Pros and Cons of Outsourcing Medical Device Development
posted 4th August 2021
Arrowfast Medical Device Engineering have shared their latest blog with us, which looks at the pros and cons of outsourcing medical device development.
"While there are many factors that affect whether a MedTech startup succeeds, the question of time is usually one of the biggest. You need to be able to the time to market for your product as much as possible and this becomes difficult if your founding team doesn't already have all the necessary skills to ensure this. Startups cannot afford to spend too much time acquiring skills or learning.
So, as a MedTech entrepreneur, you need to decide whether you are going to focus your efforts getting your startup properly established and funded or in developing and commercialising your product. From our experience, we know that you will eventually start asking yourself questions like:
- How can we reduce our entrepreneurial risk by shortening our time to market?
- Shall we build an internal development team or shall we rely on experienced partners with proven track records?
- Do we outsource or not?
In recent years, outsourcing has become the buzzword in many industries, but is it suitable in MedTech? Also, what should you outsource? In this article, we focus on completely outsourcing your medical device development.
What is outsourcing anyway?
Outsourcing is defined as the assignment of tasks to an external provider. Usually, you would choose to outsource a task if that task is necessary, but is not something you wish to divert focus to. Usually, outsourcing is appropriate for situations that include:
1. When you don't need to accumulate the competence in-house.
2. When you don't want to lose the edge to a competitor, but you don't
currently have the available resources.
3. When you don't have the experience, competence or expertise.
4. When you need to do something once or infrequently.
5. When you need to do something highly specialised, fast.
For example, setting up your quality management system (QMS) is something that you need to do just once. So, if you don't have the time and competence required to set up the QMS, then it is more efficient for you to outsource this task, while still making the final decisions about the system.
Similarly, many companies outsource web-site design and maintenance. While these tasks are not difficult, they do require time, and this means that you will be devoting less time to something else.
But you may also decide to outsource de development of the medical device your start-up will be going to commercialize - you know the market and its needs, the specialists design your product.
Pros of Outsourcing
So, what are the benefits to outsourcing your complete medical device development?
You can get an expert to do the job faster and better.
When you outsource, you target expertise and efficiency. The best outsourcers are specialists in their field with many years of experience, so they will get the job done better and faster. This means you get a higher quality result in a shorter time, thus shortening your time to market.
You don't have to hire more staff.
There are many different aspects to medical device development and hiring all the required staff is a costly undertaking in terms of both finances and time. From the time of deciding that you will hire, you need to write the job ad, advertise the position, screen the applicants, interview and decide on a candidate. Then, each candidate will require some time to acquire specific domain knowledge and it can take quite a while (months to years) before your product development team is actually independently productive.
Outsourcing to medical device development experts means they already have the staff who only need to learn about your product, but otherwise are experts in all aspects of the medical device development process.
You reduce your risk.
When you outsource your medical device development to experts, you reduce your risk because you have competent people working to develop your device, people who have followed the process many times before. They understand the world of medical technology with all its regulations and standards and so can deliver a medical device that not only satisfies your requirements, but which also complies with all regulatory and standards requirements that apply to your target market.
You can focus on securing funds.
The top priority for startups is to ensure that you have enough funding to keep going. By outsourcing your medical device development, you can focus completely on securing funding, safe in the knowledge that your product is still being developed.
You can focus on your domain.
You can devote attention to networking and keep up to date with market research. You have the time to connect with the people who will actually be using your product, e.g. physicians or patients. You can also keep up to date with your competitors.
Your team can still learn.
Your team will still be involved in the medical device development process and this is an opportunity for them to learn about the different aspects of the process thus growing your in-house competence.
Cons of Outsourcing
What are the drawbacks to outsourcing your complete medical device development?
You have to be clear about your requirements.
You must spend time to clearly define what is required and what the criteria for acceptance will be in order to outsource the task of medical device development. If you don't clearly define these, then you have no reference against which to measure the deliverable. This can increase costs and affect delivery deadlines because you will have to request changes.
You have to spend time monitoring progress.
If it is a new outsourcer, you will need to spend more time monitoring their progress. However, this monitoring should not be necessary for trusted outsourcers.
You have less control over resource management.
You have no idea about the actual workload of the company you are outsourcing to. Have they overcommitted and will they be unable to actually deliver on time? How do you confirm that the work is being completed to the level of quality you require? How do you know that your outsourcer gives the necessary priority to your work?
There are also potential problems if you are outsourcing to a large company because there can be changes in staff which affect your project because the new staff member will take time to come up to speed on your project.
You have communication issues.
It may take more time and effort to clearly communicate what you require. There may also be cultural differences which can affect how information is perceived. The more practical problems to communication is just simple time-zone differences.
You have trust concerns.
It takes time to build trust. You're bringing in outsiders to perform a key task.
What happens with the proprietary information when the contract ends? Who owns the work the outsourcer produced? What effort is required for the outsourcer to transfer any competence that the outsourcer has acquired when the contract ends? You need to remember to have all of these covered in your contracts and NDAs with the outsourcer."
If you want to discuss your medical device development project with Arrowfast they can be contacted at info@arrowfast.tech.
Interested in visiting Medical Technology UK 2022?
Let us know HERE and we will inform you as soon as registration opens, later this year.