Bringing Your Medical Device to Market

April 27th, 2016:

Bringing a medical device to market has never been an easy task. However, if proper strategy is followed while keeping in mind all the rules and regulations of governing authorities, then it becomes a reasonably understandable process. Below are the sometimes overlooked steps necessary to ensure the successful launch of your medical device in to the medical market.

Develop Your Overall Strategy

First of all, you need to develop a strategy and plan for your newly launched product. The business strategy must be formed on an overall basis that provides visibility and strategy to the entirety of the process. Taxation issues must be kept in mind and must be solved prior to launch. Then comes the task of managing financial issues and proper orientation of cash flow. Just like a new business, your new medical product will involve hiring employees and working with them so proper contracts and bylaws regarding your employees must be formed. Last but not least, the contracts with the suppliers should be made to ensure the continuous flow of the product in the market. Of course, the issues of trademarks and copyrights must be handled with care as most of the medical products have known to fail due to the establishment of various lawsuits due to copyright and trademark issues.

FDA Regulatory Considerations

After planning and successful strategic based analysis of your product, there comes there comes the step of approving your device from Food and Drug Authority. For that purpose, FDA analysis every medical product prior to launch based on the classification. You can classify your product by using their online tool. Actually, this is the step of the launch which you want to include in your strategy while developing your product. Make sure that your product is according to all FDA considerations which include the pre-launch submission of product (510(K) s) and all the other compatibility standards set by FDA. It is always good to include the risk management in the medical product launch in case the FDA decides to wipe the product from the market. The clinical tries conducted with the help of investigators must also be ensured in order to affirm the approval your medical product for market.

Human Factors Considerations

Human factor considerations are very important for medical products since these are meant to prevent the accidents and patient deaths that may occur due to the personal errors. The main human factors which you should consider while developing and designing your product are listed as follows:

  • Physical and Sensory Characteristics
  • Perceptual and Cognitive Abilities
  • Expectancies
  • Mental Models
  • Home-use factors

Manufacturing Considerations

Stepping from design phase, through development and into the production phase of your product, manufacturing is where the rubber meets the road.  Often, medical product quantities or profit margins can seem favorable to product development, however balancing manufacturing costs with sometimes very costly design and development costs can adversely affect a product’s success.  Manufacturing costs must be carefully considered and DFM practices properly implemented in order to maintain minimum margins and make a program successful.  Additionally the proper manufacturer qualifications also must be considered and certain federal standards met in order for the final product to pass regulatory requirements and make its way to market.  Developing a product with a vendor that does not meet certain regulatory standards can be a costly mistake when, close to the end of a project a new vendor must be selected, tooling transported, or recreated, and designs must be modified to accommodate the capabilities of another vendor.  Choose wisely at the onset of a program and form relationships you can be confident about.

-Timothy Johnson, Principal Mechanical Engineer