Anyone can have an idea for a medical device. Not only are highly-respected surgeons and engineers capable of creating a new device, but so is an experienced engineer from large corporations. It could be that you are sitting at the doctor’s office thinking, “There must be a better way.” Or maybe you are caring for a loved one who is in need of a device to aid them in recovery.
Many people who don’t work at large companies find it difficult to get started because the medical device industry is too heavily regulated and has too many obstacles. It is true that it is daunting and can be overwhelming. However, the process is rewarding and well worth it.
Many people who take the plunge ask themselves this simple question: Where do I begin?
You’re probably like me and have spent hours on the internet searching for a guide that would answer your questions. There is no single guide that can help you determine the right path for your device. However, there are many ways to simplify the process and create a plan that works for your needs.
This step-by-step guide will help you bring a medical device on the market. This guide is designed to be easy-to-follow, will point you in the right direction and will help you launch a successful product. So, let’s get started…
Building the Business Case
Before you even consider interacting with the FDA, or any other notified body, it is important to first establish a business case. While many people are eager to jump to the fun part of building and testing their product quickly, it is essential to do the work beforehand to create a solid business plan.
An idea is the beginning of everything.
You need to identify the problem before you can find a solution. Perhaps you are starting from scratch in order to solve a medical problem that doesn’t have a solution. You might also be trying to make existing technology more efficient or affordable.
It’s okay to change your focus as the project progresses. However, it’s important to have a clear understanding of the problem that you are trying to solve. Start by examining medical conditions, current treatment options, and user needs. Then, you can move on to the next step.
You don’t have to do this work all by yourself. It is important to identify and reach out to all stakeholders as early as possible.
When brainstorming ideas, doctors, nurses, and other medical professionals can be a great resource. These professionals are often on the front lines, so they can give you an unbiased view of the pros and cons of similar products. You may find out that there are no devices on the market similar to the one you want. This information is useful in gauging market demand.
Friends and family members can share stories about their unpleasant experiences with a particular device. Your patients’ personal stories can be a powerful motivator to help you bring your best solution to life.
Sales professionals are often overlooked. However, they are able to provide valuable feedback and ideas about how devices are used in real life. These people receive the initial feedback from end users.
You can improve your ideas by taking inspiration from colleagues, end-users, friends, family, and even family members.
It is not enough to have a great product idea. First, you need to ensure that there is a market for the product. It is a good idea to research any competitors in order to compare your proposal against their products.
These are the questions every device developer must ask:
- Can my device fulfill an unmet need
- Who would purchase this device and where could it be sold?
- What are the most competitive products/technologies / services that are currently available?
It is a good idea to take some time to describe your product and make a list with the answers. This list doesn’t need to be set in stone, but it’ll serve as a good “back-of-the-envelope” resource for you to have as you determine market demand.
This list is especially important as the answers to these questions will help you determine the time and capital required to complete your project.
Market research is important. Different countries and regions will have different prices for the exact same device. But it’s more than just crunching numbers. Cultural research is a key factor to remember – some cultures might be biased in favor of certain medical procedures and devices.
There are many reasons why the size of your target audience is important. You should not pursue a target market that is too small.
If you choose to go this route, the market size will likely determine how much capital you are able to raise. It is possible to estimate the size of specific markets using existing data. However, it is more difficult to calculate international markets.
It is a good rule of thumb to assume that the international market is approximately the same size as the US market. For more details bemer matrac
IMS Global and Frost & Sullivan published market studies on the medical device industry.
These are the questions to ask when comparing yourself with your competitors:
- What are some other products that serve the same function as the product I plan to launch?
- What is the difference between my product and those of other competitors?
Perhaps your device will offer more value than existing products. Perhaps you are trying to give a price advantage or quality advantage.
You must create a unique competitive advantage to bring a medical device on the market. This will help ensure that your product is marketable.
Project Costs and Timeline
Before you start, it is important to know the timeline of your project. You should have estimates for each phase of the project, and not your overall timeline.
