Category: Medical Industry

Medical device prototype development is different from other types of prototyping because of the additional regulatory hurdles to be considered. While some devices will require a lot of agency approvals, others are less restrictive and easier to bring to the market. While creators won’t have to worry as much about these hurdles at the prototyping stage, it is an essential component in proving the concept and potentially patenting it.

The process of medical device prototyping will depend on the level of risk perceived in the product. For that reason, it’s more challenging to prototype something intended for use inside the patient’s body as opposed to something designed for educational purposes only.  In either case, the prototype isn’t just about proving the concept. It’s also about highlighting the safety and efficacy of the product.

Three Steps of Medical Device Prototype Development 

Medical device prototype development is a bit more complex than standard product development, so guidelines aid in creating a clear outline that works to build a strategy for eventual FDA approval and mass-market use.

#1: Establish the User Profile 

Before prototype development, it’s crucial to establish a clear user profile for the product. The profile helps the developer better understand whether it’s a feasible option for their target market and gauge the cost of product development. It also helps them lay the groundwork for clinical tests later on, as they’re looking for a pool of candidates who can test the device. The user profile should include:

• The age, sex and physical condition of the end-user
• If used for a specific illness, the stage of the illness
• Whether it is a palliative option or one designed to slow or cure a condition
• The current solutions available to the patient

A robust user profile will help device makers fully understand whether their solution is practical for the treatment of the condition. It will also help them in the next step, assessing the risk level of the device.

#2: Assess the risk level 

Medical devices come in three categories of risk. Understanding what risk level the product falls into will help the creator prepare the best possible prototype to submit for seeking approval later.

• Class I – This is the lowest risk level. It is designed for items like medical instruments, which may be used on patients but aren’t invasive.
• Class II – Class II devices are typically low risk internal and external devices that patients might depend on, like syringes or wheelchairs.
• Class III – Class III devices present the highest risk to patients and, as a result, are heavily regulated. This category includes items like stents, pacemakers, and other instruments meant for long-term, in-body use.

The risk level matters in prototype development because devices that fall under these categories will often have to be prototyped in the actual materials intended for use with patients. The prototype itself will have to act as a replica for the actual product.

#3: Peer Review the Concept

Having someone in the same field review the concept in the prototype stage can help the creator recognize any barriers or improvements they can implement. Of course, at this stage, it’s wise to have any peer-reviewers sign non-disclosure agreements to prevent the risk of intellectual property theft later.

That peer reviewer can also help the creator understand whether their concept is truly a novel one worthy of patenting, or if it’s too close to something on the market to be worth pursuing. It’s not uncommon for medical professionals to discover very similar solutions to issues. A peer review can help them identify potential conflicts before too much is spent on a redundant product.

The Importance of Partnering with Experts 

Medical device prototype development is not something that should be outsourced to a general prototype creator in some overseas market. The creator must have a first-hand relationship with whoever is building the product. It’s equally vital that the medical device prototype creator has extensive experience building similar products. Through that, they’ll be able to offer insight that can help clear regulatory issues later on.

An experienced partner who understands the industry is the best possible resource to have in medical device prototype development. With their insight, creators can better understand the market, risk, and potential conflicts they’ll face through the project. It’s the single best way to control costs and effectively manage the creation of a product as they attempt to navigate the regulations and restrictions along the way.

Orthopedic medical devices can vastly improve the quality of life for people coping with orthopedic conditions like degenerative diseases or sports injuries. Some of these devices even save lives. However, despite the high demand for orthopedic devices in the medical field, designing and prototyping these devices is often a serious challenge. Design complexity, redesigns, prototype testing, and other engineering challenges can extend the amount of time you spend in the prototyping stage and could even stop your project in its tracks.

If entrepreneurs or medical companies want to create life-changing new orthopedic medical devices, they should streamline the prototyping process as much as possible. When you consider these five design and prototyping approaches, you may avoid some of these common setbacks.

