Depending on the need to outsource, there are a lot of factors a PM needs to consider when picking a third-party vendor. The PM must consider whether the task at hand is a primary service that the company offers. If not, time should not be wasted on it. The PM must consider if there may be a competitive advantage to do the job at hand in-house. Another thing to consider is how long the job at hand may potentially need outsourcing for so that budgeting can be done wisely. With budgeting at mind, the PM must also calculate all costs and figure out if the the costs of the service lower than what it would take in time and manpower to get it done in-house.

If the outsourced part is critical to the devices specific function, extra communication and scrutiny is required between the project team and the outsourcing company. Not only will the product need to meet all standards set, it will also need to be delivered reliably and on time for production to work. This should probably include a thorough examination of the companies track record, having a proper contractual agreement with the company, and researching alternative sources in case issues arise.

While selecting from a list of vendors the PM needs to keep a number of things in mind :
1. Legal and Regulatory Compliance of the vendor
2. Financial Condition of the company to make sure it can reach the projected goal.
3. Business Experience and Reputation
4. Qualifications, Backgrounds, and Reputations of Company Principals
5. Risk Management Protocols (in case of an incident)

I think that the criticality of the part being outsourced would have a great impact on the degree of background work that is done on a potential vendor. For example a low criticality part may not require as much research into the vendor company as a medium or high criticality product. For a high criticality part, a project manager likely needs to consider first the qualifications of that vendor for that particular part, any compliance or FDA related concerns that may come up, cost of doing business with them, past projects that vendor has worked on for medical devices, and anything else that may come up. For a lower criticality part a larger emphasis may be put on one of those factors such as the cost of working with that vendor; for a lower criticality part a project manager may not be as concerned with factors such as experience or history of the vendor.

As a PM, one of my greatest concerns would be time to prototype and manufacturing timeline. Depending on the equipment available and existing projects at a manufacturing company, the production time for a required part may vary. If the company selected for the outsourced part takes longer than expected for prototyping or manufacturing, it may delay the whole project.

I think the greatest concerns to the PM are quality of the product, time constraints, and cost budgeting. The PM must determine if this particular part can be produced in-house and if so what would the quality be, how much time would it take, and what would be the costs. The manager must then conduct a cost-benefit analysis and determine if its worthwhile to outsource.

One thing to remember is that most if not all companies already have an "Approved Vendor List", or AVL, for all different products and services that your company may need. The companies on the list are audits in some form by your company periodically (ideally) so that when a project appears that needs something that list is there. If the part needed is a critical component for the completion of a product (like an actual component used in the product as opposed to something needed to make/test the prototype) then you will be using that vendor long after the project is completed and the product is launched.
Companies usually have a procedure for adding in a company to the AVL and the AVL is broken down into low medium and high; each with their own set of requirements and rigor for monitoring. In the case mentioned where the service or product is critical to the functioning of the product it would be a high and likely require an auditor to actually visit their manufacturing site (if it is a part or service site if it is a service) and audit the company to ensure they comply to necessary regulatory requirements such as ANSI standards, or IEC etc. If they are registered for complying with the specific standard then that may help the credibility and reliability of the vendor since you don't just want a perfect product once but always.
checking if the vendor has a quality management system QMS will also help with picking the right supplier.
Companies outsource all the time and in many cases, they don't actually "manufacture" a single component of their device and simply assemble the device components.

Medical device companies are in constant pressure to control costs without sacrificing on R&D, with timelines and safety. By outsourcing can lower the operation cost. The project manager should see that the outsourcing shortens the timelines lower the budget and solve the technical issues. The outsourcing should be reliable and the there no exposure of sensitive company information. Managing the communication and management with the outsourcing is important. How much time savings will the outsourcing generate. The standards should be maintained so that the product performs well in the market.

When it comes time for a medical device company to select a supply vendor, many factors must be taken into consideration. Medical devices are not the simplest products as they are expected to carry a lot more risk in their design, therefore its imperative for a PM of a medical device company to hire a supply chain manager (SCM). It is the SCM's responsibility to form a strategic sourcing plan when choosing a vendor to avoid unnecessarily high manufacturing costs while receiving their required supplies in an effective manner. Strategic sourcing differs from standard purchasing by having both parties form a more intricate relationship. This can involve both companies disclosing discrete information to each other in an attempt to develop an efficient long term solution that provides the medical device company with a consistent supply of discounted goods while optimizing profit for the vendor.

The concept of strategic sourcing is primary for a medical device company because of the time constraints that certain medical devices face. For example, a cell-based product intended for infusion requires temperature and time-sensitive cell media, serum, as well as other expensive additives that requires them to be stored and processed in a strict manner. This states that the medical device company must receive these supplies in a timely manner and store them before they risk becoming compromised. Failure to do so can result in high losses, which further emphasizes the importance of acquiring supplies at a cheapened cost by finding ways to further improve the manufacturer-supplier relationship.

Do partnerships between such companies develop quickly, or is it customary for a contract to be made initially? What if the medical device is still in its pre-clinical/clinical phase and is therefore susceptible to change in its design, how can this affect the expectations from a vendor? Are there any capabilities that a PM can make that a SCM cannot towards improving a sustainable supply chain for their product?

Before outsourcing, the project manager should do a cost analysis to determine if doing this inhouse would save time, money, and man power. If not then before outsourcing the project manager should ensure that the company they plan on using has the resources to accomplish the task as well as meets all industry standards. An ISO certification is important because they are certified to be meeting standards and this raises less questions during an audit, as well as ensures that what is being manufactured is good quality and safe. Sometimes the project manager might request the company do a validation of their methods, etc

I would think there are many points to consider when selecting a vendor to outsource a specific aspect of a product. One of the most important factors I believe should be considered is the quality of the product. This includes all of the features that the device or end product will depend on to maintain the design specifications. Some examples of these features may include density, tensile strength, biocompatibility, etc. In addition to providing the quality and features needed to support the end product, the PM would also have to consider the cost of the item, as well as its availability. These factors play a large role in the profit margin of the product.

In my experience working, when looking for another supplier, my team would often send the blueprints to the supplier and ask them to make a small batch, which then we would inspect for the critical dimensions. This way we can validate their process and asses if they would make a good addition to our supplier list. Additionally, we would quote for various batch sizes to gauge what the supplier can handle and what we are looking for. After all these aspects are ready, we regularly audit these suppliers. Audits would frequently happen in the beginning, but as the supplier proves to be effective, audits would become less and less frequent. This process can take a couple of months as manufacturing and inspecting times need to be addressed. However, a small budget is used for this initial review period, often only the amount to pay for a small batch.