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The 12 Steps of Medtech Development Cheat Sheet (DRAFT) by [deleted]

This is a draft cheat sheet. It is a work in progress and is not finished yet.


No matter the medical device or product, no matter how brilliant you know your idea may be, applic­ations of medical devices are specia­lized, and therefore, the chain of events that bring that product or device to market usually follow a well-t­hought out course of action.

Awareness of what needs to get done is the first big step in getting a medical device from concept to comple­tion. This is where experts are brought on board to succes­sfully navigate the process. After all, the goal is not just to create a master­piece; the goal is to have others actually use the device and monetize a brilliant concept.

Spend signif­icant time at the front end of the process discov­ering what the market­place needs, rather than creating a glossy marketing campaign to sell something no one may want. Next, find experts to assist in each process phase. Last, but certainly not least, keep your arms and legs in at all times and enjoy the ride.

1. Identify Worthy Ideas Innova­tions & Inventions

It’s important to have an unders­tanding of the differ­ences between creati­vity, invention, and innova­tion. Creativity is the ability to come up with new ideas or concepts. It has nothing to do with value or monetizing the idea. Innovation is the process where value is created in the form of a new solution to a problem, and occurs when a need is identified and a product is developed to meet that need. Innovators use existing technology in new ways. Invention, on the other hand, involves a filed patent. It results in a better mousetrap and new way of doing something, and is an improv­ement or new idea that must be proven to be different and often superior. Paramount to moving the idea, innova­tion, or invention toward success is rememb­ering that it will not be worth much if nobody wants to buy it. Identi­fying consumer wants and needs, and subseq­uently developing the product or service to meet them, is an initial step that must be completed before moving onto other steps in the process.

2. Patent Research, IP & Develo­pment

This includes resear­ching existing and/or potential compet­ition, as well as patent defense mitiga­tion. The protection of intell­ectual property (IP) is essential to your project. In return, it stimulates medical advances, economic growth, and the introd­uction of new medical devices. You will be better positioned for compen­sation for your contri­bution to the field when the necessary and cautionary steps are taken to secure the concept. Unless you are a knowle­dgeable patent attorney that is able to complete these tasks, it is advisable to find one to advise and help legally and properly bring the concept to fruition. A reputable project developer will have worked with competent patent attorneys and can suggest one if so desired

3. Develop Business Formations

What business name and what type of business entity will you select for your project? Entity options may include a C Corpor­ation, S Corpor­ation, or Limited Liability Corpor­ation (LLC). Both legal and tax advice will help you decide which entity will serve you best.

Medtech Develo­pment Process

12. Taking the Lead

Leadership throughout the develo­pment process, including research and develo­pment, executive and general management of operat­ions, intell­ectual property, regulatory affairs, quality assurance, process engine­ering, and domestic and intern­ational manufa­cturing operations for GMP/ISO medical device manufa­cturers are some of the qualities needed to keep the process afloat. The project developer and project managers will assist in this complexity of organi­zat­ional and management skills, leaving you time to think of your next great idea.

4. Strategic Alliances for Investment Capital

Finding money is almost always one of the first problems that arises. Many investment avenues are available including, but not limited to, angel, private placement, venture capital, bridge, initial secondary public offerings, and family and friends. As in all other aspects of this process, a knowle­dge­able, competent investment advisor may save you time, money, and even the viability of your project.

5. Asset Growth

Create asset growth through identi­fic­ation, develo­pment, and execution of innovative techno­log­y-based products via business plans and strate­gies, and then contin­ually monitor progress.

6. Oversight of Financials

Implement and oversee financial activi­ties, including budgets, accounting systems, and financial reporting. Engaging competent advisors, conducting periodic reviews of the financial status of your company, and mainta­ining proper records will aid you in presenting your company accurately and completely each step of the way.

7. FDA Regist­ration, Regulatory & Compliance

This segment of the process will end your project quickly if you do not dot all of your i’s and cross all of your t’s. It is ongoing throughout your device develo­pment and is an intricate part of every step you take. The first item the FDA looks for in a submission is how the product was developed. Did the developer follow a formal Design Control Process and do they have evidence of compliance with the process? Generally, design controls for medical devices are part of a broader Quality Management System (QMS) for the developing company.