The Challenges of Prototyping Orthopedic Medical Devices

The process of prototyping new orthopedic medical devices varies depending on what type of device you’re creating. Some of the devices that are in the highest demand are:

• Joint reconstruction
• Trauma fixation
• Braces
• Spinal
• Arthroscopic
• Orthobiologic

The prototyping phase is a time to think carefully about the design and come up with innovative engineering solutions long before you apply for FDA approval or move on to the manufacturing stage. In general, the more complex the medical device is, the longer it will take to finalize the design and the higher the total product development costs will be.

Moreover, new medical device designs often take far longer to develop compared to variations on an existing design. This is one of the main challenges of prototyping new orthopedic medical devices. Designers must be able and willing to put in the extra effort and time required to ensure the device design is as accurate, precise, and potentially safe as possible.

However, orthopedic medical device designers can mitigate some of these challenges when they partner with a product development team that has designed or worked with medical devices before. A third-party medical device manufacturer with experience in designing and prototyping medical devices can streamline a few areas of this process and help you create a high-quality design. There are five approaches you might consider to make the prototyping process more efficient.

5 Ways to Optimize the Prototyping Process 

To design high quality orthopedic medical devices that are truly life-changing for patients, you should try to optimize every stage of the design and prototyping process. But how? The methods you use will depend on factors, such as the complexity of your design, your budget, your timeline, and which tools or resources you have available. Still, there are five potential design and prototyping approaches you might consider when you design a new orthopedic medical device.

#1: Understand What Patients and Medical Professionals Need

Many orthopedic medical devices never make it out of the design stage, let alone into the manufacturing stage. When a medical device company or entrepreneur is stuck on the design step, it’s usually because they didn’t take enough time to thoroughly research the device before beginning the process. To avoid this, start by identifying:

• What the market is for this product;
• Whether there are similar devices on the market, and if so, how your design differs from these other devices;
• What the risks are for the device, including potential medical, mechanical, and manufacturing risks; and
• Whether the device will be familiar or unfamiliar to orthopedic medical professionals, particularly surgeons.

This process should start before you begin the design process in earnest. Performing detailed research and development on the front end will save you time and money on redesigns and multiple prototypes in the future.

#2: Use Rapid Prototyping

When companies design orthopedic medical devices, they often produce many working prototypes and computer models before finalizing the design and beginning the regulatory approval process. Prototypes and 3D models test the feasibility of the design before the company commits to this time-consuming and complex regulatory process.

For example, one major part of the prototyping process for orthopedic medical devices is the finite element analysis. During this step, engineers perform a full structural analysis of the prototype while considering factors like:

• Material feasibility and safety, including toxicity
• How the device transfers heat
• How fluid flows through or around the device
• Adaptation of the surrounding bone
• Wear over time

This gives engineers a sense of how the device might perform once it’s implanted. Any problems or risks at this stage have to be addressed before the design is ready for the next stage.

The best way to do this is to use a rapid prototyping methodology. Rapid prototyping tools allow orthopedic medical device designers to quickly test the physical and operational properties of the product. You can make and review multiple prototypes within just a few days or even test out multiple concepts at once to find the best engineering solution. Without rapid prototyping, this process would take many months and significantly delay your production timeline.

#3: Consider Using Rapid Tooling

Advanced prototyping tools like 3D printers, CNC machinery, and other types of rapid tooling are ideal for testing the feasibility of orthopedic medical device designs. Because this process is faster than conventional tooling methods, you can create multiple prototypes simultaneously or in quick succession to test out different designs or materials. Some of these tooling options are also more precise than manual tooling techniques, which is often important when designing and prototyping orthopedic medical devices.

#4: Hire a Product Developer with Medical Industry Experience

You can’t trust just any product developer to help you design and prototype orthopedic medical devices. Experience and knowledge of the medical industry are absolutely essential. A knowledgeable engineer can:

• Perform thorough research into the design: The engineer may help you identify important design details that will allow your orthopedic medical device to operate more safely and efficiently.
• Help you select materials and test them: Engineers that have worked on medical device designs before may be familiar with tests, such as the finite element analysis and can also perform more reliable quality control tests throughout the prototyping process.
• Work closely with you on redesigns: Because safety and quality is so important with orthopedic medical devices, designers often return to the drawing board multiple types during the design and prototyping stages. Engineers with some medical industry experience not only understand the need for redesigns but can also make this process more efficient. They can offer you a reasonable estimate for how long the design and prototyping process will likely take and will communicate with you if this timeline changes.