It is important to estimate how long each phase will take. Different phases have different capital needs. You need to be efficient if you want to achieve milestones. Funding may also depend on your ability to fund.
You must include all costs in your project budget. As we will discuss below, this can be difficult to do right from the start.
You can still make a good start in estimating the costs of your project by planning carefully.
You may need to budget money for travel, labor, materials, training, consulting and product testing.
It is important to set a realistic budget to ensure the success of your project. However, new entrants to the industry may not always be able to envision all the possible costs.
It is equally important to have a good understanding of the regulatory process. While things can change as your product develops, the regulatory pathway will still have an impact on both project timing and cost.
It is easy to overlook testing at the beginning. And it can often be more costly than companies realize. Biocompatibility testing is required if your product has any patient contact. This can be costly and even cost hundreds of thousands.
Are you planning to launch internationally? You will need to pay fees and licenses, as well as paying someone to manage the registration process. This guide will provide more information on the registration of a device.
New companies often miss their launch dates due to budgetary hiccups. It is better to be proactive when planning a project, knowing that things can change.
Calculating potential revenue is the other side of this coin. Your business model should include key components such as calculating reimbursement and commercialization.
It is unlikely that your product will have the same market value in different countries. This can also be true for certain states in the United States where prices might differ.
Your early-stage value proposition should include a plan for the cost of your product in each market.
This part of the process is complex.
Sometimes, you launch a great product only to find out that hospitals in your target markets have already signed contracts with similar suppliers.
AdvaMed has a wonderful case study about Estimates for Medical Device Spending in America that I highly recommend.
Make a prototype
Now it’s time for the technical stuff. Prototyping your device is a good idea to help you troubleshoot problems and improve specific features.
There are many methods to obtain cheap prototypes. A device model is often drafted in CAD, and then manufactured with cheaper materials than the ones that will be used to make your final product.
A shift towards 3D printing is an interesting trend that we are seeing in the industry. Many companies have their prototypes printed with plastic materials and sometimes even metal. This allows for a more accurate representation of the final product.
After you are satisfied with your basic design, it might be time to hire an engineer to create a stronger prototype. Prototyping can be expensive so budget accordingly.
Once you have a working prototype you are ready to conduct basic feasibility studies. These studies are used to decide if you should pursue a full-blown project. These feasibility studies can influence your design decisions. It’s not unusual for people to make modifications at this stage.
It is important to remember that you can leverage the results of these studies to create a regulatory submission. You will need to ensure they are done under design controls. This guide will go into more detail.
- Considerations for the Early Stage
- Secure Funding and Assemble Team
You will need capital as with all businesses, and a team to make your ideas a reality.
Many costs are overlooked early on in the process. You will need to account for costs related to manufacturing equipment, testing and certifications with notified authorities, product registrations, and clinical trial management.
This is the right time to create that detailed business plan.
It would surprise you to learn how many people are interested in investing in medical device companies. There are many ways to obtain capital, including from angel investors, venture capitalists and other companies as well as grants. A solid and comprehensive plan can help alleviate the worries of potential investors.
Many entrepreneurs believe they have only one chance to succeed. Why not create an elite team?
Some choose to hire full-time employees while others look for consultants. Many great consultants are available in all functional areas, including manufacturing, quality regulatory design, and manufacturing. It is possible to draw on their expertise in bringing products to market.
It is easy to find people in your industry today. You can do this online via LinkedIn, or at an industry conference. Don’t hesitate to take advantage of networking opportunities within your local area and ask for assistance from others. Medical device professionals are a close knit group and people are always willing to help one another.
Remember that the Terapia Guru team is extremely experienced in bringing products to market. Our Guru team was involved in almost 300 devices’ launch. If you have any questions, don’t hesitate to contact us at any stage of your journey.
Create a Regulatory Plan
You are likely energized now and ready to tackle the project head-on. However, the above heading may have turned your excitement into dread.
The most difficult aspect of launching a medical device is regulatory strategy. There are many people who have navigated regulatory waters successfully in the past and many more who will do so in the future.
