The 5 Phases of Medical Device Development Process

When it comes to medical device, the entire process of prototyping, manufacturing and market implementation is regulated and requires a number of tests and analyses to confirm safety and accuracy. We trust doctors, and so we trust the devices they use. Don’t we? In this article we will discuss the five phases of medical device development. These steps include initial concept, product design, prototyping, device testing, design verification and validation. You will also know what are the stages of processing medical devices and how to successfully navigate a medtech project.

Stages of Processing Medical Devices

After 50+ MedTech projects delivered at Consonance we can tell one important piece of advice: give your product and your business time and space to pass 5 stages of medical device engineering. Missing any of these could make you join these unfortunate 75% startups which fail. 

Keep in mind that there’s plenty of opportunity for missteps in the medical device project management cycle that can set you back millions of Euros and several years – or worse, leading to the company’s downfall. 

Another piece of the jigsaw puzzle are medical regulations and certification paths which every new medical device should pass or at least match reference products which are available on the market. Recent adoption of EU MDR, FDA and EU regulations are now a much closer match than they were previously. And that’s good news! This is especially the case with regard to quality system requirements (both compliant with ISO 13485), prerequisites for conformity assessment, and conformance with harmonized standards.

FDA’s classification system is based upon device risk, with Class I (low risk) and Class II (moderate risk) mostly falling under the 510(k) pathway to market. This framework is based upon manufacturers being able to prove that their device is substantially equivalent to a predicate on the market. Class III devices are classified as high risk and require the PMA pathway, along with a substantial amount of data that validates and demonstrates the risk-benefit of the device.

In contrast, EU MDR has four device categories and five risk-based classifications. The categories are: non-invasive devices, invasive medical devices, active medical devices, and special categories (this includes contraceptive, disinfectant, and radiological diagnostic medical devices.) The risk classifications are:

• Class I – Non-sterile or no measuring function (low risk)
• Class I – Sterile and a measuring function (low/medium risk)
• Class IIa (medium risk)
• Class IIb (medium/high risk)
• Class III (high risk)

The risk classification assigned will determine the depth and amount of data required under MDR to get the approval of the medical device. The classification is also going to take any clinical studies or adverse events into consideration. Each device class has its own testing requirements (whereas under FDA, Class I and some Class II devices don’t require clinical testing).

Once we have clarified the importance of keeping track and possible issues with the FDA / MDR EU approval, let’s describe each stage and what is the result you should expect. Especially when you hire a medical device development company as a technology partner. 

Let’s check what, how and when should be done before we market the MedTech product?

Phase 1: Device Discovery and Risk Analysis

Developing a medical device is no easy task, due to a number of reasons. So take your time to define your needs. It’s crucial to generate a plan to develop your medical device and document it! I think answering these questions could help you to discover the scope of your next endeavor:

• What should my medical innovation do?
• Does my idea need a hardware device, and are there any existing competitors?
• If so, should it be a certified medical device with all strings attached or a gadget?
• Do I have enough resources to develop my idea?
• Who will become my technology (hardware and/or software) partner?
• Do I know anything about medical regulations and certifications?
• Is my idea validated in terms of business?

Think about your funding strategies, which markets you want to enter and where. Why do you think there is a need for your product? Each market has its own regulations and challenges. Make sure you protect your product by filing for IP (Intellectual Property) and patent your idea if no one has produced anything similar before.

Phase 2: Formulation, Concept, and Feasibility

I think we approach the moment where you should decide to go alone with further development or hiring experts in the medical device development field. The Concept and technical feasibility stage is critical, as it will be the phase in which you have a working device that proves your idea. Probably you’re already convinced the device has a market position, is viable and financially feasible, only then set the ball in motion. 

More funding would be necessary for prototyping and trialling your device. I would recommend starting to think about risks and customer requirements. At this stage you need to hear the voice of the customer and take feedback via surveys, competitor analysis, market research etc. and adopt this into the design of your product. And as in the previous phase – document each step to avoid missing important details.

Phase II should result in a concept and proving that your idea works. So you need to be prepared to go back over and over to revise the design and if you change anything document the changes! 

Phase 3: Design and Development – Verification and Validation

I’m sure it is a great feeling to see how your device is beginning to take shape. A medical device prototype design is behind. You have a prototype, you have done some trials. But validation and verification in the real world to prove that it will really withstand all the pressures is still head. Make sure you know what your acceptance criteria are for each test. Set up a matrix, called a design trace matrix which will ensure you have not lost track of your customer requirements. You will need to translate this into engineering requirements which is not an easy task to do when you don’t have any technical experience or education.

Risk management at this stage also comes into consideration. Call out all the potential failures of what can go wrong due to bad design, poor process or bad manufacturing, user failures by foreseeable misuse. It’s probably hard to be critical of your own idea, but try to find as many flaws in it as possible. The earlier you find design and technical gaps, the less problems you’ll face during certification and clinical trials.

Phase 4: Final Validation and Product Launch Preparation

Is it the last straight to the finish line now? Still, marketing and product branding is ahead of you. I know that there are a number of cases where product preposition has nothing to do with the real value of the product. And that’s terrible. But it’s a different story with an unpalatable bar of chocolate and a medical device, which should resolve a medical problem. 

So for your project apply a simple rule: no evidence means no marketing proposal.

Gather data now and evidence of testing – biocompatibility, electrical safety etc. where applicable. Perform all the stability testing, shipping trials. Some companies get to this stage only to realize they didn’t do all the testing, why? Because they didn’t know the regulatory requirements for the product, took shortcuts or didn’t see the real reason to do the test. 

Technical documentation should be ready by now. Bringing together a file full of all the evidence required to put in front of a notified body (MDR EU/ FDA) that will review/ audit your file for completeness against their expectations.

Phase 5: Production, Market Introduction, and Post-Market Follow-Up

The last phase doesn’t mean to be the simplest one. We need to cover important factors like medical device manufacturing, shipment, validate marketing plans by market introduction and implement processes to capture complaints, feedback and how this information will be treated. How will it loop back into your risk management system?

Regulatory clearance, technical file review is done, and you are ready to launch your product. Once you have your license or certificate, you can place your device on the market. For companies / startups outside the EU and you wish to sell products in Europe I have a piece of advice: find “Authorized Representative” who is appointed to represent your business in Europe.

Your device is in the market, in the hands of users, so be ready for feedback, improvements and continuously reviewing your internal systems. Keep customer service at the highest possible level to avoid problems with reports of unfair practices. Your company / product image is now your asset.

How long does it take to Develop a Medical Device?

To answer the question above, we should start with the risk classifications. Well, we notice a pattern, which leads to the conclusion: the higher we go, the longer the medical device development process takes. There is also another point to take into consideration. Does a planned product have a product as reference. If so – this might lower the cost and time to market.

Risk classification according to the MDR EU:

• Class I – Non-sterile or no measuring function (low risk)
• Class I – Sterile and a measuring function (low/medium risk)
• Class IIa (medium risk)
• Class IIb (medium/high risk)
• Class III (high risk)

The risk classification assigned to a product will determine the depth and amount of data required under MDR to get the medical device approved. The classification is also going to take any clinical studies or adverse events into consideration. Each device class has its own testing requirements (whereas under FDA, Class I and some Class II devices don’t require clinical testing).

That being said, medical device delivery takes time for sure and the class and how innovative a device is determine a project timeline. Some medical innovations are ready to be introduced in a year or so, others need years to pass clinical trials and certification due to their complexity and the process of evaluating the results of treatment.