Starting a Medical Device Company: 4 Development Factors to Consider

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An innovative medical device could save millions of lives, reduce healthcare costs and transform the patient experience. Yet, a few silly mistakes during the design and production stages might prevent a technology from reaching the market or it may result in costly delays.

Unfortunately, a failure to comply with regulatory requirements can signal the end for startup companies and small businesses, as they might not have the capital to recover. Here are four development factors to consider when starting a medical device company.

Medical Device Translations

Poor medical device translations can have serious repercussions for your business. If you fail to provide accurate operation or installation manuals, it could result in device misuse and lead to life-threatening consequences for patients. What’s more, poor medical device translations for various languages could prevent your company from securing approval. For this reason, you must turn to medical transcription services for professional, accurate translations that will help a device receive approval for international markets.

Detailed Product Requirement Specification

Every medical device must have a Product Requirement Specification (PRS), which will detail every aspect of a product. The document is important for a commercial, practical, and regulatory point of view, and an accurate, informative PRS can avoid project delays and ensure a rapid development.

In-House Design and Manufacturing

Prevent obstacles by working with a manufacturing company that both designs and manufactures innovative medical devices. The company will then have a greater understanding of the product from design to development. It will ensure the design engineers can engage with manufacturing engineers and assembly technicians with ease. Plus, designers and engineers can make effective changes when needed, which will be in line with your company’s vision, the established design process and the various regulatory requirements.

Cost Reductions

It is essential to minimize costs as early as possible when designing a medical device. Start by looking for ways to decrease high-cost materials first, which can remove some of the pressure off your bottom line when starting out. 

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Talk to vendors to negotiate price breaks, discuss alternative manufacturing processes, or ask for discounts after securing substantial sales. Even a few dollars off per device could help your business save a significant sum when launching a business or many years down the road.

Also, assess the customer’s perceived value of a device. For example, some medical device companies add barium sulfate into an injected molded piece, as it can increase a handheld device’s perceived value while decreasing costs. Plus, it could help you charge a higher price for a device, which will lead to a much bigger annual profit margin.


The vendors you choose, your translation services and overheads can each impact your company’s success in the medical device industry. Therefore, you must provide accurate translations of every document, contract, or packaging, find ways to lower your manufacturing expenses and ensure you work with an experienced company to enter a market at a fast rate.

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