design and re-validation in order to meet the regulatory and safety and performance requirements of their target markets.

Ensuring suitable procedures and processes are in place throughout the design and development process, such as those of the medical device quality management system standard of ISO 13485:2016, are fundamental to the organisation and success in bringing a product to market.

The early identification of those product specific standards relevant to the device can mean that they are met and therefore ensure no nasty surprises later on, with missing test reports or failure to meet specifications. Having robust clinical data that will stand up to the scrutiny of the regulators is now more important than ever, as seen with the introduction of the MDR Annex XIV clinical requirements, which restricts manufacturers in their ability to utilise equivalence to competitor devices.

The ever-changing regulatory landscape

Understanding and planning for your target markets is crucial with the ever-changing regulatory landscape. The lack of worldwide regulatory harmonisation will undoubtedly necessitate additional considerations and registration processes to be followed for different geographic markets.

In many cases, the performance standards and expectations differ between markets, meaning that market consideration should have input into the early stages of design planning.

Additional challenges in relation to mandatory market specifics can further complicate issues, such as languages for labelling, special import requirements/restrictions, and the need for in-country representation. All of this should be investigated as early as possible and inputed into the product and market realisation process in order to avoid subsequent unnecessary delays and costs to rectify issues caused by poor planning.

The UK-based medtech industry with domestic and EU markets currently faces a very significant challenge in order to plan to address, certify new, and re-certify any existing products to the forthcoming Medical Device Regulation (MDR) 2017/745. The timing of the new regulations coming into force, the current availability of notified bodies to support such applications, coupled with the political uncertainty and possible impacts caused by the UK wishing to leave the European Union, aka ‘Brexit’, make this a very demanding time on human resources and finances. For those companies wishing to sell into the UK market, keeping up to date on the requirements post-Brexit will be critical, especially if and when the new UKCA mark is introduced.

Deep pockets – funding is key

Commercialisation of a medical device takes time, no more so than in recent years. Having sufficient funds in the bank to cover all costs is crucial. Funding a new innovation often focuses on the early design and development capital requirements without sufficient consideration for other ongoing stages. Identifying available funding from grants and investors is key.

Time – the slow speed of the medical device industry

The time involved in taking the product from concept to submission for regulatory approval is lengthy. Added to that is the amount of time it takes to gain approval. The pressure of Brexit, gaining MDR designation, and changes brought about by MDSAP and ISO 13485:2016 compliance coupled with the loss of many Notified Bodies has put a strain on capacity in recent years leading to lengthy turnaround times for Technical File reviews. Only a handful of Notified Bodies are taking on new clients and those with existing clients are reporting to have lead times of up six months or longer to get an audit scheduled or a technical file reviewed. This is leaving manufacturers frustrated and stuck between a rock and a hard place in gaining regulatory approval.

Identifying a notified body early on and having ongoing discussions can make all the difference. Let them know your plans and timescales and keep in regular contact to ensure as timely a review as possible.

Ensuring you have key knowledge available to your business is key. Often, a decision is made at the beginning of the project to for go consulting advice at the risk to the project and the business. Gaining advice and a clear understanding of the regulatory pathway as early on in a project as possible will save both time and money later on down the line.

Conclusions

Innovation in medical technology has never been so bright with so many opportunities. Navigating the regulatory hurdles efficiently and cost effectively is key to ensuring they see the light of the day and both patients and manufacturers can reap the rewards.

Our advice

Have a clear idea of the target markets that you wish to enter and work with a partner to identify the quality and regulatory requirements at the outset is crucial to prevent delays and incurring additional costs. Knowing what you need to do, in what order and at what cost, will be critical to your success.

Leeanne Baker
Managing Director
IMed Consultancy Ltd
+44 (0)1295 724286
leeanne@imedconsultancy.com
Tweet @IMedConsultancy
www.imedconsultancy.com

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