Having a professionally-designed prototype and detailed 3D model of your device could also make the regulatory and manufacturing processes run smoother in the future.

#5: Keep Detailed Design Records

The engineers you work with can keep detailed copies of every design and prototype iteration, including detailed 3D models. This enables you to return to old designs and make adjustments quickly. Not only could this improve the form and function of your final design and prototype, but it could also make it easier for you to apply for FDA approval in the future or make important changes to the design based on regulatory feedback. Having detailed models of the design is also an important step if you plan on patenting your design.

While you could create these designs yourself, it is often better to use professionally-drafted designs and models. That’s because engineers understand important details like tolerances, and they also generally have the most advanced CAD design tools available to them.

While these five considerations can make the design and prototyping process run more smoothly, the most important thing to remember is that your product requires its own unique process. A trusted product development company with experience in the medical field can help you find the right process based on your timeline and budget.

Why You Should Work with an Experienced Design Team 

Ideally, you should get in touch with an experienced product developer as early in the design process as possible. Having the product developer involved in the conceptual stage gives you the benefit of their skilled team of engineers. Not only can they help you identify the best materials to use and the form your device should take, but they will also make sure that those elements can be easily recreated by a third-party medical device manufacturer in the future.

Hiring an end-to-end product developer has many benefits. These companies are heavily involved from the design concept to the final prototype. Having all of these processes under one roof makes it easy to document everything and refine your design. They are as committed as you are to the process and fully understand all of the engineering challenges you need to solve. They treat you as a partner, not just a contractual obligation. In an industry as competitive and complex as the medical device field, partnering with an experienced and passionate product designer is invaluable.

Agile development is an industry disruptor in the noninvasive medical device product lifecycle. This process of creating, testing, improving, and creating again proves concepts that support designs to guide and educate the next generation of medical professionals. While noninvasive medical device creation is a bit less regulatorily restrictive than devices meant for use inside the human body, the process is still a challenge not suitable for beginners.

Finding the right partner is often a challenge, as most medical device manufacturers aren’t that large. Seventy-three percent of these manufacturers have less than twenty people on staff. For many years, lack of resources meant an industry dominated by large medical conglomerates with in-house research and development teams. Smaller creators had few options to bring their ideas to fruition, especially in light of the complexity of the medical device product life cycle. Modern advances in technology removed this barrier to market entry. Today, smaller creators can collaborate with experienced manufacturers to develop new medical devices. 

The Five Stages of the Medical Device Product Life Cycle

Noninvasive medical devices are ones not meant for use in the human body. Invasive, surgical devices have far more complex lifecycles that require highly specialized developers and medical professionals. Essentially, their creation is more comparable to the development of new pharmaceuticals, up to and including all the complex bureaucratic red tape and FDA requirements. As a result, most invasive medical device development is handled by large medical conglomerates or specialized companies, rather than contract manufacturers.

Noninvasive medical devices, on the other hand, have fewer barriers to market entry.  They are often used in healthcare education as well as in treating or diagnosing patients. All these devices will go through the same five general stages: investigation, design, validation, launch, and post-market review.

#1: Investigating the concept

A concept might be an idea for a new device or a new way to use an existing device. In either case, due diligence is necessary to ensure a viable concept. Many products won’t make it out of this stage because the creators failed to investigate their concept properly. Ideally, they should answer the following questions:

1. Who is the market for this product? 
2. What are the mechanical and manufacturing risks? 
3. Is the idea novel when compared to all other devices designed for the same task? 

It’s best to review a concept with an experienced engineer who worked with similar medical devices in the past. They can provide a critical evaluation of a product to help answer those questions. 

