When working on an innovative medical device that could potentially save lives, it’s often crucial to get that device to market as quickly as possible. Every day you save in product development is an extra day people who need your device will have access to it. In addition, development timelines impact your company’s competitive advantage — if a competitor releases a similar device before you, they reap the rewards of being the first on the market. Lack of product development experience, overextending timeline and budget, and compliance with industry regulations are just a few reasons why medical devices and products often go over their projected timeline, but many of these issues can be avoided with the proper planning and manufacturing partnerships.
Common Delays in Medical Device Development
While new product development is never easy, medical devices certainly have some extra hoops for manufacturers to jump through. In addition to stringent industry regulations, here are several reasons why new medical devices often get delayed during production:
- Incomplete qualification package. Plain and simple, if you don’t have the necessary regulatory and compliance paperwork completed correctly and with enough lead time to get your final product to market, that could cause serious delay.
- Improper submission to the FDA. Just like the point above, if you don’t properly submit your device to the FDA in a timely fashion, you risk jeopardizing your speed to market because of the review and approval process.
- Not considering supply chain early in the design phase. When it comes to designing plastic products, sourcing raw materials and parts can have a big impact on how early you can start production. If you’re sourcing materials and components from 12 different suppliers, for example, you’ll need all 12 pieces to arrive on time in order to start assembly on time. Consolidating suppliers when you are able allows you to get a jump start and is easier logistically.
- Tooling requirements addressed too late in the design phase. Making plans for one design feature and switching them half-way through is a sure recipe for disaster when you’re trying to meet a strict deadline. Address the necessary design features and tooling requirements needed to meet them upfront, so you don’t have to redo your plans in the middle of the process.
Best Practices for Staying on Time During Product Development
Now that you know what to do to avoid big delays in your medical device development, here are a few things you can proactively do to hit your deadlines:
- Create a realistic timeline based on critical design features. This might sound like a no-brainer, but if you want to stay on top of your product development schedule, start by making a realistic action plan as early as possible. Be honest about what features of your product are critical and which are non-critical, as things like unnecessarily tight tolerances will impact your manufacturability and production time.
- Analyze your competitors. Knowing what your competitors are doing can help your product development team, from sourcing to engineering, set and stick to deadlines so your company can win the race to market. Be vigilant and keep your ears to the ground for any projects that may threaten yours.
- Centralize your company’s data. While the FDA requires you to have a Quality Management System, whether or not that system operates efficiently is up to you. Paper-based systems are still out there, and can cause massive headaches trying to find and share documents versus an all-digital system like a cloud-based ERP that provides access to all your production and quality data on-demand.
- Clearly communicate qualification documentation needs to all manufacturing partners. We mentioned above that incomplete qualification packages are serious causes for delay. Working with vendor partners who know the medical industry and clearly communicating to all of them what documentation is needed from the start, will help ensure you have enough time to submit your qualification package and meet your deadlines for getting the product to market.
- Source suppliers and equipment early in the design process. Critical-use medical devices should not be made by commodity molders or by molders who do not offer DfM support. By choosing a molder who has deep engineering support, ISO 13485 certification, and experience in the medical industry and then involving them early in the design process, you can accelerate your speed to market. The injection molder’s plastics engineers can tell you what you need to know about material selection for harsh environments, as well as how to optimize your part design for moldability and eventual assembly into the final product. If your medical device requires an antimicrobial finish, for example, it’s important you work with your supplier to choose an antimicrobial resin that is compatible with the other materials in your device.
With speed to market being a large factor determining a product’s profitability, knowing how to avoid costly delays can have a tremendous impact on your company’s bottom line. Organize your information, align your products with regulatory standards, and work with suppliers who understand your industry and sense of urgency. If you can do these things, you’ll start to hit your product development deadlines with more regularity.
To gain a further understanding on how partnering with an experienced medical injection molder can impact your next project, read our whitepaper, Complex Injection Molding for a Competitive Advantage in Medical Device Manufacturing. Click the button below to get your copy now!