Medical Device Commercialization 101

PLANNING

Cool technologies are fun but don't, in themselves, make a business. For medical products it’s good to understand your regulatory strategy and make the tradeoffs on labeled claims vs. clinical study effort (cost and time) in your plan.  Certainly durable vs. disposable models and margin considerations are central to a business plan  for most medical devices.  We are glad to prepare a rough estimate of the effort expected to commercialize your product in support of your business model, planning, and fundraising. After you’ve confirmed the potential for market success the fun begins!

Step 1. Define your user needs:
             Be Market Driven and Business Savvy

Market needs have to be defined by folks close to the market. These needs are usually compiled in a Market Requirements Document.  Define ‘What’ is needed and hold off on defining ‘how’ it should be implemented.  E.g.: “The device shall transfer usage data wirelessly to a central database.” is good.  “The device shall connect via Bluetooth 4.0 to a smartphone.” limits options that you may want to consider later in the development process.

For first-of-kind devices, keep in mind that it’s often prudent to test the Market as soon as possible with a bare-bones model that incorporates only the necessary features. You can cost reduce and add nice-to-have features after you demonstrate you have a marketable and profitable device or application.

After you have a pretty clear idea of ‘What’ needs to be developed to support your business plan; it’s time to consider ‘How’ you will go about developing it.

Step 2. Define your Resource Strategy:
             Stress ‘Time to Profit’

Should you build a development team in-house; outsource the entire development effort; or something in between?  It’s a given that you need to move fast.  Start by taking an inventory of the expertise you already have in-house and available and compare it to the expertise you will need.

The focus of your analysis should be “Time to Profit” which takes a holistic view of the commercialization effort and the product lifecycle  in the context of your business model. Three variables will impact your Time to Profit: quality, cost and delivery time. In order to be successful you need to achieve the most optimal quality at the right cost delivered to the market at the right time. From a product lifecycle perspective, you also need to think about the product in the field. For example, product quality issues could be detrimental to your business plan even though you may have met your launch targets.

While most medical devices have a unique and critical aspect that forms the basis for the business case (e.g.; the reagent chemistry for a point of care diagnostic, or the sensors in a monitoring device), the balance of the device often uses a combination of available technologies. A large part of the development effort; perhaps  the graphical user interface (GUI), a cloud database connection, and data acquisition, can be executed more quickly, efficiently, and better by a team that has done it before.

Most companies rightly maintain in-house expertise for the likely patented technologies unique and critical to their products; “the family jewels.”  Commercialization  of technology unique and critical to the company’s offerings can be outsourced to accelerate time to profit.  A plan to capture and retain this IP and know how within your company is critical.

A broad range of skills is necessary to design most medical devices; especially for  devices that are part of an integrated system that include disposables, connectivity, validation and regulatory hurdles.  The demand for many of the engineering specialties is sporadic throughout the development process,  into production and through the sustaining engineering phases of the device lifecycle.  A contracted development team provides the skills you need, when you need them.  A firm that has a track record of success, with a significant full-time staff will likely be there to support you throughout your device life cycle and into your future design projects.

The importance of strong Systems Engineering to provide technical leadership throughout the development process cannot be overstated.  Most of the “Project Rescue™” efforts that Sunrise engages in result from a lack of system-level oversight by deeply technical engineers.

Consider the appeal of a one-stop or all-under-one-roof engineering and contract manufacturing services firm versus the ‘best in breed model.’  While it would be wonderful and convenient to to find the best industrial designer for your device, the best mechanical engineers, the best electronics and software engineers, as well as the best Contract Manufacturer (CM) for your device in one location; the odds are that you compromise somewhere to find these under one roof.

Also consider whether you want to be tied to one CM, before your device is designed.  Executing the design with a team that is not tied to a particular CM gives you the ability to compare the offerings of multiple CM’s.


DESIGN EXECUTION

Step 3. Assemble your Development Team:
             Look for Experience

Follow your resource strategy.  If this includes hiring outside firms; prepare a request for proposal (RFP) that spells out your expected deliverables and timing, attach your Market Requirements and solicit proposals from firms that complement your in-house capabilities and provide the skills and expertise that you need.

Step 4. Identify Risk Areas:
             Mitigate Risk

Technical risks become schedule, budget, and quality risks. Have you demonstrated that your technology is capable of consistently meeting your market requirements? Do you need to employ ‘bleeding edge’ technology to achieve your project goals, and if so - do you understand the risks involved? Your team should address any technology risks head-on with a focused effort before engaging a full team designing a system that may have to change fundamentally.  Have you tested your design concept with the practitioners expected to use your device or application?

