Make Your Medical Product Ideas Come to Life: A Development Path

An embryo seems to miraculously mature through layers of development. Cellular differentiation, a forming spinal column, organ development, and more, are all necessary for a healthy, vital birth. Just as the developing fetus goes through a myriad of maturation steps, your medical innovation and your company must proceed methodically through multiple tasks. But this business procession is no miracle—it’s plain old work. I would say the adage, “plan your work, and work your plan” is invaluable advice—provided that your plan is well constructed.

Development tasks, and their associated timelines and costs make up the technology’s vital development or commercialization plan; without a commercialization plan, the maturing of your technology will likely stall. Do you have a grasp of the numerous tasks that must be undertaken to get your product to market launch? Truthfully, it can be time consuming and non-trivial process.

The plan is best developed, I believe, through a small team effort. Depending on the kind of innovation, the group could include the inventors, engineers (perhaps mechanical, electrical, and software), other clinicians, scientists, and individuals with prior development experience. But, because a commercialization plan should encompass, for example, technical development, human resources, financial, regulatory, and marketing tasks, your small team may require a range of competencies. For certain topics, like technical development, for example, you would be well-served to have your engineers present, rather than[s2If !is_user_logged_in()]…

[/s2If][s2If is_user_logged_in()] someone with human resources knowledge. However, if you are planning the build out of the executive management team, having the input of a human relations person would be good.

I think the commercialization plan is most useful in the form of a task and timeline, which includes estimated costs. In other words, each task that must be accomplished is listed, along with its estimated starting and completion time. The task and timeline below focuses on the technical development activities for an example medical device.

Development Path

Figure 1: Example timeline. (Click image to enlarge)

Notice how certain tasks must be completed before others are started. In this example, certain development activities occur prior to animal testing, and animal testing occurs prior to submitting for regulatory clearance. In this case, we at least want engineers, those individuals that will be conducting the animal tests, and someone with regulatory experience involved in constructing this task and timeline. While costs do not appear in this example, it is convenient to include them while the team is thinking through the plan specifics. The cost amounts can be transferred to pro-forma (projected) financial spreadsheets for financial planning purposes.

Because the commercialization plan is the “working plan” for the business, this example technical task and timeline is one portion of the whole plan, albeit, a critical portion. Planning could also include elements related to transitioning to manufacturing, market development, strategic contacts, patent filings, fund raising, and hiring of key staff. The commercialization plan is not only a working plan for the business, it is also a source of key, useful information. Let’s look into that next.

Big Ideas: An Article Series
donda Russ Donda is currently serving as the Entrepreneur-in-Residence in the life sciences at the Great Lakes Innovation & Development Enterprise, BioEnterprise and Jumpstart, and as Director of the Office of Community Technology Transfer at LCCC, Russ Donda has more than 25 years of management experience at both executive and entrepreneurial levels. Among other startup projects, Mr. Donda was the founding CEO and chairman of the board for ViewRay Incorporated, (www.viewray.com), a company developing a novel form of radiation therapy. Mr. Donda was a founding member of, and co-chair of investment review for, the Emergent Growth Fund, LLC (www.emergentgrowth.com), an angel investment fund focused on technology businesses; additionally, he was a founding manager of, and spearheaded business development for, the allograft implant company, Regeneration Technologies (www.rtix.com), a privately held, for-profit spinout of The University of Florida Orthopedic Tissue Bank which went public after three years in operation. He is familiar with start-up operations, development related issues, intellectual property management, strategic planning and strategic alliance structuring, and is named as an inventor on 15 patents and applications.

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