Understanding the Noninvasive Medical Device Product Life Cycle

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.