When you wrote your business plan, it is important to have done research about the regulatory pathways that may be available for your device. This is the right time to create a detailed regulatory plan. For more details bemer készülék
It is important that you remember that each device is unique and will have its own regulatory strategy. You can tell your own story, and you don’t have to follow any prescribed plan. Based on past experience, proactive planning combined with a well-documented and solid rationale for the final decisions is one of the best strategies.
Selecting Interest Markets
It’s not surprising that every major market for medical products has its own regulatory framework. It’s not possible for it to be so simple.
The starting point for your regulatory strategy should be your business plan. Don’t waste your time trying to figure out the regulations of markets that won’t provide a good return. Stick to your plan.
Don’t feel pressured to launch in all target markets at once. A startup can sometimes use one market to gain entry into another. One example: I was a part of a company with a Class IIb device in Europe, but a Class IIb device here in the USA. To help finance our IDE clinical trial in America, it was only logical that we first sell into the EU.
It is essential that you understand, document, and define the intended use of your medical device in order to be approved for any regulatory market. Terapia Guru founder Jon Speer, VP of QA/RA, discussed this topic in a podcast, with guest Mike Drues, Ph.D. There are two reasons why the intended use is important:
- This will help to define the device’s scope and be helpful when designing inputs and user needs.
- It is crucial to support regulatory product classification. This ultimately determines the path you will follow to obtain market clearance with FDA or other regulatory agencies.
There are many routes to take in order to bring a medical device on the market. It all depends on what your device is classified.
Your product type’s perceived risk will determine the classification. Regulators determine your classification. Different regulators may have different views on risk and classification categories.
This classification will tell you what regulations you must follow when designing and developing your device. You will also get more information about the cost and timeline to bring your device on the market.
This has a significant impact on your business model. We’ll break down the most popular market now.
How to determine the US classification
The Food and Drug Administration (FDA), oversees US medical device regulations. Specifically, the FDA branch known as the Center for Devices & Radiological Health is responsible.
CDRH assigns medical equipment to one of the three classes .
- general controls Class I (low-to-moderate risk)
- Class II (moderate-high risk): General controls and specific controls
- Class III (high-risk): General controls and premarket authorization (PMA)
This classification will affect the type of submission required to clear the clearance. It is important that you have an idea of the class of your device early on in the project. This will impact your project’s timeline and cost.
The majority of Class I devices have been exempted from any premarket submission. However, there are some that still require a 510 (k).
Most Class II devices, and a few exceptions will require FDA approval. A substantial equivalence test will be required to prove your device’s legal equivalence with another legally-marketed device. This is often called a “predicate” device.
A premarket approval application (PMA), will be required for Class III devices. The FDA will require you to conduct a clinical trial to ensure that your device is safe and effective.
One additional route to market approval that is becoming increasingly popular among device manufacturers is the De Novo pathway. It is available for Class I and II US devices. Devices that are eligible must be “novel” to be included in the FDA’s classifications. The device must be low or moderately risk to qualify.
To find out if this is a good route for you, take a look to our previous blog post on De Novo path.
How do you determine which device is classified in the United States?
This FDA Product Classification Database can be a great resource. It might even be a good idea to bookmark this page.
You can search for device names, review panels, product codes and many other criteria. You will get a lot of information from this search that will help to develop a regulatory strategy for your product.
It is not always as simple as it seems. There will be many questions and doubts. That is normal. It happens to everyone.
Ask others in the industry that have gone through it. Terapia Guru’s team is made up of experts in medical devices and can help you navigate these difficult regulatory processes with confidence.
Another important thing that is often overlooked is the possibility to get feedback from the FDA early on regarding your regulatory pathway via the FDA Pre-Submission Program. This is a great way to work with FDA early on to address any concerns and to be confident in your plan to get to market.
How to determine the EU Classification
All requirements for selling into the EU are laid out in the European Commission Regulation (EU No. 2017/745 is also known as the Medical Device Regulations (MDR).
