Developing medical device products is in most ways no different from developing any other kind of product. Therefore, let us first look at the similarities of generic product development and medical device product development.
How medical device product development is similar
Development of any product, whether it is an electromechanical product, a product with electronics, a product with imbedded software, a medical device product, or any other type of product, involves the following necessities:
- Understanding the precise needs of an innovator and the stakeholders
- Recognizing all the constraints of new product development
- Implementing a coherent way of realizing the needs, i.e. creating an effectual new product design after thorough research
- Proving that the product development company has met the needs of realizing a new product, i.e. developing new product prototypes and thereafter finalizing the prototype based on which mass manufacturing can initiate
- Taking the new product to the market
The development of medical device products also faces certain specific challenges, which also affect many companies these days:
- Fierce competition
- Take the new product to global markets
- Shorten development time as well as time to market
How medical device product development is different
The cardinal difference between generic product development and medical device product development is the highly controlled domain in which medical device products are developed, sold, and utilized. From the very early days, the medical industry has been operating within stringent compliance structures. This has repercussions that need to be considered carefully:
- Regulatory agencies always demand proof of compliance, and to make things worse, regulations vary between markets
- Conflicts with regulatory agencies can result in substantial damage
- Product designers need to record and show traceability from the actual user needs through to the delivered products
- Product manufacturers need to have a system set up that ensures consumers’ requests and complaints are managed and resolved
- Everything needs to be recorded / documented and reported
- Ineffective product can cause injury or even loss of life
Safety has always been one cardinal aspect when it comes to the development of new medical device products. In addition, technology, especially software application, is emerging as a crucial differentiator. Medical innovations powered by technology / software application range from the robot-assisted surgery to automation of lab work and reporting of results. The imbedded software has the capability to keep up with rapid product development, because product development companies can add functionality more quickly to a software application, than to the hardware. If the product development company cannot assimilate software into its product fulfillment processes, the time to roll out new products increases. For that reason, it is crucially important to connect software development to product design and other product development processes.
Everyone needs to consider different sets of regulatory requirements when it comes to medical product development. This can get complicated because different regulations are based on different philosophies. Local regulations, for instance, the FDA, are based on results and not on proposing specific activities. Many international standards, however, propose ways of working. For that reason, medical device product manufacturers need to find a balance. It can indeed add more complexity towards maintaining compliance with applicable regulations.
Failure to comply with any of these regulations can result in grave consequences. These can include large fines, shutting down of the company, and even jail.
Best approach to the development of medical device products
As mentioned, medical product development needs absolute adherence to different regulations, pertaining to the medical industry; hence, the best approach to the development of medical device products is to partner with a reputable product development company, like the GID Development Corporation (http://www.gidcompany.com/), that has an extensive experience in the realms of product development for the medical sector.
New product development companies, like the GID Development Corporation, know the severe compliance structures of the medical industry. Complying to those structures, along with using the latest technologies, these product development companies can build medical device products that adhere to all the necessary standards of the medical industry. They have tools and technologies, for instance, Dassault Systèmes’ 3DEXPERIENCE platform, which enable them to create pragmatic product designs and prototypes quickly, accurately, and economically. With these technologies and knowledge, new product development companies not only can realize a product quickly but can also materialize a product that could prove lucrative to the innovators and stakeholders.
Thus, in order to realize new medical device products, innovators should collaborate with product development companies that have enough knowledge about the medical industry. Some companies can even help these innovators take their new medical device products to the local as well as international markets.
Learn more about GID Development Corporation, their engineering procedures, the technologies they use, and how they can help bring a product idea to life, by visiting their website http://www.gidcompany.com/.
You can also Call Jim Grimes at 714-323-1052 between 8:00 AM to 5:00 PM PST for a free consultation.