Risky Technology + Risky Market Need =
                                     Low probability of success

Human factors and safety related risk investigations, are a critical part of a device's foundation. Note that these are not steps you take only because they are required by the FDA; doing these analyses early will save costly rework down the road and improve chances for success.

Step 5. Derive System Requirements:
             Make Clear What Is to Be Designed

Translate the voice of the customer captured in the market requirements into clearly defined, unambiguous, and testable requirements. These requirements provide development engineers clear directions on what to develop, and when they are done. Testing to these requirements demonstrates that the engineers developed what was asked for. Done properly, you will lay a robust foundation on which development efforts can accelerate without introducing further risk. Done poorly, frustration and rework may stall the effort. Engage experienced system engineers with the judgement to generate the appropriate number and level of system requirements.

Step 6. Architect the Solution:
             Use a System Approach

The architecture shows how mechanical, electrical, software, and other subsystems integrate to solve the design problem.  Make sure to architect the system, including the definition of interfaces, before designing the subsystems for the commercial product.  As with the System Requirements; the architecture is foundational and will affect all aspects of the design that follow; make sure it is done well.  A good architecture addresses: all defined use-cases of the device, all connections internal and external, all critical performance parameters with margin, all known and significant hazards and safety concerns (fail-safe or fault tolerance were appropriate), and maintenance considerations including SW upgrades.

Step 7. Design the Subsystems:
             Implement the Design

Each engineering discipline implements their part of the system. Electronics engineers write electrical requirements as needed and design circuits and printed circuit boards; the software developers generate the appropriate software documentation and write the code, industrial designers create models for the look and feel and define the user interface; the mechanical engineers design the mechanisms and the enclosure parts, and so forth.

Development teams often prefer to develop new products in multiple prototype ‘design-build-test’ cycles. This promotes learning and allows the team to learn what works and iterate to optimize the design before it hits production. Sometimes the early prototypes can be used for testing with end users to get feedback on the design while there is still time to incorporate changes based on the feedback.

Step 8. Verification and Validation:
             Prove the Design Works

Formal verification testing is done to formal test protocols to verify that the design meets its system and subsystem requirements.  This is where the investment made in writing appropriate requirements pays off.

Validation is a field based test, or simulated-use test, to validate that the product developed safely meets the market needs with real end users. This often requires a clinical study, overseen by an investigational review board (IRB).

It’s efficient to have design tools to enable tracing and maintenance of the tracing to requirements, including requirements added to mitigate risks identified during the design and development process.


REGULATORY CLEARANCE & TRANSFER

Step 9. Regulatory Submission:
            Get Clearance or Approval to Ship

In the US, both "510(k) cleared" and "PMA approved" medical devices require the submission of the development dossier referred to as the Design History File or DHF. This contains copies of the evidence that proves to the FDA that the required design controls were followed; including conformance with the appropriate industry standards. This is discussed more below.

For devices that will be distributed in the EU countries device manufacturers need to obtain a CE Mark. The clearance/approval process is different than the FDA’s but still relies heavily on the same international standards to define safety requirements. A report generated by a Registered Body is used to self-declare conformance before medical devices are labeled with a CE mark and marketed in the EU countries.

Other countries have various other means to control distribution of devices in their markets. Fortunately, most countries depend on the same set of international standards at the core of their systems.

Step 10. Transfer to Manufacturing:
               Building the device

The applicable section of the DHF is given to the manufacturing enterprise which in turn generates a Device Master Record (DMR) for each, or covering each device manufactured. Any required tooling is procured and first article parts off of the tools and inspected to the drawings in the DHF/DMR. The development team works with the manufacturer to set up the appropriate in-process tests and possibly calibration steps. The manufacturing processes are validated using installation, operational, and performance qualification testing (IQ, OQ, PQ) and ultimately testing of the final devices, produced in multiple lots, are tested to an acceptance test procedure (ATP).

Attention to DFM (Design for Manufacturing), DFT (Design for Testing) and supply chain considerations earlier in the design phase will ensure this transfer goes smoothly, without late design changes, additional cost and time.

Step 11. Design Maintenance
From time to time in a product’s life cycle manufacturing will need to replace an obsolete part, your customers will request an added feature, or new regulatory requirements will require design modifications.  It’s good to have a team available that knows your design inside and out to address these issues and in some cases turn them into opportunities.  Choose established partners that will be available to support your complete product life-cycle.From time to time in a product’s life cycle manufacturing will need to replace an obsolete part, your customers will request an added feature, or new regulatory requirements will require design modifications.  It’s good to have a team available that knows your design inside and out to address these issues and in some cases turn them into opportunities.  Choose established partners that will be available to support your complete product life-cycle. 

To see how Sunrise can dig in and apply its resources and help turn your concept into a commercial product; expeditiously and effectively, click here...