There are five general categories of medtech vendor partners. If the end is apparent in the beginning, the correct type of partner will be more apparent.

medical device partner medtech vendors consultants design contract manufacturers

[Image from Pixabay]

Jim Reed, Minnetronix Medical

Stephen Covey gave the business world this mantra in one of his bestsellers: “Start with the end in mind.” Whether they didn’t read the book or simply choose to ignore the advice, many companies enter into discussions with vendors without their end goal in mind. It sets the partnership on an inefficient course from the beginning. If the end results aren’t front and center from the beginning of the vendor selection process, the outcomes may include frustration and misunderstanding.

When looking for a vendor partner to bring a product to life, the choices can be as widespread as 1) a $12 billion global contract manufacturer with 50,000 employees that develops both industrial and consumer products, 2) a mid-sized (roughly 500 employee) integrated developer, manufacturer, and product lifecycle company focused on medtech, or 3) a sharp four-person consulting/engineering design company that’s never developed a medical device.

This bewildering array of options and the complexity of the changing vendor landscape can be a challenge for many companies when selecting a partner. Yet, it is also an opportunity as this breadth of competing vendor solutions means there is an optimal partner type for almost any medical device company’s need. Therefore, the most important first step is clearly defining that need. Then, companies can move to the selection process.

Choosing the wrong type of partner can turn out to be the biggest fundamental mistake of the process. In other words, a company that is fantastic within its category but that also happens to be the wrong kind of partner for a particular project will foretell undesirable outcomes from the very beginning.

Here are the five general categories of medtech vendor-partners, along with their respective features and trade-offs:

1. Individual design consultants

  • Best for quick and rough proof of concepts, early feasibility work, or prototyping when documentation, repeatability, and technical continuity are not required.
  • Individual consultants can build a great technical road to proof-of-concept systems or prototypes but aren’t equipped to drive the project to its destination.

2. Consulting groups

  • Groups of consultants generally provide the same pros and cons as individual consultants but with the ability to tackle projects of greater magnitude.

3. Design and development companies

  • Appropriate for developing simpler products, often for clinical studies only, where manufacturing readiness or regulatory preparedness might be less important.
  • They’re generally more systematic than consulting groups, with a greater diversity of technical experience and depth, with better continuity.
  • Unbiased regarding the selection of the eventual manufacturer.
  • Without in-house manufacturing, no tight post-development feedback loops exist. Design for manufacture (DFM) necessarily lacks in these firms, and resulting designs often require substantial redevelopment or remediation before full commercialization.

4. Contract manufacturers

  • Contract manufacturers (CMs) are a good fit for products where manufacturing at high volumes is the paramount driver.
  • Typically only do development work as a means to secure long-term manufacturing contracts.
  • They’re generally uninterested in technically supporting customers over the long term unless they can drive short- or medium-term manufacturing volume.
  • Sophisticated supply chains.
  • Very solid and methodical if the product is refined and stable.
  • Limited operational flexibility; generally with systems, organizations, and facilities optimized to specific volume levels and process flows. Products or customers that vary from that optimal situation may be problematic. Large CMs, therefore, have to shed customers that are not achieving the originally planned volume in the original time frame.

5. Integrated design, development and manufacturing companies

  • Fit a fairly diverse range of projects and can accommodate customers across multiple phases of their business and product lifecycle and growth.
  • Act as a single partner to take requirements and prototype early and potentially bring clinical units to commercialization.
  • Offer the benefits of a design and development firm as well as those of a contract manufacturer.
  • Tend to be DFM-oriented and systematic in their design and documentation approach.
  • Customers can avoid finger-pointing between developers and manufacturers who may point to each other when issues arise. An integrated partner is unavoidably accountable when issues inevitably arise.
  • The best-integrated partners can also act as a virtual extension of a company’s internal team and Quality Management System (QMS), managing design history files and fielding topic-specific FDA, CE, and diligence audits, are examples.
  • Often poorly suited for very early proof of concept units and early prototyping.

It is common for companies to spend substantial time considering different vendor-partners scattered among the various option types and attempting to compare each to the other.  A more successful approach is to first be very clear on the end goal: Quick prototype? Absolute lowest cost at high volume for products requiring extensive labor?  An integrated lifecycle solution matched to the company’s strategy and current situation?  If the end is clear in the beginning, the correct type of partner will be more apparent. As a result, the subsequent vendor selection process will be efficient, the vendor-partner appropriate, and the probability of success much higher.

Jim Reed is VP and general manager of RF Stimulation and Wearables at Minnetronix Medical (St. Paul, Minn.), which has developed dozens of RF-based medical devices over 25 years. Minnetronix has substantial electroporation-specific capabilities around designing, verifying, and manufacturing different types of reversible and irreversible electroporation electrodes and pulse generators.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.



Source link