When a U.S. Food and Drug Admini­str­ation (FDA) invest­igator reviews your design control requir­ements, they will evaluate the control process, not determine if the design is approp­riate, safe, or effective. The challenges of incorp­orating the design and develo­pment process into your QMS can be daunting. Since a signif­icant number of medical device recalls are due to design problems, it is advisable for design controls to be in place prior to approval of the system­-level requir­ements document and after completion of the feasib­ility phase.

8. Clinical Trials­/St­udies Project Management

Clinical Trials­/St­udies Project Manage­ment, Execution, and Compliance
Managing clinical trials of any size and complexity requires an expert in this particular field. This portion of the device develo­pment process will have five inherent process stages: initia­ting, planning, executing, monitoring and contro­lling, and analysis and reporting.

Select a trial manager who knows how to include the details of the arrang­ements for developing and monitoring all aspects of the clinical trial, and also possesses the commun­ication skills to keep you up to date.

To select a trial manager that will properly serve you and the specific clinical trial your device or product requires, take care to discover the following attrib­utes.

1 .Qualify the contract research organi­zation (CRO) by visiting the facility and checking out the range of expertise within the CRO. Hold meetings with manage­ment, scient­ists, and quality assurance personnel who would be involved in your trial.
2. Ensure the proposed CRO and selected profes­sionals within that company are capable of doing the kind of work required (device vs. product vs. procedure) and they work well as a team.
3. Conduct an invest­igator meeting where all invest­igators and site staff are informed of the partic­ula­rities of your clinical trial. During this meeting, be sure to provide background inform­ation for the clinical trial, why it is being conducted, and its clinical endpoints. This meeting is intera­ctive in nature, and gives the partic­ipants a chance to ask questions.
4. Since the clinical trial must be supervised by a qualified person, confirm qualif­ica­tions specific to your applicable regula­tions and guidel­ines.

9. Sales, Marketing & Branding

The market for medical devices is not a single channel, but rather a plethora of buyers in various audiences, such as doctors, hospitals, clinics, and consumers. Regardless of the product, it is imperative to get doctors on board with the device. If the medical profes­sionals in your intended marketing space don’t believe the device is effective and/or it is too difficult to use, they won’t use it. And word will spread.

It’s also important to implement a consumer campaign because consumers are going to invest­igate what procedure is right for them, and then ask their doctor about it. If you are lucky enough to find a marketing partner who is well-v­ersed in digital marketing and knowle­dgeable about virtual product tours, you may benefit from their advanced expertise.

10. Design for Manufa­ctu­rab­ility

Paramount to a successful end product is the importance of your device engineer working closely with the manufa­cturer in the design phase. This collab­oration builds value into the product. For example, if design changes can be made to increase production efficiency while meeting the end-use requir­ements, it’s a win-win for all involved. At the end of the day, the product needs to be able to be manufa­ctured in a cost-e­ffe­ctive manner, so design with the end in mind. Some of the many additional consid­era­tions in this develo­pment stage include the enterprise license, reprod­uction, territory, term, termin­ation rights, fees, warranty and discla­imer, infrin­gement indemnity, limitation of liability, assign­abi­lity, and miscel­laneous contract provis­ions.

11. Thinking Ahead

Transa­ctional activi­tie­s—b­usiness sales, mergers, acquis­itions, due diligence, negoti­ations, and implem­ent­ati­on—­should initially be considered at the beginning of the process in terms of a potential exit strategy, and then revisited throughout the product develo­pment process. Sometimes, corporate partnering or strategic alliances are formed at this juncture in order to move the project ahead more effici­ently. By way of defini­tion, corporate partnering is not the same as a strategic alliance, in that a strategic alliance may be shorter in duration, less formal, and/or contain fewer contra­ctual or transa­ctional elements. Your business sales interm­ediary, often a financial advisor, should possess the knowledge and skills needed to execute these activities on your behalf.