How to Design a Medical Device in 10 Easy Steps
By Luke Vos, Director at LUMA-iD
January 13th, 2019
In order to produce a medical device that meets the needs of the end user, there is a considerable amount of planning and detail that has to be committed to the project. From identifying a market need, to achieving the many regulatory requirements and passing the testing stage, designing and manufacturing a successful medical device depends on good team work and a clear understanding of the objectives involved throughout.
We’ve broken down how to design a medical device in 10 steps to help you get a clearer understanding of what needs to happen during the process.
1. Identify a need
In order for any new product to achieve success in its desired market, it ultimately needs to fulfil an existing – or unmet – need, and medical devices are no different in that regard. Whether it’s to be used to monitor and improve a patient’s health, or to make the delivery of treatment more efficient, a new medical device should be able to tick at least one of these boxes in order to be perceived as credible.
Not every new medical device needs to be a brand new innovation. In many cases they can simply offer advancements on existing technology or instruments by making them more cost effective, easier to use or improve the performance levels. This removes the need to constantly think outside of the box to identify a medical device that doesn’t yet exist. By focussing on market needs you can still successfully add tangible value to the healthcare industry.
2. Classify the device
Now you know what need the device is going to address, fundamentals such as intellectual property (IP) rights and the classification of the device need to be finalised.
How the device will be classified depends on the level risk involved when it is put to use and the laws associated with that. By securing the concept you are future-proofing it against any future claims or the development of a similar device by a third party who could prevent your own from ever reaching fruition.
At this point it makes sense to check for any pre-existing IP based on the same idea or similar – it could save you a lot of time by revealing that the same technology or mechanism already exists. That is something you’ll want to be aware of before valuable time, money and resources have been wasted on a device that cannot legally be put to use.
3. Regulatory and compliance issues
Depending on where the medical device is to be released, it will need to pass through stringent regulatory requirements in order for it to be considered safe for use by healthcare professionals. This applies to the design stage, where legal boundaries dictate particular practical and performance levels must be met. The medical device standards that need to be achieved on an international stage include:
International Electrotechnical Commission (IEC)
IEC 60601-1 is recognised on an international level as it deals with standards associated with safety and essential performance, with most recent amendments made in 2012.
International Organization for Standardization
Both ISO 13485 and ISO 14971 are widely recognised and implemented for the quality management of medical devices.
There are also region specific standards that have been adopted from the above which include:
- Medical devices being targeted for the American market will have to be approved by the Food and Drug administration (FDA).
- For countries in the European Union, the European Committee for Standardization (CEN) deal with ISO certification, while the European Committee for Electrotechnical Standardization (CENELEC) is equivilant to the IEC above.
With the UK’s departure from the EU still to be confirmed and finalised, and medical device regulations still outstanding, at this stage we can only assume that the UK will maintain the current EU standards it has been using since joining in the 1973.
4. Focus on your Minimum Viable Product
Each stage of your product development can be determined as a minimum viable product (MVP). This relates to the various stages involved in the design process, from conceptualising the idea, through to the finished product being manufactured.
For example, the first sketch made of the device is an MVP. It is defined as having just enough features to satisfy early-stage customers, while also providing feedback for you to progress to the next stage of development. It’s typically the most cost effective way of evolving the device without wasting valuable resources on a product that will find no use by the target audience.
The more feedback you get, the further the device can be refined and the closer to the production you become. By engaging with end users from the start of the process your device has a far better chance of success once launched.
5. Raising investment capital
Unless you are lucky enough to already have a wealthy backer in place, one of the main obstacles that will have to be overcome is finance related. Aside from relying on family and friends willing to fund the project, there are a number of other options available. This can range from venture capital investments, angel investment, private placement, bridge loans or initial secondary public offerings.
If the process is brand new, the best place to start would be to align yourself with an experienced and well-connected investment advisor. While this will add to the cost of the project, it will invariably prevent you from wasting valuable time and money pursuing opportunities that may not be suited to your circumstances.
6. Design controls
Good Manufacturing Practice (cGMP) lays out a framework of best practices for designers and manufacturers, serving as a minimum standard that must be met during the production process. In Europe it is further verified by the European Medicines Agency (EMA) who conduct compliance inspections to ensure they are being met at all stages. In America, this falls under the remit of the FDA’s Quality System Regulations (QSR).
In both cases, designers need to ensure devices meet quality system requirements for safety and efficacy, as well as developing procedures that remain in-line during the production stage and distribution of the device. This part of the design process allows designers to address any issues and make adjustments where necessary to continually work towards making a device that satisfies all the quality and safety requirements.
7. Testing and validation
In order for the medical device to find success on the market, it has to be deemed as reliable, usable and functional enough to support professional activities. Given the often critical nature of the application of the devices, professionals also need to have assurances they are effective and safe to use. This refers back to the earlier stages of the design process and underlines the importance of using MVPs and user feedback.
Not only does testing the product provide insight into its viability, but it provides a number of important benefits to the designer. Putting together a strategy will enable you to keep costs manageable and a tighter rein on the testing period, so there are no unforeseen delays in delivering the product to market. The end result of the testing stage is to confirm that the needs of the user are being fulfilled by the device by performing as intended.
8. Risk Management Procedures
As mentioned in the part 3 of this list (regulatory and compliance issues) every medical device must meet ISO 14971.This is done by establishing firm risk management procedures that lay out a clear pathway towards achieving this regulatory requirement.
From identifying any associated hazards, to controlling identified risks and evaluating associated risks, these must be applied to every stage of the design process. It is important to remember that ISO standards are also reviewed and updated (if required) every five years, so be sure to keep up-to-date with the latest standards.
9. Quality Assurance Standards
We also referred to ISO 13485 earlier in this article as all manufactures must have a quality management system (QMS) in place to ensure requisite regulatory standards are being achieved. This has an impact on very stage of the product development process, from design and production, through to storage, distribution and servicing.
There are no exemptions to achieving these standards and they also apply to any third-party organisation that has supplied services or components along the way. This is why when it comes to the manufacturing stage it is imperative that outside suppliers and partners are chosen carefully, ensuring they are able to meet these and other such requirements. Ultimately, it is the manufacturer that is liable for any failure to uphold them.
10. Project review
There is no set methodology when it comes to applying this stage to an individual medical device, as each project has different parameters. At heart it revolves around defining what needs to be completed, when it needs to be completed and who will be responsible for each stage. Having these set in stone will lay the groundwork for ongoing reviews that will assess if these targets are being completed successfully. Rather than making this a series of rigid meetings that occur on set dates, they should be responsive to the various stages of the design process as they are completed, so they remain relevant and productive.