It is not simple to take a concept for a medical device and turn it into a marketable product. Bringing these ideas from the drawing board to the marketplace requires patience, resources, insight, and ingenuity.
Every device has its own set of difficulties and prerequisites.
Commercializing a medical device can be difficult due to the many stakeholders involved and the regulatory hurdles that must be cleared. However, it is possible to bring a medical device to market if the correct commercialization plan is implemented.
Let’s have a look at a proper process that you can follow while devising a commercialization plan that involves developing and bringing a medical device to market.
Steps To Make An Effective Medical Device Commercialization Plan
The following steps are detailed and consecutive. However, some commercialization plans have different approaches as well.
Step 1: Pay Attention and Understand Market Demand
The ability to listen and comprehend the underlying demand lies at the heart of effective project creation.
When planning a project, it is vital to consider any investor requirements as well as any relevant milestones and deadlines.
Taking things one step at a time is preferable to leaping to conclusions based on progress toward an end.
You may learn what your product needs and adjust the development process accordingly if you make small, meaningful efforts.
Step 2: Focus More On De-Risking at the Start
Successful medical device development requires early risk assessment and investigation of the project’s technical components.
The main risks can be mitigated and extra padding can be added during final manufacturing if the prototyping phase and experimentation phase get enough time.
By putting more effort into lowering risks and improving the product from the beginning, you can prevent delays in getting your product to market.
Step 3: Create New Ideas
As a medical device manufacturer, you might have to collaborate with doctors, innovators, and business owners at various points in the design process.
While some clients provide fully formed prototypes, others show up with nothing more than a napkin sketch.
Concept development is the process of giving form to these ideas by considering relevant technological, regulatory, and business considerations.
Engineers make up the bulk of the members of the cross-functional teams. These teams use computer-aided design (CAD) and other software to collaborate on ideas, sketches, and renderings.
Step 4: Design the Device and Packaging
An engineering team can now begin developing the gadget under Design Control procedures, with the groundwork of user research and early designs already in place.
The ideas will be turned into technical design requirements and 3D CAD models.
The design process will yield several official documents, such as:
- A design history file
- A detailed requirements document
- Component specifications
- Software and hardware specifications
- Assembly drawings
- Material selections
Packaging is often overlooked in the design process for medical devices. However, it is integral to the product’s success and should be developed in collaboration with the device itself.
Design for manufacturability should be a primary concern throughout the whole design process. Also, consider how much time and effort will be needed to assemble the device’s various parts.
Step 5: Test
Physical, biological, electrical, software and performance testing may all be part of the process at various points. Each device will need its formal test techniques and procedures and a Design Verification and validation (DV&V) plan.
The development and validation phases occur late in the process. The device’s success depends on the Design Verification process’s results. The medical device’s design must be validated to show that it serves its intended purpose.
The finalized test reports will be utilized in submissions to governing bodies.
Step 6: Stay Prepared for Changes in Regulation
It is crucial to understand the regulatory landscape and how it will affect your medical device commercialization plan.
Before entering a new market, it is wise to become familiar with the applicable regulations in that area to prepare for any potential complications. Your company will be well-prepared for success if you are aware of the regulations in place and which markets are easiest to access.
We can take the European Union’s (EU’s) Medical Device Regulation (MDR) as an example. The EU revealed big modifications to the MDR’s implementation dates right before the holidays, which may have a profound effect on companies’ efforts to break into the EU market.
This is only one reason why it is essential to monitor regulatory developments to adapt your commercialization strategies for medical devices properly.
Step 7: Promptly Engage Your Production and Supply Chain
The manufacturing and supply chain teams are sometimes overlooked during the design phase. It can cause significant delays and changes if necessary components are not readily available or cannot be manufactured to meet the present design.
Maintaining consensus and communicating any changes to the bill of materials that impact production can help prevent delays in getting a product to market.
Working with smaller structures and stocking up on even seemingly insignificant adjustments can have a significant impact.
Step 8: Consider an Iterative Approach in the Early Stages
If you design your medical equipment intending to undergo several iterations, you give yourself a chance to make adjustments and refinements, even if the first few attempts fail.
You should begin by drawing out a plan that includes numerous iterations so that you can learn from past achievements and correct for past failures. You can make a fantastic medical tool by rewriting and reworking it over and over again until you get the results you want.
It’s usually worth the extra effort, even if generating numerous iterations takes more time and resources than developing just one.
Step 9: Determine Pivots in Basic Requirements
The difference between a successful and unsuccessful project often comes down to how well its leaders anticipate future shifts in core requirements.
One approach is to consider who will be using your medical device and what they will use it for. As you get more information about the clinical need and the options available, you may discover that a different strategy will bring better results.
Step 10: Apply Product Management Techniques
Sometimes, the first idea doesn’t perform when developing new products. For instance, A device initially intended for surgeons can also be altered to be put to use by someone else.
As the business model and product management requirements change, the product must go through the right validation processes to ensure ultimate success.
The first stage in validating a modified product is ensuring that the original plan remains realistic. This requires revisiting the original plan to ensure it can be implemented in the current setting.
Is the design workable in light of the new audience or clientele? Does the current cost of production fit well within the plan?
Some of the questions that must be answered during validation include the ones listed above.
Next, consider the potential risks that using the new product may present.
Is there anything that could go wrong if it were put into place? Is it necessary to resolve any legal or regulatory issues?
If you want to ensure your product is successful in its revised version, the answers to these questions will point you in the right direction.
Step 11: Maintain Communication with Stakeholders Effectively
Throughout the commercialization of a medical device, keeping lines of communication open and cooperating with all relevant parties is crucial.
Unexpected shifts in requirements or external factors jeopardize a project if the team is unable to communicate effectively. Consistent contact between all parties involved in a project is essential for keeping it on track.
This can take the form of daily meetings, weekly reviews, or monthly reports, depending on the project’s size and duration.
Final Words
A company can go through diverse commercialization processes to bring its product to market and make it a profitable business.
However, it’s not really an easy task, as to make a product successful in the market, certain aspects must be taken care of on top of making sure of the product’s quality and innovative features.
While, as a company, you might have innovative ways to commercialize your medical device, it is best if you can follow certain measures while marketing your product so that it can reach people easily and become successful while competing against your competitors.
The aforementioned measures will help a company devise a proper commercialization plan for their medical device and make it do well in the market.