This is a updated set of regulations. The transition period will end in May 2020. It is therefore important to fully understand and implement these changes.
The MDR outlines four types of medical devices:
- Class l (low/medium)
- Class lla (medium risk)
- Class llb (medium/high Risk)
- High risk class lll
My experience is that determining your classification in Europe is easier than it is in the USA. Annexe VIII of the regulation includes classification rules that can be used as a flowchart to determine your classification.
Your classification, just like the US, will allow you to determine what is required for approval of your device.
You will need a CE marking or CE mark to launch your product in Europe. This seal of approval, also known as a CE Mark (or CE Mark), indicates that the product meets all requirements of the applicable legislation.
The CE Marking allows the product to be sold within the single market. The single market currently includes all EU countries, Iceland, Liechtenstein and Norway.
You will need to create a Quality Management System (QMS), and keep all documentation in a Technical file. Our Essential Guide to Preparing Your QMS for EU MDR will help you to get started.
You will need to collaborate with an outside party, called a “notified body”, for any Class IIa, IIb or III device. The EU has accredited notified bodies to perform regulatory audits and ensure that you meet the regulatory requirements.
The EU MDR has had an impact on more than just device manufacturers. It makes it seem more difficult for notified body to remain active certified. There are less notified bodies each day as the landscape changes. It is important to plan ahead in order to find a notified agency that can assist you with your project timeline.
Self-certification is possible for Class I devices. This means that your Technical File does not have to be audited before you can obtain a CE mark.
Devices in Class IIa, IIb and III will require your Technical File (or Design Dossier) which has been audited by your Notified Body.
After a successful audit that ensures your compliance with the regulations, you will be issued a CE Certificate.
Prepare for other markets
Every major market has its own regulatory requirements. You will need to be familiar with the regulations in each region if you plan to launch your business outside of the US and EU.
Here are some important points to remember when assessing the needs of different regions
- The classification categories are likely to vary from one country to the next.
- Some countries might require registrations or licensing.
- In some areas, clinical data may be available.
- In certain countries, physical representation may be required through a local agent or representative.
- Not all approvals or clearances in one area will mean that you have an easier path to other areas.
This is where you will learn that you must follow a Quality Management System (QMS), when you bring a product to market.
There are many similarities between them, and they are becoming increasingly aligned. Complying with one will usually set you up to comply to the other without much extra effort.
Many people who have worked in multiple medical device companies will have noticed something: no two quality systems are the same.
Many people are surprised to learn that there is no “one-size fits all” QMS. You can create one that suits your company’s needs and preferences.
It is not enough to comply with the regulations. You must also ensure that you are creating a culture that is truly. A culture in which employees do the right things and do them well. It is almost always a safe, effective tool.
How can quality systems differ?
We have already talked about creating a solid business strategy, which will include the markets you plan to launch. A simple way to tailor your QMS to suit your needs is to only focus on the regulations that are applicable.
ISO 13485 is not recommended if you only sell in the US. If you plan to sell in the US and EU, you should set up your QMS so that it complies with both Part 820 (and ISO 13485).
A QMS should be tailored to your company’s size. A startup of four people does not need a large QMS immediately. They can work together in one room and can use a light QMS that would not work for a company with 50 employees.
To determine where you should be focusing first, look at your short-term goals. Early stage companies are usually focused on getting their product through the regulatory submissions process. There are certain QMS processes that must always be followed from the beginning.
- Document management and control
- Design controls
- Risk management
- Supplier management
You can start there and then worry about the rest (CAPA, Complaint Handling etc.). When you get closer to manufacturing and product release.
Last but not least, I want to remind you that it is important to keep it simple when implementing a QMS. I have seen companies where SOPs became so complicated and confusing that no one knows what they should do. Sometimes, procedures can even conflict with each other.
Actually, an auditor wrote an observation for a company which was following regulations correctly but its employees weren’t following their internal procedures.
You need to have a set or procedures that tell people what to do and how. This ensures that you follow the regulations and ensures that people do their jobs correctly the first time.