Keeping the End in Sight: Lessons from the MPO Summit

Teachers know it as “backward planning.”

Contrary to the more traditional mode of chronological tutelage, backward planning is used by educators to design learning experiences and instructional techniques to achieve specific goals. The process begins by envisioning the objectives of a particular course—i.e., the specific information, concept or principle that students are expected to learn—and then proceeding “backward” to create lessons that achieve those desired goals.

“For the past several years, backward planning has moved from a behind-the-scenes process that I used to designed my lessons,” veteran teacher Dave Orphal noted in a blog. “Before, I would backward plan, then guide my students through the lesson from start to finish. Today, I realize that not only is backward planning a good way for me to think about my lessons, it’s also a good way for my students to think about their own work.”

And an effective way to tackle medical device development.

Linda Braddon uses such an approach when helping medtech innovators market their inventions. One of the first questions she asks customers is usually a game-stopper: What is their ultimate goal after securing regulatory clearance?

“Sometimes I get the deer in the headlights look,” said Braddon, president of Secure BioMed Evaluations, a Woodstock, Ga.-based medical device consulting firm focused on risk assessments, design review and mechanical testing. “And I tell them, ‘Nothing will happen if you don’t have a good marketing or commercialization plan.’ I really challenge clients to look at what their goals are after regulatory clearance.”

Addressing a full house of medical device OEMs and contract manufacturers attending the MPO Summit in Park City, Utah, late last month, Braddon outlined her strategy for helping clients navigate the regulatory process and expedite product commercialization. She said most customers fall into one of three buckets: those looking to be acquired by a large organization upon product approval, those who want to run their own medical device firm, and those seeking acquisition upon commercialization.

Clients who want to become part of a larger company (possibly an OEM) upon product approval should have a clean design history file, guard against design creep, attach lot records to every test report to show full traceability to a frozen design/cleared product, draft a “great” business model for device profitability and have a backup plan (perhaps the most important ingredient).
“Let’s face it, the big companies don’t buy a product solely because it’s good for the patient, they buy it because it’s also going to make them money,” Braddon said. “Make sure you have a Plan B. Don’t automatically assume that every large company that wants to discuss your product is ready to invest.”

Aspiring entrepreneurs should be prepared to invest significant time and product in the validation process, and have adequate funding to purchase inventory. Braddon typically advises clients against launching products with a short shelf life because such innovations often can result in time-consuming, costly revamps. She also apprises clients on the challenges of overseas regulatory approval.

“Many of the clients we advise think the golden goose is FDA (U.S. Food and Drug Administration) clearance, and that CE marking is easier to obtain than FDA clearance,” she said. “CE marking is different, not necessarily easier. Going to another country is not easy. CE marking is so much easier—I hear that all the time. Interview your notified bodies; not all of them are created equally. And don’t assume the notified body will hold your hand through the process. Many don’t.”

Executive wannabes also must realize that running a medical device company is more complicated than it seems. A quality system that is compliant with federal regulations and corporate goals is a necessity, as are accurate product design records. Braddon usually tells clients to modify their quality systems as necessary for their respective business models. She also counsels them against “throwing something together” while awaiting FDA approval.

Other factors that new executives must consider when forming/operating their own medtech business include quality system housing and maintenance, risk assessment, product distribution, feedback/complaints, and returns. Plus, clients must determine the kinds of services they want/should outsource and keep in-house.

“A lot of startups want the contract manufacturer to conduct the inspection and figure out what that entails. The inspection should be run off your risk assessment—what is the riskiest part of your device?” Braddon asked. “Remember, it’s not the contract manufacturer that’s going to get a warning letter, it’s medical device company. It’s important to take that seriously.”

Finally, clients seeking acquisition after commercialization should have solid clinical results as well as clean quality/regulatory records associated with their product(s). Most importantly, however, the product should be profitable.

“There’s a lot of dollars available at the end of the process with disruptive technologies because you’ve de-risked it but on the flip side, it takes a lot of dollars to get there,” Braddon noted. “And many of the big guys don’t like to take risks. I have a client that has a disruptive technology … it’s really a rock star in terms of performance. But every big company that has looked at it has been hesitant to back it. They’ve been burned in the past.”

Burned by the lack of backward planning, no doubt.