Medtech innovation is as much about practicality as it is brilliant ideas. The idea is often the easy part; it’s the steps that follow – from funding and IP to regulatory compliance and reimbursement – that can make or break a business. This series is all about implementation – how to bring brilliant ideas to life, from concept validation through to commercialisation, as efficiently and effectively as possible. We call it the MedTech Roadmap™ – and this first article is an overview of the entire journey. Have a read, and make sure your device is heading in the right direction…
So you have an idea for a medical device that you believe will have a positive impact on the delivery of healthcare? Before you jump into R&D, run a reality check: make sure there is a clear unmet clinical need for your product. Establish the medical segment and standard of care you will be addressing. This due diligence will prevent you from wasting time and money on an idea that is not needed by clinicians. Find key opinion leaders in your target segment and think of how you can cultivate a relationship with them to help you tailor your device to their needs.
This is also the time to conduct a market assessment. Together with a market assessment specialist, establish what other existing devices target the same clinical need and how your new device can add value to what is already available on the market. This assessment is crucial for when you present your business proposition to potential investors.
Next, work with a law firm specialised in Intellectual Property to conduct an assessment of the patents in this area and determine your Freedom to Operate (FTO).
Here’s where you pull together your team of designers. This team will help you determine the functional specification of your product and what materials and components will be used to develop the prototype. You then need to think of how to adapt your prototype to the targeted medical segment – this will be your proof of concept.
Next, you bring in your clinical team to run a series of pre-clinical testing, depending on the classification of your device. For this you will have to manufacture a certain amount of product and it is wise to start implementing your manufacturing quality system. Pre-clinical tests include animal testing, toxicology, sterility and biocompatibility testing.
After this, it’s time to write the risk assessment plan. There may be some stopping signs here suggesting that your device idea is not feasible or could cause significant harm. Be realistic about every possible risk that could arise from using the device. It’s still early enough to go back and rethink your design.
Implementing a quality management system upstream is also essential so that you can ensure your device addresses certain regulatory aspects such as design control.
Once your device has been validated via proof of concept and pre-clinical testing, the next decision is to determine if it’s best to manufacture on your own or work with an OEM partner. OEM partners offer the advantage of existing quality systems and certifications that new startups can leverage rather than investing in their own – something that can be expensive and time consuming.
Either as part of the market assessment or in parallel with manufacturing, it is critical to assess the reimbursement landscape in your target market, if you intend for your product to be covered under either private insurance schemes or part of a government health care programme.
These usually vary from country to country so you need to research what is the reimbursement process and how long it takes in each of the territories you have in mind. This will enable you to make an informed decision about which country/ies to target first.
Here you also need to run a health technology assessment to establish if your product complies with the standard of care of each target country, and a health economics assessment to help you prove the benefits of your product versus each country’s product of reference. A health economics consultant will help you evaluate the economic model of each country and the compliance requirements of their health authorities.
Once you’ve received approval from your target country’s health authority, it’s time to kick start clinical trials. If all your pre-clinicals have shown positive results you are ready to move into human testing.
With the help of a clinical research organisation (CRO) or clinical consultant, you will develop your first-in-human proof-of-concept which must demonstrate that your product is faultless from a functionality perspective and that it’s as least as efficient as other comparable devices. The classification of your device will determine your trial plan, which will later support regulatory approval, reimbursement submissions and product marketing.
Clinical trials are an important step and need to confirm that through pre-clinical results, combined with existing data on very similar products, you have sufficient data to prove your device is safe and is performing the way you want it to.
The first step in gaining market access involves obtaining regulatory approval which ensures your device meets the safety, health and environmental protection requirements of your chosen market(s).
To get a European CE-mark you need to consult with a regulatory expert on the requirements of your application dossier. These requirements vary depending on device classification but will generally include the device’s technical file and the safety and efficacy studies you’ve carried out previously. You will also need to appoint a Notified Body to assess your device and an Authorised Representative to overlook this process if your company is based outside the EU.
Once you’ve received your certification and if your classification requires it, you must affix the CE marking and Notified Body identification number to your device.
Here is where your reimbursement strategy is put into practice. Once your reimbursement consultant has helped you gather all the necessary documentation for each target country you are ready to start complying with their respective reimbursement procedures. The health authorities will now decide if your device should have a reimbursement price or if it should be integrated into a healthcare plan. Your consultant will also help you negotiate the pricing of your device with the health authorities.
At the same time you will need to gain authority approval to get your device registered in your chosen markets. Look up the competent authorities and their approval requirements in accordance with your device classification as well as the length of the authorisation once received, then prepare the necessary documentation for review.
Bring in your commercial team, it’s time to start the seeding trials. This is the first market where you will commercialise your device so you should have your commercial strategy set in place. Based on your first market feedback, determine whether your device is ready for commercial expansion. Set up distribution contracts in your different markets and monitor product delivery.
If you’ve reached this point it means your device got the all clear and is now being used across your targeted markets. Well done! Now you need to make sure its performance lives up to the standard of the CE-mark.
You will need to carry out post-market follow-up studies, analysing the device’s use in the community practice or home care, how it interacts with other devices and drugs, whether it has had any performance failures or if it has been used off label. Here you will also communicate with your device’s selected patient groups to address any concerns they might have using it.
Make sure your risk management system is suited to follow process in the event of a defect and that you are familiarised with incident reporting in each of your markets. At this time you should have a clearly defined cycle of continuous improvement for your device.
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