Optimizing RFPs for Medical Device Manufacturing

June 2, 2011

by David C. Robson, VP of Development

What’s the most important choice a medical device OEM makes once it decides to build a new product? Considering that most OEM’s use third-party resources to augment their staff and help bring new devices to market, I’d say it’s choosing the right development partner. And choosing the right firm starts with establishing a robust and reliable request for proposal (RFP) process.

n the process of designing and developing medical devices,
the RFP preceeds every step, even Phase 0.

The primary purpose of a RFP is to enable the requesting party (a.k.a. the client) to describe a project’s objectives and deliverables, and have a potential solution provider respond via a detailed proposal. The client will typically distribute an RFP to multiple potential outsource firms to compare their capabilities and costs. The resulting proposal should help answer key questions:

I’ve been thinking recently about the variety of RFPs we’ve received over the years. Some are great: clear and well defined. Some are vague. Some can be a bit myopic or tunnel-visioned. Others don’t provide enough information about the project to make a valid proposal. When I see RFPs that are not well defined and that are open to wide interpretation and variance, I wonder how the client will compare the resulting proposals on an apples-to-apples basis. What will be their measurement and comparison methods?

  • Can the firm take a program successfully through the process with the entire spectrum of work required?
  • Who will be responsible for things like the design control process, the final design history file, the regulatory submission path, the first human-use devices for clinical trials, etc?
  • Does the partner have a breadth of expertise on-site that matches the need and sophistication of the project?
  • Does the potential firm have the ability to close any gaps in the client’s current understanding of the market environment or in user needs?

This is a traditional problem I’ve heard expressed by the client companies. They aren’t getting back proposals that are comparing apples to apples, or even apples to oranges. Rather, they’re getting proposals comparing apples to cheese – they might both be round, but that’s the only similarity (perhaps a poor analogy, I admit, but you get the idea).

At a minimum, a medical device manufacturer’s RFP needs to provide a development firm with enough information to forecast what work must be done and the types of resources required. In turn, that firm should respond with enough detail for the client’s analysis. Ultimately, the RFP should enable the client company to decide which partner may be the best choice and then to hold that partner accountable for what they quoted. If the development firm can legitimately say, “We didn’t know that was what you wanted,” the client company may have a tough time managing the situation.

Based on years of experience in receiving and responding to RFPs, I have developed some guidelines to help client companies make the most informed choice. I often send this guidance out to potential client companies who have requested a proposal without providing much background. The intent in forwarding this type of document to them is to safeguard both parties from potential misunderstanding and heartache. By creating a solid baseline of context and background between each organization, a more accurate work agreement should result. In turn, the risk of becoming misaligned is reduced — not always eliminated perhaps, but reduced. Starting out with the right information will help client companies choose the best partner to speed products to market that are ultimately safe and successful.