#2: Designing the prototype

In agile product engineering, the device is designed, tested, reviewed, and designed again. Computer models and prototypes test the concept and determine its feasibility for the market. Some supportive tools to consider include: 

• 3D printing: 3D printing brought rapid prototyping into the near-mainstream by helping manufacturers to make models faster and understand them on a deeper level. This allows for a rough idea that the designer can build on to improve the product. 
• Powder bed fusions: A high-power-density laser binds powdered metallic material to create 3D models and shapes. With powder bed fusions, designers create sturdier prototypes, which makes this a popular option in medical device prototyping. 
• Computer Numerical Control (CNC) machining: This method is especially useful when creating a design with raw materials. It produces the highest quality of prototypes as a computer controls machining tools and 3D printers to build an intricately detailed design. 

Once a perfected, working prototype is in place, the creator needs to prove that it works as directed, and will provide a benefit to the patient or medical community. At this stage, they will also face the most regulatory hurdles. 

#3: Validating the concept 

Certain medical devices must meet the established Food and Drug Administration criteria. The controls and criteria vary based on the device class, with devices receiving a rating from one to three based on their purpose, invasiveness, and risk level. 

Class I	Class II	Class III
These devices pose little risk to consumers and in most cases, are exempt from the FDA’s regulatory process.  They are typically non-complex and involve a few moving parts.  Manual wheelchairs, adhesive bandages, and other non-invasive and non-vital devices make up this category	Most medical devices fall under this classification.  These devices have a higher burden than Class I, and typically have to meet certain performance and post-market criteria. Examples include motorized wheelchairs, ventilators, hospital beds, and other similar medical devices.	These medical devices support or prolong human life, are often invasive, and present major risk if defective. This class of devices is the most heavily regulated by the FDA and lawmakers. Examples include pacemakers, stents, artificial hips, and other similar devices which the patient may use internally, for the long term.

The class of the device will determine what controls are necessary when it comes to testing the result and ensuring a beneficial outcome. If clinical trials are required, they should be completed and submitted during this stage so the creator can request Pre-Market Approval.    

#4: Launching

On receipt of pre-market approval from the FDA—if necessary—the creator can begin marketing and selling their product. Pre-market approval is a letter the FDA provides to the creators for certain devices to indicate they are safe for the public. If the device requires such approval, no marketing or selling can start until it is received. On the upside, only about 5% of all medical devices requires this rigorous—and expensive—process. That’s extremely good news for most small creators, who likely don’t have the estimated $94 million needed to bring a device needing premarket approval to the public. 

Marketing must work closely with a legal team to ensure materials meet regulations and marketing methods are appropriate. Marketing messages and strategies will need to be carefully planned due to this and are likely best handled by firms with specific medical device experience. 

 #5: Adhering to postmarket requirements 

The job is not over once the device reaches the market. After the release, the creator must monitor for adverse effects, complete required inspections, report adverse events and potentially, complete recalls and removals of defective devices. 

Postmarket surveillance is a crucial part of this, as creators must follow up on the results achieved from their products and keep careful records of these results. Storing health records and managing patient registries is also a necessity. This stage can also involve rolling out the device in secondary markets. 

Leveraging Strategic Partnerships for Noninvasive Medical Device Development

Regulations complicate medical device development for creators. Typically, contract manufacturing relationships are only suitable for devices meant to educate medical practitioners, or for use outside of the body. Devices used internally will usually be developed in a medical laboratory environment, not a manufacturing one. 

For creators who want to develop noninvasive medical devices, a partner with experience specific to the medical device product life cycle will be invaluable. They can help build prototypes accurately, cost-effectively, and rapidly enough to meet the ever-evolving needs of healthcare training.  

With expert assistance, creators can build prototypes and models that prove their concept and speed their entry into the market. Whether those devices are training models designed to aid the next generation of doctors or simple tools to make it easier to sanitize hospitals and provide care to patients, an effective design starts with an experienced engineer. Through this, the medical device product life cycle is shortened, and the project made more cost-effective without sacrificing accuracy.