We cultivate clear thinking to define opportunities and shape outcomes.
THINK. PLAN. DO.
We collect the many requirements
needed to create clear strategies for market success.
We manage the twist and turns of product development, issue-resolution and compliance to keep projects on schedule.
WE MAKE PRODUCT IDEAS COME TO LIFE
OUR MISSION: MEDICAL TECHNOLOGY INNOVATION
Can Do Medical (CDM) is a team of experienced medical professionals that understand how to navigate through the twists and turns of product development and commercialization. Our approach is integrated, transparent, and purposefully designed to harmonize with your company’s processes.
“Think. Plan. Do.” That’s our mantra, and it is important. When you have an opportunity, or a problem, we bring our expertise and experience to help you. From the high level considerations down to the details of execution, our team knows that strategy has to be created with wisdom and then delivered in detail.
LEADING, COACHING, EDUCATING
Regulatory & Compliance
Ideation & Strategy
Operations & Quality
Angelica Domschke, PhD
Science & Commercialization
“Planning is what people do instead of thinking.” - Robertson Davies
Innovation is not easy, markets are not static, and regulations are complex. Sort the puzzle pieces first.
Focused expert sessions and research, using structured innovation tools, to define the ideal product.
Rules change and international requirements conflict – learn how to stay ahead. Executive training nurtures understanding.
STARTUP / INVESTORS
Getting from “Aha!” to patentable ideas that are investment ready is complicated and confusing. Our structured methods make this a lot easier.
“Plans are worthless, but planning is everything.” - USA Army Doctrine
Effective planning connects objectives to strategy, with details and contingencies, and realistic understanding of your operational and financial constraints.
Using our Integrated Parallel Execution tools we ensure that all of the activities from ideation through launch are coordinated and completed.
The Quality Management System should support business objectives, instead of creating costly delays. Let us help you create or refine your QMS.
FDA AND CE MARK SUBMISSIONS
Our team has completed almost 100 FDA & CE approvals with near 100% success. Experience counts when you need to succeed.
“Talk won’t dig a ditch, so grab a shovel.” - Jack Whinery
Launching or maintaining a medical product in the marketplace requires experience and a Can Do attitude.
We provide target support through to complete management of all phases of commercialization, manufacturing changes, and new facility implementations.
VERIFICATION & VALIDATION
Equipment and process V&V, including cleanrooms, sterilization, packaging, shelf life, and IQ/OQ/PQ/EQ studies.
AUDITS & AUDIT PREP
Supply chain, supplier, and vendor audits – or preparing your team for audits by customers, the FDA, or CE issuing bodies.
A FEW PROUD MOMENTS FROM AROUND THE WORLD
MEDICAL COMMERCIALIZATION IS HARD – SOME INSIGHT TO HELP OTHERS
A Few Thoughts about Medical Device Design Control
Everyone that works in product development knows the dreaded words, “design control.” If we set the Wayback machine for 1985 we would find that design controls, as the ISO and FDA expressed them in their first attempts, were developed based on that absurdly inane academic development model called the “cascade” model. I love academics for a lot of […]..read more
Getting from objectives to executing the strategy
To empower a product development team for success, the definition of objectives depend on clear thinking by the responsible executives. To help clarify objectives, we have a few questions that are helpful (and this is by no means an exhaustive list). Are we selecting technologies that expand our capabilities or ones that draw on current strengths? If moving […]..read more
The key role of executive leadership in product development
We are all familiar with the idea that a short time to market is one of the keys to profitability. I own at least five books on fast product development, and there are common themes: tight integration of design, engineering, marketing, and manufacturing; clear communications in a flat structure; and of course, good direction. To pull that off, […]..read more