Should I be outsourcing prototyping services or taking it in-house?

The advantages of outsourcing medical device prototyping

As a product development company, your aim is to design a commercially viable medical device that you can take to market. To achieve this goal, you need to optimize every aspect of your production cycle to ensure an appealing profit margin and consequently the best ROI possible for a financial backer. Outsourcing and using prototyping services suppliers can offer certain benefits. Below are some key aspects to consider when deciding what to outsource.

1 In-house knowledge

Taking a new medical device to market involves innovation. This means that, often, new processes and methodologies will need to be employed. As such, resource requirements will vary from project to project. It can be financially straining to acquire the necessary know-how for each new project you are taking on. It often makes more sense to rely on a third party that possesses the right skillset for the duration of your development cycle.

2 Infrastructure

Technological advances mean manufacturing techniques constantly evolve. For instance, 3D printing has become a viable way of developing specific device components; but not everything can be printed with just one printer model. Why not use prototype services providers that have the latest and most complete printer selection available on a per project basis?

3 Personnel

You need qualified staff to operate your needed infrastructure. But it can be difficult to hire new staff each time you start a new development cycle. It is a costly endeavor, not to mention that it’s difficult to hire staff, who are looking for job security, on a temporary base. Prototyping services providers have their own experienced staff that will work with you for the duration of a project, keeping your payroll expenses in check and allowing your own company’s resources to be used elsewhere.

4 Balance

A development cycle comprises many different aspects, including:

  • Research and development
  • Raw materials procurement
  • Prototyping
  • Mechanical testing
  • Clinical trials
  • Regulatory affairs
  • Market research

Outsourcing design and development can help alleviate the probability of inadequate procedures and, ultimately, keep your time to market within commercially acceptable limits for financial backers. But you mustn’t spread your project out over too many different players, so it’s important to choose the right outsourcing partners.

5 Compliance

In the United States, compliance and market clearance are regulated by the FDA. To take your device to market, you need to submit for premarket approval. The requirements can be difficult and time consuming to navigate, and need to be taken into consideration from early stages of development. This can be an extra drain on your existing resources if you have not partnered with a knowledgeable prototyping services provider that understand the relation between optimal product development and regulatory compliance.

Choosing to outsource

Outsourcing makes sense as using prototyping services, rather than keeping development in-house, simplifies the aspects of your product development outlined in the paragraphs above. By working with third parties, you’ll benefit from expert resources, shorten your development cycle and time to market, keep expenses in check for the duration of your project, and ultimately create a product with a higher profit margin and optimal return of investment. With the right partners, you can focus your resources on developing the best marketing strategy to attract investors and successfully take your product to market.

Technosoft is a prototyping services provider that offers in-house resources and facilities for every aspect of your product development cycle, from raw materials procurement to small-scale production, testing, and clinical trials. We operate with regulatory requirements in mind and can help you prepare for your FDA submissions, such as the 510(k) submission.

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